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8152019 Revision sobre formas farmaceuticas nuevas
kinetics along with controlled release and well established safety
and biocompatibility Synthesis methods for Lupron Depotreg micro-
particles must be highly reproducible and consistent in order to main-tain ef 1047297cacy across patients Indeed the encapsulation of proteins and
peptides in PLGA particles has proven challenging in general as is
maintaining protein stability in microparticles [12] Lupron Depotreg
and in general all microparticle protein formulations face these
same challenges Further the production process of PLGA polymer de-
termines product performance and different suppliers may not have
identical procedures which ties down drug companies to speci1047297c sup-
plier(s) A variety of reasons ranging from supplier shut down to the
high material costs may pose a manufacturing challenge for
microparticles
23 Lessons learned from Lupron Depotreg mdash current academic research
As one of the 1047297rst clinically and commercially successful peptidedelivery microparticle depot DDS in the US Lupron Depotreg inspired
not only polymeric depot DDS but also nanoparticle DDS in general
Lupron Depotreg is a perfect example of a polymeric controlled delivery
system that improves patient compliance by offering long-acting and
long-lasting alternatives to highly invasive (ie daily injections) thera-
pies Since the introduction of Lupron Depotreg researchers have ad-
vanced the technology of sustained protein-release microparticles in
various ways including new methods for improving the stability and
protection of encapsulated proteins [1314]
24 Current clinical landscape and future prospects
Many other microparticle depot systems are in clinical use and have
been approved by the FDA (Table 2) One example is Nutropin Depotregdeveloped by Genentech and Alkermes the 1047297rst long-acting formula-
tion for recombinant growthhormoneNutropinDepotreg is a biodegrad-
able microparticle depot formulation that was approved by the FDA in
1999 for pediatric growth hormone de1047297ciency Nutropin Depotreg per-
formed well in preclinical studies showing reliable delivery for over
one month in monkeys [15] In clinical trials Nutropin Depotreg showed
Table 1
Routes of administration Advantages disadvantages potential targets and examples of the most commonly used routes of administration for drug delivery The number of top 100
commercial drugs and their route of administration were determined by counting the best selling drugs in 2013 as determined by Drugscom [155]
Route of
administration
Advantages Disadvantages Targets Examples Number of top 100
commercial drugs
Injections
IV IM and SQ
bull Rapid onset (IV)
bull U p to 100 bioavailability
bull Controlled depot release (IM SQ)
bull Suitable for most therapeutic molecules
bull Dif 1047297cult for patient to self-administer (IV)
bull Patients fear of needles leads to noncompliance
bull Higher instance of infection
bull Tissue with
blood access (IV)
bull Systemic
bull Vaccines (IM)
bull Chemotherapy
(IV)
bull Insulin (SQ)
42
Oral bull Patient compliant and most convenient bull Poor bioavailability
bull Generally nontargeted
bull Not viable for larger therapeutics (peptidesproteins)
bull Potentially inconsistent due to the presence of food
bull Systemic bull Pills
bull Liquid
medications
54
Inhalation bull Direct target to the lungs
bull Fast absorption
bull Inconsistent delivery stemming from variation in
patient-to-patient technique
bull Lungs
bull Brain
bull Systemic
bull Inhalers
bull Anesthetics
7
Transdermal bull Less side-effects due to direct delivery
to the skin
bull Bypasses 1047297rst-pass degradation
bull Patients can potentially use incorrect dose (creams)
bull Absorption dependent on skin condition and location
bull Skin
bull Systemic
bull Patches
bull Creams
4
16 AC Anselmo S Mitragotri Journal of Controlled Release 190 (2014) 15ndash 28
8152019 Revision sobre formas farmaceuticas nuevas
[1] M Kermode Unsafe injections in low-income country health settings need forinjection safety promotion to prevent the spread of blood-borne viruses HealthPromot Int 19 (1) (2004) 95ndash103
[2] M Goldberg I Gomez-Orellana Challenges for the oral delivery of macromole-cules Nat Rev Drug Discov 2 (4) (2003) 289ndash295
[3] JS Patton PR ByronInhalingmedicinesdelivering drugs to thebodythroughthelungs Nat Rev Drug Discov 6 (1) (2007) 67ndash74
[4] MR Prausnitz R Langer Transdermal drug delivery Nat Biotechnol 26 (11)(2008) 1261ndash1268
[5] R Gaudana et al Ocular drug delivery AAPS J 12 (3) (2010) 348ndash360[6] L Illum Nasal drug deliverynew developments andstrategiesDrugDiscov Today
7 (23) (2002) 1184ndash1189[7] JE Talmadge The pharmaceutics and delivery of therapeutic polypeptides and
proteins Adv Drug Deliv Rev 10 (2) (1993) 247ndash299[8] RLanger Controlledrelease of a therapeuticproteinNat Med 2 (7)(1996)742ndash743[9] R Langer J Folkman Polymers for the sustained release of proteins and other
macromolecules Nature 263 (5580) (1976) 797ndash800[10] JC Wright AS Hoffman Historical overview of long acting injections and
implants Long Acting Injections and Implants Springer 2012 pp 11ndash24[11] M Chaubal Polylactidesglycolidesmdashexcipients for injectable drug delivery and
beyond Drug Deliv Technol 2 (2002) 34ndash36[12] G Zhu SR Mallery SP Schwendeman Stabilization of proteins encapsulated in
injectable poly (lactide-co-glycolide) Nat Biotechnol 18 (1) (2000) 52ndash57[13] V Sinha A Trehan Biodegradable microspheres for protein delivery J Control
Release 90 (3) (2003) 261ndash280[14] M van de Weert WE Hennink W Jiskoot Protein instability in poly (lactic-co-
glycolic acid) microparticles Pharm Res 17 (10) (2000) 1159ndash1167[15] OL Johnson et al A month-longeffect froma single injection of microencapsulated
human growth hormone Nat Med 2 (7) (1996) 795ndash799[16] W Jianget al Biodegradable poly(lactic-co-glycolic acid) microparticles for inject-
able delivery of vaccine antigens Adv Drug Deliv Rev 57 (3) (2005) 391 ndash410[17] F Jordan et al Sustained release hGH microsphere formulation produced by a
novel supercritical 1047298uid technology in vivo studies J Control Release 141 (2)(2010) 153ndash160
[18] MA Tracy Development and scale-up of a microsphere protein delivery systemBiotechnol Prog 14 (1) (1998) 108ndash115
[20] Johnson amp Johnson Annual Report 2012 (February 9 2014) Available fromhttpswwwjnjcomsitesdefault 1047297lespdfJNJ2012annualreportpdf
[21] TM Allen PR Cullis Drug delivery systems entering themainstreamScience303(5665) (2004) 1818ndash1822
[22] T Allen A Chonn Large unilamellar liposomes with low uptake into the reticulo-endothelial system FEBS Lett 223 (1) (1987) 42ndash46
[23] Y Matsumura H Maeda A new concept for macromolecular therapeuticsin cancer chemotherapy mechanism of tumoritropic accumulation of
proteins and the antitumor agent smancs Cancer Res 46 (12 Part 1) (1986)6387ndash6392[24] G Haran et al Transmembrane ammonium sulfate gradients in liposomes
produce ef 1047297cient and stable entrapment of amphipathic weak bases BiochimBiophys Acta (BBA)mdashBiomembr 1151 (2) (1993) 201ndash215
[25] AT Horowitz Y Barenholz AA Gabizon In vitro cytotoxicity of liposome-encapsulated doxorubicin dependence on liposome composition anddrug release Biochim Biophys Acta (BBA)mdashBiomembr 1109 (2) (1992)203ndash209
[26] AA Gabizon Y Barenholz M Bialer Prolongation of the circulation time of doxo-rubicin encapsulated in liposomes containing a polyethylene glycol-derivatizedphospholipid pharmacokinetic studies in rodents and dogs Pharm Res 10 (5)(1993) 703ndash708
[27] A Gabizon et al Prolonged circulation time and enhanced accumulation in malig-nant exudates of doxorubicin encapsulated in polyethylene-glycol coated lipo-somes Cancer Res 54 (4) (1994) 987ndash992
[28] H Maedaet alTumorvascularpermeabilityand theEPR effectin macromoleculartherapeutics a review J Control Release 65 (1) (2000) 271ndash284
[29] Important Update Regarding Supply Outage of DOXILreg Available from http
wwwdoxilcomdoxil-supply-shortage February 9 2014[30] D Peer et al Nanocarriers as an emerging platform for cancer therapy Nat
Nanotechnol 2 (12) (2007) 751ndash760[31] E Ruoslahti Peptides as targeting elements and tissue penetration devices for
nanoparticles Adv Mater 24 (28) (2012) 3747ndash3756[32] PL Rodriguez et al Minimal ldquoself rdquo peptides that inhibit phagocytic clearance and
enhance delivery of nanoparticles Science 339 (6122) (2013) 971ndash975[33] SM Moghimi AC Hunter JC Murray Long-circulating and target-speci1047297c
nanoparticles theory to practice Pharmacol Rev 53 (2) (2001) 283ndash318[34] JP Rolland et al Direct fabrication and harvesting of monodisperse shape-
speci1047297c nanobiomaterials J Am Chem Soc 127 (28) (2005) 10096ndash10100[35] SW Morton et al Scalable manufacture of built-to-order nanomedicine spray-
assisted layer-by-layer functionalization of PRINT nanoparticles Adv Mater 25(34) (2013) 4707ndash4713
[36] M Ferrari Cancer nanotechnology opportunities and challenges Nat Rev Cancer5 (3) (2005) 161ndash171
[37] WJ Gradishar et al Phase III trial of nanoparticle albumin-bound paclitaxel com-pared with polyethylated castor oil-based paclitaxel in women with breast cancer
J Clin Oncol 23 (31) (2005) 7794ndash7803
[38] M Green et al Abraxanereg a novel Cremophorreg-free albumin-bound particleform of paclitaxel for the treatment of advanced non-small-cell lung cancer AnnOncol 17 (8) (2006) 1263ndash1268
[39] DW Nymanet alPhaseI andpharmacokinetics trial of ABI-007 a novel nanopar-ticle formulation of paclitaxel in patients with advanced nonhematologic malig-nancies J Clin Oncol 23 (31) (2005) 7785ndash7793
[40] Celgene Corporation Announces 2014 Financial Outlook and Preliminary 2013Results (February 9 2014) Available from httpircelgenecomreleasedetailcfmReleaseID=821044
[41] J Hrkach et al Preclinical development and clinical translation of a PSMA-targeteddocetaxel nanoparticle with a differentiated pharmacological pro1047297le Sci Transl
Med 4 (128) (2012) 128ra39[42] S Svenson et al Preclinical to clinical development of the novel camptothecin
nanopharmaceutical CRLX101 J Control Release 153 (1) (2011) 49ndash55[43] S Eliasof et al Correlating preclinical animal studies and human clinical trials of a
multifunctional polymeric nanoparticle Proc Natl Acad Sci U S A 110 (37)(2013) 15127ndash15132
[44] ME Davis et al Evidence of RNAi in humans from systemically administeredsiRNA via targeted nanoparticles Nature 464 (7291) (2010) 1067ndash1070
[45] AZ Wang R Langer OC Farokhzad Nanoparticle delivery of cancer drugs AnnuRev Med 63 (2012) 185ndash198
[46] Y Matsumura K Kataoka Preclinical and clinical studies of anticancer agent-incorporating polymer micelles Cancer Sci 100 (4) (2009) 572ndash579
[47] JD Heidel ME Davis Clinical developments in nanotechnology for cancer thera-py Pharm Res 28 (2) (2011) 187ndash199
[48] B D alby et al Advanced transfection with Lipofectamine 2000 reagent primaryneurons siRNAand high-throughput applicationsMethods 33 (2) (2004)95ndash103
[49] S Venkatraman R Gale Skin adhesives and skin adhesion 1 Transdermal drugdelivery systems Biomaterials 19 (13) (1998) 1119ndash1136
[50] AC Watkinson A commentary on transdermal drug delivery systems in clinicaltrials J Pharm Sci 102 (9) (2013) 3082ndash3088
[51] TH Stanley Fentanyl J Pain Symptom Manage 29 (5 Suppl) (2005) S67ndashS71[52] TH Stanley The history and development of the fentanyl series J Pain Symptom
Manage 7 (3 Suppl) (1992) S3ndashS7[53] Lidoderm Sales Data (February 9 2014) Available from httpwwwdrugscom
statslidoderm[54] S Mitragotri Healingsound theuse of ultrasoundin drug delivery andotherther-
apeutic applications Nat Rev Drug Discov 4 (3) (2005) 255ndash260[55] P Karande A Jain S Mitragotri Insights into synergistic interactions in binary
mixtures of chemical permeation enhancers for transdermal drug delivery J Control Release 115 (1) (2006) 85ndash93
[56] MR Prausnitz Microneedles for transdermal drug delivery Adv Drug Deliv Rev56 (5) (2004) 581ndash587
[57] YN Kalia et al Iontophoretic drug delivery Adv Drug Deliv Rev 56 (5) (2004)619ndash658
[58] P Karande A Jain S Mitragotri Discovery of transdermal penetration enhancersby high-throughput screening Nat Biotechnol 22 (2) (2004) 192ndash197
[59] MA Ashburn et al Iontophoretic delivery of morphinefor postoperative analgesia
J Pain Symptom Manage 7 (1) (1992) 27ndash
33[60] R van der Geest et al Iontophoretic delivery of apomorphine II An in vivo studyin patients with Parkinsons disease Pharm Res 14 (12) (1997) 1804ndash1810
[61] M Cormier et al Effect of transdermal iontophoresis codelivery of hydrocortisoneon metoclopramide pharmacokinetics and skin-induced reactions in humansubjects J Pharm Sci 88 (10) (1999) 1030ndash1035
[62] MP James RM Graham J English Percutaneous iontophoresis of prednisolonemdashapharmacokinetic study Clin Exp Dermatol 11 (1) (1986) 54ndash61
[63] PG Green Iontophoretic delivery of peptide drugs J Control Release 41 (1)(1996) 33ndash48
[64] EL Spierings JA Brevard NP Katz Two‐minute skin anesthesia through ultra-sound pretreatment and iontophoretic delivery of a topical anesthetic a feasibilitystudy Pain Med 9 (1) (2008) 55ndash59
[65] P SantoiannI M Nino G Calabro Intradermal Drug Delivery by Low FrequencySonophoresis (25 kHz) 2004
[66] BE Polat et al Ultrasound-mediated transdermal drug delivery mechanismsscope and emerging trends J Control Release 152 (3) (2011) 330ndash348
[67] JJ Norman et al Faster pharmacokinetics and increased patient acceptance of intradermal insulin delivery using a single hollow microneedle in children and
adolescents with type 1 diabetes Pediatr Diabetes 14 (6) (2013) 459 ndash465[68] J Gupta EI Felner MR Prausnitz Rapid pharmacokinetics of intradermal insulin
administered using microneedles in type 1 diabetes subjects Diabetes TechnolTher 13 (4) (2011) 451ndash456
[69] J Gupta EI Felner MR Prausnitz Minimally invasive insulin delivery in subjectswith type 1 diabetes using hollow microneedles Diabetes Technol Ther 11 (6)(2009) 329ndash337
[70] J Gupta et al Rapid local anesthesia in humans using minimally invasivemicroneedles Clin J Pain 28 (2) (2012) 129ndash135
[72] M Ameri SC Fan YF Maa Parathyroid hormone PTH(1ndash34) formulation thatenables uniform coating on a novel transdermal microprojection delivery systemPharm Res 27 (2) (2010) 303ndash313
[73] PE Daddona et al Parathyroid hormone (1ndash34)-coated microneedle patchsystem clinical pharmacokinetics and pharmacodynamics for treatment of osteo-porosis Pharm Res 28 (1) (2011) 159ndash165
[74] A Arora MR Prausnitz S Mitragotri Micro-scale devices for transdermal drugdelivery Int J Pharm 364 (2) (2008) 227ndash236
26 AC Anselmo S Mitragotri Journal of Controlled Release 190 (2014) 15ndash 28
8152019 Revision sobre formas farmaceuticas nuevas
[75] S Mayes M Ferrone Fentanyl HCl patient-controlled iontophoretic transdermalsystem for the management of acute postoperative pain Ann Pharmacother 40(12) (2006) 2178ndash2186
[76] WT Zempsky et al Evaluation of a low-dose lidocaine iontophoresis system fortopical anesthesia in adults and children a randomized controlled trial ClinTher 26 (7) (2004) 1110ndash1119
[77] BM Becker et al Ultrasound with topical anesthetic rapidly decreases pain of intravenous cannulation Acad Emerg Med 12 (4) (2005) 289ndash295
[78] SK Vashist Non-invasive glucose monitoring technology in diabetes managementa review Anal Chim Acta 750 (2012) 16ndash27
[79] H Chuang et al Pilot studies of transdermal continuous glucose measurement
in outpatient diabetic patients and in patients during and after cardiac surgery J Diabetes Sci Technol 2 (4) (2008) 595ndash602[80] S Rose JF Nelson A continuous long-term injector Aust J Exp Biol Med Sci 33
(4) (1955) 415ndash419[81] F Theeuwes Elementary osmotic pump J Pharm Sci 64 (12) (1975) 1987ndash1991[82] V Malaterre et al Oral osmotically driven systems 30 years of development and
clinical use Eur J Pharm Biopharm 73 (3) (2009) 311ndash323[83] E Rosenthal The Soaring Cost of a Simple Breath (February 9 2014) Published
October 12 2013] Available from httpwwwnytimescom20131013usthe-soaring-cost-of-a-simple-breathhtml_r=0
[84] F Theeuwes Orososmotic system development Drug Dev Ind Pharm 9 (7)(1983) 1331ndash1357
[85] CG Park et al A nano1047297brous sheet-based system for linear delivery of nifedipine J Control Release 149 (3) (2011) 250ndash257
[86] DM Bass M Prevo DS Waxman Gastrointestinal safety of an extended-releasenondeformable oral dosage form (OROS) a retrospective study Drug Saf 25(14) (2002) 1021ndash1033
[87] GA Agyilirah GS Banker Polymers for Enteric Coating Applications Polymers forControlled Drug Delivery CRC Press Boca Raton 1991 39ndash66
[88] G Ponchel J-M Irache Speci1047297c and non-speci1047297c bioadhesive particulate systemsfor oral delivery to the gastrointestinal tract Adv Drug Deliv Rev 34 (2) (1998)191ndash219
[89] M Morishita NA Peppas Is the oral route possible for peptide and protein drugdelivery Drug Discov Today 11 (19) (2006) 905ndash910
[90] A Bernkop-Schnuumlrch The use of inhibitory agents to overcome the enzymatic bar-rier to perorally administered therapeuticpeptides and proteins J Control Release52 (1) (1998) 1ndash16
[91] LM Ensign R Cone J HanesOral drug delivery with polymeric nanoparticles thegastrointestinal mucus barriers Adv Drug Deliv Rev 64 (6) (2012) 557ndash570
[92] E Mathiowitz et al Biologically erodable microspheres as potential oral drugdelivery systems Nature 386 (6623) (1997) 410ndash414
[93] V Gupta et alMucoadhesiveintestinaldevices fororal delivery of salmon calcitonin J Control Release 172 (3) (2013) 753ndash762
[95] PW Swaan Recent advances in intestinal macromolecular drug delivery viareceptor-mediated transport pathways Pharm Res 15 (6) (1998) 826ndash834
[96] R Eldor et al Glucose-reducing effect of the ORMD-0801 oral insulin preparationin patients with uncontrolled type 1 diabetes a pilot study PLoS One 8 (4) (2013)e59524
[97] TheEligenreg Library(February9 2014) Available from httpwwwemispherecom eligen_libraryhtml
[98] MC Castelli et al Comparing the ef 1047297cacy and tolerability of a new daily oral vita-min B12 formulation and intermittent intramuscular vitamin B12 in normalizinglow cobalamin levels a randomized open-label parallel-group study Clin Ther33 (3) (2011) 358ndash371 (e2)
[99] K Whitehead Z Shen S Mitragotri Oraldelivery of macromoleculesusing intestinalpatches applications for insulin delivery J Control Release 98 (1) (2004) 37ndash45
[100] EM Pridgen et al Transepithelial transport of fc-targeted nanoparticles by theneonatal fc receptor for oral delivery Sci Transl Med 5 (213) (2013) 213ra167
[101] M Torres‐Lugo et al pH‐sensitive hydrogels as gastrointestinal tract absorptionenhancers transport mechanisms of salmoncalcitoninand other modelmoleculesusing the Caco‐2 cell model Biotechnol Prog 18 (3) (2002) 612ndash616
[102] M Torres-Lugo et al Physicochemical behavior and cytotoxic effects of p (methacrylic acidndashg-ethylene glycol) nanospheres for oral delivery of proteins
J Control Release 80 (1) (2002) 197ndash
205[103] RU Agu et alThe lung as a route forsystemicdeliveryof therapeuticproteins and
peptides Respir Res 2 (4) (2001) 198[104] R Dalby J Suman Inhalation therapy technological milestones in asthma treat-
ment Adv Drug Deliv Rev 55 (7) (2003) 779ndash791[105] PJ Anderson History of aerosol therapy liquid nebulization to MDIs to DPIs
Respir Care 50 (9) (2005) 1139ndash1150[106] JB Fink BK Rubin Problems with inhaler use a call for improved clinician and
patient education Respir Care 50 (10) (2005) 1360ndash1375[107] MJ Telko AJ Hickey Dry powder inhaler formulation Respir Care 50 (9) (2005)
1209ndash1227[108] DAEdwardsA Ben-Jebria R Langer Recentadvances in pulmonary drug delivery
using large porous inhaled particles J Appl Physiol 85 (2) (1998) 379ndash385[109] MB DolovichR DhandAerosol drug deliverydevelopments in devicedesign and
clinical use Lancet 377 (9770) (2011) 1032ndash1045[110] A Hussain et al Absorption enhancers in pulmonary protein delivery J Control
Release 94 (1) (2004) 15ndash24[111] J L Cleland A Daugherty R Mrsny Emerging protein delivery methods Curr
Opin Biotechnol 12 (2) (2001) 212ndash219
[112] JS Patton J Bukar S Nagarajan Inhaled insulin Adv Drug Deliv Rev 35 (2ndash3)(1999) 235ndash247
[113] FDA to Complete Phase-out of Chloro1047298uorocarbon Inhalers (February 9 2014Published October 23 2013) Available from httpwwwfdagovnewsevents newsroompressannouncementsucm371901htm
[114] Drug Treatments for Asthma and Chronic Obstructive Pulmonary Disease ThatDo Not Use Chloro1047298uorocarbons (February 9 2014) Available from http wwwfdagovDrugsDrugSafetyInformationbyDrugClassucm082370htm
[115] AJ Hickey Back to the future inhaled drug products J Pharm Sci 102 (4) (2013)1165ndash1172
[116] S White et al EXUBERA pharmaceutical development of a novel product for
906[117] T Quattrin et al Ef 1047297cacy and safety of inhaled insulin (Exubera) compared withsubcutaneous insulin therapy in patients with type 1 diabetes results of a 6-month randomized comparative trial Diabetes Care 27 (11) (2004) 2622ndash2627
[118] PA Hollander etal Ef 1047297cacyand safety of inhaled insulin (exubera)comparedwithsubcutaneousinsulin therapy in patients with type 2 diabetesresults of a 6-monthrandomized comparative trial Diabetes Care 27 (10) (2004) 2356ndash2362
[119] C Black et al The clinical effectiveness and cost-effectiveness of inhaled insulin indiabetes mellitus a systematic review and economic evaluation Health TechnolAssess 11 (33) (2007) 1ndash126
[120] A Opar Another blowfor inhaled protein therapeutics Nat Rev Drug Discov 7 (3)(2008) 189ndash190
[121] J Kling Dreamboat sinks prospects for fast approval of inhaled insulin NatBiotechnol 29 (3) (2011) 175ndash176
[122] Press Releases MannKind Reports Positive Data from a Phase 3 Clinical Study of AFREZZA in Patients with Type 1 Diabetes (February 9 2014 Published August14 2013) Available from httpwwwnewsmannkindcorpcomphoenixzhtmlc=147953ampp=irol-newsArticleampID=1847441amphighlight=
[123] Available from httpwwwcivitastherapeuticscomCVT-301html
[124] Cardeas Pharma Announces that FDA Grants QIDP Designation and Fast TrackReview for the Companys Antibiotic Combination Product (February 9 2014Published January 8 2014) Available from httpcardeaspharmacom press-releasescardeas-pharma-announces-that-fda-grants-qidp-designation-and-fast-track-review-for-the-companys-antibiotic-combination-product
[125] M Staples et al Application of micro- and nano-electromechanical devices todrug delivery Pharm Res 23 (5) (2006) 847ndash863
[126] TJ Smith et al Intravitreal sustained-release ganciclovir Arch Ophthalmol 110(2) (1992) 255ndash258
[127] GE Sanborn et al Sustained-release ganciclovir therapy for treatment of cyto-megalovirus retinitis Use of an intravitreal device Arch Ophthalmol 110 (2)(1992) 188ndash195
[128] G Velez SM Whitcup New developments in sustained release drug deliveryfor the treatment of intraocular disease Br J Ophthalmol 83 (11) (1999)1225ndash1229
[129] DH Geroski HF Edelhauser Drug delivery for posterior segment eye diseaseInvest Ophthalmol Vis Sci 41 (5) (2000) 961ndash964
[130] DC Musch et al Treatment of cytomegalovirus retinitis with a sustained-releaseganciclovir implant The Ganciclovir Implant Study Group N Engl J Med 337 (2)(1997) 83ndash90
[131] CL Stevenson JT Santini Jr R Langer Reservoir-based drug delivery systemsutilizing microtechnology Adv Drug Deliv Rev 64 (14) (2012) 1590ndash1602
[132] RA Receveur FW Lindemans NF de Rooij Microsystem technologies forimplantable applications J Micromech Microeng 17 (5) (2007) R50
[133] AC Richards Grayson et al Electronic MEMS for triggered delivery Adv DrugDeliv Rev 56 (2) (2004) 173ndash184
[134] HowOzurdex(R) Works(March11 2014) Available fromhttpwwwozurdexcom HowItWorksaspx
[135] A Giese et al Pattern of recurrencefollowinglocal chemotherapy with biodegrad-able carmustine (BCNU) implants in patients with glioblastoma J Neurooncol 66(3) (2004) 351ndash360
[136] EL Weber EA Goebel Cerebral edema associated with Gliadel wafers two casestudies Neuro Oncol 7 (1) (2005) 84ndash89
[137] JT Santini Jr MJ Cima R Langer A controlled-release microchip Nature 397(6717) (1999) 335ndash338
[138] R Farra et al First-in-human testing of a wirelessly controlled drug deliverymicrochip Sci Transl Med 4 (122) (2012) 122ra21
[139] B Hughes Antibodyndash
drug conjugates for cancer poised to deliver Nat Rev DrugDiscov 9 (9) (2010) 665ndash667
[140] JR Junutula et al Site-speci1047297c conjugation of a cytotoxic drug to an antibodyimproves the therapeutic index Nat Biotechnol 26 (8) (2008) 925ndash932
[141] S Verma et al Trastuzumab emtansinefor HER2-positive advanced breast cancerN Engl J Med 367 (19) (2012) 1783ndash1791
[142] ImmunoGen Inc Reports First Quarter Fiscal Year 2014 Financial Results andProvides Quarterly Update (February 9 2014 Published October 25 2013) Avail-able from httpinvestorimmunogencomreleasedetailcfmReleaseID=800370
[143] P Chames et al Therapeutic antibodies successes limit ations and hopes for thefuture Br J Pharmacol 157 (2) (2009) 220ndash233
[144] CF McDonagh et al Engineered antibodyndashdrugconjugateswith de1047297ned sites andstoichiometries of drug attachment Protein Eng Des Sel 19 (7) (2006) 299ndash307
[145] JY Axup et al Synthesis of site-speci1047297c antibodyndashdrug conjugates using unnatu-ral amino acids Proc Natl Acad Sci U S A 109 (40) (2012) 16101ndash16106
[146] SCAlleyNM Okeley PD Senter Antibodyndashdrug conjugates targeted drug deliveryfor cancer Curr Opin Chem Biol 14 (4) (2010) 529ndash537
[147] JM Lambert Drug-conjugated antibodies for the treatment of cancer Br J ClinPharmacol 76 (2) (2013) 248ndash262
27 AC Anselmo S Mitragotri Journal of Controlled Release 190 (2014) 15ndash 28
8152019 Revision sobre formas farmaceuticas nuevas
[149] A Younes et al Brentuximab vedotin (SGN-35) for relapsed CD30-positive lym-phomas N Engl J Med 363 (19) (2010) 1812ndash1821
[150] RS Zolot S Basu RP Million Antibodyndashdrugconjugates Nat Rev Drug Discov12(4) (2013) 259ndash260
[151] FDA P1047297zer Voluntarily Withdraws Cancer Treatment Mylotarg from US Market(February 9 2014 Published June 21 2010) Available from httpwwwfdagov NewsEventsNewsroomPressAnnouncementsucm216448htm
[152] AM Wu PD Senter Arming antibodies prospects and challenges forimmunoconjugates Nat Biotechnol 23 (9) (2005) 1137ndash1146
[153] AK Burnett et al The addition of gemtuzumab ozogamicin to intensive chemo-therapy in older patients with AML produces a signi1047297cant improvement in overallsurvival results of the UK NCRI AML16 randomizedtrial Blood 2011 (AMER SOCHEMATOLOGY 1900 M STREET NW SUITE 200 WASHINGTON DC 20036 USA)
[154] R Langer A personal account of translating discoveries in an academic lab NatBiotechnol 31 (6) (2013) 487ndash489
[155] US Pharmaceutical Sales mdash 2013 (January 17 2014) Available from httpwwwdrugscomstatstop1002013sales
28 AC Anselmo S Mitragotri Journal of Controlled Release 190 (2014) 15ndash 28
8152019 Revision sobre formas farmaceuticas nuevas
kinetics along with controlled release and well established safety
and biocompatibility Synthesis methods for Lupron Depotreg micro-
particles must be highly reproducible and consistent in order to main-tain ef 1047297cacy across patients Indeed the encapsulation of proteins and
peptides in PLGA particles has proven challenging in general as is
maintaining protein stability in microparticles [12] Lupron Depotreg
and in general all microparticle protein formulations face these
same challenges Further the production process of PLGA polymer de-
termines product performance and different suppliers may not have
identical procedures which ties down drug companies to speci1047297c sup-
plier(s) A variety of reasons ranging from supplier shut down to the
high material costs may pose a manufacturing challenge for
microparticles
23 Lessons learned from Lupron Depotreg mdash current academic research
As one of the 1047297rst clinically and commercially successful peptidedelivery microparticle depot DDS in the US Lupron Depotreg inspired
not only polymeric depot DDS but also nanoparticle DDS in general
Lupron Depotreg is a perfect example of a polymeric controlled delivery
system that improves patient compliance by offering long-acting and
long-lasting alternatives to highly invasive (ie daily injections) thera-
pies Since the introduction of Lupron Depotreg researchers have ad-
vanced the technology of sustained protein-release microparticles in
various ways including new methods for improving the stability and
protection of encapsulated proteins [1314]
24 Current clinical landscape and future prospects
Many other microparticle depot systems are in clinical use and have
been approved by the FDA (Table 2) One example is Nutropin Depotregdeveloped by Genentech and Alkermes the 1047297rst long-acting formula-
tion for recombinant growthhormoneNutropinDepotreg is a biodegrad-
able microparticle depot formulation that was approved by the FDA in
1999 for pediatric growth hormone de1047297ciency Nutropin Depotreg per-
formed well in preclinical studies showing reliable delivery for over
one month in monkeys [15] In clinical trials Nutropin Depotreg showed
Table 1
Routes of administration Advantages disadvantages potential targets and examples of the most commonly used routes of administration for drug delivery The number of top 100
commercial drugs and their route of administration were determined by counting the best selling drugs in 2013 as determined by Drugscom [155]
Route of
administration
Advantages Disadvantages Targets Examples Number of top 100
commercial drugs
Injections
IV IM and SQ
bull Rapid onset (IV)
bull U p to 100 bioavailability
bull Controlled depot release (IM SQ)
bull Suitable for most therapeutic molecules
bull Dif 1047297cult for patient to self-administer (IV)
bull Patients fear of needles leads to noncompliance
bull Higher instance of infection
bull Tissue with
blood access (IV)
bull Systemic
bull Vaccines (IM)
bull Chemotherapy
(IV)
bull Insulin (SQ)
42
Oral bull Patient compliant and most convenient bull Poor bioavailability
bull Generally nontargeted
bull Not viable for larger therapeutics (peptidesproteins)
bull Potentially inconsistent due to the presence of food
bull Systemic bull Pills
bull Liquid
medications
54
Inhalation bull Direct target to the lungs
bull Fast absorption
bull Inconsistent delivery stemming from variation in
patient-to-patient technique
bull Lungs
bull Brain
bull Systemic
bull Inhalers
bull Anesthetics
7
Transdermal bull Less side-effects due to direct delivery
to the skin
bull Bypasses 1047297rst-pass degradation
bull Patients can potentially use incorrect dose (creams)
bull Absorption dependent on skin condition and location
bull Skin
bull Systemic
bull Patches
bull Creams
4
16 AC Anselmo S Mitragotri Journal of Controlled Release 190 (2014) 15ndash 28
8152019 Revision sobre formas farmaceuticas nuevas
[1] M Kermode Unsafe injections in low-income country health settings need forinjection safety promotion to prevent the spread of blood-borne viruses HealthPromot Int 19 (1) (2004) 95ndash103
[2] M Goldberg I Gomez-Orellana Challenges for the oral delivery of macromole-cules Nat Rev Drug Discov 2 (4) (2003) 289ndash295
[3] JS Patton PR ByronInhalingmedicinesdelivering drugs to thebodythroughthelungs Nat Rev Drug Discov 6 (1) (2007) 67ndash74
[4] MR Prausnitz R Langer Transdermal drug delivery Nat Biotechnol 26 (11)(2008) 1261ndash1268
[5] R Gaudana et al Ocular drug delivery AAPS J 12 (3) (2010) 348ndash360[6] L Illum Nasal drug deliverynew developments andstrategiesDrugDiscov Today
7 (23) (2002) 1184ndash1189[7] JE Talmadge The pharmaceutics and delivery of therapeutic polypeptides and
proteins Adv Drug Deliv Rev 10 (2) (1993) 247ndash299[8] RLanger Controlledrelease of a therapeuticproteinNat Med 2 (7)(1996)742ndash743[9] R Langer J Folkman Polymers for the sustained release of proteins and other
macromolecules Nature 263 (5580) (1976) 797ndash800[10] JC Wright AS Hoffman Historical overview of long acting injections and
implants Long Acting Injections and Implants Springer 2012 pp 11ndash24[11] M Chaubal Polylactidesglycolidesmdashexcipients for injectable drug delivery and
beyond Drug Deliv Technol 2 (2002) 34ndash36[12] G Zhu SR Mallery SP Schwendeman Stabilization of proteins encapsulated in
injectable poly (lactide-co-glycolide) Nat Biotechnol 18 (1) (2000) 52ndash57[13] V Sinha A Trehan Biodegradable microspheres for protein delivery J Control
Release 90 (3) (2003) 261ndash280[14] M van de Weert WE Hennink W Jiskoot Protein instability in poly (lactic-co-
glycolic acid) microparticles Pharm Res 17 (10) (2000) 1159ndash1167[15] OL Johnson et al A month-longeffect froma single injection of microencapsulated
human growth hormone Nat Med 2 (7) (1996) 795ndash799[16] W Jianget al Biodegradable poly(lactic-co-glycolic acid) microparticles for inject-
able delivery of vaccine antigens Adv Drug Deliv Rev 57 (3) (2005) 391 ndash410[17] F Jordan et al Sustained release hGH microsphere formulation produced by a
novel supercritical 1047298uid technology in vivo studies J Control Release 141 (2)(2010) 153ndash160
[18] MA Tracy Development and scale-up of a microsphere protein delivery systemBiotechnol Prog 14 (1) (1998) 108ndash115
[20] Johnson amp Johnson Annual Report 2012 (February 9 2014) Available fromhttpswwwjnjcomsitesdefault 1047297lespdfJNJ2012annualreportpdf
[21] TM Allen PR Cullis Drug delivery systems entering themainstreamScience303(5665) (2004) 1818ndash1822
[22] T Allen A Chonn Large unilamellar liposomes with low uptake into the reticulo-endothelial system FEBS Lett 223 (1) (1987) 42ndash46
[23] Y Matsumura H Maeda A new concept for macromolecular therapeuticsin cancer chemotherapy mechanism of tumoritropic accumulation of
proteins and the antitumor agent smancs Cancer Res 46 (12 Part 1) (1986)6387ndash6392[24] G Haran et al Transmembrane ammonium sulfate gradients in liposomes
produce ef 1047297cient and stable entrapment of amphipathic weak bases BiochimBiophys Acta (BBA)mdashBiomembr 1151 (2) (1993) 201ndash215
[25] AT Horowitz Y Barenholz AA Gabizon In vitro cytotoxicity of liposome-encapsulated doxorubicin dependence on liposome composition anddrug release Biochim Biophys Acta (BBA)mdashBiomembr 1109 (2) (1992)203ndash209
[26] AA Gabizon Y Barenholz M Bialer Prolongation of the circulation time of doxo-rubicin encapsulated in liposomes containing a polyethylene glycol-derivatizedphospholipid pharmacokinetic studies in rodents and dogs Pharm Res 10 (5)(1993) 703ndash708
[27] A Gabizon et al Prolonged circulation time and enhanced accumulation in malig-nant exudates of doxorubicin encapsulated in polyethylene-glycol coated lipo-somes Cancer Res 54 (4) (1994) 987ndash992
[28] H Maedaet alTumorvascularpermeabilityand theEPR effectin macromoleculartherapeutics a review J Control Release 65 (1) (2000) 271ndash284
[29] Important Update Regarding Supply Outage of DOXILreg Available from http
wwwdoxilcomdoxil-supply-shortage February 9 2014[30] D Peer et al Nanocarriers as an emerging platform for cancer therapy Nat
Nanotechnol 2 (12) (2007) 751ndash760[31] E Ruoslahti Peptides as targeting elements and tissue penetration devices for
nanoparticles Adv Mater 24 (28) (2012) 3747ndash3756[32] PL Rodriguez et al Minimal ldquoself rdquo peptides that inhibit phagocytic clearance and
enhance delivery of nanoparticles Science 339 (6122) (2013) 971ndash975[33] SM Moghimi AC Hunter JC Murray Long-circulating and target-speci1047297c
nanoparticles theory to practice Pharmacol Rev 53 (2) (2001) 283ndash318[34] JP Rolland et al Direct fabrication and harvesting of monodisperse shape-
speci1047297c nanobiomaterials J Am Chem Soc 127 (28) (2005) 10096ndash10100[35] SW Morton et al Scalable manufacture of built-to-order nanomedicine spray-
assisted layer-by-layer functionalization of PRINT nanoparticles Adv Mater 25(34) (2013) 4707ndash4713
[36] M Ferrari Cancer nanotechnology opportunities and challenges Nat Rev Cancer5 (3) (2005) 161ndash171
[37] WJ Gradishar et al Phase III trial of nanoparticle albumin-bound paclitaxel com-pared with polyethylated castor oil-based paclitaxel in women with breast cancer
J Clin Oncol 23 (31) (2005) 7794ndash7803
[38] M Green et al Abraxanereg a novel Cremophorreg-free albumin-bound particleform of paclitaxel for the treatment of advanced non-small-cell lung cancer AnnOncol 17 (8) (2006) 1263ndash1268
[39] DW Nymanet alPhaseI andpharmacokinetics trial of ABI-007 a novel nanopar-ticle formulation of paclitaxel in patients with advanced nonhematologic malig-nancies J Clin Oncol 23 (31) (2005) 7785ndash7793
[40] Celgene Corporation Announces 2014 Financial Outlook and Preliminary 2013Results (February 9 2014) Available from httpircelgenecomreleasedetailcfmReleaseID=821044
[41] J Hrkach et al Preclinical development and clinical translation of a PSMA-targeteddocetaxel nanoparticle with a differentiated pharmacological pro1047297le Sci Transl
Med 4 (128) (2012) 128ra39[42] S Svenson et al Preclinical to clinical development of the novel camptothecin
nanopharmaceutical CRLX101 J Control Release 153 (1) (2011) 49ndash55[43] S Eliasof et al Correlating preclinical animal studies and human clinical trials of a
multifunctional polymeric nanoparticle Proc Natl Acad Sci U S A 110 (37)(2013) 15127ndash15132
[44] ME Davis et al Evidence of RNAi in humans from systemically administeredsiRNA via targeted nanoparticles Nature 464 (7291) (2010) 1067ndash1070
[45] AZ Wang R Langer OC Farokhzad Nanoparticle delivery of cancer drugs AnnuRev Med 63 (2012) 185ndash198
[46] Y Matsumura K Kataoka Preclinical and clinical studies of anticancer agent-incorporating polymer micelles Cancer Sci 100 (4) (2009) 572ndash579
[47] JD Heidel ME Davis Clinical developments in nanotechnology for cancer thera-py Pharm Res 28 (2) (2011) 187ndash199
[48] B D alby et al Advanced transfection with Lipofectamine 2000 reagent primaryneurons siRNAand high-throughput applicationsMethods 33 (2) (2004)95ndash103
[49] S Venkatraman R Gale Skin adhesives and skin adhesion 1 Transdermal drugdelivery systems Biomaterials 19 (13) (1998) 1119ndash1136
[50] AC Watkinson A commentary on transdermal drug delivery systems in clinicaltrials J Pharm Sci 102 (9) (2013) 3082ndash3088
[51] TH Stanley Fentanyl J Pain Symptom Manage 29 (5 Suppl) (2005) S67ndashS71[52] TH Stanley The history and development of the fentanyl series J Pain Symptom
Manage 7 (3 Suppl) (1992) S3ndashS7[53] Lidoderm Sales Data (February 9 2014) Available from httpwwwdrugscom
statslidoderm[54] S Mitragotri Healingsound theuse of ultrasoundin drug delivery andotherther-
apeutic applications Nat Rev Drug Discov 4 (3) (2005) 255ndash260[55] P Karande A Jain S Mitragotri Insights into synergistic interactions in binary
mixtures of chemical permeation enhancers for transdermal drug delivery J Control Release 115 (1) (2006) 85ndash93
[56] MR Prausnitz Microneedles for transdermal drug delivery Adv Drug Deliv Rev56 (5) (2004) 581ndash587
[57] YN Kalia et al Iontophoretic drug delivery Adv Drug Deliv Rev 56 (5) (2004)619ndash658
[58] P Karande A Jain S Mitragotri Discovery of transdermal penetration enhancersby high-throughput screening Nat Biotechnol 22 (2) (2004) 192ndash197
[59] MA Ashburn et al Iontophoretic delivery of morphinefor postoperative analgesia
J Pain Symptom Manage 7 (1) (1992) 27ndash
33[60] R van der Geest et al Iontophoretic delivery of apomorphine II An in vivo studyin patients with Parkinsons disease Pharm Res 14 (12) (1997) 1804ndash1810
[61] M Cormier et al Effect of transdermal iontophoresis codelivery of hydrocortisoneon metoclopramide pharmacokinetics and skin-induced reactions in humansubjects J Pharm Sci 88 (10) (1999) 1030ndash1035
[62] MP James RM Graham J English Percutaneous iontophoresis of prednisolonemdashapharmacokinetic study Clin Exp Dermatol 11 (1) (1986) 54ndash61
[63] PG Green Iontophoretic delivery of peptide drugs J Control Release 41 (1)(1996) 33ndash48
[64] EL Spierings JA Brevard NP Katz Two‐minute skin anesthesia through ultra-sound pretreatment and iontophoretic delivery of a topical anesthetic a feasibilitystudy Pain Med 9 (1) (2008) 55ndash59
[65] P SantoiannI M Nino G Calabro Intradermal Drug Delivery by Low FrequencySonophoresis (25 kHz) 2004
[66] BE Polat et al Ultrasound-mediated transdermal drug delivery mechanismsscope and emerging trends J Control Release 152 (3) (2011) 330ndash348
[67] JJ Norman et al Faster pharmacokinetics and increased patient acceptance of intradermal insulin delivery using a single hollow microneedle in children and
adolescents with type 1 diabetes Pediatr Diabetes 14 (6) (2013) 459 ndash465[68] J Gupta EI Felner MR Prausnitz Rapid pharmacokinetics of intradermal insulin
administered using microneedles in type 1 diabetes subjects Diabetes TechnolTher 13 (4) (2011) 451ndash456
[69] J Gupta EI Felner MR Prausnitz Minimally invasive insulin delivery in subjectswith type 1 diabetes using hollow microneedles Diabetes Technol Ther 11 (6)(2009) 329ndash337
[70] J Gupta et al Rapid local anesthesia in humans using minimally invasivemicroneedles Clin J Pain 28 (2) (2012) 129ndash135
[72] M Ameri SC Fan YF Maa Parathyroid hormone PTH(1ndash34) formulation thatenables uniform coating on a novel transdermal microprojection delivery systemPharm Res 27 (2) (2010) 303ndash313
[73] PE Daddona et al Parathyroid hormone (1ndash34)-coated microneedle patchsystem clinical pharmacokinetics and pharmacodynamics for treatment of osteo-porosis Pharm Res 28 (1) (2011) 159ndash165
[74] A Arora MR Prausnitz S Mitragotri Micro-scale devices for transdermal drugdelivery Int J Pharm 364 (2) (2008) 227ndash236
26 AC Anselmo S Mitragotri Journal of Controlled Release 190 (2014) 15ndash 28
8152019 Revision sobre formas farmaceuticas nuevas
[75] S Mayes M Ferrone Fentanyl HCl patient-controlled iontophoretic transdermalsystem for the management of acute postoperative pain Ann Pharmacother 40(12) (2006) 2178ndash2186
[76] WT Zempsky et al Evaluation of a low-dose lidocaine iontophoresis system fortopical anesthesia in adults and children a randomized controlled trial ClinTher 26 (7) (2004) 1110ndash1119
[77] BM Becker et al Ultrasound with topical anesthetic rapidly decreases pain of intravenous cannulation Acad Emerg Med 12 (4) (2005) 289ndash295
[78] SK Vashist Non-invasive glucose monitoring technology in diabetes managementa review Anal Chim Acta 750 (2012) 16ndash27
[79] H Chuang et al Pilot studies of transdermal continuous glucose measurement
in outpatient diabetic patients and in patients during and after cardiac surgery J Diabetes Sci Technol 2 (4) (2008) 595ndash602[80] S Rose JF Nelson A continuous long-term injector Aust J Exp Biol Med Sci 33
(4) (1955) 415ndash419[81] F Theeuwes Elementary osmotic pump J Pharm Sci 64 (12) (1975) 1987ndash1991[82] V Malaterre et al Oral osmotically driven systems 30 years of development and
clinical use Eur J Pharm Biopharm 73 (3) (2009) 311ndash323[83] E Rosenthal The Soaring Cost of a Simple Breath (February 9 2014) Published
October 12 2013] Available from httpwwwnytimescom20131013usthe-soaring-cost-of-a-simple-breathhtml_r=0
[84] F Theeuwes Orososmotic system development Drug Dev Ind Pharm 9 (7)(1983) 1331ndash1357
[85] CG Park et al A nano1047297brous sheet-based system for linear delivery of nifedipine J Control Release 149 (3) (2011) 250ndash257
[86] DM Bass M Prevo DS Waxman Gastrointestinal safety of an extended-releasenondeformable oral dosage form (OROS) a retrospective study Drug Saf 25(14) (2002) 1021ndash1033
[87] GA Agyilirah GS Banker Polymers for Enteric Coating Applications Polymers forControlled Drug Delivery CRC Press Boca Raton 1991 39ndash66
[88] G Ponchel J-M Irache Speci1047297c and non-speci1047297c bioadhesive particulate systemsfor oral delivery to the gastrointestinal tract Adv Drug Deliv Rev 34 (2) (1998)191ndash219
[89] M Morishita NA Peppas Is the oral route possible for peptide and protein drugdelivery Drug Discov Today 11 (19) (2006) 905ndash910
[90] A Bernkop-Schnuumlrch The use of inhibitory agents to overcome the enzymatic bar-rier to perorally administered therapeuticpeptides and proteins J Control Release52 (1) (1998) 1ndash16
[91] LM Ensign R Cone J HanesOral drug delivery with polymeric nanoparticles thegastrointestinal mucus barriers Adv Drug Deliv Rev 64 (6) (2012) 557ndash570
[92] E Mathiowitz et al Biologically erodable microspheres as potential oral drugdelivery systems Nature 386 (6623) (1997) 410ndash414
[93] V Gupta et alMucoadhesiveintestinaldevices fororal delivery of salmon calcitonin J Control Release 172 (3) (2013) 753ndash762
[95] PW Swaan Recent advances in intestinal macromolecular drug delivery viareceptor-mediated transport pathways Pharm Res 15 (6) (1998) 826ndash834
[96] R Eldor et al Glucose-reducing effect of the ORMD-0801 oral insulin preparationin patients with uncontrolled type 1 diabetes a pilot study PLoS One 8 (4) (2013)e59524
[97] TheEligenreg Library(February9 2014) Available from httpwwwemispherecom eligen_libraryhtml
[98] MC Castelli et al Comparing the ef 1047297cacy and tolerability of a new daily oral vita-min B12 formulation and intermittent intramuscular vitamin B12 in normalizinglow cobalamin levels a randomized open-label parallel-group study Clin Ther33 (3) (2011) 358ndash371 (e2)
[99] K Whitehead Z Shen S Mitragotri Oraldelivery of macromoleculesusing intestinalpatches applications for insulin delivery J Control Release 98 (1) (2004) 37ndash45
[100] EM Pridgen et al Transepithelial transport of fc-targeted nanoparticles by theneonatal fc receptor for oral delivery Sci Transl Med 5 (213) (2013) 213ra167
[101] M Torres‐Lugo et al pH‐sensitive hydrogels as gastrointestinal tract absorptionenhancers transport mechanisms of salmoncalcitoninand other modelmoleculesusing the Caco‐2 cell model Biotechnol Prog 18 (3) (2002) 612ndash616
[102] M Torres-Lugo et al Physicochemical behavior and cytotoxic effects of p (methacrylic acidndashg-ethylene glycol) nanospheres for oral delivery of proteins
J Control Release 80 (1) (2002) 197ndash
205[103] RU Agu et alThe lung as a route forsystemicdeliveryof therapeuticproteins and
peptides Respir Res 2 (4) (2001) 198[104] R Dalby J Suman Inhalation therapy technological milestones in asthma treat-
ment Adv Drug Deliv Rev 55 (7) (2003) 779ndash791[105] PJ Anderson History of aerosol therapy liquid nebulization to MDIs to DPIs
Respir Care 50 (9) (2005) 1139ndash1150[106] JB Fink BK Rubin Problems with inhaler use a call for improved clinician and
patient education Respir Care 50 (10) (2005) 1360ndash1375[107] MJ Telko AJ Hickey Dry powder inhaler formulation Respir Care 50 (9) (2005)
1209ndash1227[108] DAEdwardsA Ben-Jebria R Langer Recentadvances in pulmonary drug delivery
using large porous inhaled particles J Appl Physiol 85 (2) (1998) 379ndash385[109] MB DolovichR DhandAerosol drug deliverydevelopments in devicedesign and
clinical use Lancet 377 (9770) (2011) 1032ndash1045[110] A Hussain et al Absorption enhancers in pulmonary protein delivery J Control
Release 94 (1) (2004) 15ndash24[111] J L Cleland A Daugherty R Mrsny Emerging protein delivery methods Curr
Opin Biotechnol 12 (2) (2001) 212ndash219
[112] JS Patton J Bukar S Nagarajan Inhaled insulin Adv Drug Deliv Rev 35 (2ndash3)(1999) 235ndash247
[113] FDA to Complete Phase-out of Chloro1047298uorocarbon Inhalers (February 9 2014Published October 23 2013) Available from httpwwwfdagovnewsevents newsroompressannouncementsucm371901htm
[114] Drug Treatments for Asthma and Chronic Obstructive Pulmonary Disease ThatDo Not Use Chloro1047298uorocarbons (February 9 2014) Available from http wwwfdagovDrugsDrugSafetyInformationbyDrugClassucm082370htm
[115] AJ Hickey Back to the future inhaled drug products J Pharm Sci 102 (4) (2013)1165ndash1172
[116] S White et al EXUBERA pharmaceutical development of a novel product for
906[117] T Quattrin et al Ef 1047297cacy and safety of inhaled insulin (Exubera) compared withsubcutaneous insulin therapy in patients with type 1 diabetes results of a 6-month randomized comparative trial Diabetes Care 27 (11) (2004) 2622ndash2627
[118] PA Hollander etal Ef 1047297cacyand safety of inhaled insulin (exubera)comparedwithsubcutaneousinsulin therapy in patients with type 2 diabetesresults of a 6-monthrandomized comparative trial Diabetes Care 27 (10) (2004) 2356ndash2362
[119] C Black et al The clinical effectiveness and cost-effectiveness of inhaled insulin indiabetes mellitus a systematic review and economic evaluation Health TechnolAssess 11 (33) (2007) 1ndash126
[120] A Opar Another blowfor inhaled protein therapeutics Nat Rev Drug Discov 7 (3)(2008) 189ndash190
[121] J Kling Dreamboat sinks prospects for fast approval of inhaled insulin NatBiotechnol 29 (3) (2011) 175ndash176
[122] Press Releases MannKind Reports Positive Data from a Phase 3 Clinical Study of AFREZZA in Patients with Type 1 Diabetes (February 9 2014 Published August14 2013) Available from httpwwwnewsmannkindcorpcomphoenixzhtmlc=147953ampp=irol-newsArticleampID=1847441amphighlight=
[123] Available from httpwwwcivitastherapeuticscomCVT-301html
[124] Cardeas Pharma Announces that FDA Grants QIDP Designation and Fast TrackReview for the Companys Antibiotic Combination Product (February 9 2014Published January 8 2014) Available from httpcardeaspharmacom press-releasescardeas-pharma-announces-that-fda-grants-qidp-designation-and-fast-track-review-for-the-companys-antibiotic-combination-product
[125] M Staples et al Application of micro- and nano-electromechanical devices todrug delivery Pharm Res 23 (5) (2006) 847ndash863
[126] TJ Smith et al Intravitreal sustained-release ganciclovir Arch Ophthalmol 110(2) (1992) 255ndash258
[127] GE Sanborn et al Sustained-release ganciclovir therapy for treatment of cyto-megalovirus retinitis Use of an intravitreal device Arch Ophthalmol 110 (2)(1992) 188ndash195
[128] G Velez SM Whitcup New developments in sustained release drug deliveryfor the treatment of intraocular disease Br J Ophthalmol 83 (11) (1999)1225ndash1229
[129] DH Geroski HF Edelhauser Drug delivery for posterior segment eye diseaseInvest Ophthalmol Vis Sci 41 (5) (2000) 961ndash964
[130] DC Musch et al Treatment of cytomegalovirus retinitis with a sustained-releaseganciclovir implant The Ganciclovir Implant Study Group N Engl J Med 337 (2)(1997) 83ndash90
[131] CL Stevenson JT Santini Jr R Langer Reservoir-based drug delivery systemsutilizing microtechnology Adv Drug Deliv Rev 64 (14) (2012) 1590ndash1602
[132] RA Receveur FW Lindemans NF de Rooij Microsystem technologies forimplantable applications J Micromech Microeng 17 (5) (2007) R50
[133] AC Richards Grayson et al Electronic MEMS for triggered delivery Adv DrugDeliv Rev 56 (2) (2004) 173ndash184
[134] HowOzurdex(R) Works(March11 2014) Available fromhttpwwwozurdexcom HowItWorksaspx
[135] A Giese et al Pattern of recurrencefollowinglocal chemotherapy with biodegrad-able carmustine (BCNU) implants in patients with glioblastoma J Neurooncol 66(3) (2004) 351ndash360
[136] EL Weber EA Goebel Cerebral edema associated with Gliadel wafers two casestudies Neuro Oncol 7 (1) (2005) 84ndash89
[137] JT Santini Jr MJ Cima R Langer A controlled-release microchip Nature 397(6717) (1999) 335ndash338
[138] R Farra et al First-in-human testing of a wirelessly controlled drug deliverymicrochip Sci Transl Med 4 (122) (2012) 122ra21
[139] B Hughes Antibodyndash
drug conjugates for cancer poised to deliver Nat Rev DrugDiscov 9 (9) (2010) 665ndash667
[140] JR Junutula et al Site-speci1047297c conjugation of a cytotoxic drug to an antibodyimproves the therapeutic index Nat Biotechnol 26 (8) (2008) 925ndash932
[141] S Verma et al Trastuzumab emtansinefor HER2-positive advanced breast cancerN Engl J Med 367 (19) (2012) 1783ndash1791
[142] ImmunoGen Inc Reports First Quarter Fiscal Year 2014 Financial Results andProvides Quarterly Update (February 9 2014 Published October 25 2013) Avail-able from httpinvestorimmunogencomreleasedetailcfmReleaseID=800370
[143] P Chames et al Therapeutic antibodies successes limit ations and hopes for thefuture Br J Pharmacol 157 (2) (2009) 220ndash233
[144] CF McDonagh et al Engineered antibodyndashdrugconjugateswith de1047297ned sites andstoichiometries of drug attachment Protein Eng Des Sel 19 (7) (2006) 299ndash307
[145] JY Axup et al Synthesis of site-speci1047297c antibodyndashdrug conjugates using unnatu-ral amino acids Proc Natl Acad Sci U S A 109 (40) (2012) 16101ndash16106
[146] SCAlleyNM Okeley PD Senter Antibodyndashdrug conjugates targeted drug deliveryfor cancer Curr Opin Chem Biol 14 (4) (2010) 529ndash537
[147] JM Lambert Drug-conjugated antibodies for the treatment of cancer Br J ClinPharmacol 76 (2) (2013) 248ndash262
27 AC Anselmo S Mitragotri Journal of Controlled Release 190 (2014) 15ndash 28
8152019 Revision sobre formas farmaceuticas nuevas
[149] A Younes et al Brentuximab vedotin (SGN-35) for relapsed CD30-positive lym-phomas N Engl J Med 363 (19) (2010) 1812ndash1821
[150] RS Zolot S Basu RP Million Antibodyndashdrugconjugates Nat Rev Drug Discov12(4) (2013) 259ndash260
[151] FDA P1047297zer Voluntarily Withdraws Cancer Treatment Mylotarg from US Market(February 9 2014 Published June 21 2010) Available from httpwwwfdagov NewsEventsNewsroomPressAnnouncementsucm216448htm
[152] AM Wu PD Senter Arming antibodies prospects and challenges forimmunoconjugates Nat Biotechnol 23 (9) (2005) 1137ndash1146
[153] AK Burnett et al The addition of gemtuzumab ozogamicin to intensive chemo-therapy in older patients with AML produces a signi1047297cant improvement in overallsurvival results of the UK NCRI AML16 randomizedtrial Blood 2011 (AMER SOCHEMATOLOGY 1900 M STREET NW SUITE 200 WASHINGTON DC 20036 USA)
[154] R Langer A personal account of translating discoveries in an academic lab NatBiotechnol 31 (6) (2013) 487ndash489
[155] US Pharmaceutical Sales mdash 2013 (January 17 2014) Available from httpwwwdrugscomstatstop1002013sales
28 AC Anselmo S Mitragotri Journal of Controlled Release 190 (2014) 15ndash 28
8152019 Revision sobre formas farmaceuticas nuevas
[1] M Kermode Unsafe injections in low-income country health settings need forinjection safety promotion to prevent the spread of blood-borne viruses HealthPromot Int 19 (1) (2004) 95ndash103
[2] M Goldberg I Gomez-Orellana Challenges for the oral delivery of macromole-cules Nat Rev Drug Discov 2 (4) (2003) 289ndash295
[3] JS Patton PR ByronInhalingmedicinesdelivering drugs to thebodythroughthelungs Nat Rev Drug Discov 6 (1) (2007) 67ndash74
[4] MR Prausnitz R Langer Transdermal drug delivery Nat Biotechnol 26 (11)(2008) 1261ndash1268
[5] R Gaudana et al Ocular drug delivery AAPS J 12 (3) (2010) 348ndash360[6] L Illum Nasal drug deliverynew developments andstrategiesDrugDiscov Today
7 (23) (2002) 1184ndash1189[7] JE Talmadge The pharmaceutics and delivery of therapeutic polypeptides and
proteins Adv Drug Deliv Rev 10 (2) (1993) 247ndash299[8] RLanger Controlledrelease of a therapeuticproteinNat Med 2 (7)(1996)742ndash743[9] R Langer J Folkman Polymers for the sustained release of proteins and other
macromolecules Nature 263 (5580) (1976) 797ndash800[10] JC Wright AS Hoffman Historical overview of long acting injections and
implants Long Acting Injections and Implants Springer 2012 pp 11ndash24[11] M Chaubal Polylactidesglycolidesmdashexcipients for injectable drug delivery and
beyond Drug Deliv Technol 2 (2002) 34ndash36[12] G Zhu SR Mallery SP Schwendeman Stabilization of proteins encapsulated in
injectable poly (lactide-co-glycolide) Nat Biotechnol 18 (1) (2000) 52ndash57[13] V Sinha A Trehan Biodegradable microspheres for protein delivery J Control
Release 90 (3) (2003) 261ndash280[14] M van de Weert WE Hennink W Jiskoot Protein instability in poly (lactic-co-
glycolic acid) microparticles Pharm Res 17 (10) (2000) 1159ndash1167[15] OL Johnson et al A month-longeffect froma single injection of microencapsulated
human growth hormone Nat Med 2 (7) (1996) 795ndash799[16] W Jianget al Biodegradable poly(lactic-co-glycolic acid) microparticles for inject-
able delivery of vaccine antigens Adv Drug Deliv Rev 57 (3) (2005) 391 ndash410[17] F Jordan et al Sustained release hGH microsphere formulation produced by a
novel supercritical 1047298uid technology in vivo studies J Control Release 141 (2)(2010) 153ndash160
[18] MA Tracy Development and scale-up of a microsphere protein delivery systemBiotechnol Prog 14 (1) (1998) 108ndash115
[20] Johnson amp Johnson Annual Report 2012 (February 9 2014) Available fromhttpswwwjnjcomsitesdefault 1047297lespdfJNJ2012annualreportpdf
[21] TM Allen PR Cullis Drug delivery systems entering themainstreamScience303(5665) (2004) 1818ndash1822
[22] T Allen A Chonn Large unilamellar liposomes with low uptake into the reticulo-endothelial system FEBS Lett 223 (1) (1987) 42ndash46
[23] Y Matsumura H Maeda A new concept for macromolecular therapeuticsin cancer chemotherapy mechanism of tumoritropic accumulation of
proteins and the antitumor agent smancs Cancer Res 46 (12 Part 1) (1986)6387ndash6392[24] G Haran et al Transmembrane ammonium sulfate gradients in liposomes
produce ef 1047297cient and stable entrapment of amphipathic weak bases BiochimBiophys Acta (BBA)mdashBiomembr 1151 (2) (1993) 201ndash215
[25] AT Horowitz Y Barenholz AA Gabizon In vitro cytotoxicity of liposome-encapsulated doxorubicin dependence on liposome composition anddrug release Biochim Biophys Acta (BBA)mdashBiomembr 1109 (2) (1992)203ndash209
[26] AA Gabizon Y Barenholz M Bialer Prolongation of the circulation time of doxo-rubicin encapsulated in liposomes containing a polyethylene glycol-derivatizedphospholipid pharmacokinetic studies in rodents and dogs Pharm Res 10 (5)(1993) 703ndash708
[27] A Gabizon et al Prolonged circulation time and enhanced accumulation in malig-nant exudates of doxorubicin encapsulated in polyethylene-glycol coated lipo-somes Cancer Res 54 (4) (1994) 987ndash992
[28] H Maedaet alTumorvascularpermeabilityand theEPR effectin macromoleculartherapeutics a review J Control Release 65 (1) (2000) 271ndash284
[29] Important Update Regarding Supply Outage of DOXILreg Available from http
wwwdoxilcomdoxil-supply-shortage February 9 2014[30] D Peer et al Nanocarriers as an emerging platform for cancer therapy Nat
Nanotechnol 2 (12) (2007) 751ndash760[31] E Ruoslahti Peptides as targeting elements and tissue penetration devices for
nanoparticles Adv Mater 24 (28) (2012) 3747ndash3756[32] PL Rodriguez et al Minimal ldquoself rdquo peptides that inhibit phagocytic clearance and
enhance delivery of nanoparticles Science 339 (6122) (2013) 971ndash975[33] SM Moghimi AC Hunter JC Murray Long-circulating and target-speci1047297c
nanoparticles theory to practice Pharmacol Rev 53 (2) (2001) 283ndash318[34] JP Rolland et al Direct fabrication and harvesting of monodisperse shape-
speci1047297c nanobiomaterials J Am Chem Soc 127 (28) (2005) 10096ndash10100[35] SW Morton et al Scalable manufacture of built-to-order nanomedicine spray-
assisted layer-by-layer functionalization of PRINT nanoparticles Adv Mater 25(34) (2013) 4707ndash4713
[36] M Ferrari Cancer nanotechnology opportunities and challenges Nat Rev Cancer5 (3) (2005) 161ndash171
[37] WJ Gradishar et al Phase III trial of nanoparticle albumin-bound paclitaxel com-pared with polyethylated castor oil-based paclitaxel in women with breast cancer
J Clin Oncol 23 (31) (2005) 7794ndash7803
[38] M Green et al Abraxanereg a novel Cremophorreg-free albumin-bound particleform of paclitaxel for the treatment of advanced non-small-cell lung cancer AnnOncol 17 (8) (2006) 1263ndash1268
[39] DW Nymanet alPhaseI andpharmacokinetics trial of ABI-007 a novel nanopar-ticle formulation of paclitaxel in patients with advanced nonhematologic malig-nancies J Clin Oncol 23 (31) (2005) 7785ndash7793
[40] Celgene Corporation Announces 2014 Financial Outlook and Preliminary 2013Results (February 9 2014) Available from httpircelgenecomreleasedetailcfmReleaseID=821044
[41] J Hrkach et al Preclinical development and clinical translation of a PSMA-targeteddocetaxel nanoparticle with a differentiated pharmacological pro1047297le Sci Transl
Med 4 (128) (2012) 128ra39[42] S Svenson et al Preclinical to clinical development of the novel camptothecin
nanopharmaceutical CRLX101 J Control Release 153 (1) (2011) 49ndash55[43] S Eliasof et al Correlating preclinical animal studies and human clinical trials of a
multifunctional polymeric nanoparticle Proc Natl Acad Sci U S A 110 (37)(2013) 15127ndash15132
[44] ME Davis et al Evidence of RNAi in humans from systemically administeredsiRNA via targeted nanoparticles Nature 464 (7291) (2010) 1067ndash1070
[45] AZ Wang R Langer OC Farokhzad Nanoparticle delivery of cancer drugs AnnuRev Med 63 (2012) 185ndash198
[46] Y Matsumura K Kataoka Preclinical and clinical studies of anticancer agent-incorporating polymer micelles Cancer Sci 100 (4) (2009) 572ndash579
[47] JD Heidel ME Davis Clinical developments in nanotechnology for cancer thera-py Pharm Res 28 (2) (2011) 187ndash199
[48] B D alby et al Advanced transfection with Lipofectamine 2000 reagent primaryneurons siRNAand high-throughput applicationsMethods 33 (2) (2004)95ndash103
[49] S Venkatraman R Gale Skin adhesives and skin adhesion 1 Transdermal drugdelivery systems Biomaterials 19 (13) (1998) 1119ndash1136
[50] AC Watkinson A commentary on transdermal drug delivery systems in clinicaltrials J Pharm Sci 102 (9) (2013) 3082ndash3088
[51] TH Stanley Fentanyl J Pain Symptom Manage 29 (5 Suppl) (2005) S67ndashS71[52] TH Stanley The history and development of the fentanyl series J Pain Symptom
Manage 7 (3 Suppl) (1992) S3ndashS7[53] Lidoderm Sales Data (February 9 2014) Available from httpwwwdrugscom
statslidoderm[54] S Mitragotri Healingsound theuse of ultrasoundin drug delivery andotherther-
apeutic applications Nat Rev Drug Discov 4 (3) (2005) 255ndash260[55] P Karande A Jain S Mitragotri Insights into synergistic interactions in binary
mixtures of chemical permeation enhancers for transdermal drug delivery J Control Release 115 (1) (2006) 85ndash93
[56] MR Prausnitz Microneedles for transdermal drug delivery Adv Drug Deliv Rev56 (5) (2004) 581ndash587
[57] YN Kalia et al Iontophoretic drug delivery Adv Drug Deliv Rev 56 (5) (2004)619ndash658
[58] P Karande A Jain S Mitragotri Discovery of transdermal penetration enhancersby high-throughput screening Nat Biotechnol 22 (2) (2004) 192ndash197
[59] MA Ashburn et al Iontophoretic delivery of morphinefor postoperative analgesia
J Pain Symptom Manage 7 (1) (1992) 27ndash
33[60] R van der Geest et al Iontophoretic delivery of apomorphine II An in vivo studyin patients with Parkinsons disease Pharm Res 14 (12) (1997) 1804ndash1810
[61] M Cormier et al Effect of transdermal iontophoresis codelivery of hydrocortisoneon metoclopramide pharmacokinetics and skin-induced reactions in humansubjects J Pharm Sci 88 (10) (1999) 1030ndash1035
[62] MP James RM Graham J English Percutaneous iontophoresis of prednisolonemdashapharmacokinetic study Clin Exp Dermatol 11 (1) (1986) 54ndash61
[63] PG Green Iontophoretic delivery of peptide drugs J Control Release 41 (1)(1996) 33ndash48
[64] EL Spierings JA Brevard NP Katz Two‐minute skin anesthesia through ultra-sound pretreatment and iontophoretic delivery of a topical anesthetic a feasibilitystudy Pain Med 9 (1) (2008) 55ndash59
[65] P SantoiannI M Nino G Calabro Intradermal Drug Delivery by Low FrequencySonophoresis (25 kHz) 2004
[66] BE Polat et al Ultrasound-mediated transdermal drug delivery mechanismsscope and emerging trends J Control Release 152 (3) (2011) 330ndash348
[67] JJ Norman et al Faster pharmacokinetics and increased patient acceptance of intradermal insulin delivery using a single hollow microneedle in children and
adolescents with type 1 diabetes Pediatr Diabetes 14 (6) (2013) 459 ndash465[68] J Gupta EI Felner MR Prausnitz Rapid pharmacokinetics of intradermal insulin
administered using microneedles in type 1 diabetes subjects Diabetes TechnolTher 13 (4) (2011) 451ndash456
[69] J Gupta EI Felner MR Prausnitz Minimally invasive insulin delivery in subjectswith type 1 diabetes using hollow microneedles Diabetes Technol Ther 11 (6)(2009) 329ndash337
[70] J Gupta et al Rapid local anesthesia in humans using minimally invasivemicroneedles Clin J Pain 28 (2) (2012) 129ndash135
[72] M Ameri SC Fan YF Maa Parathyroid hormone PTH(1ndash34) formulation thatenables uniform coating on a novel transdermal microprojection delivery systemPharm Res 27 (2) (2010) 303ndash313
[73] PE Daddona et al Parathyroid hormone (1ndash34)-coated microneedle patchsystem clinical pharmacokinetics and pharmacodynamics for treatment of osteo-porosis Pharm Res 28 (1) (2011) 159ndash165
[74] A Arora MR Prausnitz S Mitragotri Micro-scale devices for transdermal drugdelivery Int J Pharm 364 (2) (2008) 227ndash236
26 AC Anselmo S Mitragotri Journal of Controlled Release 190 (2014) 15ndash 28
8152019 Revision sobre formas farmaceuticas nuevas
[75] S Mayes M Ferrone Fentanyl HCl patient-controlled iontophoretic transdermalsystem for the management of acute postoperative pain Ann Pharmacother 40(12) (2006) 2178ndash2186
[76] WT Zempsky et al Evaluation of a low-dose lidocaine iontophoresis system fortopical anesthesia in adults and children a randomized controlled trial ClinTher 26 (7) (2004) 1110ndash1119
[77] BM Becker et al Ultrasound with topical anesthetic rapidly decreases pain of intravenous cannulation Acad Emerg Med 12 (4) (2005) 289ndash295
[78] SK Vashist Non-invasive glucose monitoring technology in diabetes managementa review Anal Chim Acta 750 (2012) 16ndash27
[79] H Chuang et al Pilot studies of transdermal continuous glucose measurement
in outpatient diabetic patients and in patients during and after cardiac surgery J Diabetes Sci Technol 2 (4) (2008) 595ndash602[80] S Rose JF Nelson A continuous long-term injector Aust J Exp Biol Med Sci 33
(4) (1955) 415ndash419[81] F Theeuwes Elementary osmotic pump J Pharm Sci 64 (12) (1975) 1987ndash1991[82] V Malaterre et al Oral osmotically driven systems 30 years of development and
clinical use Eur J Pharm Biopharm 73 (3) (2009) 311ndash323[83] E Rosenthal The Soaring Cost of a Simple Breath (February 9 2014) Published
October 12 2013] Available from httpwwwnytimescom20131013usthe-soaring-cost-of-a-simple-breathhtml_r=0
[84] F Theeuwes Orososmotic system development Drug Dev Ind Pharm 9 (7)(1983) 1331ndash1357
[85] CG Park et al A nano1047297brous sheet-based system for linear delivery of nifedipine J Control Release 149 (3) (2011) 250ndash257
[86] DM Bass M Prevo DS Waxman Gastrointestinal safety of an extended-releasenondeformable oral dosage form (OROS) a retrospective study Drug Saf 25(14) (2002) 1021ndash1033
[87] GA Agyilirah GS Banker Polymers for Enteric Coating Applications Polymers forControlled Drug Delivery CRC Press Boca Raton 1991 39ndash66
[88] G Ponchel J-M Irache Speci1047297c and non-speci1047297c bioadhesive particulate systemsfor oral delivery to the gastrointestinal tract Adv Drug Deliv Rev 34 (2) (1998)191ndash219
[89] M Morishita NA Peppas Is the oral route possible for peptide and protein drugdelivery Drug Discov Today 11 (19) (2006) 905ndash910
[90] A Bernkop-Schnuumlrch The use of inhibitory agents to overcome the enzymatic bar-rier to perorally administered therapeuticpeptides and proteins J Control Release52 (1) (1998) 1ndash16
[91] LM Ensign R Cone J HanesOral drug delivery with polymeric nanoparticles thegastrointestinal mucus barriers Adv Drug Deliv Rev 64 (6) (2012) 557ndash570
[92] E Mathiowitz et al Biologically erodable microspheres as potential oral drugdelivery systems Nature 386 (6623) (1997) 410ndash414
[93] V Gupta et alMucoadhesiveintestinaldevices fororal delivery of salmon calcitonin J Control Release 172 (3) (2013) 753ndash762
[95] PW Swaan Recent advances in intestinal macromolecular drug delivery viareceptor-mediated transport pathways Pharm Res 15 (6) (1998) 826ndash834
[96] R Eldor et al Glucose-reducing effect of the ORMD-0801 oral insulin preparationin patients with uncontrolled type 1 diabetes a pilot study PLoS One 8 (4) (2013)e59524
[97] TheEligenreg Library(February9 2014) Available from httpwwwemispherecom eligen_libraryhtml
[98] MC Castelli et al Comparing the ef 1047297cacy and tolerability of a new daily oral vita-min B12 formulation and intermittent intramuscular vitamin B12 in normalizinglow cobalamin levels a randomized open-label parallel-group study Clin Ther33 (3) (2011) 358ndash371 (e2)
[99] K Whitehead Z Shen S Mitragotri Oraldelivery of macromoleculesusing intestinalpatches applications for insulin delivery J Control Release 98 (1) (2004) 37ndash45
[100] EM Pridgen et al Transepithelial transport of fc-targeted nanoparticles by theneonatal fc receptor for oral delivery Sci Transl Med 5 (213) (2013) 213ra167
[101] M Torres‐Lugo et al pH‐sensitive hydrogels as gastrointestinal tract absorptionenhancers transport mechanisms of salmoncalcitoninand other modelmoleculesusing the Caco‐2 cell model Biotechnol Prog 18 (3) (2002) 612ndash616
[102] M Torres-Lugo et al Physicochemical behavior and cytotoxic effects of p (methacrylic acidndashg-ethylene glycol) nanospheres for oral delivery of proteins
J Control Release 80 (1) (2002) 197ndash
205[103] RU Agu et alThe lung as a route forsystemicdeliveryof therapeuticproteins and
peptides Respir Res 2 (4) (2001) 198[104] R Dalby J Suman Inhalation therapy technological milestones in asthma treat-
ment Adv Drug Deliv Rev 55 (7) (2003) 779ndash791[105] PJ Anderson History of aerosol therapy liquid nebulization to MDIs to DPIs
Respir Care 50 (9) (2005) 1139ndash1150[106] JB Fink BK Rubin Problems with inhaler use a call for improved clinician and
patient education Respir Care 50 (10) (2005) 1360ndash1375[107] MJ Telko AJ Hickey Dry powder inhaler formulation Respir Care 50 (9) (2005)
1209ndash1227[108] DAEdwardsA Ben-Jebria R Langer Recentadvances in pulmonary drug delivery
using large porous inhaled particles J Appl Physiol 85 (2) (1998) 379ndash385[109] MB DolovichR DhandAerosol drug deliverydevelopments in devicedesign and
clinical use Lancet 377 (9770) (2011) 1032ndash1045[110] A Hussain et al Absorption enhancers in pulmonary protein delivery J Control
Release 94 (1) (2004) 15ndash24[111] J L Cleland A Daugherty R Mrsny Emerging protein delivery methods Curr
Opin Biotechnol 12 (2) (2001) 212ndash219
[112] JS Patton J Bukar S Nagarajan Inhaled insulin Adv Drug Deliv Rev 35 (2ndash3)(1999) 235ndash247
[113] FDA to Complete Phase-out of Chloro1047298uorocarbon Inhalers (February 9 2014Published October 23 2013) Available from httpwwwfdagovnewsevents newsroompressannouncementsucm371901htm
[114] Drug Treatments for Asthma and Chronic Obstructive Pulmonary Disease ThatDo Not Use Chloro1047298uorocarbons (February 9 2014) Available from http wwwfdagovDrugsDrugSafetyInformationbyDrugClassucm082370htm
[115] AJ Hickey Back to the future inhaled drug products J Pharm Sci 102 (4) (2013)1165ndash1172
[116] S White et al EXUBERA pharmaceutical development of a novel product for
906[117] T Quattrin et al Ef 1047297cacy and safety of inhaled insulin (Exubera) compared withsubcutaneous insulin therapy in patients with type 1 diabetes results of a 6-month randomized comparative trial Diabetes Care 27 (11) (2004) 2622ndash2627
[118] PA Hollander etal Ef 1047297cacyand safety of inhaled insulin (exubera)comparedwithsubcutaneousinsulin therapy in patients with type 2 diabetesresults of a 6-monthrandomized comparative trial Diabetes Care 27 (10) (2004) 2356ndash2362
[119] C Black et al The clinical effectiveness and cost-effectiveness of inhaled insulin indiabetes mellitus a systematic review and economic evaluation Health TechnolAssess 11 (33) (2007) 1ndash126
[120] A Opar Another blowfor inhaled protein therapeutics Nat Rev Drug Discov 7 (3)(2008) 189ndash190
[121] J Kling Dreamboat sinks prospects for fast approval of inhaled insulin NatBiotechnol 29 (3) (2011) 175ndash176
[122] Press Releases MannKind Reports Positive Data from a Phase 3 Clinical Study of AFREZZA in Patients with Type 1 Diabetes (February 9 2014 Published August14 2013) Available from httpwwwnewsmannkindcorpcomphoenixzhtmlc=147953ampp=irol-newsArticleampID=1847441amphighlight=
[123] Available from httpwwwcivitastherapeuticscomCVT-301html
[124] Cardeas Pharma Announces that FDA Grants QIDP Designation and Fast TrackReview for the Companys Antibiotic Combination Product (February 9 2014Published January 8 2014) Available from httpcardeaspharmacom press-releasescardeas-pharma-announces-that-fda-grants-qidp-designation-and-fast-track-review-for-the-companys-antibiotic-combination-product
[125] M Staples et al Application of micro- and nano-electromechanical devices todrug delivery Pharm Res 23 (5) (2006) 847ndash863
[126] TJ Smith et al Intravitreal sustained-release ganciclovir Arch Ophthalmol 110(2) (1992) 255ndash258
[127] GE Sanborn et al Sustained-release ganciclovir therapy for treatment of cyto-megalovirus retinitis Use of an intravitreal device Arch Ophthalmol 110 (2)(1992) 188ndash195
[128] G Velez SM Whitcup New developments in sustained release drug deliveryfor the treatment of intraocular disease Br J Ophthalmol 83 (11) (1999)1225ndash1229
[129] DH Geroski HF Edelhauser Drug delivery for posterior segment eye diseaseInvest Ophthalmol Vis Sci 41 (5) (2000) 961ndash964
[130] DC Musch et al Treatment of cytomegalovirus retinitis with a sustained-releaseganciclovir implant The Ganciclovir Implant Study Group N Engl J Med 337 (2)(1997) 83ndash90
[131] CL Stevenson JT Santini Jr R Langer Reservoir-based drug delivery systemsutilizing microtechnology Adv Drug Deliv Rev 64 (14) (2012) 1590ndash1602
[132] RA Receveur FW Lindemans NF de Rooij Microsystem technologies forimplantable applications J Micromech Microeng 17 (5) (2007) R50
[133] AC Richards Grayson et al Electronic MEMS for triggered delivery Adv DrugDeliv Rev 56 (2) (2004) 173ndash184
[134] HowOzurdex(R) Works(March11 2014) Available fromhttpwwwozurdexcom HowItWorksaspx
[135] A Giese et al Pattern of recurrencefollowinglocal chemotherapy with biodegrad-able carmustine (BCNU) implants in patients with glioblastoma J Neurooncol 66(3) (2004) 351ndash360
[136] EL Weber EA Goebel Cerebral edema associated with Gliadel wafers two casestudies Neuro Oncol 7 (1) (2005) 84ndash89
[137] JT Santini Jr MJ Cima R Langer A controlled-release microchip Nature 397(6717) (1999) 335ndash338
[138] R Farra et al First-in-human testing of a wirelessly controlled drug deliverymicrochip Sci Transl Med 4 (122) (2012) 122ra21
[139] B Hughes Antibodyndash
drug conjugates for cancer poised to deliver Nat Rev DrugDiscov 9 (9) (2010) 665ndash667
[140] JR Junutula et al Site-speci1047297c conjugation of a cytotoxic drug to an antibodyimproves the therapeutic index Nat Biotechnol 26 (8) (2008) 925ndash932
[141] S Verma et al Trastuzumab emtansinefor HER2-positive advanced breast cancerN Engl J Med 367 (19) (2012) 1783ndash1791
[142] ImmunoGen Inc Reports First Quarter Fiscal Year 2014 Financial Results andProvides Quarterly Update (February 9 2014 Published October 25 2013) Avail-able from httpinvestorimmunogencomreleasedetailcfmReleaseID=800370
[143] P Chames et al Therapeutic antibodies successes limit ations and hopes for thefuture Br J Pharmacol 157 (2) (2009) 220ndash233
[144] CF McDonagh et al Engineered antibodyndashdrugconjugateswith de1047297ned sites andstoichiometries of drug attachment Protein Eng Des Sel 19 (7) (2006) 299ndash307
[145] JY Axup et al Synthesis of site-speci1047297c antibodyndashdrug conjugates using unnatu-ral amino acids Proc Natl Acad Sci U S A 109 (40) (2012) 16101ndash16106
[146] SCAlleyNM Okeley PD Senter Antibodyndashdrug conjugates targeted drug deliveryfor cancer Curr Opin Chem Biol 14 (4) (2010) 529ndash537
[147] JM Lambert Drug-conjugated antibodies for the treatment of cancer Br J ClinPharmacol 76 (2) (2013) 248ndash262
27 AC Anselmo S Mitragotri Journal of Controlled Release 190 (2014) 15ndash 28
8152019 Revision sobre formas farmaceuticas nuevas
[149] A Younes et al Brentuximab vedotin (SGN-35) for relapsed CD30-positive lym-phomas N Engl J Med 363 (19) (2010) 1812ndash1821
[150] RS Zolot S Basu RP Million Antibodyndashdrugconjugates Nat Rev Drug Discov12(4) (2013) 259ndash260
[151] FDA P1047297zer Voluntarily Withdraws Cancer Treatment Mylotarg from US Market(February 9 2014 Published June 21 2010) Available from httpwwwfdagov NewsEventsNewsroomPressAnnouncementsucm216448htm
[152] AM Wu PD Senter Arming antibodies prospects and challenges forimmunoconjugates Nat Biotechnol 23 (9) (2005) 1137ndash1146
[153] AK Burnett et al The addition of gemtuzumab ozogamicin to intensive chemo-therapy in older patients with AML produces a signi1047297cant improvement in overallsurvival results of the UK NCRI AML16 randomizedtrial Blood 2011 (AMER SOCHEMATOLOGY 1900 M STREET NW SUITE 200 WASHINGTON DC 20036 USA)
[154] R Langer A personal account of translating discoveries in an academic lab NatBiotechnol 31 (6) (2013) 487ndash489
[155] US Pharmaceutical Sales mdash 2013 (January 17 2014) Available from httpwwwdrugscomstatstop1002013sales
28 AC Anselmo S Mitragotri Journal of Controlled Release 190 (2014) 15ndash 28
8152019 Revision sobre formas farmaceuticas nuevas
[1] M Kermode Unsafe injections in low-income country health settings need forinjection safety promotion to prevent the spread of blood-borne viruses HealthPromot Int 19 (1) (2004) 95ndash103
[2] M Goldberg I Gomez-Orellana Challenges for the oral delivery of macromole-cules Nat Rev Drug Discov 2 (4) (2003) 289ndash295
[3] JS Patton PR ByronInhalingmedicinesdelivering drugs to thebodythroughthelungs Nat Rev Drug Discov 6 (1) (2007) 67ndash74
[4] MR Prausnitz R Langer Transdermal drug delivery Nat Biotechnol 26 (11)(2008) 1261ndash1268
[5] R Gaudana et al Ocular drug delivery AAPS J 12 (3) (2010) 348ndash360[6] L Illum Nasal drug deliverynew developments andstrategiesDrugDiscov Today
7 (23) (2002) 1184ndash1189[7] JE Talmadge The pharmaceutics and delivery of therapeutic polypeptides and
proteins Adv Drug Deliv Rev 10 (2) (1993) 247ndash299[8] RLanger Controlledrelease of a therapeuticproteinNat Med 2 (7)(1996)742ndash743[9] R Langer J Folkman Polymers for the sustained release of proteins and other
macromolecules Nature 263 (5580) (1976) 797ndash800[10] JC Wright AS Hoffman Historical overview of long acting injections and
implants Long Acting Injections and Implants Springer 2012 pp 11ndash24[11] M Chaubal Polylactidesglycolidesmdashexcipients for injectable drug delivery and
beyond Drug Deliv Technol 2 (2002) 34ndash36[12] G Zhu SR Mallery SP Schwendeman Stabilization of proteins encapsulated in
injectable poly (lactide-co-glycolide) Nat Biotechnol 18 (1) (2000) 52ndash57[13] V Sinha A Trehan Biodegradable microspheres for protein delivery J Control
Release 90 (3) (2003) 261ndash280[14] M van de Weert WE Hennink W Jiskoot Protein instability in poly (lactic-co-
glycolic acid) microparticles Pharm Res 17 (10) (2000) 1159ndash1167[15] OL Johnson et al A month-longeffect froma single injection of microencapsulated
human growth hormone Nat Med 2 (7) (1996) 795ndash799[16] W Jianget al Biodegradable poly(lactic-co-glycolic acid) microparticles for inject-
able delivery of vaccine antigens Adv Drug Deliv Rev 57 (3) (2005) 391 ndash410[17] F Jordan et al Sustained release hGH microsphere formulation produced by a
novel supercritical 1047298uid technology in vivo studies J Control Release 141 (2)(2010) 153ndash160
[18] MA Tracy Development and scale-up of a microsphere protein delivery systemBiotechnol Prog 14 (1) (1998) 108ndash115
[20] Johnson amp Johnson Annual Report 2012 (February 9 2014) Available fromhttpswwwjnjcomsitesdefault 1047297lespdfJNJ2012annualreportpdf
[21] TM Allen PR Cullis Drug delivery systems entering themainstreamScience303(5665) (2004) 1818ndash1822
[22] T Allen A Chonn Large unilamellar liposomes with low uptake into the reticulo-endothelial system FEBS Lett 223 (1) (1987) 42ndash46
[23] Y Matsumura H Maeda A new concept for macromolecular therapeuticsin cancer chemotherapy mechanism of tumoritropic accumulation of
proteins and the antitumor agent smancs Cancer Res 46 (12 Part 1) (1986)6387ndash6392[24] G Haran et al Transmembrane ammonium sulfate gradients in liposomes
produce ef 1047297cient and stable entrapment of amphipathic weak bases BiochimBiophys Acta (BBA)mdashBiomembr 1151 (2) (1993) 201ndash215
[25] AT Horowitz Y Barenholz AA Gabizon In vitro cytotoxicity of liposome-encapsulated doxorubicin dependence on liposome composition anddrug release Biochim Biophys Acta (BBA)mdashBiomembr 1109 (2) (1992)203ndash209
[26] AA Gabizon Y Barenholz M Bialer Prolongation of the circulation time of doxo-rubicin encapsulated in liposomes containing a polyethylene glycol-derivatizedphospholipid pharmacokinetic studies in rodents and dogs Pharm Res 10 (5)(1993) 703ndash708
[27] A Gabizon et al Prolonged circulation time and enhanced accumulation in malig-nant exudates of doxorubicin encapsulated in polyethylene-glycol coated lipo-somes Cancer Res 54 (4) (1994) 987ndash992
[28] H Maedaet alTumorvascularpermeabilityand theEPR effectin macromoleculartherapeutics a review J Control Release 65 (1) (2000) 271ndash284
[29] Important Update Regarding Supply Outage of DOXILreg Available from http
wwwdoxilcomdoxil-supply-shortage February 9 2014[30] D Peer et al Nanocarriers as an emerging platform for cancer therapy Nat
Nanotechnol 2 (12) (2007) 751ndash760[31] E Ruoslahti Peptides as targeting elements and tissue penetration devices for
nanoparticles Adv Mater 24 (28) (2012) 3747ndash3756[32] PL Rodriguez et al Minimal ldquoself rdquo peptides that inhibit phagocytic clearance and
enhance delivery of nanoparticles Science 339 (6122) (2013) 971ndash975[33] SM Moghimi AC Hunter JC Murray Long-circulating and target-speci1047297c
nanoparticles theory to practice Pharmacol Rev 53 (2) (2001) 283ndash318[34] JP Rolland et al Direct fabrication and harvesting of monodisperse shape-
speci1047297c nanobiomaterials J Am Chem Soc 127 (28) (2005) 10096ndash10100[35] SW Morton et al Scalable manufacture of built-to-order nanomedicine spray-
assisted layer-by-layer functionalization of PRINT nanoparticles Adv Mater 25(34) (2013) 4707ndash4713
[36] M Ferrari Cancer nanotechnology opportunities and challenges Nat Rev Cancer5 (3) (2005) 161ndash171
[37] WJ Gradishar et al Phase III trial of nanoparticle albumin-bound paclitaxel com-pared with polyethylated castor oil-based paclitaxel in women with breast cancer
J Clin Oncol 23 (31) (2005) 7794ndash7803
[38] M Green et al Abraxanereg a novel Cremophorreg-free albumin-bound particleform of paclitaxel for the treatment of advanced non-small-cell lung cancer AnnOncol 17 (8) (2006) 1263ndash1268
[39] DW Nymanet alPhaseI andpharmacokinetics trial of ABI-007 a novel nanopar-ticle formulation of paclitaxel in patients with advanced nonhematologic malig-nancies J Clin Oncol 23 (31) (2005) 7785ndash7793
[40] Celgene Corporation Announces 2014 Financial Outlook and Preliminary 2013Results (February 9 2014) Available from httpircelgenecomreleasedetailcfmReleaseID=821044
[41] J Hrkach et al Preclinical development and clinical translation of a PSMA-targeteddocetaxel nanoparticle with a differentiated pharmacological pro1047297le Sci Transl
Med 4 (128) (2012) 128ra39[42] S Svenson et al Preclinical to clinical development of the novel camptothecin
nanopharmaceutical CRLX101 J Control Release 153 (1) (2011) 49ndash55[43] S Eliasof et al Correlating preclinical animal studies and human clinical trials of a
multifunctional polymeric nanoparticle Proc Natl Acad Sci U S A 110 (37)(2013) 15127ndash15132
[44] ME Davis et al Evidence of RNAi in humans from systemically administeredsiRNA via targeted nanoparticles Nature 464 (7291) (2010) 1067ndash1070
[45] AZ Wang R Langer OC Farokhzad Nanoparticle delivery of cancer drugs AnnuRev Med 63 (2012) 185ndash198
[46] Y Matsumura K Kataoka Preclinical and clinical studies of anticancer agent-incorporating polymer micelles Cancer Sci 100 (4) (2009) 572ndash579
[47] JD Heidel ME Davis Clinical developments in nanotechnology for cancer thera-py Pharm Res 28 (2) (2011) 187ndash199
[48] B D alby et al Advanced transfection with Lipofectamine 2000 reagent primaryneurons siRNAand high-throughput applicationsMethods 33 (2) (2004)95ndash103
[49] S Venkatraman R Gale Skin adhesives and skin adhesion 1 Transdermal drugdelivery systems Biomaterials 19 (13) (1998) 1119ndash1136
[50] AC Watkinson A commentary on transdermal drug delivery systems in clinicaltrials J Pharm Sci 102 (9) (2013) 3082ndash3088
[51] TH Stanley Fentanyl J Pain Symptom Manage 29 (5 Suppl) (2005) S67ndashS71[52] TH Stanley The history and development of the fentanyl series J Pain Symptom
Manage 7 (3 Suppl) (1992) S3ndashS7[53] Lidoderm Sales Data (February 9 2014) Available from httpwwwdrugscom
statslidoderm[54] S Mitragotri Healingsound theuse of ultrasoundin drug delivery andotherther-
apeutic applications Nat Rev Drug Discov 4 (3) (2005) 255ndash260[55] P Karande A Jain S Mitragotri Insights into synergistic interactions in binary
mixtures of chemical permeation enhancers for transdermal drug delivery J Control Release 115 (1) (2006) 85ndash93
[56] MR Prausnitz Microneedles for transdermal drug delivery Adv Drug Deliv Rev56 (5) (2004) 581ndash587
[57] YN Kalia et al Iontophoretic drug delivery Adv Drug Deliv Rev 56 (5) (2004)619ndash658
[58] P Karande A Jain S Mitragotri Discovery of transdermal penetration enhancersby high-throughput screening Nat Biotechnol 22 (2) (2004) 192ndash197
[59] MA Ashburn et al Iontophoretic delivery of morphinefor postoperative analgesia
J Pain Symptom Manage 7 (1) (1992) 27ndash
33[60] R van der Geest et al Iontophoretic delivery of apomorphine II An in vivo studyin patients with Parkinsons disease Pharm Res 14 (12) (1997) 1804ndash1810
[61] M Cormier et al Effect of transdermal iontophoresis codelivery of hydrocortisoneon metoclopramide pharmacokinetics and skin-induced reactions in humansubjects J Pharm Sci 88 (10) (1999) 1030ndash1035
[62] MP James RM Graham J English Percutaneous iontophoresis of prednisolonemdashapharmacokinetic study Clin Exp Dermatol 11 (1) (1986) 54ndash61
[63] PG Green Iontophoretic delivery of peptide drugs J Control Release 41 (1)(1996) 33ndash48
[64] EL Spierings JA Brevard NP Katz Two‐minute skin anesthesia through ultra-sound pretreatment and iontophoretic delivery of a topical anesthetic a feasibilitystudy Pain Med 9 (1) (2008) 55ndash59
[65] P SantoiannI M Nino G Calabro Intradermal Drug Delivery by Low FrequencySonophoresis (25 kHz) 2004
[66] BE Polat et al Ultrasound-mediated transdermal drug delivery mechanismsscope and emerging trends J Control Release 152 (3) (2011) 330ndash348
[67] JJ Norman et al Faster pharmacokinetics and increased patient acceptance of intradermal insulin delivery using a single hollow microneedle in children and
adolescents with type 1 diabetes Pediatr Diabetes 14 (6) (2013) 459 ndash465[68] J Gupta EI Felner MR Prausnitz Rapid pharmacokinetics of intradermal insulin
administered using microneedles in type 1 diabetes subjects Diabetes TechnolTher 13 (4) (2011) 451ndash456
[69] J Gupta EI Felner MR Prausnitz Minimally invasive insulin delivery in subjectswith type 1 diabetes using hollow microneedles Diabetes Technol Ther 11 (6)(2009) 329ndash337
[70] J Gupta et al Rapid local anesthesia in humans using minimally invasivemicroneedles Clin J Pain 28 (2) (2012) 129ndash135
[72] M Ameri SC Fan YF Maa Parathyroid hormone PTH(1ndash34) formulation thatenables uniform coating on a novel transdermal microprojection delivery systemPharm Res 27 (2) (2010) 303ndash313
[73] PE Daddona et al Parathyroid hormone (1ndash34)-coated microneedle patchsystem clinical pharmacokinetics and pharmacodynamics for treatment of osteo-porosis Pharm Res 28 (1) (2011) 159ndash165
[74] A Arora MR Prausnitz S Mitragotri Micro-scale devices for transdermal drugdelivery Int J Pharm 364 (2) (2008) 227ndash236
26 AC Anselmo S Mitragotri Journal of Controlled Release 190 (2014) 15ndash 28
8152019 Revision sobre formas farmaceuticas nuevas
[75] S Mayes M Ferrone Fentanyl HCl patient-controlled iontophoretic transdermalsystem for the management of acute postoperative pain Ann Pharmacother 40(12) (2006) 2178ndash2186
[76] WT Zempsky et al Evaluation of a low-dose lidocaine iontophoresis system fortopical anesthesia in adults and children a randomized controlled trial ClinTher 26 (7) (2004) 1110ndash1119
[77] BM Becker et al Ultrasound with topical anesthetic rapidly decreases pain of intravenous cannulation Acad Emerg Med 12 (4) (2005) 289ndash295
[78] SK Vashist Non-invasive glucose monitoring technology in diabetes managementa review Anal Chim Acta 750 (2012) 16ndash27
[79] H Chuang et al Pilot studies of transdermal continuous glucose measurement
in outpatient diabetic patients and in patients during and after cardiac surgery J Diabetes Sci Technol 2 (4) (2008) 595ndash602[80] S Rose JF Nelson A continuous long-term injector Aust J Exp Biol Med Sci 33
(4) (1955) 415ndash419[81] F Theeuwes Elementary osmotic pump J Pharm Sci 64 (12) (1975) 1987ndash1991[82] V Malaterre et al Oral osmotically driven systems 30 years of development and
clinical use Eur J Pharm Biopharm 73 (3) (2009) 311ndash323[83] E Rosenthal The Soaring Cost of a Simple Breath (February 9 2014) Published
October 12 2013] Available from httpwwwnytimescom20131013usthe-soaring-cost-of-a-simple-breathhtml_r=0
[84] F Theeuwes Orososmotic system development Drug Dev Ind Pharm 9 (7)(1983) 1331ndash1357
[85] CG Park et al A nano1047297brous sheet-based system for linear delivery of nifedipine J Control Release 149 (3) (2011) 250ndash257
[86] DM Bass M Prevo DS Waxman Gastrointestinal safety of an extended-releasenondeformable oral dosage form (OROS) a retrospective study Drug Saf 25(14) (2002) 1021ndash1033
[87] GA Agyilirah GS Banker Polymers for Enteric Coating Applications Polymers forControlled Drug Delivery CRC Press Boca Raton 1991 39ndash66
[88] G Ponchel J-M Irache Speci1047297c and non-speci1047297c bioadhesive particulate systemsfor oral delivery to the gastrointestinal tract Adv Drug Deliv Rev 34 (2) (1998)191ndash219
[89] M Morishita NA Peppas Is the oral route possible for peptide and protein drugdelivery Drug Discov Today 11 (19) (2006) 905ndash910
[90] A Bernkop-Schnuumlrch The use of inhibitory agents to overcome the enzymatic bar-rier to perorally administered therapeuticpeptides and proteins J Control Release52 (1) (1998) 1ndash16
[91] LM Ensign R Cone J HanesOral drug delivery with polymeric nanoparticles thegastrointestinal mucus barriers Adv Drug Deliv Rev 64 (6) (2012) 557ndash570
[92] E Mathiowitz et al Biologically erodable microspheres as potential oral drugdelivery systems Nature 386 (6623) (1997) 410ndash414
[93] V Gupta et alMucoadhesiveintestinaldevices fororal delivery of salmon calcitonin J Control Release 172 (3) (2013) 753ndash762
[95] PW Swaan Recent advances in intestinal macromolecular drug delivery viareceptor-mediated transport pathways Pharm Res 15 (6) (1998) 826ndash834
[96] R Eldor et al Glucose-reducing effect of the ORMD-0801 oral insulin preparationin patients with uncontrolled type 1 diabetes a pilot study PLoS One 8 (4) (2013)e59524
[97] TheEligenreg Library(February9 2014) Available from httpwwwemispherecom eligen_libraryhtml
[98] MC Castelli et al Comparing the ef 1047297cacy and tolerability of a new daily oral vita-min B12 formulation and intermittent intramuscular vitamin B12 in normalizinglow cobalamin levels a randomized open-label parallel-group study Clin Ther33 (3) (2011) 358ndash371 (e2)
[99] K Whitehead Z Shen S Mitragotri Oraldelivery of macromoleculesusing intestinalpatches applications for insulin delivery J Control Release 98 (1) (2004) 37ndash45
[100] EM Pridgen et al Transepithelial transport of fc-targeted nanoparticles by theneonatal fc receptor for oral delivery Sci Transl Med 5 (213) (2013) 213ra167
[101] M Torres‐Lugo et al pH‐sensitive hydrogels as gastrointestinal tract absorptionenhancers transport mechanisms of salmoncalcitoninand other modelmoleculesusing the Caco‐2 cell model Biotechnol Prog 18 (3) (2002) 612ndash616
[102] M Torres-Lugo et al Physicochemical behavior and cytotoxic effects of p (methacrylic acidndashg-ethylene glycol) nanospheres for oral delivery of proteins
J Control Release 80 (1) (2002) 197ndash
205[103] RU Agu et alThe lung as a route forsystemicdeliveryof therapeuticproteins and
peptides Respir Res 2 (4) (2001) 198[104] R Dalby J Suman Inhalation therapy technological milestones in asthma treat-
ment Adv Drug Deliv Rev 55 (7) (2003) 779ndash791[105] PJ Anderson History of aerosol therapy liquid nebulization to MDIs to DPIs
Respir Care 50 (9) (2005) 1139ndash1150[106] JB Fink BK Rubin Problems with inhaler use a call for improved clinician and
patient education Respir Care 50 (10) (2005) 1360ndash1375[107] MJ Telko AJ Hickey Dry powder inhaler formulation Respir Care 50 (9) (2005)
1209ndash1227[108] DAEdwardsA Ben-Jebria R Langer Recentadvances in pulmonary drug delivery
using large porous inhaled particles J Appl Physiol 85 (2) (1998) 379ndash385[109] MB DolovichR DhandAerosol drug deliverydevelopments in devicedesign and
clinical use Lancet 377 (9770) (2011) 1032ndash1045[110] A Hussain et al Absorption enhancers in pulmonary protein delivery J Control
Release 94 (1) (2004) 15ndash24[111] J L Cleland A Daugherty R Mrsny Emerging protein delivery methods Curr
Opin Biotechnol 12 (2) (2001) 212ndash219
[112] JS Patton J Bukar S Nagarajan Inhaled insulin Adv Drug Deliv Rev 35 (2ndash3)(1999) 235ndash247
[113] FDA to Complete Phase-out of Chloro1047298uorocarbon Inhalers (February 9 2014Published October 23 2013) Available from httpwwwfdagovnewsevents newsroompressannouncementsucm371901htm
[114] Drug Treatments for Asthma and Chronic Obstructive Pulmonary Disease ThatDo Not Use Chloro1047298uorocarbons (February 9 2014) Available from http wwwfdagovDrugsDrugSafetyInformationbyDrugClassucm082370htm
[115] AJ Hickey Back to the future inhaled drug products J Pharm Sci 102 (4) (2013)1165ndash1172
[116] S White et al EXUBERA pharmaceutical development of a novel product for
906[117] T Quattrin et al Ef 1047297cacy and safety of inhaled insulin (Exubera) compared withsubcutaneous insulin therapy in patients with type 1 diabetes results of a 6-month randomized comparative trial Diabetes Care 27 (11) (2004) 2622ndash2627
[118] PA Hollander etal Ef 1047297cacyand safety of inhaled insulin (exubera)comparedwithsubcutaneousinsulin therapy in patients with type 2 diabetesresults of a 6-monthrandomized comparative trial Diabetes Care 27 (10) (2004) 2356ndash2362
[119] C Black et al The clinical effectiveness and cost-effectiveness of inhaled insulin indiabetes mellitus a systematic review and economic evaluation Health TechnolAssess 11 (33) (2007) 1ndash126
[120] A Opar Another blowfor inhaled protein therapeutics Nat Rev Drug Discov 7 (3)(2008) 189ndash190
[121] J Kling Dreamboat sinks prospects for fast approval of inhaled insulin NatBiotechnol 29 (3) (2011) 175ndash176
[122] Press Releases MannKind Reports Positive Data from a Phase 3 Clinical Study of AFREZZA in Patients with Type 1 Diabetes (February 9 2014 Published August14 2013) Available from httpwwwnewsmannkindcorpcomphoenixzhtmlc=147953ampp=irol-newsArticleampID=1847441amphighlight=
[123] Available from httpwwwcivitastherapeuticscomCVT-301html
[124] Cardeas Pharma Announces that FDA Grants QIDP Designation and Fast TrackReview for the Companys Antibiotic Combination Product (February 9 2014Published January 8 2014) Available from httpcardeaspharmacom press-releasescardeas-pharma-announces-that-fda-grants-qidp-designation-and-fast-track-review-for-the-companys-antibiotic-combination-product
[125] M Staples et al Application of micro- and nano-electromechanical devices todrug delivery Pharm Res 23 (5) (2006) 847ndash863
[126] TJ Smith et al Intravitreal sustained-release ganciclovir Arch Ophthalmol 110(2) (1992) 255ndash258
[127] GE Sanborn et al Sustained-release ganciclovir therapy for treatment of cyto-megalovirus retinitis Use of an intravitreal device Arch Ophthalmol 110 (2)(1992) 188ndash195
[128] G Velez SM Whitcup New developments in sustained release drug deliveryfor the treatment of intraocular disease Br J Ophthalmol 83 (11) (1999)1225ndash1229
[129] DH Geroski HF Edelhauser Drug delivery for posterior segment eye diseaseInvest Ophthalmol Vis Sci 41 (5) (2000) 961ndash964
[130] DC Musch et al Treatment of cytomegalovirus retinitis with a sustained-releaseganciclovir implant The Ganciclovir Implant Study Group N Engl J Med 337 (2)(1997) 83ndash90
[131] CL Stevenson JT Santini Jr R Langer Reservoir-based drug delivery systemsutilizing microtechnology Adv Drug Deliv Rev 64 (14) (2012) 1590ndash1602
[132] RA Receveur FW Lindemans NF de Rooij Microsystem technologies forimplantable applications J Micromech Microeng 17 (5) (2007) R50
[133] AC Richards Grayson et al Electronic MEMS for triggered delivery Adv DrugDeliv Rev 56 (2) (2004) 173ndash184
[134] HowOzurdex(R) Works(March11 2014) Available fromhttpwwwozurdexcom HowItWorksaspx
[135] A Giese et al Pattern of recurrencefollowinglocal chemotherapy with biodegrad-able carmustine (BCNU) implants in patients with glioblastoma J Neurooncol 66(3) (2004) 351ndash360
[136] EL Weber EA Goebel Cerebral edema associated with Gliadel wafers two casestudies Neuro Oncol 7 (1) (2005) 84ndash89
[137] JT Santini Jr MJ Cima R Langer A controlled-release microchip Nature 397(6717) (1999) 335ndash338
[138] R Farra et al First-in-human testing of a wirelessly controlled drug deliverymicrochip Sci Transl Med 4 (122) (2012) 122ra21
[139] B Hughes Antibodyndash
drug conjugates for cancer poised to deliver Nat Rev DrugDiscov 9 (9) (2010) 665ndash667
[140] JR Junutula et al Site-speci1047297c conjugation of a cytotoxic drug to an antibodyimproves the therapeutic index Nat Biotechnol 26 (8) (2008) 925ndash932
[141] S Verma et al Trastuzumab emtansinefor HER2-positive advanced breast cancerN Engl J Med 367 (19) (2012) 1783ndash1791
[142] ImmunoGen Inc Reports First Quarter Fiscal Year 2014 Financial Results andProvides Quarterly Update (February 9 2014 Published October 25 2013) Avail-able from httpinvestorimmunogencomreleasedetailcfmReleaseID=800370
[143] P Chames et al Therapeutic antibodies successes limit ations and hopes for thefuture Br J Pharmacol 157 (2) (2009) 220ndash233
[144] CF McDonagh et al Engineered antibodyndashdrugconjugateswith de1047297ned sites andstoichiometries of drug attachment Protein Eng Des Sel 19 (7) (2006) 299ndash307
[145] JY Axup et al Synthesis of site-speci1047297c antibodyndashdrug conjugates using unnatu-ral amino acids Proc Natl Acad Sci U S A 109 (40) (2012) 16101ndash16106
[146] SCAlleyNM Okeley PD Senter Antibodyndashdrug conjugates targeted drug deliveryfor cancer Curr Opin Chem Biol 14 (4) (2010) 529ndash537
[147] JM Lambert Drug-conjugated antibodies for the treatment of cancer Br J ClinPharmacol 76 (2) (2013) 248ndash262
27 AC Anselmo S Mitragotri Journal of Controlled Release 190 (2014) 15ndash 28
8152019 Revision sobre formas farmaceuticas nuevas
[149] A Younes et al Brentuximab vedotin (SGN-35) for relapsed CD30-positive lym-phomas N Engl J Med 363 (19) (2010) 1812ndash1821
[150] RS Zolot S Basu RP Million Antibodyndashdrugconjugates Nat Rev Drug Discov12(4) (2013) 259ndash260
[151] FDA P1047297zer Voluntarily Withdraws Cancer Treatment Mylotarg from US Market(February 9 2014 Published June 21 2010) Available from httpwwwfdagov NewsEventsNewsroomPressAnnouncementsucm216448htm
[152] AM Wu PD Senter Arming antibodies prospects and challenges forimmunoconjugates Nat Biotechnol 23 (9) (2005) 1137ndash1146
[153] AK Burnett et al The addition of gemtuzumab ozogamicin to intensive chemo-therapy in older patients with AML produces a signi1047297cant improvement in overallsurvival results of the UK NCRI AML16 randomizedtrial Blood 2011 (AMER SOCHEMATOLOGY 1900 M STREET NW SUITE 200 WASHINGTON DC 20036 USA)
[154] R Langer A personal account of translating discoveries in an academic lab NatBiotechnol 31 (6) (2013) 487ndash489
[155] US Pharmaceutical Sales mdash 2013 (January 17 2014) Available from httpwwwdrugscomstatstop1002013sales
28 AC Anselmo S Mitragotri Journal of Controlled Release 190 (2014) 15ndash 28
8152019 Revision sobre formas farmaceuticas nuevas
[1] M Kermode Unsafe injections in low-income country health settings need forinjection safety promotion to prevent the spread of blood-borne viruses HealthPromot Int 19 (1) (2004) 95ndash103
[2] M Goldberg I Gomez-Orellana Challenges for the oral delivery of macromole-cules Nat Rev Drug Discov 2 (4) (2003) 289ndash295
[3] JS Patton PR ByronInhalingmedicinesdelivering drugs to thebodythroughthelungs Nat Rev Drug Discov 6 (1) (2007) 67ndash74
[4] MR Prausnitz R Langer Transdermal drug delivery Nat Biotechnol 26 (11)(2008) 1261ndash1268
[5] R Gaudana et al Ocular drug delivery AAPS J 12 (3) (2010) 348ndash360[6] L Illum Nasal drug deliverynew developments andstrategiesDrugDiscov Today
7 (23) (2002) 1184ndash1189[7] JE Talmadge The pharmaceutics and delivery of therapeutic polypeptides and
proteins Adv Drug Deliv Rev 10 (2) (1993) 247ndash299[8] RLanger Controlledrelease of a therapeuticproteinNat Med 2 (7)(1996)742ndash743[9] R Langer J Folkman Polymers for the sustained release of proteins and other
macromolecules Nature 263 (5580) (1976) 797ndash800[10] JC Wright AS Hoffman Historical overview of long acting injections and
implants Long Acting Injections and Implants Springer 2012 pp 11ndash24[11] M Chaubal Polylactidesglycolidesmdashexcipients for injectable drug delivery and
beyond Drug Deliv Technol 2 (2002) 34ndash36[12] G Zhu SR Mallery SP Schwendeman Stabilization of proteins encapsulated in
injectable poly (lactide-co-glycolide) Nat Biotechnol 18 (1) (2000) 52ndash57[13] V Sinha A Trehan Biodegradable microspheres for protein delivery J Control
Release 90 (3) (2003) 261ndash280[14] M van de Weert WE Hennink W Jiskoot Protein instability in poly (lactic-co-
glycolic acid) microparticles Pharm Res 17 (10) (2000) 1159ndash1167[15] OL Johnson et al A month-longeffect froma single injection of microencapsulated
human growth hormone Nat Med 2 (7) (1996) 795ndash799[16] W Jianget al Biodegradable poly(lactic-co-glycolic acid) microparticles for inject-
able delivery of vaccine antigens Adv Drug Deliv Rev 57 (3) (2005) 391 ndash410[17] F Jordan et al Sustained release hGH microsphere formulation produced by a
novel supercritical 1047298uid technology in vivo studies J Control Release 141 (2)(2010) 153ndash160
[18] MA Tracy Development and scale-up of a microsphere protein delivery systemBiotechnol Prog 14 (1) (1998) 108ndash115
[20] Johnson amp Johnson Annual Report 2012 (February 9 2014) Available fromhttpswwwjnjcomsitesdefault 1047297lespdfJNJ2012annualreportpdf
[21] TM Allen PR Cullis Drug delivery systems entering themainstreamScience303(5665) (2004) 1818ndash1822
[22] T Allen A Chonn Large unilamellar liposomes with low uptake into the reticulo-endothelial system FEBS Lett 223 (1) (1987) 42ndash46
[23] Y Matsumura H Maeda A new concept for macromolecular therapeuticsin cancer chemotherapy mechanism of tumoritropic accumulation of
proteins and the antitumor agent smancs Cancer Res 46 (12 Part 1) (1986)6387ndash6392[24] G Haran et al Transmembrane ammonium sulfate gradients in liposomes
produce ef 1047297cient and stable entrapment of amphipathic weak bases BiochimBiophys Acta (BBA)mdashBiomembr 1151 (2) (1993) 201ndash215
[25] AT Horowitz Y Barenholz AA Gabizon In vitro cytotoxicity of liposome-encapsulated doxorubicin dependence on liposome composition anddrug release Biochim Biophys Acta (BBA)mdashBiomembr 1109 (2) (1992)203ndash209
[26] AA Gabizon Y Barenholz M Bialer Prolongation of the circulation time of doxo-rubicin encapsulated in liposomes containing a polyethylene glycol-derivatizedphospholipid pharmacokinetic studies in rodents and dogs Pharm Res 10 (5)(1993) 703ndash708
[27] A Gabizon et al Prolonged circulation time and enhanced accumulation in malig-nant exudates of doxorubicin encapsulated in polyethylene-glycol coated lipo-somes Cancer Res 54 (4) (1994) 987ndash992
[28] H Maedaet alTumorvascularpermeabilityand theEPR effectin macromoleculartherapeutics a review J Control Release 65 (1) (2000) 271ndash284
[29] Important Update Regarding Supply Outage of DOXILreg Available from http
wwwdoxilcomdoxil-supply-shortage February 9 2014[30] D Peer et al Nanocarriers as an emerging platform for cancer therapy Nat
Nanotechnol 2 (12) (2007) 751ndash760[31] E Ruoslahti Peptides as targeting elements and tissue penetration devices for
nanoparticles Adv Mater 24 (28) (2012) 3747ndash3756[32] PL Rodriguez et al Minimal ldquoself rdquo peptides that inhibit phagocytic clearance and
enhance delivery of nanoparticles Science 339 (6122) (2013) 971ndash975[33] SM Moghimi AC Hunter JC Murray Long-circulating and target-speci1047297c
nanoparticles theory to practice Pharmacol Rev 53 (2) (2001) 283ndash318[34] JP Rolland et al Direct fabrication and harvesting of monodisperse shape-
speci1047297c nanobiomaterials J Am Chem Soc 127 (28) (2005) 10096ndash10100[35] SW Morton et al Scalable manufacture of built-to-order nanomedicine spray-
assisted layer-by-layer functionalization of PRINT nanoparticles Adv Mater 25(34) (2013) 4707ndash4713
[36] M Ferrari Cancer nanotechnology opportunities and challenges Nat Rev Cancer5 (3) (2005) 161ndash171
[37] WJ Gradishar et al Phase III trial of nanoparticle albumin-bound paclitaxel com-pared with polyethylated castor oil-based paclitaxel in women with breast cancer
J Clin Oncol 23 (31) (2005) 7794ndash7803
[38] M Green et al Abraxanereg a novel Cremophorreg-free albumin-bound particleform of paclitaxel for the treatment of advanced non-small-cell lung cancer AnnOncol 17 (8) (2006) 1263ndash1268
[39] DW Nymanet alPhaseI andpharmacokinetics trial of ABI-007 a novel nanopar-ticle formulation of paclitaxel in patients with advanced nonhematologic malig-nancies J Clin Oncol 23 (31) (2005) 7785ndash7793
[40] Celgene Corporation Announces 2014 Financial Outlook and Preliminary 2013Results (February 9 2014) Available from httpircelgenecomreleasedetailcfmReleaseID=821044
[41] J Hrkach et al Preclinical development and clinical translation of a PSMA-targeteddocetaxel nanoparticle with a differentiated pharmacological pro1047297le Sci Transl
Med 4 (128) (2012) 128ra39[42] S Svenson et al Preclinical to clinical development of the novel camptothecin
nanopharmaceutical CRLX101 J Control Release 153 (1) (2011) 49ndash55[43] S Eliasof et al Correlating preclinical animal studies and human clinical trials of a
multifunctional polymeric nanoparticle Proc Natl Acad Sci U S A 110 (37)(2013) 15127ndash15132
[44] ME Davis et al Evidence of RNAi in humans from systemically administeredsiRNA via targeted nanoparticles Nature 464 (7291) (2010) 1067ndash1070
[45] AZ Wang R Langer OC Farokhzad Nanoparticle delivery of cancer drugs AnnuRev Med 63 (2012) 185ndash198
[46] Y Matsumura K Kataoka Preclinical and clinical studies of anticancer agent-incorporating polymer micelles Cancer Sci 100 (4) (2009) 572ndash579
[47] JD Heidel ME Davis Clinical developments in nanotechnology for cancer thera-py Pharm Res 28 (2) (2011) 187ndash199
[48] B D alby et al Advanced transfection with Lipofectamine 2000 reagent primaryneurons siRNAand high-throughput applicationsMethods 33 (2) (2004)95ndash103
[49] S Venkatraman R Gale Skin adhesives and skin adhesion 1 Transdermal drugdelivery systems Biomaterials 19 (13) (1998) 1119ndash1136
[50] AC Watkinson A commentary on transdermal drug delivery systems in clinicaltrials J Pharm Sci 102 (9) (2013) 3082ndash3088
[51] TH Stanley Fentanyl J Pain Symptom Manage 29 (5 Suppl) (2005) S67ndashS71[52] TH Stanley The history and development of the fentanyl series J Pain Symptom
Manage 7 (3 Suppl) (1992) S3ndashS7[53] Lidoderm Sales Data (February 9 2014) Available from httpwwwdrugscom
statslidoderm[54] S Mitragotri Healingsound theuse of ultrasoundin drug delivery andotherther-
apeutic applications Nat Rev Drug Discov 4 (3) (2005) 255ndash260[55] P Karande A Jain S Mitragotri Insights into synergistic interactions in binary
mixtures of chemical permeation enhancers for transdermal drug delivery J Control Release 115 (1) (2006) 85ndash93
[56] MR Prausnitz Microneedles for transdermal drug delivery Adv Drug Deliv Rev56 (5) (2004) 581ndash587
[57] YN Kalia et al Iontophoretic drug delivery Adv Drug Deliv Rev 56 (5) (2004)619ndash658
[58] P Karande A Jain S Mitragotri Discovery of transdermal penetration enhancersby high-throughput screening Nat Biotechnol 22 (2) (2004) 192ndash197
[59] MA Ashburn et al Iontophoretic delivery of morphinefor postoperative analgesia
J Pain Symptom Manage 7 (1) (1992) 27ndash
33[60] R van der Geest et al Iontophoretic delivery of apomorphine II An in vivo studyin patients with Parkinsons disease Pharm Res 14 (12) (1997) 1804ndash1810
[61] M Cormier et al Effect of transdermal iontophoresis codelivery of hydrocortisoneon metoclopramide pharmacokinetics and skin-induced reactions in humansubjects J Pharm Sci 88 (10) (1999) 1030ndash1035
[62] MP James RM Graham J English Percutaneous iontophoresis of prednisolonemdashapharmacokinetic study Clin Exp Dermatol 11 (1) (1986) 54ndash61
[63] PG Green Iontophoretic delivery of peptide drugs J Control Release 41 (1)(1996) 33ndash48
[64] EL Spierings JA Brevard NP Katz Two‐minute skin anesthesia through ultra-sound pretreatment and iontophoretic delivery of a topical anesthetic a feasibilitystudy Pain Med 9 (1) (2008) 55ndash59
[65] P SantoiannI M Nino G Calabro Intradermal Drug Delivery by Low FrequencySonophoresis (25 kHz) 2004
[66] BE Polat et al Ultrasound-mediated transdermal drug delivery mechanismsscope and emerging trends J Control Release 152 (3) (2011) 330ndash348
[67] JJ Norman et al Faster pharmacokinetics and increased patient acceptance of intradermal insulin delivery using a single hollow microneedle in children and
adolescents with type 1 diabetes Pediatr Diabetes 14 (6) (2013) 459 ndash465[68] J Gupta EI Felner MR Prausnitz Rapid pharmacokinetics of intradermal insulin
administered using microneedles in type 1 diabetes subjects Diabetes TechnolTher 13 (4) (2011) 451ndash456
[69] J Gupta EI Felner MR Prausnitz Minimally invasive insulin delivery in subjectswith type 1 diabetes using hollow microneedles Diabetes Technol Ther 11 (6)(2009) 329ndash337
[70] J Gupta et al Rapid local anesthesia in humans using minimally invasivemicroneedles Clin J Pain 28 (2) (2012) 129ndash135
[72] M Ameri SC Fan YF Maa Parathyroid hormone PTH(1ndash34) formulation thatenables uniform coating on a novel transdermal microprojection delivery systemPharm Res 27 (2) (2010) 303ndash313
[73] PE Daddona et al Parathyroid hormone (1ndash34)-coated microneedle patchsystem clinical pharmacokinetics and pharmacodynamics for treatment of osteo-porosis Pharm Res 28 (1) (2011) 159ndash165
[74] A Arora MR Prausnitz S Mitragotri Micro-scale devices for transdermal drugdelivery Int J Pharm 364 (2) (2008) 227ndash236
26 AC Anselmo S Mitragotri Journal of Controlled Release 190 (2014) 15ndash 28
8152019 Revision sobre formas farmaceuticas nuevas
[75] S Mayes M Ferrone Fentanyl HCl patient-controlled iontophoretic transdermalsystem for the management of acute postoperative pain Ann Pharmacother 40(12) (2006) 2178ndash2186
[76] WT Zempsky et al Evaluation of a low-dose lidocaine iontophoresis system fortopical anesthesia in adults and children a randomized controlled trial ClinTher 26 (7) (2004) 1110ndash1119
[77] BM Becker et al Ultrasound with topical anesthetic rapidly decreases pain of intravenous cannulation Acad Emerg Med 12 (4) (2005) 289ndash295
[78] SK Vashist Non-invasive glucose monitoring technology in diabetes managementa review Anal Chim Acta 750 (2012) 16ndash27
[79] H Chuang et al Pilot studies of transdermal continuous glucose measurement
in outpatient diabetic patients and in patients during and after cardiac surgery J Diabetes Sci Technol 2 (4) (2008) 595ndash602[80] S Rose JF Nelson A continuous long-term injector Aust J Exp Biol Med Sci 33
(4) (1955) 415ndash419[81] F Theeuwes Elementary osmotic pump J Pharm Sci 64 (12) (1975) 1987ndash1991[82] V Malaterre et al Oral osmotically driven systems 30 years of development and
clinical use Eur J Pharm Biopharm 73 (3) (2009) 311ndash323[83] E Rosenthal The Soaring Cost of a Simple Breath (February 9 2014) Published
October 12 2013] Available from httpwwwnytimescom20131013usthe-soaring-cost-of-a-simple-breathhtml_r=0
[84] F Theeuwes Orososmotic system development Drug Dev Ind Pharm 9 (7)(1983) 1331ndash1357
[85] CG Park et al A nano1047297brous sheet-based system for linear delivery of nifedipine J Control Release 149 (3) (2011) 250ndash257
[86] DM Bass M Prevo DS Waxman Gastrointestinal safety of an extended-releasenondeformable oral dosage form (OROS) a retrospective study Drug Saf 25(14) (2002) 1021ndash1033
[87] GA Agyilirah GS Banker Polymers for Enteric Coating Applications Polymers forControlled Drug Delivery CRC Press Boca Raton 1991 39ndash66
[88] G Ponchel J-M Irache Speci1047297c and non-speci1047297c bioadhesive particulate systemsfor oral delivery to the gastrointestinal tract Adv Drug Deliv Rev 34 (2) (1998)191ndash219
[89] M Morishita NA Peppas Is the oral route possible for peptide and protein drugdelivery Drug Discov Today 11 (19) (2006) 905ndash910
[90] A Bernkop-Schnuumlrch The use of inhibitory agents to overcome the enzymatic bar-rier to perorally administered therapeuticpeptides and proteins J Control Release52 (1) (1998) 1ndash16
[91] LM Ensign R Cone J HanesOral drug delivery with polymeric nanoparticles thegastrointestinal mucus barriers Adv Drug Deliv Rev 64 (6) (2012) 557ndash570
[92] E Mathiowitz et al Biologically erodable microspheres as potential oral drugdelivery systems Nature 386 (6623) (1997) 410ndash414
[93] V Gupta et alMucoadhesiveintestinaldevices fororal delivery of salmon calcitonin J Control Release 172 (3) (2013) 753ndash762
[95] PW Swaan Recent advances in intestinal macromolecular drug delivery viareceptor-mediated transport pathways Pharm Res 15 (6) (1998) 826ndash834
[96] R Eldor et al Glucose-reducing effect of the ORMD-0801 oral insulin preparationin patients with uncontrolled type 1 diabetes a pilot study PLoS One 8 (4) (2013)e59524
[97] TheEligenreg Library(February9 2014) Available from httpwwwemispherecom eligen_libraryhtml
[98] MC Castelli et al Comparing the ef 1047297cacy and tolerability of a new daily oral vita-min B12 formulation and intermittent intramuscular vitamin B12 in normalizinglow cobalamin levels a randomized open-label parallel-group study Clin Ther33 (3) (2011) 358ndash371 (e2)
[99] K Whitehead Z Shen S Mitragotri Oraldelivery of macromoleculesusing intestinalpatches applications for insulin delivery J Control Release 98 (1) (2004) 37ndash45
[100] EM Pridgen et al Transepithelial transport of fc-targeted nanoparticles by theneonatal fc receptor for oral delivery Sci Transl Med 5 (213) (2013) 213ra167
[101] M Torres‐Lugo et al pH‐sensitive hydrogels as gastrointestinal tract absorptionenhancers transport mechanisms of salmoncalcitoninand other modelmoleculesusing the Caco‐2 cell model Biotechnol Prog 18 (3) (2002) 612ndash616
[102] M Torres-Lugo et al Physicochemical behavior and cytotoxic effects of p (methacrylic acidndashg-ethylene glycol) nanospheres for oral delivery of proteins
J Control Release 80 (1) (2002) 197ndash
205[103] RU Agu et alThe lung as a route forsystemicdeliveryof therapeuticproteins and
peptides Respir Res 2 (4) (2001) 198[104] R Dalby J Suman Inhalation therapy technological milestones in asthma treat-
ment Adv Drug Deliv Rev 55 (7) (2003) 779ndash791[105] PJ Anderson History of aerosol therapy liquid nebulization to MDIs to DPIs
Respir Care 50 (9) (2005) 1139ndash1150[106] JB Fink BK Rubin Problems with inhaler use a call for improved clinician and
patient education Respir Care 50 (10) (2005) 1360ndash1375[107] MJ Telko AJ Hickey Dry powder inhaler formulation Respir Care 50 (9) (2005)
1209ndash1227[108] DAEdwardsA Ben-Jebria R Langer Recentadvances in pulmonary drug delivery
using large porous inhaled particles J Appl Physiol 85 (2) (1998) 379ndash385[109] MB DolovichR DhandAerosol drug deliverydevelopments in devicedesign and
clinical use Lancet 377 (9770) (2011) 1032ndash1045[110] A Hussain et al Absorption enhancers in pulmonary protein delivery J Control
Release 94 (1) (2004) 15ndash24[111] J L Cleland A Daugherty R Mrsny Emerging protein delivery methods Curr
Opin Biotechnol 12 (2) (2001) 212ndash219
[112] JS Patton J Bukar S Nagarajan Inhaled insulin Adv Drug Deliv Rev 35 (2ndash3)(1999) 235ndash247
[113] FDA to Complete Phase-out of Chloro1047298uorocarbon Inhalers (February 9 2014Published October 23 2013) Available from httpwwwfdagovnewsevents newsroompressannouncementsucm371901htm
[114] Drug Treatments for Asthma and Chronic Obstructive Pulmonary Disease ThatDo Not Use Chloro1047298uorocarbons (February 9 2014) Available from http wwwfdagovDrugsDrugSafetyInformationbyDrugClassucm082370htm
[115] AJ Hickey Back to the future inhaled drug products J Pharm Sci 102 (4) (2013)1165ndash1172
[116] S White et al EXUBERA pharmaceutical development of a novel product for
906[117] T Quattrin et al Ef 1047297cacy and safety of inhaled insulin (Exubera) compared withsubcutaneous insulin therapy in patients with type 1 diabetes results of a 6-month randomized comparative trial Diabetes Care 27 (11) (2004) 2622ndash2627
[118] PA Hollander etal Ef 1047297cacyand safety of inhaled insulin (exubera)comparedwithsubcutaneousinsulin therapy in patients with type 2 diabetesresults of a 6-monthrandomized comparative trial Diabetes Care 27 (10) (2004) 2356ndash2362
[119] C Black et al The clinical effectiveness and cost-effectiveness of inhaled insulin indiabetes mellitus a systematic review and economic evaluation Health TechnolAssess 11 (33) (2007) 1ndash126
[120] A Opar Another blowfor inhaled protein therapeutics Nat Rev Drug Discov 7 (3)(2008) 189ndash190
[121] J Kling Dreamboat sinks prospects for fast approval of inhaled insulin NatBiotechnol 29 (3) (2011) 175ndash176
[122] Press Releases MannKind Reports Positive Data from a Phase 3 Clinical Study of AFREZZA in Patients with Type 1 Diabetes (February 9 2014 Published August14 2013) Available from httpwwwnewsmannkindcorpcomphoenixzhtmlc=147953ampp=irol-newsArticleampID=1847441amphighlight=
[123] Available from httpwwwcivitastherapeuticscomCVT-301html
[124] Cardeas Pharma Announces that FDA Grants QIDP Designation and Fast TrackReview for the Companys Antibiotic Combination Product (February 9 2014Published January 8 2014) Available from httpcardeaspharmacom press-releasescardeas-pharma-announces-that-fda-grants-qidp-designation-and-fast-track-review-for-the-companys-antibiotic-combination-product
[125] M Staples et al Application of micro- and nano-electromechanical devices todrug delivery Pharm Res 23 (5) (2006) 847ndash863
[126] TJ Smith et al Intravitreal sustained-release ganciclovir Arch Ophthalmol 110(2) (1992) 255ndash258
[127] GE Sanborn et al Sustained-release ganciclovir therapy for treatment of cyto-megalovirus retinitis Use of an intravitreal device Arch Ophthalmol 110 (2)(1992) 188ndash195
[128] G Velez SM Whitcup New developments in sustained release drug deliveryfor the treatment of intraocular disease Br J Ophthalmol 83 (11) (1999)1225ndash1229
[129] DH Geroski HF Edelhauser Drug delivery for posterior segment eye diseaseInvest Ophthalmol Vis Sci 41 (5) (2000) 961ndash964
[130] DC Musch et al Treatment of cytomegalovirus retinitis with a sustained-releaseganciclovir implant The Ganciclovir Implant Study Group N Engl J Med 337 (2)(1997) 83ndash90
[131] CL Stevenson JT Santini Jr R Langer Reservoir-based drug delivery systemsutilizing microtechnology Adv Drug Deliv Rev 64 (14) (2012) 1590ndash1602
[132] RA Receveur FW Lindemans NF de Rooij Microsystem technologies forimplantable applications J Micromech Microeng 17 (5) (2007) R50
[133] AC Richards Grayson et al Electronic MEMS for triggered delivery Adv DrugDeliv Rev 56 (2) (2004) 173ndash184
[134] HowOzurdex(R) Works(March11 2014) Available fromhttpwwwozurdexcom HowItWorksaspx
[135] A Giese et al Pattern of recurrencefollowinglocal chemotherapy with biodegrad-able carmustine (BCNU) implants in patients with glioblastoma J Neurooncol 66(3) (2004) 351ndash360
[136] EL Weber EA Goebel Cerebral edema associated with Gliadel wafers two casestudies Neuro Oncol 7 (1) (2005) 84ndash89
[137] JT Santini Jr MJ Cima R Langer A controlled-release microchip Nature 397(6717) (1999) 335ndash338
[138] R Farra et al First-in-human testing of a wirelessly controlled drug deliverymicrochip Sci Transl Med 4 (122) (2012) 122ra21
[139] B Hughes Antibodyndash
drug conjugates for cancer poised to deliver Nat Rev DrugDiscov 9 (9) (2010) 665ndash667
[140] JR Junutula et al Site-speci1047297c conjugation of a cytotoxic drug to an antibodyimproves the therapeutic index Nat Biotechnol 26 (8) (2008) 925ndash932
[141] S Verma et al Trastuzumab emtansinefor HER2-positive advanced breast cancerN Engl J Med 367 (19) (2012) 1783ndash1791
[142] ImmunoGen Inc Reports First Quarter Fiscal Year 2014 Financial Results andProvides Quarterly Update (February 9 2014 Published October 25 2013) Avail-able from httpinvestorimmunogencomreleasedetailcfmReleaseID=800370
[143] P Chames et al Therapeutic antibodies successes limit ations and hopes for thefuture Br J Pharmacol 157 (2) (2009) 220ndash233
[144] CF McDonagh et al Engineered antibodyndashdrugconjugateswith de1047297ned sites andstoichiometries of drug attachment Protein Eng Des Sel 19 (7) (2006) 299ndash307
[145] JY Axup et al Synthesis of site-speci1047297c antibodyndashdrug conjugates using unnatu-ral amino acids Proc Natl Acad Sci U S A 109 (40) (2012) 16101ndash16106
[146] SCAlleyNM Okeley PD Senter Antibodyndashdrug conjugates targeted drug deliveryfor cancer Curr Opin Chem Biol 14 (4) (2010) 529ndash537
[147] JM Lambert Drug-conjugated antibodies for the treatment of cancer Br J ClinPharmacol 76 (2) (2013) 248ndash262
27 AC Anselmo S Mitragotri Journal of Controlled Release 190 (2014) 15ndash 28
8152019 Revision sobre formas farmaceuticas nuevas
[149] A Younes et al Brentuximab vedotin (SGN-35) for relapsed CD30-positive lym-phomas N Engl J Med 363 (19) (2010) 1812ndash1821
[150] RS Zolot S Basu RP Million Antibodyndashdrugconjugates Nat Rev Drug Discov12(4) (2013) 259ndash260
[151] FDA P1047297zer Voluntarily Withdraws Cancer Treatment Mylotarg from US Market(February 9 2014 Published June 21 2010) Available from httpwwwfdagov NewsEventsNewsroomPressAnnouncementsucm216448htm
[152] AM Wu PD Senter Arming antibodies prospects and challenges forimmunoconjugates Nat Biotechnol 23 (9) (2005) 1137ndash1146
[153] AK Burnett et al The addition of gemtuzumab ozogamicin to intensive chemo-therapy in older patients with AML produces a signi1047297cant improvement in overallsurvival results of the UK NCRI AML16 randomizedtrial Blood 2011 (AMER SOCHEMATOLOGY 1900 M STREET NW SUITE 200 WASHINGTON DC 20036 USA)
[154] R Langer A personal account of translating discoveries in an academic lab NatBiotechnol 31 (6) (2013) 487ndash489
[155] US Pharmaceutical Sales mdash 2013 (January 17 2014) Available from httpwwwdrugscomstatstop1002013sales
28 AC Anselmo S Mitragotri Journal of Controlled Release 190 (2014) 15ndash 28
8152019 Revision sobre formas farmaceuticas nuevas
[1] M Kermode Unsafe injections in low-income country health settings need forinjection safety promotion to prevent the spread of blood-borne viruses HealthPromot Int 19 (1) (2004) 95ndash103
[2] M Goldberg I Gomez-Orellana Challenges for the oral delivery of macromole-cules Nat Rev Drug Discov 2 (4) (2003) 289ndash295
[3] JS Patton PR ByronInhalingmedicinesdelivering drugs to thebodythroughthelungs Nat Rev Drug Discov 6 (1) (2007) 67ndash74
[4] MR Prausnitz R Langer Transdermal drug delivery Nat Biotechnol 26 (11)(2008) 1261ndash1268
[5] R Gaudana et al Ocular drug delivery AAPS J 12 (3) (2010) 348ndash360[6] L Illum Nasal drug deliverynew developments andstrategiesDrugDiscov Today
7 (23) (2002) 1184ndash1189[7] JE Talmadge The pharmaceutics and delivery of therapeutic polypeptides and
proteins Adv Drug Deliv Rev 10 (2) (1993) 247ndash299[8] RLanger Controlledrelease of a therapeuticproteinNat Med 2 (7)(1996)742ndash743[9] R Langer J Folkman Polymers for the sustained release of proteins and other
macromolecules Nature 263 (5580) (1976) 797ndash800[10] JC Wright AS Hoffman Historical overview of long acting injections and
implants Long Acting Injections and Implants Springer 2012 pp 11ndash24[11] M Chaubal Polylactidesglycolidesmdashexcipients for injectable drug delivery and
beyond Drug Deliv Technol 2 (2002) 34ndash36[12] G Zhu SR Mallery SP Schwendeman Stabilization of proteins encapsulated in
injectable poly (lactide-co-glycolide) Nat Biotechnol 18 (1) (2000) 52ndash57[13] V Sinha A Trehan Biodegradable microspheres for protein delivery J Control
Release 90 (3) (2003) 261ndash280[14] M van de Weert WE Hennink W Jiskoot Protein instability in poly (lactic-co-
glycolic acid) microparticles Pharm Res 17 (10) (2000) 1159ndash1167[15] OL Johnson et al A month-longeffect froma single injection of microencapsulated
human growth hormone Nat Med 2 (7) (1996) 795ndash799[16] W Jianget al Biodegradable poly(lactic-co-glycolic acid) microparticles for inject-
able delivery of vaccine antigens Adv Drug Deliv Rev 57 (3) (2005) 391 ndash410[17] F Jordan et al Sustained release hGH microsphere formulation produced by a
novel supercritical 1047298uid technology in vivo studies J Control Release 141 (2)(2010) 153ndash160
[18] MA Tracy Development and scale-up of a microsphere protein delivery systemBiotechnol Prog 14 (1) (1998) 108ndash115
[20] Johnson amp Johnson Annual Report 2012 (February 9 2014) Available fromhttpswwwjnjcomsitesdefault 1047297lespdfJNJ2012annualreportpdf
[21] TM Allen PR Cullis Drug delivery systems entering themainstreamScience303(5665) (2004) 1818ndash1822
[22] T Allen A Chonn Large unilamellar liposomes with low uptake into the reticulo-endothelial system FEBS Lett 223 (1) (1987) 42ndash46
[23] Y Matsumura H Maeda A new concept for macromolecular therapeuticsin cancer chemotherapy mechanism of tumoritropic accumulation of
proteins and the antitumor agent smancs Cancer Res 46 (12 Part 1) (1986)6387ndash6392[24] G Haran et al Transmembrane ammonium sulfate gradients in liposomes
produce ef 1047297cient and stable entrapment of amphipathic weak bases BiochimBiophys Acta (BBA)mdashBiomembr 1151 (2) (1993) 201ndash215
[25] AT Horowitz Y Barenholz AA Gabizon In vitro cytotoxicity of liposome-encapsulated doxorubicin dependence on liposome composition anddrug release Biochim Biophys Acta (BBA)mdashBiomembr 1109 (2) (1992)203ndash209
[26] AA Gabizon Y Barenholz M Bialer Prolongation of the circulation time of doxo-rubicin encapsulated in liposomes containing a polyethylene glycol-derivatizedphospholipid pharmacokinetic studies in rodents and dogs Pharm Res 10 (5)(1993) 703ndash708
[27] A Gabizon et al Prolonged circulation time and enhanced accumulation in malig-nant exudates of doxorubicin encapsulated in polyethylene-glycol coated lipo-somes Cancer Res 54 (4) (1994) 987ndash992
[28] H Maedaet alTumorvascularpermeabilityand theEPR effectin macromoleculartherapeutics a review J Control Release 65 (1) (2000) 271ndash284
[29] Important Update Regarding Supply Outage of DOXILreg Available from http
wwwdoxilcomdoxil-supply-shortage February 9 2014[30] D Peer et al Nanocarriers as an emerging platform for cancer therapy Nat
Nanotechnol 2 (12) (2007) 751ndash760[31] E Ruoslahti Peptides as targeting elements and tissue penetration devices for
nanoparticles Adv Mater 24 (28) (2012) 3747ndash3756[32] PL Rodriguez et al Minimal ldquoself rdquo peptides that inhibit phagocytic clearance and
enhance delivery of nanoparticles Science 339 (6122) (2013) 971ndash975[33] SM Moghimi AC Hunter JC Murray Long-circulating and target-speci1047297c
nanoparticles theory to practice Pharmacol Rev 53 (2) (2001) 283ndash318[34] JP Rolland et al Direct fabrication and harvesting of monodisperse shape-
speci1047297c nanobiomaterials J Am Chem Soc 127 (28) (2005) 10096ndash10100[35] SW Morton et al Scalable manufacture of built-to-order nanomedicine spray-
assisted layer-by-layer functionalization of PRINT nanoparticles Adv Mater 25(34) (2013) 4707ndash4713
[36] M Ferrari Cancer nanotechnology opportunities and challenges Nat Rev Cancer5 (3) (2005) 161ndash171
[37] WJ Gradishar et al Phase III trial of nanoparticle albumin-bound paclitaxel com-pared with polyethylated castor oil-based paclitaxel in women with breast cancer
J Clin Oncol 23 (31) (2005) 7794ndash7803
[38] M Green et al Abraxanereg a novel Cremophorreg-free albumin-bound particleform of paclitaxel for the treatment of advanced non-small-cell lung cancer AnnOncol 17 (8) (2006) 1263ndash1268
[39] DW Nymanet alPhaseI andpharmacokinetics trial of ABI-007 a novel nanopar-ticle formulation of paclitaxel in patients with advanced nonhematologic malig-nancies J Clin Oncol 23 (31) (2005) 7785ndash7793
[40] Celgene Corporation Announces 2014 Financial Outlook and Preliminary 2013Results (February 9 2014) Available from httpircelgenecomreleasedetailcfmReleaseID=821044
[41] J Hrkach et al Preclinical development and clinical translation of a PSMA-targeteddocetaxel nanoparticle with a differentiated pharmacological pro1047297le Sci Transl
Med 4 (128) (2012) 128ra39[42] S Svenson et al Preclinical to clinical development of the novel camptothecin
nanopharmaceutical CRLX101 J Control Release 153 (1) (2011) 49ndash55[43] S Eliasof et al Correlating preclinical animal studies and human clinical trials of a
multifunctional polymeric nanoparticle Proc Natl Acad Sci U S A 110 (37)(2013) 15127ndash15132
[44] ME Davis et al Evidence of RNAi in humans from systemically administeredsiRNA via targeted nanoparticles Nature 464 (7291) (2010) 1067ndash1070
[45] AZ Wang R Langer OC Farokhzad Nanoparticle delivery of cancer drugs AnnuRev Med 63 (2012) 185ndash198
[46] Y Matsumura K Kataoka Preclinical and clinical studies of anticancer agent-incorporating polymer micelles Cancer Sci 100 (4) (2009) 572ndash579
[47] JD Heidel ME Davis Clinical developments in nanotechnology for cancer thera-py Pharm Res 28 (2) (2011) 187ndash199
[48] B D alby et al Advanced transfection with Lipofectamine 2000 reagent primaryneurons siRNAand high-throughput applicationsMethods 33 (2) (2004)95ndash103
[49] S Venkatraman R Gale Skin adhesives and skin adhesion 1 Transdermal drugdelivery systems Biomaterials 19 (13) (1998) 1119ndash1136
[50] AC Watkinson A commentary on transdermal drug delivery systems in clinicaltrials J Pharm Sci 102 (9) (2013) 3082ndash3088
[51] TH Stanley Fentanyl J Pain Symptom Manage 29 (5 Suppl) (2005) S67ndashS71[52] TH Stanley The history and development of the fentanyl series J Pain Symptom
Manage 7 (3 Suppl) (1992) S3ndashS7[53] Lidoderm Sales Data (February 9 2014) Available from httpwwwdrugscom
statslidoderm[54] S Mitragotri Healingsound theuse of ultrasoundin drug delivery andotherther-
apeutic applications Nat Rev Drug Discov 4 (3) (2005) 255ndash260[55] P Karande A Jain S Mitragotri Insights into synergistic interactions in binary
mixtures of chemical permeation enhancers for transdermal drug delivery J Control Release 115 (1) (2006) 85ndash93
[56] MR Prausnitz Microneedles for transdermal drug delivery Adv Drug Deliv Rev56 (5) (2004) 581ndash587
[57] YN Kalia et al Iontophoretic drug delivery Adv Drug Deliv Rev 56 (5) (2004)619ndash658
[58] P Karande A Jain S Mitragotri Discovery of transdermal penetration enhancersby high-throughput screening Nat Biotechnol 22 (2) (2004) 192ndash197
[59] MA Ashburn et al Iontophoretic delivery of morphinefor postoperative analgesia
J Pain Symptom Manage 7 (1) (1992) 27ndash
33[60] R van der Geest et al Iontophoretic delivery of apomorphine II An in vivo studyin patients with Parkinsons disease Pharm Res 14 (12) (1997) 1804ndash1810
[61] M Cormier et al Effect of transdermal iontophoresis codelivery of hydrocortisoneon metoclopramide pharmacokinetics and skin-induced reactions in humansubjects J Pharm Sci 88 (10) (1999) 1030ndash1035
[62] MP James RM Graham J English Percutaneous iontophoresis of prednisolonemdashapharmacokinetic study Clin Exp Dermatol 11 (1) (1986) 54ndash61
[63] PG Green Iontophoretic delivery of peptide drugs J Control Release 41 (1)(1996) 33ndash48
[64] EL Spierings JA Brevard NP Katz Two‐minute skin anesthesia through ultra-sound pretreatment and iontophoretic delivery of a topical anesthetic a feasibilitystudy Pain Med 9 (1) (2008) 55ndash59
[65] P SantoiannI M Nino G Calabro Intradermal Drug Delivery by Low FrequencySonophoresis (25 kHz) 2004
[66] BE Polat et al Ultrasound-mediated transdermal drug delivery mechanismsscope and emerging trends J Control Release 152 (3) (2011) 330ndash348
[67] JJ Norman et al Faster pharmacokinetics and increased patient acceptance of intradermal insulin delivery using a single hollow microneedle in children and
adolescents with type 1 diabetes Pediatr Diabetes 14 (6) (2013) 459 ndash465[68] J Gupta EI Felner MR Prausnitz Rapid pharmacokinetics of intradermal insulin
administered using microneedles in type 1 diabetes subjects Diabetes TechnolTher 13 (4) (2011) 451ndash456
[69] J Gupta EI Felner MR Prausnitz Minimally invasive insulin delivery in subjectswith type 1 diabetes using hollow microneedles Diabetes Technol Ther 11 (6)(2009) 329ndash337
[70] J Gupta et al Rapid local anesthesia in humans using minimally invasivemicroneedles Clin J Pain 28 (2) (2012) 129ndash135
[72] M Ameri SC Fan YF Maa Parathyroid hormone PTH(1ndash34) formulation thatenables uniform coating on a novel transdermal microprojection delivery systemPharm Res 27 (2) (2010) 303ndash313
[73] PE Daddona et al Parathyroid hormone (1ndash34)-coated microneedle patchsystem clinical pharmacokinetics and pharmacodynamics for treatment of osteo-porosis Pharm Res 28 (1) (2011) 159ndash165
[74] A Arora MR Prausnitz S Mitragotri Micro-scale devices for transdermal drugdelivery Int J Pharm 364 (2) (2008) 227ndash236
26 AC Anselmo S Mitragotri Journal of Controlled Release 190 (2014) 15ndash 28
8152019 Revision sobre formas farmaceuticas nuevas
[75] S Mayes M Ferrone Fentanyl HCl patient-controlled iontophoretic transdermalsystem for the management of acute postoperative pain Ann Pharmacother 40(12) (2006) 2178ndash2186
[76] WT Zempsky et al Evaluation of a low-dose lidocaine iontophoresis system fortopical anesthesia in adults and children a randomized controlled trial ClinTher 26 (7) (2004) 1110ndash1119
[77] BM Becker et al Ultrasound with topical anesthetic rapidly decreases pain of intravenous cannulation Acad Emerg Med 12 (4) (2005) 289ndash295
[78] SK Vashist Non-invasive glucose monitoring technology in diabetes managementa review Anal Chim Acta 750 (2012) 16ndash27
[79] H Chuang et al Pilot studies of transdermal continuous glucose measurement
in outpatient diabetic patients and in patients during and after cardiac surgery J Diabetes Sci Technol 2 (4) (2008) 595ndash602[80] S Rose JF Nelson A continuous long-term injector Aust J Exp Biol Med Sci 33
(4) (1955) 415ndash419[81] F Theeuwes Elementary osmotic pump J Pharm Sci 64 (12) (1975) 1987ndash1991[82] V Malaterre et al Oral osmotically driven systems 30 years of development and
clinical use Eur J Pharm Biopharm 73 (3) (2009) 311ndash323[83] E Rosenthal The Soaring Cost of a Simple Breath (February 9 2014) Published
October 12 2013] Available from httpwwwnytimescom20131013usthe-soaring-cost-of-a-simple-breathhtml_r=0
[84] F Theeuwes Orososmotic system development Drug Dev Ind Pharm 9 (7)(1983) 1331ndash1357
[85] CG Park et al A nano1047297brous sheet-based system for linear delivery of nifedipine J Control Release 149 (3) (2011) 250ndash257
[86] DM Bass M Prevo DS Waxman Gastrointestinal safety of an extended-releasenondeformable oral dosage form (OROS) a retrospective study Drug Saf 25(14) (2002) 1021ndash1033
[87] GA Agyilirah GS Banker Polymers for Enteric Coating Applications Polymers forControlled Drug Delivery CRC Press Boca Raton 1991 39ndash66
[88] G Ponchel J-M Irache Speci1047297c and non-speci1047297c bioadhesive particulate systemsfor oral delivery to the gastrointestinal tract Adv Drug Deliv Rev 34 (2) (1998)191ndash219
[89] M Morishita NA Peppas Is the oral route possible for peptide and protein drugdelivery Drug Discov Today 11 (19) (2006) 905ndash910
[90] A Bernkop-Schnuumlrch The use of inhibitory agents to overcome the enzymatic bar-rier to perorally administered therapeuticpeptides and proteins J Control Release52 (1) (1998) 1ndash16
[91] LM Ensign R Cone J HanesOral drug delivery with polymeric nanoparticles thegastrointestinal mucus barriers Adv Drug Deliv Rev 64 (6) (2012) 557ndash570
[92] E Mathiowitz et al Biologically erodable microspheres as potential oral drugdelivery systems Nature 386 (6623) (1997) 410ndash414
[93] V Gupta et alMucoadhesiveintestinaldevices fororal delivery of salmon calcitonin J Control Release 172 (3) (2013) 753ndash762
[95] PW Swaan Recent advances in intestinal macromolecular drug delivery viareceptor-mediated transport pathways Pharm Res 15 (6) (1998) 826ndash834
[96] R Eldor et al Glucose-reducing effect of the ORMD-0801 oral insulin preparationin patients with uncontrolled type 1 diabetes a pilot study PLoS One 8 (4) (2013)e59524
[97] TheEligenreg Library(February9 2014) Available from httpwwwemispherecom eligen_libraryhtml
[98] MC Castelli et al Comparing the ef 1047297cacy and tolerability of a new daily oral vita-min B12 formulation and intermittent intramuscular vitamin B12 in normalizinglow cobalamin levels a randomized open-label parallel-group study Clin Ther33 (3) (2011) 358ndash371 (e2)
[99] K Whitehead Z Shen S Mitragotri Oraldelivery of macromoleculesusing intestinalpatches applications for insulin delivery J Control Release 98 (1) (2004) 37ndash45
[100] EM Pridgen et al Transepithelial transport of fc-targeted nanoparticles by theneonatal fc receptor for oral delivery Sci Transl Med 5 (213) (2013) 213ra167
[101] M Torres‐Lugo et al pH‐sensitive hydrogels as gastrointestinal tract absorptionenhancers transport mechanisms of salmoncalcitoninand other modelmoleculesusing the Caco‐2 cell model Biotechnol Prog 18 (3) (2002) 612ndash616
[102] M Torres-Lugo et al Physicochemical behavior and cytotoxic effects of p (methacrylic acidndashg-ethylene glycol) nanospheres for oral delivery of proteins
J Control Release 80 (1) (2002) 197ndash
205[103] RU Agu et alThe lung as a route forsystemicdeliveryof therapeuticproteins and
peptides Respir Res 2 (4) (2001) 198[104] R Dalby J Suman Inhalation therapy technological milestones in asthma treat-
ment Adv Drug Deliv Rev 55 (7) (2003) 779ndash791[105] PJ Anderson History of aerosol therapy liquid nebulization to MDIs to DPIs
Respir Care 50 (9) (2005) 1139ndash1150[106] JB Fink BK Rubin Problems with inhaler use a call for improved clinician and
patient education Respir Care 50 (10) (2005) 1360ndash1375[107] MJ Telko AJ Hickey Dry powder inhaler formulation Respir Care 50 (9) (2005)
1209ndash1227[108] DAEdwardsA Ben-Jebria R Langer Recentadvances in pulmonary drug delivery
using large porous inhaled particles J Appl Physiol 85 (2) (1998) 379ndash385[109] MB DolovichR DhandAerosol drug deliverydevelopments in devicedesign and
clinical use Lancet 377 (9770) (2011) 1032ndash1045[110] A Hussain et al Absorption enhancers in pulmonary protein delivery J Control
Release 94 (1) (2004) 15ndash24[111] J L Cleland A Daugherty R Mrsny Emerging protein delivery methods Curr
Opin Biotechnol 12 (2) (2001) 212ndash219
[112] JS Patton J Bukar S Nagarajan Inhaled insulin Adv Drug Deliv Rev 35 (2ndash3)(1999) 235ndash247
[113] FDA to Complete Phase-out of Chloro1047298uorocarbon Inhalers (February 9 2014Published October 23 2013) Available from httpwwwfdagovnewsevents newsroompressannouncementsucm371901htm
[114] Drug Treatments for Asthma and Chronic Obstructive Pulmonary Disease ThatDo Not Use Chloro1047298uorocarbons (February 9 2014) Available from http wwwfdagovDrugsDrugSafetyInformationbyDrugClassucm082370htm
[115] AJ Hickey Back to the future inhaled drug products J Pharm Sci 102 (4) (2013)1165ndash1172
[116] S White et al EXUBERA pharmaceutical development of a novel product for
906[117] T Quattrin et al Ef 1047297cacy and safety of inhaled insulin (Exubera) compared withsubcutaneous insulin therapy in patients with type 1 diabetes results of a 6-month randomized comparative trial Diabetes Care 27 (11) (2004) 2622ndash2627
[118] PA Hollander etal Ef 1047297cacyand safety of inhaled insulin (exubera)comparedwithsubcutaneousinsulin therapy in patients with type 2 diabetesresults of a 6-monthrandomized comparative trial Diabetes Care 27 (10) (2004) 2356ndash2362
[119] C Black et al The clinical effectiveness and cost-effectiveness of inhaled insulin indiabetes mellitus a systematic review and economic evaluation Health TechnolAssess 11 (33) (2007) 1ndash126
[120] A Opar Another blowfor inhaled protein therapeutics Nat Rev Drug Discov 7 (3)(2008) 189ndash190
[121] J Kling Dreamboat sinks prospects for fast approval of inhaled insulin NatBiotechnol 29 (3) (2011) 175ndash176
[122] Press Releases MannKind Reports Positive Data from a Phase 3 Clinical Study of AFREZZA in Patients with Type 1 Diabetes (February 9 2014 Published August14 2013) Available from httpwwwnewsmannkindcorpcomphoenixzhtmlc=147953ampp=irol-newsArticleampID=1847441amphighlight=
[123] Available from httpwwwcivitastherapeuticscomCVT-301html
[124] Cardeas Pharma Announces that FDA Grants QIDP Designation and Fast TrackReview for the Companys Antibiotic Combination Product (February 9 2014Published January 8 2014) Available from httpcardeaspharmacom press-releasescardeas-pharma-announces-that-fda-grants-qidp-designation-and-fast-track-review-for-the-companys-antibiotic-combination-product
[125] M Staples et al Application of micro- and nano-electromechanical devices todrug delivery Pharm Res 23 (5) (2006) 847ndash863
[126] TJ Smith et al Intravitreal sustained-release ganciclovir Arch Ophthalmol 110(2) (1992) 255ndash258
[127] GE Sanborn et al Sustained-release ganciclovir therapy for treatment of cyto-megalovirus retinitis Use of an intravitreal device Arch Ophthalmol 110 (2)(1992) 188ndash195
[128] G Velez SM Whitcup New developments in sustained release drug deliveryfor the treatment of intraocular disease Br J Ophthalmol 83 (11) (1999)1225ndash1229
[129] DH Geroski HF Edelhauser Drug delivery for posterior segment eye diseaseInvest Ophthalmol Vis Sci 41 (5) (2000) 961ndash964
[130] DC Musch et al Treatment of cytomegalovirus retinitis with a sustained-releaseganciclovir implant The Ganciclovir Implant Study Group N Engl J Med 337 (2)(1997) 83ndash90
[131] CL Stevenson JT Santini Jr R Langer Reservoir-based drug delivery systemsutilizing microtechnology Adv Drug Deliv Rev 64 (14) (2012) 1590ndash1602
[132] RA Receveur FW Lindemans NF de Rooij Microsystem technologies forimplantable applications J Micromech Microeng 17 (5) (2007) R50
[133] AC Richards Grayson et al Electronic MEMS for triggered delivery Adv DrugDeliv Rev 56 (2) (2004) 173ndash184
[134] HowOzurdex(R) Works(March11 2014) Available fromhttpwwwozurdexcom HowItWorksaspx
[135] A Giese et al Pattern of recurrencefollowinglocal chemotherapy with biodegrad-able carmustine (BCNU) implants in patients with glioblastoma J Neurooncol 66(3) (2004) 351ndash360
[136] EL Weber EA Goebel Cerebral edema associated with Gliadel wafers two casestudies Neuro Oncol 7 (1) (2005) 84ndash89
[137] JT Santini Jr MJ Cima R Langer A controlled-release microchip Nature 397(6717) (1999) 335ndash338
[138] R Farra et al First-in-human testing of a wirelessly controlled drug deliverymicrochip Sci Transl Med 4 (122) (2012) 122ra21
[139] B Hughes Antibodyndash
drug conjugates for cancer poised to deliver Nat Rev DrugDiscov 9 (9) (2010) 665ndash667
[140] JR Junutula et al Site-speci1047297c conjugation of a cytotoxic drug to an antibodyimproves the therapeutic index Nat Biotechnol 26 (8) (2008) 925ndash932
[141] S Verma et al Trastuzumab emtansinefor HER2-positive advanced breast cancerN Engl J Med 367 (19) (2012) 1783ndash1791
[142] ImmunoGen Inc Reports First Quarter Fiscal Year 2014 Financial Results andProvides Quarterly Update (February 9 2014 Published October 25 2013) Avail-able from httpinvestorimmunogencomreleasedetailcfmReleaseID=800370
[143] P Chames et al Therapeutic antibodies successes limit ations and hopes for thefuture Br J Pharmacol 157 (2) (2009) 220ndash233
[144] CF McDonagh et al Engineered antibodyndashdrugconjugateswith de1047297ned sites andstoichiometries of drug attachment Protein Eng Des Sel 19 (7) (2006) 299ndash307
[145] JY Axup et al Synthesis of site-speci1047297c antibodyndashdrug conjugates using unnatu-ral amino acids Proc Natl Acad Sci U S A 109 (40) (2012) 16101ndash16106
[146] SCAlleyNM Okeley PD Senter Antibodyndashdrug conjugates targeted drug deliveryfor cancer Curr Opin Chem Biol 14 (4) (2010) 529ndash537
[147] JM Lambert Drug-conjugated antibodies for the treatment of cancer Br J ClinPharmacol 76 (2) (2013) 248ndash262
27 AC Anselmo S Mitragotri Journal of Controlled Release 190 (2014) 15ndash 28
8152019 Revision sobre formas farmaceuticas nuevas
[149] A Younes et al Brentuximab vedotin (SGN-35) for relapsed CD30-positive lym-phomas N Engl J Med 363 (19) (2010) 1812ndash1821
[150] RS Zolot S Basu RP Million Antibodyndashdrugconjugates Nat Rev Drug Discov12(4) (2013) 259ndash260
[151] FDA P1047297zer Voluntarily Withdraws Cancer Treatment Mylotarg from US Market(February 9 2014 Published June 21 2010) Available from httpwwwfdagov NewsEventsNewsroomPressAnnouncementsucm216448htm
[152] AM Wu PD Senter Arming antibodies prospects and challenges forimmunoconjugates Nat Biotechnol 23 (9) (2005) 1137ndash1146
[153] AK Burnett et al The addition of gemtuzumab ozogamicin to intensive chemo-therapy in older patients with AML produces a signi1047297cant improvement in overallsurvival results of the UK NCRI AML16 randomizedtrial Blood 2011 (AMER SOCHEMATOLOGY 1900 M STREET NW SUITE 200 WASHINGTON DC 20036 USA)
[154] R Langer A personal account of translating discoveries in an academic lab NatBiotechnol 31 (6) (2013) 487ndash489
[155] US Pharmaceutical Sales mdash 2013 (January 17 2014) Available from httpwwwdrugscomstatstop1002013sales
28 AC Anselmo S Mitragotri Journal of Controlled Release 190 (2014) 15ndash 28
8152019 Revision sobre formas farmaceuticas nuevas
[1] M Kermode Unsafe injections in low-income country health settings need forinjection safety promotion to prevent the spread of blood-borne viruses HealthPromot Int 19 (1) (2004) 95ndash103
[2] M Goldberg I Gomez-Orellana Challenges for the oral delivery of macromole-cules Nat Rev Drug Discov 2 (4) (2003) 289ndash295
[3] JS Patton PR ByronInhalingmedicinesdelivering drugs to thebodythroughthelungs Nat Rev Drug Discov 6 (1) (2007) 67ndash74
[4] MR Prausnitz R Langer Transdermal drug delivery Nat Biotechnol 26 (11)(2008) 1261ndash1268
[5] R Gaudana et al Ocular drug delivery AAPS J 12 (3) (2010) 348ndash360[6] L Illum Nasal drug deliverynew developments andstrategiesDrugDiscov Today
7 (23) (2002) 1184ndash1189[7] JE Talmadge The pharmaceutics and delivery of therapeutic polypeptides and
proteins Adv Drug Deliv Rev 10 (2) (1993) 247ndash299[8] RLanger Controlledrelease of a therapeuticproteinNat Med 2 (7)(1996)742ndash743[9] R Langer J Folkman Polymers for the sustained release of proteins and other
macromolecules Nature 263 (5580) (1976) 797ndash800[10] JC Wright AS Hoffman Historical overview of long acting injections and
implants Long Acting Injections and Implants Springer 2012 pp 11ndash24[11] M Chaubal Polylactidesglycolidesmdashexcipients for injectable drug delivery and
beyond Drug Deliv Technol 2 (2002) 34ndash36[12] G Zhu SR Mallery SP Schwendeman Stabilization of proteins encapsulated in
injectable poly (lactide-co-glycolide) Nat Biotechnol 18 (1) (2000) 52ndash57[13] V Sinha A Trehan Biodegradable microspheres for protein delivery J Control
Release 90 (3) (2003) 261ndash280[14] M van de Weert WE Hennink W Jiskoot Protein instability in poly (lactic-co-
glycolic acid) microparticles Pharm Res 17 (10) (2000) 1159ndash1167[15] OL Johnson et al A month-longeffect froma single injection of microencapsulated
human growth hormone Nat Med 2 (7) (1996) 795ndash799[16] W Jianget al Biodegradable poly(lactic-co-glycolic acid) microparticles for inject-
able delivery of vaccine antigens Adv Drug Deliv Rev 57 (3) (2005) 391 ndash410[17] F Jordan et al Sustained release hGH microsphere formulation produced by a
novel supercritical 1047298uid technology in vivo studies J Control Release 141 (2)(2010) 153ndash160
[18] MA Tracy Development and scale-up of a microsphere protein delivery systemBiotechnol Prog 14 (1) (1998) 108ndash115
[20] Johnson amp Johnson Annual Report 2012 (February 9 2014) Available fromhttpswwwjnjcomsitesdefault 1047297lespdfJNJ2012annualreportpdf
[21] TM Allen PR Cullis Drug delivery systems entering themainstreamScience303(5665) (2004) 1818ndash1822
[22] T Allen A Chonn Large unilamellar liposomes with low uptake into the reticulo-endothelial system FEBS Lett 223 (1) (1987) 42ndash46
[23] Y Matsumura H Maeda A new concept for macromolecular therapeuticsin cancer chemotherapy mechanism of tumoritropic accumulation of
proteins and the antitumor agent smancs Cancer Res 46 (12 Part 1) (1986)6387ndash6392[24] G Haran et al Transmembrane ammonium sulfate gradients in liposomes
produce ef 1047297cient and stable entrapment of amphipathic weak bases BiochimBiophys Acta (BBA)mdashBiomembr 1151 (2) (1993) 201ndash215
[25] AT Horowitz Y Barenholz AA Gabizon In vitro cytotoxicity of liposome-encapsulated doxorubicin dependence on liposome composition anddrug release Biochim Biophys Acta (BBA)mdashBiomembr 1109 (2) (1992)203ndash209
[26] AA Gabizon Y Barenholz M Bialer Prolongation of the circulation time of doxo-rubicin encapsulated in liposomes containing a polyethylene glycol-derivatizedphospholipid pharmacokinetic studies in rodents and dogs Pharm Res 10 (5)(1993) 703ndash708
[27] A Gabizon et al Prolonged circulation time and enhanced accumulation in malig-nant exudates of doxorubicin encapsulated in polyethylene-glycol coated lipo-somes Cancer Res 54 (4) (1994) 987ndash992
[28] H Maedaet alTumorvascularpermeabilityand theEPR effectin macromoleculartherapeutics a review J Control Release 65 (1) (2000) 271ndash284
[29] Important Update Regarding Supply Outage of DOXILreg Available from http
wwwdoxilcomdoxil-supply-shortage February 9 2014[30] D Peer et al Nanocarriers as an emerging platform for cancer therapy Nat
Nanotechnol 2 (12) (2007) 751ndash760[31] E Ruoslahti Peptides as targeting elements and tissue penetration devices for
nanoparticles Adv Mater 24 (28) (2012) 3747ndash3756[32] PL Rodriguez et al Minimal ldquoself rdquo peptides that inhibit phagocytic clearance and
enhance delivery of nanoparticles Science 339 (6122) (2013) 971ndash975[33] SM Moghimi AC Hunter JC Murray Long-circulating and target-speci1047297c
nanoparticles theory to practice Pharmacol Rev 53 (2) (2001) 283ndash318[34] JP Rolland et al Direct fabrication and harvesting of monodisperse shape-
speci1047297c nanobiomaterials J Am Chem Soc 127 (28) (2005) 10096ndash10100[35] SW Morton et al Scalable manufacture of built-to-order nanomedicine spray-
assisted layer-by-layer functionalization of PRINT nanoparticles Adv Mater 25(34) (2013) 4707ndash4713
[36] M Ferrari Cancer nanotechnology opportunities and challenges Nat Rev Cancer5 (3) (2005) 161ndash171
[37] WJ Gradishar et al Phase III trial of nanoparticle albumin-bound paclitaxel com-pared with polyethylated castor oil-based paclitaxel in women with breast cancer
J Clin Oncol 23 (31) (2005) 7794ndash7803
[38] M Green et al Abraxanereg a novel Cremophorreg-free albumin-bound particleform of paclitaxel for the treatment of advanced non-small-cell lung cancer AnnOncol 17 (8) (2006) 1263ndash1268
[39] DW Nymanet alPhaseI andpharmacokinetics trial of ABI-007 a novel nanopar-ticle formulation of paclitaxel in patients with advanced nonhematologic malig-nancies J Clin Oncol 23 (31) (2005) 7785ndash7793
[40] Celgene Corporation Announces 2014 Financial Outlook and Preliminary 2013Results (February 9 2014) Available from httpircelgenecomreleasedetailcfmReleaseID=821044
[41] J Hrkach et al Preclinical development and clinical translation of a PSMA-targeteddocetaxel nanoparticle with a differentiated pharmacological pro1047297le Sci Transl
Med 4 (128) (2012) 128ra39[42] S Svenson et al Preclinical to clinical development of the novel camptothecin
nanopharmaceutical CRLX101 J Control Release 153 (1) (2011) 49ndash55[43] S Eliasof et al Correlating preclinical animal studies and human clinical trials of a
multifunctional polymeric nanoparticle Proc Natl Acad Sci U S A 110 (37)(2013) 15127ndash15132
[44] ME Davis et al Evidence of RNAi in humans from systemically administeredsiRNA via targeted nanoparticles Nature 464 (7291) (2010) 1067ndash1070
[45] AZ Wang R Langer OC Farokhzad Nanoparticle delivery of cancer drugs AnnuRev Med 63 (2012) 185ndash198
[46] Y Matsumura K Kataoka Preclinical and clinical studies of anticancer agent-incorporating polymer micelles Cancer Sci 100 (4) (2009) 572ndash579
[47] JD Heidel ME Davis Clinical developments in nanotechnology for cancer thera-py Pharm Res 28 (2) (2011) 187ndash199
[48] B D alby et al Advanced transfection with Lipofectamine 2000 reagent primaryneurons siRNAand high-throughput applicationsMethods 33 (2) (2004)95ndash103
[49] S Venkatraman R Gale Skin adhesives and skin adhesion 1 Transdermal drugdelivery systems Biomaterials 19 (13) (1998) 1119ndash1136
[50] AC Watkinson A commentary on transdermal drug delivery systems in clinicaltrials J Pharm Sci 102 (9) (2013) 3082ndash3088
[51] TH Stanley Fentanyl J Pain Symptom Manage 29 (5 Suppl) (2005) S67ndashS71[52] TH Stanley The history and development of the fentanyl series J Pain Symptom
Manage 7 (3 Suppl) (1992) S3ndashS7[53] Lidoderm Sales Data (February 9 2014) Available from httpwwwdrugscom
statslidoderm[54] S Mitragotri Healingsound theuse of ultrasoundin drug delivery andotherther-
apeutic applications Nat Rev Drug Discov 4 (3) (2005) 255ndash260[55] P Karande A Jain S Mitragotri Insights into synergistic interactions in binary
mixtures of chemical permeation enhancers for transdermal drug delivery J Control Release 115 (1) (2006) 85ndash93
[56] MR Prausnitz Microneedles for transdermal drug delivery Adv Drug Deliv Rev56 (5) (2004) 581ndash587
[57] YN Kalia et al Iontophoretic drug delivery Adv Drug Deliv Rev 56 (5) (2004)619ndash658
[58] P Karande A Jain S Mitragotri Discovery of transdermal penetration enhancersby high-throughput screening Nat Biotechnol 22 (2) (2004) 192ndash197
[59] MA Ashburn et al Iontophoretic delivery of morphinefor postoperative analgesia
J Pain Symptom Manage 7 (1) (1992) 27ndash
33[60] R van der Geest et al Iontophoretic delivery of apomorphine II An in vivo studyin patients with Parkinsons disease Pharm Res 14 (12) (1997) 1804ndash1810
[61] M Cormier et al Effect of transdermal iontophoresis codelivery of hydrocortisoneon metoclopramide pharmacokinetics and skin-induced reactions in humansubjects J Pharm Sci 88 (10) (1999) 1030ndash1035
[62] MP James RM Graham J English Percutaneous iontophoresis of prednisolonemdashapharmacokinetic study Clin Exp Dermatol 11 (1) (1986) 54ndash61
[63] PG Green Iontophoretic delivery of peptide drugs J Control Release 41 (1)(1996) 33ndash48
[64] EL Spierings JA Brevard NP Katz Two‐minute skin anesthesia through ultra-sound pretreatment and iontophoretic delivery of a topical anesthetic a feasibilitystudy Pain Med 9 (1) (2008) 55ndash59
[65] P SantoiannI M Nino G Calabro Intradermal Drug Delivery by Low FrequencySonophoresis (25 kHz) 2004
[66] BE Polat et al Ultrasound-mediated transdermal drug delivery mechanismsscope and emerging trends J Control Release 152 (3) (2011) 330ndash348
[67] JJ Norman et al Faster pharmacokinetics and increased patient acceptance of intradermal insulin delivery using a single hollow microneedle in children and
adolescents with type 1 diabetes Pediatr Diabetes 14 (6) (2013) 459 ndash465[68] J Gupta EI Felner MR Prausnitz Rapid pharmacokinetics of intradermal insulin
administered using microneedles in type 1 diabetes subjects Diabetes TechnolTher 13 (4) (2011) 451ndash456
[69] J Gupta EI Felner MR Prausnitz Minimally invasive insulin delivery in subjectswith type 1 diabetes using hollow microneedles Diabetes Technol Ther 11 (6)(2009) 329ndash337
[70] J Gupta et al Rapid local anesthesia in humans using minimally invasivemicroneedles Clin J Pain 28 (2) (2012) 129ndash135
[72] M Ameri SC Fan YF Maa Parathyroid hormone PTH(1ndash34) formulation thatenables uniform coating on a novel transdermal microprojection delivery systemPharm Res 27 (2) (2010) 303ndash313
[73] PE Daddona et al Parathyroid hormone (1ndash34)-coated microneedle patchsystem clinical pharmacokinetics and pharmacodynamics for treatment of osteo-porosis Pharm Res 28 (1) (2011) 159ndash165
[74] A Arora MR Prausnitz S Mitragotri Micro-scale devices for transdermal drugdelivery Int J Pharm 364 (2) (2008) 227ndash236
26 AC Anselmo S Mitragotri Journal of Controlled Release 190 (2014) 15ndash 28
8152019 Revision sobre formas farmaceuticas nuevas
[75] S Mayes M Ferrone Fentanyl HCl patient-controlled iontophoretic transdermalsystem for the management of acute postoperative pain Ann Pharmacother 40(12) (2006) 2178ndash2186
[76] WT Zempsky et al Evaluation of a low-dose lidocaine iontophoresis system fortopical anesthesia in adults and children a randomized controlled trial ClinTher 26 (7) (2004) 1110ndash1119
[77] BM Becker et al Ultrasound with topical anesthetic rapidly decreases pain of intravenous cannulation Acad Emerg Med 12 (4) (2005) 289ndash295
[78] SK Vashist Non-invasive glucose monitoring technology in diabetes managementa review Anal Chim Acta 750 (2012) 16ndash27
[79] H Chuang et al Pilot studies of transdermal continuous glucose measurement
in outpatient diabetic patients and in patients during and after cardiac surgery J Diabetes Sci Technol 2 (4) (2008) 595ndash602[80] S Rose JF Nelson A continuous long-term injector Aust J Exp Biol Med Sci 33
(4) (1955) 415ndash419[81] F Theeuwes Elementary osmotic pump J Pharm Sci 64 (12) (1975) 1987ndash1991[82] V Malaterre et al Oral osmotically driven systems 30 years of development and
clinical use Eur J Pharm Biopharm 73 (3) (2009) 311ndash323[83] E Rosenthal The Soaring Cost of a Simple Breath (February 9 2014) Published
October 12 2013] Available from httpwwwnytimescom20131013usthe-soaring-cost-of-a-simple-breathhtml_r=0
[84] F Theeuwes Orososmotic system development Drug Dev Ind Pharm 9 (7)(1983) 1331ndash1357
[85] CG Park et al A nano1047297brous sheet-based system for linear delivery of nifedipine J Control Release 149 (3) (2011) 250ndash257
[86] DM Bass M Prevo DS Waxman Gastrointestinal safety of an extended-releasenondeformable oral dosage form (OROS) a retrospective study Drug Saf 25(14) (2002) 1021ndash1033
[87] GA Agyilirah GS Banker Polymers for Enteric Coating Applications Polymers forControlled Drug Delivery CRC Press Boca Raton 1991 39ndash66
[88] G Ponchel J-M Irache Speci1047297c and non-speci1047297c bioadhesive particulate systemsfor oral delivery to the gastrointestinal tract Adv Drug Deliv Rev 34 (2) (1998)191ndash219
[89] M Morishita NA Peppas Is the oral route possible for peptide and protein drugdelivery Drug Discov Today 11 (19) (2006) 905ndash910
[90] A Bernkop-Schnuumlrch The use of inhibitory agents to overcome the enzymatic bar-rier to perorally administered therapeuticpeptides and proteins J Control Release52 (1) (1998) 1ndash16
[91] LM Ensign R Cone J HanesOral drug delivery with polymeric nanoparticles thegastrointestinal mucus barriers Adv Drug Deliv Rev 64 (6) (2012) 557ndash570
[92] E Mathiowitz et al Biologically erodable microspheres as potential oral drugdelivery systems Nature 386 (6623) (1997) 410ndash414
[93] V Gupta et alMucoadhesiveintestinaldevices fororal delivery of salmon calcitonin J Control Release 172 (3) (2013) 753ndash762
[95] PW Swaan Recent advances in intestinal macromolecular drug delivery viareceptor-mediated transport pathways Pharm Res 15 (6) (1998) 826ndash834
[96] R Eldor et al Glucose-reducing effect of the ORMD-0801 oral insulin preparationin patients with uncontrolled type 1 diabetes a pilot study PLoS One 8 (4) (2013)e59524
[97] TheEligenreg Library(February9 2014) Available from httpwwwemispherecom eligen_libraryhtml
[98] MC Castelli et al Comparing the ef 1047297cacy and tolerability of a new daily oral vita-min B12 formulation and intermittent intramuscular vitamin B12 in normalizinglow cobalamin levels a randomized open-label parallel-group study Clin Ther33 (3) (2011) 358ndash371 (e2)
[99] K Whitehead Z Shen S Mitragotri Oraldelivery of macromoleculesusing intestinalpatches applications for insulin delivery J Control Release 98 (1) (2004) 37ndash45
[100] EM Pridgen et al Transepithelial transport of fc-targeted nanoparticles by theneonatal fc receptor for oral delivery Sci Transl Med 5 (213) (2013) 213ra167
[101] M Torres‐Lugo et al pH‐sensitive hydrogels as gastrointestinal tract absorptionenhancers transport mechanisms of salmoncalcitoninand other modelmoleculesusing the Caco‐2 cell model Biotechnol Prog 18 (3) (2002) 612ndash616
[102] M Torres-Lugo et al Physicochemical behavior and cytotoxic effects of p (methacrylic acidndashg-ethylene glycol) nanospheres for oral delivery of proteins
J Control Release 80 (1) (2002) 197ndash
205[103] RU Agu et alThe lung as a route forsystemicdeliveryof therapeuticproteins and
peptides Respir Res 2 (4) (2001) 198[104] R Dalby J Suman Inhalation therapy technological milestones in asthma treat-
ment Adv Drug Deliv Rev 55 (7) (2003) 779ndash791[105] PJ Anderson History of aerosol therapy liquid nebulization to MDIs to DPIs
Respir Care 50 (9) (2005) 1139ndash1150[106] JB Fink BK Rubin Problems with inhaler use a call for improved clinician and
patient education Respir Care 50 (10) (2005) 1360ndash1375[107] MJ Telko AJ Hickey Dry powder inhaler formulation Respir Care 50 (9) (2005)
1209ndash1227[108] DAEdwardsA Ben-Jebria R Langer Recentadvances in pulmonary drug delivery
using large porous inhaled particles J Appl Physiol 85 (2) (1998) 379ndash385[109] MB DolovichR DhandAerosol drug deliverydevelopments in devicedesign and
clinical use Lancet 377 (9770) (2011) 1032ndash1045[110] A Hussain et al Absorption enhancers in pulmonary protein delivery J Control
Release 94 (1) (2004) 15ndash24[111] J L Cleland A Daugherty R Mrsny Emerging protein delivery methods Curr
Opin Biotechnol 12 (2) (2001) 212ndash219
[112] JS Patton J Bukar S Nagarajan Inhaled insulin Adv Drug Deliv Rev 35 (2ndash3)(1999) 235ndash247
[113] FDA to Complete Phase-out of Chloro1047298uorocarbon Inhalers (February 9 2014Published October 23 2013) Available from httpwwwfdagovnewsevents newsroompressannouncementsucm371901htm
[114] Drug Treatments for Asthma and Chronic Obstructive Pulmonary Disease ThatDo Not Use Chloro1047298uorocarbons (February 9 2014) Available from http wwwfdagovDrugsDrugSafetyInformationbyDrugClassucm082370htm
[115] AJ Hickey Back to the future inhaled drug products J Pharm Sci 102 (4) (2013)1165ndash1172
[116] S White et al EXUBERA pharmaceutical development of a novel product for
906[117] T Quattrin et al Ef 1047297cacy and safety of inhaled insulin (Exubera) compared withsubcutaneous insulin therapy in patients with type 1 diabetes results of a 6-month randomized comparative trial Diabetes Care 27 (11) (2004) 2622ndash2627
[118] PA Hollander etal Ef 1047297cacyand safety of inhaled insulin (exubera)comparedwithsubcutaneousinsulin therapy in patients with type 2 diabetesresults of a 6-monthrandomized comparative trial Diabetes Care 27 (10) (2004) 2356ndash2362
[119] C Black et al The clinical effectiveness and cost-effectiveness of inhaled insulin indiabetes mellitus a systematic review and economic evaluation Health TechnolAssess 11 (33) (2007) 1ndash126
[120] A Opar Another blowfor inhaled protein therapeutics Nat Rev Drug Discov 7 (3)(2008) 189ndash190
[121] J Kling Dreamboat sinks prospects for fast approval of inhaled insulin NatBiotechnol 29 (3) (2011) 175ndash176
[122] Press Releases MannKind Reports Positive Data from a Phase 3 Clinical Study of AFREZZA in Patients with Type 1 Diabetes (February 9 2014 Published August14 2013) Available from httpwwwnewsmannkindcorpcomphoenixzhtmlc=147953ampp=irol-newsArticleampID=1847441amphighlight=
[123] Available from httpwwwcivitastherapeuticscomCVT-301html
[124] Cardeas Pharma Announces that FDA Grants QIDP Designation and Fast TrackReview for the Companys Antibiotic Combination Product (February 9 2014Published January 8 2014) Available from httpcardeaspharmacom press-releasescardeas-pharma-announces-that-fda-grants-qidp-designation-and-fast-track-review-for-the-companys-antibiotic-combination-product
[125] M Staples et al Application of micro- and nano-electromechanical devices todrug delivery Pharm Res 23 (5) (2006) 847ndash863
[126] TJ Smith et al Intravitreal sustained-release ganciclovir Arch Ophthalmol 110(2) (1992) 255ndash258
[127] GE Sanborn et al Sustained-release ganciclovir therapy for treatment of cyto-megalovirus retinitis Use of an intravitreal device Arch Ophthalmol 110 (2)(1992) 188ndash195
[128] G Velez SM Whitcup New developments in sustained release drug deliveryfor the treatment of intraocular disease Br J Ophthalmol 83 (11) (1999)1225ndash1229
[129] DH Geroski HF Edelhauser Drug delivery for posterior segment eye diseaseInvest Ophthalmol Vis Sci 41 (5) (2000) 961ndash964
[130] DC Musch et al Treatment of cytomegalovirus retinitis with a sustained-releaseganciclovir implant The Ganciclovir Implant Study Group N Engl J Med 337 (2)(1997) 83ndash90
[131] CL Stevenson JT Santini Jr R Langer Reservoir-based drug delivery systemsutilizing microtechnology Adv Drug Deliv Rev 64 (14) (2012) 1590ndash1602
[132] RA Receveur FW Lindemans NF de Rooij Microsystem technologies forimplantable applications J Micromech Microeng 17 (5) (2007) R50
[133] AC Richards Grayson et al Electronic MEMS for triggered delivery Adv DrugDeliv Rev 56 (2) (2004) 173ndash184
[134] HowOzurdex(R) Works(March11 2014) Available fromhttpwwwozurdexcom HowItWorksaspx
[135] A Giese et al Pattern of recurrencefollowinglocal chemotherapy with biodegrad-able carmustine (BCNU) implants in patients with glioblastoma J Neurooncol 66(3) (2004) 351ndash360
[136] EL Weber EA Goebel Cerebral edema associated with Gliadel wafers two casestudies Neuro Oncol 7 (1) (2005) 84ndash89
[137] JT Santini Jr MJ Cima R Langer A controlled-release microchip Nature 397(6717) (1999) 335ndash338
[138] R Farra et al First-in-human testing of a wirelessly controlled drug deliverymicrochip Sci Transl Med 4 (122) (2012) 122ra21
[139] B Hughes Antibodyndash
drug conjugates for cancer poised to deliver Nat Rev DrugDiscov 9 (9) (2010) 665ndash667
[140] JR Junutula et al Site-speci1047297c conjugation of a cytotoxic drug to an antibodyimproves the therapeutic index Nat Biotechnol 26 (8) (2008) 925ndash932
[141] S Verma et al Trastuzumab emtansinefor HER2-positive advanced breast cancerN Engl J Med 367 (19) (2012) 1783ndash1791
[142] ImmunoGen Inc Reports First Quarter Fiscal Year 2014 Financial Results andProvides Quarterly Update (February 9 2014 Published October 25 2013) Avail-able from httpinvestorimmunogencomreleasedetailcfmReleaseID=800370
[143] P Chames et al Therapeutic antibodies successes limit ations and hopes for thefuture Br J Pharmacol 157 (2) (2009) 220ndash233
[144] CF McDonagh et al Engineered antibodyndashdrugconjugateswith de1047297ned sites andstoichiometries of drug attachment Protein Eng Des Sel 19 (7) (2006) 299ndash307
[145] JY Axup et al Synthesis of site-speci1047297c antibodyndashdrug conjugates using unnatu-ral amino acids Proc Natl Acad Sci U S A 109 (40) (2012) 16101ndash16106
[146] SCAlleyNM Okeley PD Senter Antibodyndashdrug conjugates targeted drug deliveryfor cancer Curr Opin Chem Biol 14 (4) (2010) 529ndash537
[147] JM Lambert Drug-conjugated antibodies for the treatment of cancer Br J ClinPharmacol 76 (2) (2013) 248ndash262
27 AC Anselmo S Mitragotri Journal of Controlled Release 190 (2014) 15ndash 28
8152019 Revision sobre formas farmaceuticas nuevas
[149] A Younes et al Brentuximab vedotin (SGN-35) for relapsed CD30-positive lym-phomas N Engl J Med 363 (19) (2010) 1812ndash1821
[150] RS Zolot S Basu RP Million Antibodyndashdrugconjugates Nat Rev Drug Discov12(4) (2013) 259ndash260
[151] FDA P1047297zer Voluntarily Withdraws Cancer Treatment Mylotarg from US Market(February 9 2014 Published June 21 2010) Available from httpwwwfdagov NewsEventsNewsroomPressAnnouncementsucm216448htm
[152] AM Wu PD Senter Arming antibodies prospects and challenges forimmunoconjugates Nat Biotechnol 23 (9) (2005) 1137ndash1146
[153] AK Burnett et al The addition of gemtuzumab ozogamicin to intensive chemo-therapy in older patients with AML produces a signi1047297cant improvement in overallsurvival results of the UK NCRI AML16 randomizedtrial Blood 2011 (AMER SOCHEMATOLOGY 1900 M STREET NW SUITE 200 WASHINGTON DC 20036 USA)
[154] R Langer A personal account of translating discoveries in an academic lab NatBiotechnol 31 (6) (2013) 487ndash489
[155] US Pharmaceutical Sales mdash 2013 (January 17 2014) Available from httpwwwdrugscomstatstop1002013sales
28 AC Anselmo S Mitragotri Journal of Controlled Release 190 (2014) 15ndash 28
8152019 Revision sobre formas farmaceuticas nuevas
[1] M Kermode Unsafe injections in low-income country health settings need forinjection safety promotion to prevent the spread of blood-borne viruses HealthPromot Int 19 (1) (2004) 95ndash103
[2] M Goldberg I Gomez-Orellana Challenges for the oral delivery of macromole-cules Nat Rev Drug Discov 2 (4) (2003) 289ndash295
[3] JS Patton PR ByronInhalingmedicinesdelivering drugs to thebodythroughthelungs Nat Rev Drug Discov 6 (1) (2007) 67ndash74
[4] MR Prausnitz R Langer Transdermal drug delivery Nat Biotechnol 26 (11)(2008) 1261ndash1268
[5] R Gaudana et al Ocular drug delivery AAPS J 12 (3) (2010) 348ndash360[6] L Illum Nasal drug deliverynew developments andstrategiesDrugDiscov Today
7 (23) (2002) 1184ndash1189[7] JE Talmadge The pharmaceutics and delivery of therapeutic polypeptides and
proteins Adv Drug Deliv Rev 10 (2) (1993) 247ndash299[8] RLanger Controlledrelease of a therapeuticproteinNat Med 2 (7)(1996)742ndash743[9] R Langer J Folkman Polymers for the sustained release of proteins and other
macromolecules Nature 263 (5580) (1976) 797ndash800[10] JC Wright AS Hoffman Historical overview of long acting injections and
implants Long Acting Injections and Implants Springer 2012 pp 11ndash24[11] M Chaubal Polylactidesglycolidesmdashexcipients for injectable drug delivery and
beyond Drug Deliv Technol 2 (2002) 34ndash36[12] G Zhu SR Mallery SP Schwendeman Stabilization of proteins encapsulated in
injectable poly (lactide-co-glycolide) Nat Biotechnol 18 (1) (2000) 52ndash57[13] V Sinha A Trehan Biodegradable microspheres for protein delivery J Control
Release 90 (3) (2003) 261ndash280[14] M van de Weert WE Hennink W Jiskoot Protein instability in poly (lactic-co-
glycolic acid) microparticles Pharm Res 17 (10) (2000) 1159ndash1167[15] OL Johnson et al A month-longeffect froma single injection of microencapsulated
human growth hormone Nat Med 2 (7) (1996) 795ndash799[16] W Jianget al Biodegradable poly(lactic-co-glycolic acid) microparticles for inject-
able delivery of vaccine antigens Adv Drug Deliv Rev 57 (3) (2005) 391 ndash410[17] F Jordan et al Sustained release hGH microsphere formulation produced by a
novel supercritical 1047298uid technology in vivo studies J Control Release 141 (2)(2010) 153ndash160
[18] MA Tracy Development and scale-up of a microsphere protein delivery systemBiotechnol Prog 14 (1) (1998) 108ndash115
[20] Johnson amp Johnson Annual Report 2012 (February 9 2014) Available fromhttpswwwjnjcomsitesdefault 1047297lespdfJNJ2012annualreportpdf
[21] TM Allen PR Cullis Drug delivery systems entering themainstreamScience303(5665) (2004) 1818ndash1822
[22] T Allen A Chonn Large unilamellar liposomes with low uptake into the reticulo-endothelial system FEBS Lett 223 (1) (1987) 42ndash46
[23] Y Matsumura H Maeda A new concept for macromolecular therapeuticsin cancer chemotherapy mechanism of tumoritropic accumulation of
proteins and the antitumor agent smancs Cancer Res 46 (12 Part 1) (1986)6387ndash6392[24] G Haran et al Transmembrane ammonium sulfate gradients in liposomes
produce ef 1047297cient and stable entrapment of amphipathic weak bases BiochimBiophys Acta (BBA)mdashBiomembr 1151 (2) (1993) 201ndash215
[25] AT Horowitz Y Barenholz AA Gabizon In vitro cytotoxicity of liposome-encapsulated doxorubicin dependence on liposome composition anddrug release Biochim Biophys Acta (BBA)mdashBiomembr 1109 (2) (1992)203ndash209
[26] AA Gabizon Y Barenholz M Bialer Prolongation of the circulation time of doxo-rubicin encapsulated in liposomes containing a polyethylene glycol-derivatizedphospholipid pharmacokinetic studies in rodents and dogs Pharm Res 10 (5)(1993) 703ndash708
[27] A Gabizon et al Prolonged circulation time and enhanced accumulation in malig-nant exudates of doxorubicin encapsulated in polyethylene-glycol coated lipo-somes Cancer Res 54 (4) (1994) 987ndash992
[28] H Maedaet alTumorvascularpermeabilityand theEPR effectin macromoleculartherapeutics a review J Control Release 65 (1) (2000) 271ndash284
[29] Important Update Regarding Supply Outage of DOXILreg Available from http
wwwdoxilcomdoxil-supply-shortage February 9 2014[30] D Peer et al Nanocarriers as an emerging platform for cancer therapy Nat
Nanotechnol 2 (12) (2007) 751ndash760[31] E Ruoslahti Peptides as targeting elements and tissue penetration devices for
nanoparticles Adv Mater 24 (28) (2012) 3747ndash3756[32] PL Rodriguez et al Minimal ldquoself rdquo peptides that inhibit phagocytic clearance and
enhance delivery of nanoparticles Science 339 (6122) (2013) 971ndash975[33] SM Moghimi AC Hunter JC Murray Long-circulating and target-speci1047297c
nanoparticles theory to practice Pharmacol Rev 53 (2) (2001) 283ndash318[34] JP Rolland et al Direct fabrication and harvesting of monodisperse shape-
speci1047297c nanobiomaterials J Am Chem Soc 127 (28) (2005) 10096ndash10100[35] SW Morton et al Scalable manufacture of built-to-order nanomedicine spray-
assisted layer-by-layer functionalization of PRINT nanoparticles Adv Mater 25(34) (2013) 4707ndash4713
[36] M Ferrari Cancer nanotechnology opportunities and challenges Nat Rev Cancer5 (3) (2005) 161ndash171
[37] WJ Gradishar et al Phase III trial of nanoparticle albumin-bound paclitaxel com-pared with polyethylated castor oil-based paclitaxel in women with breast cancer
J Clin Oncol 23 (31) (2005) 7794ndash7803
[38] M Green et al Abraxanereg a novel Cremophorreg-free albumin-bound particleform of paclitaxel for the treatment of advanced non-small-cell lung cancer AnnOncol 17 (8) (2006) 1263ndash1268
[39] DW Nymanet alPhaseI andpharmacokinetics trial of ABI-007 a novel nanopar-ticle formulation of paclitaxel in patients with advanced nonhematologic malig-nancies J Clin Oncol 23 (31) (2005) 7785ndash7793
[40] Celgene Corporation Announces 2014 Financial Outlook and Preliminary 2013Results (February 9 2014) Available from httpircelgenecomreleasedetailcfmReleaseID=821044
[41] J Hrkach et al Preclinical development and clinical translation of a PSMA-targeteddocetaxel nanoparticle with a differentiated pharmacological pro1047297le Sci Transl
Med 4 (128) (2012) 128ra39[42] S Svenson et al Preclinical to clinical development of the novel camptothecin
nanopharmaceutical CRLX101 J Control Release 153 (1) (2011) 49ndash55[43] S Eliasof et al Correlating preclinical animal studies and human clinical trials of a
multifunctional polymeric nanoparticle Proc Natl Acad Sci U S A 110 (37)(2013) 15127ndash15132
[44] ME Davis et al Evidence of RNAi in humans from systemically administeredsiRNA via targeted nanoparticles Nature 464 (7291) (2010) 1067ndash1070
[45] AZ Wang R Langer OC Farokhzad Nanoparticle delivery of cancer drugs AnnuRev Med 63 (2012) 185ndash198
[46] Y Matsumura K Kataoka Preclinical and clinical studies of anticancer agent-incorporating polymer micelles Cancer Sci 100 (4) (2009) 572ndash579
[47] JD Heidel ME Davis Clinical developments in nanotechnology for cancer thera-py Pharm Res 28 (2) (2011) 187ndash199
[48] B D alby et al Advanced transfection with Lipofectamine 2000 reagent primaryneurons siRNAand high-throughput applicationsMethods 33 (2) (2004)95ndash103
[49] S Venkatraman R Gale Skin adhesives and skin adhesion 1 Transdermal drugdelivery systems Biomaterials 19 (13) (1998) 1119ndash1136
[50] AC Watkinson A commentary on transdermal drug delivery systems in clinicaltrials J Pharm Sci 102 (9) (2013) 3082ndash3088
[51] TH Stanley Fentanyl J Pain Symptom Manage 29 (5 Suppl) (2005) S67ndashS71[52] TH Stanley The history and development of the fentanyl series J Pain Symptom
Manage 7 (3 Suppl) (1992) S3ndashS7[53] Lidoderm Sales Data (February 9 2014) Available from httpwwwdrugscom
statslidoderm[54] S Mitragotri Healingsound theuse of ultrasoundin drug delivery andotherther-
apeutic applications Nat Rev Drug Discov 4 (3) (2005) 255ndash260[55] P Karande A Jain S Mitragotri Insights into synergistic interactions in binary
mixtures of chemical permeation enhancers for transdermal drug delivery J Control Release 115 (1) (2006) 85ndash93
[56] MR Prausnitz Microneedles for transdermal drug delivery Adv Drug Deliv Rev56 (5) (2004) 581ndash587
[57] YN Kalia et al Iontophoretic drug delivery Adv Drug Deliv Rev 56 (5) (2004)619ndash658
[58] P Karande A Jain S Mitragotri Discovery of transdermal penetration enhancersby high-throughput screening Nat Biotechnol 22 (2) (2004) 192ndash197
[59] MA Ashburn et al Iontophoretic delivery of morphinefor postoperative analgesia
J Pain Symptom Manage 7 (1) (1992) 27ndash
33[60] R van der Geest et al Iontophoretic delivery of apomorphine II An in vivo studyin patients with Parkinsons disease Pharm Res 14 (12) (1997) 1804ndash1810
[61] M Cormier et al Effect of transdermal iontophoresis codelivery of hydrocortisoneon metoclopramide pharmacokinetics and skin-induced reactions in humansubjects J Pharm Sci 88 (10) (1999) 1030ndash1035
[62] MP James RM Graham J English Percutaneous iontophoresis of prednisolonemdashapharmacokinetic study Clin Exp Dermatol 11 (1) (1986) 54ndash61
[63] PG Green Iontophoretic delivery of peptide drugs J Control Release 41 (1)(1996) 33ndash48
[64] EL Spierings JA Brevard NP Katz Two‐minute skin anesthesia through ultra-sound pretreatment and iontophoretic delivery of a topical anesthetic a feasibilitystudy Pain Med 9 (1) (2008) 55ndash59
[65] P SantoiannI M Nino G Calabro Intradermal Drug Delivery by Low FrequencySonophoresis (25 kHz) 2004
[66] BE Polat et al Ultrasound-mediated transdermal drug delivery mechanismsscope and emerging trends J Control Release 152 (3) (2011) 330ndash348
[67] JJ Norman et al Faster pharmacokinetics and increased patient acceptance of intradermal insulin delivery using a single hollow microneedle in children and
adolescents with type 1 diabetes Pediatr Diabetes 14 (6) (2013) 459 ndash465[68] J Gupta EI Felner MR Prausnitz Rapid pharmacokinetics of intradermal insulin
administered using microneedles in type 1 diabetes subjects Diabetes TechnolTher 13 (4) (2011) 451ndash456
[69] J Gupta EI Felner MR Prausnitz Minimally invasive insulin delivery in subjectswith type 1 diabetes using hollow microneedles Diabetes Technol Ther 11 (6)(2009) 329ndash337
[70] J Gupta et al Rapid local anesthesia in humans using minimally invasivemicroneedles Clin J Pain 28 (2) (2012) 129ndash135
[72] M Ameri SC Fan YF Maa Parathyroid hormone PTH(1ndash34) formulation thatenables uniform coating on a novel transdermal microprojection delivery systemPharm Res 27 (2) (2010) 303ndash313
[73] PE Daddona et al Parathyroid hormone (1ndash34)-coated microneedle patchsystem clinical pharmacokinetics and pharmacodynamics for treatment of osteo-porosis Pharm Res 28 (1) (2011) 159ndash165
[74] A Arora MR Prausnitz S Mitragotri Micro-scale devices for transdermal drugdelivery Int J Pharm 364 (2) (2008) 227ndash236
26 AC Anselmo S Mitragotri Journal of Controlled Release 190 (2014) 15ndash 28
8152019 Revision sobre formas farmaceuticas nuevas
[75] S Mayes M Ferrone Fentanyl HCl patient-controlled iontophoretic transdermalsystem for the management of acute postoperative pain Ann Pharmacother 40(12) (2006) 2178ndash2186
[76] WT Zempsky et al Evaluation of a low-dose lidocaine iontophoresis system fortopical anesthesia in adults and children a randomized controlled trial ClinTher 26 (7) (2004) 1110ndash1119
[77] BM Becker et al Ultrasound with topical anesthetic rapidly decreases pain of intravenous cannulation Acad Emerg Med 12 (4) (2005) 289ndash295
[78] SK Vashist Non-invasive glucose monitoring technology in diabetes managementa review Anal Chim Acta 750 (2012) 16ndash27
[79] H Chuang et al Pilot studies of transdermal continuous glucose measurement
in outpatient diabetic patients and in patients during and after cardiac surgery J Diabetes Sci Technol 2 (4) (2008) 595ndash602[80] S Rose JF Nelson A continuous long-term injector Aust J Exp Biol Med Sci 33
(4) (1955) 415ndash419[81] F Theeuwes Elementary osmotic pump J Pharm Sci 64 (12) (1975) 1987ndash1991[82] V Malaterre et al Oral osmotically driven systems 30 years of development and
clinical use Eur J Pharm Biopharm 73 (3) (2009) 311ndash323[83] E Rosenthal The Soaring Cost of a Simple Breath (February 9 2014) Published
October 12 2013] Available from httpwwwnytimescom20131013usthe-soaring-cost-of-a-simple-breathhtml_r=0
[84] F Theeuwes Orososmotic system development Drug Dev Ind Pharm 9 (7)(1983) 1331ndash1357
[85] CG Park et al A nano1047297brous sheet-based system for linear delivery of nifedipine J Control Release 149 (3) (2011) 250ndash257
[86] DM Bass M Prevo DS Waxman Gastrointestinal safety of an extended-releasenondeformable oral dosage form (OROS) a retrospective study Drug Saf 25(14) (2002) 1021ndash1033
[87] GA Agyilirah GS Banker Polymers for Enteric Coating Applications Polymers forControlled Drug Delivery CRC Press Boca Raton 1991 39ndash66
[88] G Ponchel J-M Irache Speci1047297c and non-speci1047297c bioadhesive particulate systemsfor oral delivery to the gastrointestinal tract Adv Drug Deliv Rev 34 (2) (1998)191ndash219
[89] M Morishita NA Peppas Is the oral route possible for peptide and protein drugdelivery Drug Discov Today 11 (19) (2006) 905ndash910
[90] A Bernkop-Schnuumlrch The use of inhibitory agents to overcome the enzymatic bar-rier to perorally administered therapeuticpeptides and proteins J Control Release52 (1) (1998) 1ndash16
[91] LM Ensign R Cone J HanesOral drug delivery with polymeric nanoparticles thegastrointestinal mucus barriers Adv Drug Deliv Rev 64 (6) (2012) 557ndash570
[92] E Mathiowitz et al Biologically erodable microspheres as potential oral drugdelivery systems Nature 386 (6623) (1997) 410ndash414
[93] V Gupta et alMucoadhesiveintestinaldevices fororal delivery of salmon calcitonin J Control Release 172 (3) (2013) 753ndash762
[95] PW Swaan Recent advances in intestinal macromolecular drug delivery viareceptor-mediated transport pathways Pharm Res 15 (6) (1998) 826ndash834
[96] R Eldor et al Glucose-reducing effect of the ORMD-0801 oral insulin preparationin patients with uncontrolled type 1 diabetes a pilot study PLoS One 8 (4) (2013)e59524
[97] TheEligenreg Library(February9 2014) Available from httpwwwemispherecom eligen_libraryhtml
[98] MC Castelli et al Comparing the ef 1047297cacy and tolerability of a new daily oral vita-min B12 formulation and intermittent intramuscular vitamin B12 in normalizinglow cobalamin levels a randomized open-label parallel-group study Clin Ther33 (3) (2011) 358ndash371 (e2)
[99] K Whitehead Z Shen S Mitragotri Oraldelivery of macromoleculesusing intestinalpatches applications for insulin delivery J Control Release 98 (1) (2004) 37ndash45
[100] EM Pridgen et al Transepithelial transport of fc-targeted nanoparticles by theneonatal fc receptor for oral delivery Sci Transl Med 5 (213) (2013) 213ra167
[101] M Torres‐Lugo et al pH‐sensitive hydrogels as gastrointestinal tract absorptionenhancers transport mechanisms of salmoncalcitoninand other modelmoleculesusing the Caco‐2 cell model Biotechnol Prog 18 (3) (2002) 612ndash616
[102] M Torres-Lugo et al Physicochemical behavior and cytotoxic effects of p (methacrylic acidndashg-ethylene glycol) nanospheres for oral delivery of proteins
J Control Release 80 (1) (2002) 197ndash
205[103] RU Agu et alThe lung as a route forsystemicdeliveryof therapeuticproteins and
peptides Respir Res 2 (4) (2001) 198[104] R Dalby J Suman Inhalation therapy technological milestones in asthma treat-
ment Adv Drug Deliv Rev 55 (7) (2003) 779ndash791[105] PJ Anderson History of aerosol therapy liquid nebulization to MDIs to DPIs
Respir Care 50 (9) (2005) 1139ndash1150[106] JB Fink BK Rubin Problems with inhaler use a call for improved clinician and
patient education Respir Care 50 (10) (2005) 1360ndash1375[107] MJ Telko AJ Hickey Dry powder inhaler formulation Respir Care 50 (9) (2005)
1209ndash1227[108] DAEdwardsA Ben-Jebria R Langer Recentadvances in pulmonary drug delivery
using large porous inhaled particles J Appl Physiol 85 (2) (1998) 379ndash385[109] MB DolovichR DhandAerosol drug deliverydevelopments in devicedesign and
clinical use Lancet 377 (9770) (2011) 1032ndash1045[110] A Hussain et al Absorption enhancers in pulmonary protein delivery J Control
Release 94 (1) (2004) 15ndash24[111] J L Cleland A Daugherty R Mrsny Emerging protein delivery methods Curr
Opin Biotechnol 12 (2) (2001) 212ndash219
[112] JS Patton J Bukar S Nagarajan Inhaled insulin Adv Drug Deliv Rev 35 (2ndash3)(1999) 235ndash247
[113] FDA to Complete Phase-out of Chloro1047298uorocarbon Inhalers (February 9 2014Published October 23 2013) Available from httpwwwfdagovnewsevents newsroompressannouncementsucm371901htm
[114] Drug Treatments for Asthma and Chronic Obstructive Pulmonary Disease ThatDo Not Use Chloro1047298uorocarbons (February 9 2014) Available from http wwwfdagovDrugsDrugSafetyInformationbyDrugClassucm082370htm
[115] AJ Hickey Back to the future inhaled drug products J Pharm Sci 102 (4) (2013)1165ndash1172
[116] S White et al EXUBERA pharmaceutical development of a novel product for
906[117] T Quattrin et al Ef 1047297cacy and safety of inhaled insulin (Exubera) compared withsubcutaneous insulin therapy in patients with type 1 diabetes results of a 6-month randomized comparative trial Diabetes Care 27 (11) (2004) 2622ndash2627
[118] PA Hollander etal Ef 1047297cacyand safety of inhaled insulin (exubera)comparedwithsubcutaneousinsulin therapy in patients with type 2 diabetesresults of a 6-monthrandomized comparative trial Diabetes Care 27 (10) (2004) 2356ndash2362
[119] C Black et al The clinical effectiveness and cost-effectiveness of inhaled insulin indiabetes mellitus a systematic review and economic evaluation Health TechnolAssess 11 (33) (2007) 1ndash126
[120] A Opar Another blowfor inhaled protein therapeutics Nat Rev Drug Discov 7 (3)(2008) 189ndash190
[121] J Kling Dreamboat sinks prospects for fast approval of inhaled insulin NatBiotechnol 29 (3) (2011) 175ndash176
[122] Press Releases MannKind Reports Positive Data from a Phase 3 Clinical Study of AFREZZA in Patients with Type 1 Diabetes (February 9 2014 Published August14 2013) Available from httpwwwnewsmannkindcorpcomphoenixzhtmlc=147953ampp=irol-newsArticleampID=1847441amphighlight=
[123] Available from httpwwwcivitastherapeuticscomCVT-301html
[124] Cardeas Pharma Announces that FDA Grants QIDP Designation and Fast TrackReview for the Companys Antibiotic Combination Product (February 9 2014Published January 8 2014) Available from httpcardeaspharmacom press-releasescardeas-pharma-announces-that-fda-grants-qidp-designation-and-fast-track-review-for-the-companys-antibiotic-combination-product
[125] M Staples et al Application of micro- and nano-electromechanical devices todrug delivery Pharm Res 23 (5) (2006) 847ndash863
[126] TJ Smith et al Intravitreal sustained-release ganciclovir Arch Ophthalmol 110(2) (1992) 255ndash258
[127] GE Sanborn et al Sustained-release ganciclovir therapy for treatment of cyto-megalovirus retinitis Use of an intravitreal device Arch Ophthalmol 110 (2)(1992) 188ndash195
[128] G Velez SM Whitcup New developments in sustained release drug deliveryfor the treatment of intraocular disease Br J Ophthalmol 83 (11) (1999)1225ndash1229
[129] DH Geroski HF Edelhauser Drug delivery for posterior segment eye diseaseInvest Ophthalmol Vis Sci 41 (5) (2000) 961ndash964
[130] DC Musch et al Treatment of cytomegalovirus retinitis with a sustained-releaseganciclovir implant The Ganciclovir Implant Study Group N Engl J Med 337 (2)(1997) 83ndash90
[131] CL Stevenson JT Santini Jr R Langer Reservoir-based drug delivery systemsutilizing microtechnology Adv Drug Deliv Rev 64 (14) (2012) 1590ndash1602
[132] RA Receveur FW Lindemans NF de Rooij Microsystem technologies forimplantable applications J Micromech Microeng 17 (5) (2007) R50
[133] AC Richards Grayson et al Electronic MEMS for triggered delivery Adv DrugDeliv Rev 56 (2) (2004) 173ndash184
[134] HowOzurdex(R) Works(March11 2014) Available fromhttpwwwozurdexcom HowItWorksaspx
[135] A Giese et al Pattern of recurrencefollowinglocal chemotherapy with biodegrad-able carmustine (BCNU) implants in patients with glioblastoma J Neurooncol 66(3) (2004) 351ndash360
[136] EL Weber EA Goebel Cerebral edema associated with Gliadel wafers two casestudies Neuro Oncol 7 (1) (2005) 84ndash89
[137] JT Santini Jr MJ Cima R Langer A controlled-release microchip Nature 397(6717) (1999) 335ndash338
[138] R Farra et al First-in-human testing of a wirelessly controlled drug deliverymicrochip Sci Transl Med 4 (122) (2012) 122ra21
[139] B Hughes Antibodyndash
drug conjugates for cancer poised to deliver Nat Rev DrugDiscov 9 (9) (2010) 665ndash667
[140] JR Junutula et al Site-speci1047297c conjugation of a cytotoxic drug to an antibodyimproves the therapeutic index Nat Biotechnol 26 (8) (2008) 925ndash932
[141] S Verma et al Trastuzumab emtansinefor HER2-positive advanced breast cancerN Engl J Med 367 (19) (2012) 1783ndash1791
[142] ImmunoGen Inc Reports First Quarter Fiscal Year 2014 Financial Results andProvides Quarterly Update (February 9 2014 Published October 25 2013) Avail-able from httpinvestorimmunogencomreleasedetailcfmReleaseID=800370
[143] P Chames et al Therapeutic antibodies successes limit ations and hopes for thefuture Br J Pharmacol 157 (2) (2009) 220ndash233
[144] CF McDonagh et al Engineered antibodyndashdrugconjugateswith de1047297ned sites andstoichiometries of drug attachment Protein Eng Des Sel 19 (7) (2006) 299ndash307
[145] JY Axup et al Synthesis of site-speci1047297c antibodyndashdrug conjugates using unnatu-ral amino acids Proc Natl Acad Sci U S A 109 (40) (2012) 16101ndash16106
[146] SCAlleyNM Okeley PD Senter Antibodyndashdrug conjugates targeted drug deliveryfor cancer Curr Opin Chem Biol 14 (4) (2010) 529ndash537
[147] JM Lambert Drug-conjugated antibodies for the treatment of cancer Br J ClinPharmacol 76 (2) (2013) 248ndash262
27 AC Anselmo S Mitragotri Journal of Controlled Release 190 (2014) 15ndash 28
8152019 Revision sobre formas farmaceuticas nuevas
[149] A Younes et al Brentuximab vedotin (SGN-35) for relapsed CD30-positive lym-phomas N Engl J Med 363 (19) (2010) 1812ndash1821
[150] RS Zolot S Basu RP Million Antibodyndashdrugconjugates Nat Rev Drug Discov12(4) (2013) 259ndash260
[151] FDA P1047297zer Voluntarily Withdraws Cancer Treatment Mylotarg from US Market(February 9 2014 Published June 21 2010) Available from httpwwwfdagov NewsEventsNewsroomPressAnnouncementsucm216448htm
[152] AM Wu PD Senter Arming antibodies prospects and challenges forimmunoconjugates Nat Biotechnol 23 (9) (2005) 1137ndash1146
[153] AK Burnett et al The addition of gemtuzumab ozogamicin to intensive chemo-therapy in older patients with AML produces a signi1047297cant improvement in overallsurvival results of the UK NCRI AML16 randomizedtrial Blood 2011 (AMER SOCHEMATOLOGY 1900 M STREET NW SUITE 200 WASHINGTON DC 20036 USA)
[154] R Langer A personal account of translating discoveries in an academic lab NatBiotechnol 31 (6) (2013) 487ndash489
[155] US Pharmaceutical Sales mdash 2013 (January 17 2014) Available from httpwwwdrugscomstatstop1002013sales
28 AC Anselmo S Mitragotri Journal of Controlled Release 190 (2014) 15ndash 28
8152019 Revision sobre formas farmaceuticas nuevas
[1] M Kermode Unsafe injections in low-income country health settings need forinjection safety promotion to prevent the spread of blood-borne viruses HealthPromot Int 19 (1) (2004) 95ndash103
[2] M Goldberg I Gomez-Orellana Challenges for the oral delivery of macromole-cules Nat Rev Drug Discov 2 (4) (2003) 289ndash295
[3] JS Patton PR ByronInhalingmedicinesdelivering drugs to thebodythroughthelungs Nat Rev Drug Discov 6 (1) (2007) 67ndash74
[4] MR Prausnitz R Langer Transdermal drug delivery Nat Biotechnol 26 (11)(2008) 1261ndash1268
[5] R Gaudana et al Ocular drug delivery AAPS J 12 (3) (2010) 348ndash360[6] L Illum Nasal drug deliverynew developments andstrategiesDrugDiscov Today
7 (23) (2002) 1184ndash1189[7] JE Talmadge The pharmaceutics and delivery of therapeutic polypeptides and
proteins Adv Drug Deliv Rev 10 (2) (1993) 247ndash299[8] RLanger Controlledrelease of a therapeuticproteinNat Med 2 (7)(1996)742ndash743[9] R Langer J Folkman Polymers for the sustained release of proteins and other
macromolecules Nature 263 (5580) (1976) 797ndash800[10] JC Wright AS Hoffman Historical overview of long acting injections and
implants Long Acting Injections and Implants Springer 2012 pp 11ndash24[11] M Chaubal Polylactidesglycolidesmdashexcipients for injectable drug delivery and
beyond Drug Deliv Technol 2 (2002) 34ndash36[12] G Zhu SR Mallery SP Schwendeman Stabilization of proteins encapsulated in
injectable poly (lactide-co-glycolide) Nat Biotechnol 18 (1) (2000) 52ndash57[13] V Sinha A Trehan Biodegradable microspheres for protein delivery J Control
Release 90 (3) (2003) 261ndash280[14] M van de Weert WE Hennink W Jiskoot Protein instability in poly (lactic-co-
glycolic acid) microparticles Pharm Res 17 (10) (2000) 1159ndash1167[15] OL Johnson et al A month-longeffect froma single injection of microencapsulated
human growth hormone Nat Med 2 (7) (1996) 795ndash799[16] W Jianget al Biodegradable poly(lactic-co-glycolic acid) microparticles for inject-
able delivery of vaccine antigens Adv Drug Deliv Rev 57 (3) (2005) 391 ndash410[17] F Jordan et al Sustained release hGH microsphere formulation produced by a
novel supercritical 1047298uid technology in vivo studies J Control Release 141 (2)(2010) 153ndash160
[18] MA Tracy Development and scale-up of a microsphere protein delivery systemBiotechnol Prog 14 (1) (1998) 108ndash115
[20] Johnson amp Johnson Annual Report 2012 (February 9 2014) Available fromhttpswwwjnjcomsitesdefault 1047297lespdfJNJ2012annualreportpdf
[21] TM Allen PR Cullis Drug delivery systems entering themainstreamScience303(5665) (2004) 1818ndash1822
[22] T Allen A Chonn Large unilamellar liposomes with low uptake into the reticulo-endothelial system FEBS Lett 223 (1) (1987) 42ndash46
[23] Y Matsumura H Maeda A new concept for macromolecular therapeuticsin cancer chemotherapy mechanism of tumoritropic accumulation of
proteins and the antitumor agent smancs Cancer Res 46 (12 Part 1) (1986)6387ndash6392[24] G Haran et al Transmembrane ammonium sulfate gradients in liposomes
produce ef 1047297cient and stable entrapment of amphipathic weak bases BiochimBiophys Acta (BBA)mdashBiomembr 1151 (2) (1993) 201ndash215
[25] AT Horowitz Y Barenholz AA Gabizon In vitro cytotoxicity of liposome-encapsulated doxorubicin dependence on liposome composition anddrug release Biochim Biophys Acta (BBA)mdashBiomembr 1109 (2) (1992)203ndash209
[26] AA Gabizon Y Barenholz M Bialer Prolongation of the circulation time of doxo-rubicin encapsulated in liposomes containing a polyethylene glycol-derivatizedphospholipid pharmacokinetic studies in rodents and dogs Pharm Res 10 (5)(1993) 703ndash708
[27] A Gabizon et al Prolonged circulation time and enhanced accumulation in malig-nant exudates of doxorubicin encapsulated in polyethylene-glycol coated lipo-somes Cancer Res 54 (4) (1994) 987ndash992
[28] H Maedaet alTumorvascularpermeabilityand theEPR effectin macromoleculartherapeutics a review J Control Release 65 (1) (2000) 271ndash284
[29] Important Update Regarding Supply Outage of DOXILreg Available from http
wwwdoxilcomdoxil-supply-shortage February 9 2014[30] D Peer et al Nanocarriers as an emerging platform for cancer therapy Nat
Nanotechnol 2 (12) (2007) 751ndash760[31] E Ruoslahti Peptides as targeting elements and tissue penetration devices for
nanoparticles Adv Mater 24 (28) (2012) 3747ndash3756[32] PL Rodriguez et al Minimal ldquoself rdquo peptides that inhibit phagocytic clearance and
enhance delivery of nanoparticles Science 339 (6122) (2013) 971ndash975[33] SM Moghimi AC Hunter JC Murray Long-circulating and target-speci1047297c
nanoparticles theory to practice Pharmacol Rev 53 (2) (2001) 283ndash318[34] JP Rolland et al Direct fabrication and harvesting of monodisperse shape-
speci1047297c nanobiomaterials J Am Chem Soc 127 (28) (2005) 10096ndash10100[35] SW Morton et al Scalable manufacture of built-to-order nanomedicine spray-
assisted layer-by-layer functionalization of PRINT nanoparticles Adv Mater 25(34) (2013) 4707ndash4713
[36] M Ferrari Cancer nanotechnology opportunities and challenges Nat Rev Cancer5 (3) (2005) 161ndash171
[37] WJ Gradishar et al Phase III trial of nanoparticle albumin-bound paclitaxel com-pared with polyethylated castor oil-based paclitaxel in women with breast cancer
J Clin Oncol 23 (31) (2005) 7794ndash7803
[38] M Green et al Abraxanereg a novel Cremophorreg-free albumin-bound particleform of paclitaxel for the treatment of advanced non-small-cell lung cancer AnnOncol 17 (8) (2006) 1263ndash1268
[39] DW Nymanet alPhaseI andpharmacokinetics trial of ABI-007 a novel nanopar-ticle formulation of paclitaxel in patients with advanced nonhematologic malig-nancies J Clin Oncol 23 (31) (2005) 7785ndash7793
[40] Celgene Corporation Announces 2014 Financial Outlook and Preliminary 2013Results (February 9 2014) Available from httpircelgenecomreleasedetailcfmReleaseID=821044
[41] J Hrkach et al Preclinical development and clinical translation of a PSMA-targeteddocetaxel nanoparticle with a differentiated pharmacological pro1047297le Sci Transl
Med 4 (128) (2012) 128ra39[42] S Svenson et al Preclinical to clinical development of the novel camptothecin
nanopharmaceutical CRLX101 J Control Release 153 (1) (2011) 49ndash55[43] S Eliasof et al Correlating preclinical animal studies and human clinical trials of a
multifunctional polymeric nanoparticle Proc Natl Acad Sci U S A 110 (37)(2013) 15127ndash15132
[44] ME Davis et al Evidence of RNAi in humans from systemically administeredsiRNA via targeted nanoparticles Nature 464 (7291) (2010) 1067ndash1070
[45] AZ Wang R Langer OC Farokhzad Nanoparticle delivery of cancer drugs AnnuRev Med 63 (2012) 185ndash198
[46] Y Matsumura K Kataoka Preclinical and clinical studies of anticancer agent-incorporating polymer micelles Cancer Sci 100 (4) (2009) 572ndash579
[47] JD Heidel ME Davis Clinical developments in nanotechnology for cancer thera-py Pharm Res 28 (2) (2011) 187ndash199
[48] B D alby et al Advanced transfection with Lipofectamine 2000 reagent primaryneurons siRNAand high-throughput applicationsMethods 33 (2) (2004)95ndash103
[49] S Venkatraman R Gale Skin adhesives and skin adhesion 1 Transdermal drugdelivery systems Biomaterials 19 (13) (1998) 1119ndash1136
[50] AC Watkinson A commentary on transdermal drug delivery systems in clinicaltrials J Pharm Sci 102 (9) (2013) 3082ndash3088
[51] TH Stanley Fentanyl J Pain Symptom Manage 29 (5 Suppl) (2005) S67ndashS71[52] TH Stanley The history and development of the fentanyl series J Pain Symptom
Manage 7 (3 Suppl) (1992) S3ndashS7[53] Lidoderm Sales Data (February 9 2014) Available from httpwwwdrugscom
statslidoderm[54] S Mitragotri Healingsound theuse of ultrasoundin drug delivery andotherther-
apeutic applications Nat Rev Drug Discov 4 (3) (2005) 255ndash260[55] P Karande A Jain S Mitragotri Insights into synergistic interactions in binary
mixtures of chemical permeation enhancers for transdermal drug delivery J Control Release 115 (1) (2006) 85ndash93
[56] MR Prausnitz Microneedles for transdermal drug delivery Adv Drug Deliv Rev56 (5) (2004) 581ndash587
[57] YN Kalia et al Iontophoretic drug delivery Adv Drug Deliv Rev 56 (5) (2004)619ndash658
[58] P Karande A Jain S Mitragotri Discovery of transdermal penetration enhancersby high-throughput screening Nat Biotechnol 22 (2) (2004) 192ndash197
[59] MA Ashburn et al Iontophoretic delivery of morphinefor postoperative analgesia
J Pain Symptom Manage 7 (1) (1992) 27ndash
33[60] R van der Geest et al Iontophoretic delivery of apomorphine II An in vivo studyin patients with Parkinsons disease Pharm Res 14 (12) (1997) 1804ndash1810
[61] M Cormier et al Effect of transdermal iontophoresis codelivery of hydrocortisoneon metoclopramide pharmacokinetics and skin-induced reactions in humansubjects J Pharm Sci 88 (10) (1999) 1030ndash1035
[62] MP James RM Graham J English Percutaneous iontophoresis of prednisolonemdashapharmacokinetic study Clin Exp Dermatol 11 (1) (1986) 54ndash61
[63] PG Green Iontophoretic delivery of peptide drugs J Control Release 41 (1)(1996) 33ndash48
[64] EL Spierings JA Brevard NP Katz Two‐minute skin anesthesia through ultra-sound pretreatment and iontophoretic delivery of a topical anesthetic a feasibilitystudy Pain Med 9 (1) (2008) 55ndash59
[65] P SantoiannI M Nino G Calabro Intradermal Drug Delivery by Low FrequencySonophoresis (25 kHz) 2004
[66] BE Polat et al Ultrasound-mediated transdermal drug delivery mechanismsscope and emerging trends J Control Release 152 (3) (2011) 330ndash348
[67] JJ Norman et al Faster pharmacokinetics and increased patient acceptance of intradermal insulin delivery using a single hollow microneedle in children and
adolescents with type 1 diabetes Pediatr Diabetes 14 (6) (2013) 459 ndash465[68] J Gupta EI Felner MR Prausnitz Rapid pharmacokinetics of intradermal insulin
administered using microneedles in type 1 diabetes subjects Diabetes TechnolTher 13 (4) (2011) 451ndash456
[69] J Gupta EI Felner MR Prausnitz Minimally invasive insulin delivery in subjectswith type 1 diabetes using hollow microneedles Diabetes Technol Ther 11 (6)(2009) 329ndash337
[70] J Gupta et al Rapid local anesthesia in humans using minimally invasivemicroneedles Clin J Pain 28 (2) (2012) 129ndash135
[72] M Ameri SC Fan YF Maa Parathyroid hormone PTH(1ndash34) formulation thatenables uniform coating on a novel transdermal microprojection delivery systemPharm Res 27 (2) (2010) 303ndash313
[73] PE Daddona et al Parathyroid hormone (1ndash34)-coated microneedle patchsystem clinical pharmacokinetics and pharmacodynamics for treatment of osteo-porosis Pharm Res 28 (1) (2011) 159ndash165
[74] A Arora MR Prausnitz S Mitragotri Micro-scale devices for transdermal drugdelivery Int J Pharm 364 (2) (2008) 227ndash236
26 AC Anselmo S Mitragotri Journal of Controlled Release 190 (2014) 15ndash 28
8152019 Revision sobre formas farmaceuticas nuevas
[75] S Mayes M Ferrone Fentanyl HCl patient-controlled iontophoretic transdermalsystem for the management of acute postoperative pain Ann Pharmacother 40(12) (2006) 2178ndash2186
[76] WT Zempsky et al Evaluation of a low-dose lidocaine iontophoresis system fortopical anesthesia in adults and children a randomized controlled trial ClinTher 26 (7) (2004) 1110ndash1119
[77] BM Becker et al Ultrasound with topical anesthetic rapidly decreases pain of intravenous cannulation Acad Emerg Med 12 (4) (2005) 289ndash295
[78] SK Vashist Non-invasive glucose monitoring technology in diabetes managementa review Anal Chim Acta 750 (2012) 16ndash27
[79] H Chuang et al Pilot studies of transdermal continuous glucose measurement
in outpatient diabetic patients and in patients during and after cardiac surgery J Diabetes Sci Technol 2 (4) (2008) 595ndash602[80] S Rose JF Nelson A continuous long-term injector Aust J Exp Biol Med Sci 33
(4) (1955) 415ndash419[81] F Theeuwes Elementary osmotic pump J Pharm Sci 64 (12) (1975) 1987ndash1991[82] V Malaterre et al Oral osmotically driven systems 30 years of development and
clinical use Eur J Pharm Biopharm 73 (3) (2009) 311ndash323[83] E Rosenthal The Soaring Cost of a Simple Breath (February 9 2014) Published
October 12 2013] Available from httpwwwnytimescom20131013usthe-soaring-cost-of-a-simple-breathhtml_r=0
[84] F Theeuwes Orososmotic system development Drug Dev Ind Pharm 9 (7)(1983) 1331ndash1357
[85] CG Park et al A nano1047297brous sheet-based system for linear delivery of nifedipine J Control Release 149 (3) (2011) 250ndash257
[86] DM Bass M Prevo DS Waxman Gastrointestinal safety of an extended-releasenondeformable oral dosage form (OROS) a retrospective study Drug Saf 25(14) (2002) 1021ndash1033
[87] GA Agyilirah GS Banker Polymers for Enteric Coating Applications Polymers forControlled Drug Delivery CRC Press Boca Raton 1991 39ndash66
[88] G Ponchel J-M Irache Speci1047297c and non-speci1047297c bioadhesive particulate systemsfor oral delivery to the gastrointestinal tract Adv Drug Deliv Rev 34 (2) (1998)191ndash219
[89] M Morishita NA Peppas Is the oral route possible for peptide and protein drugdelivery Drug Discov Today 11 (19) (2006) 905ndash910
[90] A Bernkop-Schnuumlrch The use of inhibitory agents to overcome the enzymatic bar-rier to perorally administered therapeuticpeptides and proteins J Control Release52 (1) (1998) 1ndash16
[91] LM Ensign R Cone J HanesOral drug delivery with polymeric nanoparticles thegastrointestinal mucus barriers Adv Drug Deliv Rev 64 (6) (2012) 557ndash570
[92] E Mathiowitz et al Biologically erodable microspheres as potential oral drugdelivery systems Nature 386 (6623) (1997) 410ndash414
[93] V Gupta et alMucoadhesiveintestinaldevices fororal delivery of salmon calcitonin J Control Release 172 (3) (2013) 753ndash762
[95] PW Swaan Recent advances in intestinal macromolecular drug delivery viareceptor-mediated transport pathways Pharm Res 15 (6) (1998) 826ndash834
[96] R Eldor et al Glucose-reducing effect of the ORMD-0801 oral insulin preparationin patients with uncontrolled type 1 diabetes a pilot study PLoS One 8 (4) (2013)e59524
[97] TheEligenreg Library(February9 2014) Available from httpwwwemispherecom eligen_libraryhtml
[98] MC Castelli et al Comparing the ef 1047297cacy and tolerability of a new daily oral vita-min B12 formulation and intermittent intramuscular vitamin B12 in normalizinglow cobalamin levels a randomized open-label parallel-group study Clin Ther33 (3) (2011) 358ndash371 (e2)
[99] K Whitehead Z Shen S Mitragotri Oraldelivery of macromoleculesusing intestinalpatches applications for insulin delivery J Control Release 98 (1) (2004) 37ndash45
[100] EM Pridgen et al Transepithelial transport of fc-targeted nanoparticles by theneonatal fc receptor for oral delivery Sci Transl Med 5 (213) (2013) 213ra167
[101] M Torres‐Lugo et al pH‐sensitive hydrogels as gastrointestinal tract absorptionenhancers transport mechanisms of salmoncalcitoninand other modelmoleculesusing the Caco‐2 cell model Biotechnol Prog 18 (3) (2002) 612ndash616
[102] M Torres-Lugo et al Physicochemical behavior and cytotoxic effects of p (methacrylic acidndashg-ethylene glycol) nanospheres for oral delivery of proteins
J Control Release 80 (1) (2002) 197ndash
205[103] RU Agu et alThe lung as a route forsystemicdeliveryof therapeuticproteins and
peptides Respir Res 2 (4) (2001) 198[104] R Dalby J Suman Inhalation therapy technological milestones in asthma treat-
ment Adv Drug Deliv Rev 55 (7) (2003) 779ndash791[105] PJ Anderson History of aerosol therapy liquid nebulization to MDIs to DPIs
Respir Care 50 (9) (2005) 1139ndash1150[106] JB Fink BK Rubin Problems with inhaler use a call for improved clinician and
patient education Respir Care 50 (10) (2005) 1360ndash1375[107] MJ Telko AJ Hickey Dry powder inhaler formulation Respir Care 50 (9) (2005)
1209ndash1227[108] DAEdwardsA Ben-Jebria R Langer Recentadvances in pulmonary drug delivery
using large porous inhaled particles J Appl Physiol 85 (2) (1998) 379ndash385[109] MB DolovichR DhandAerosol drug deliverydevelopments in devicedesign and
clinical use Lancet 377 (9770) (2011) 1032ndash1045[110] A Hussain et al Absorption enhancers in pulmonary protein delivery J Control
Release 94 (1) (2004) 15ndash24[111] J L Cleland A Daugherty R Mrsny Emerging protein delivery methods Curr
Opin Biotechnol 12 (2) (2001) 212ndash219
[112] JS Patton J Bukar S Nagarajan Inhaled insulin Adv Drug Deliv Rev 35 (2ndash3)(1999) 235ndash247
[113] FDA to Complete Phase-out of Chloro1047298uorocarbon Inhalers (February 9 2014Published October 23 2013) Available from httpwwwfdagovnewsevents newsroompressannouncementsucm371901htm
[114] Drug Treatments for Asthma and Chronic Obstructive Pulmonary Disease ThatDo Not Use Chloro1047298uorocarbons (February 9 2014) Available from http wwwfdagovDrugsDrugSafetyInformationbyDrugClassucm082370htm
[115] AJ Hickey Back to the future inhaled drug products J Pharm Sci 102 (4) (2013)1165ndash1172
[116] S White et al EXUBERA pharmaceutical development of a novel product for
906[117] T Quattrin et al Ef 1047297cacy and safety of inhaled insulin (Exubera) compared withsubcutaneous insulin therapy in patients with type 1 diabetes results of a 6-month randomized comparative trial Diabetes Care 27 (11) (2004) 2622ndash2627
[118] PA Hollander etal Ef 1047297cacyand safety of inhaled insulin (exubera)comparedwithsubcutaneousinsulin therapy in patients with type 2 diabetesresults of a 6-monthrandomized comparative trial Diabetes Care 27 (10) (2004) 2356ndash2362
[119] C Black et al The clinical effectiveness and cost-effectiveness of inhaled insulin indiabetes mellitus a systematic review and economic evaluation Health TechnolAssess 11 (33) (2007) 1ndash126
[120] A Opar Another blowfor inhaled protein therapeutics Nat Rev Drug Discov 7 (3)(2008) 189ndash190
[121] J Kling Dreamboat sinks prospects for fast approval of inhaled insulin NatBiotechnol 29 (3) (2011) 175ndash176
[122] Press Releases MannKind Reports Positive Data from a Phase 3 Clinical Study of AFREZZA in Patients with Type 1 Diabetes (February 9 2014 Published August14 2013) Available from httpwwwnewsmannkindcorpcomphoenixzhtmlc=147953ampp=irol-newsArticleampID=1847441amphighlight=
[123] Available from httpwwwcivitastherapeuticscomCVT-301html
[124] Cardeas Pharma Announces that FDA Grants QIDP Designation and Fast TrackReview for the Companys Antibiotic Combination Product (February 9 2014Published January 8 2014) Available from httpcardeaspharmacom press-releasescardeas-pharma-announces-that-fda-grants-qidp-designation-and-fast-track-review-for-the-companys-antibiotic-combination-product
[125] M Staples et al Application of micro- and nano-electromechanical devices todrug delivery Pharm Res 23 (5) (2006) 847ndash863
[126] TJ Smith et al Intravitreal sustained-release ganciclovir Arch Ophthalmol 110(2) (1992) 255ndash258
[127] GE Sanborn et al Sustained-release ganciclovir therapy for treatment of cyto-megalovirus retinitis Use of an intravitreal device Arch Ophthalmol 110 (2)(1992) 188ndash195
[128] G Velez SM Whitcup New developments in sustained release drug deliveryfor the treatment of intraocular disease Br J Ophthalmol 83 (11) (1999)1225ndash1229
[129] DH Geroski HF Edelhauser Drug delivery for posterior segment eye diseaseInvest Ophthalmol Vis Sci 41 (5) (2000) 961ndash964
[130] DC Musch et al Treatment of cytomegalovirus retinitis with a sustained-releaseganciclovir implant The Ganciclovir Implant Study Group N Engl J Med 337 (2)(1997) 83ndash90
[131] CL Stevenson JT Santini Jr R Langer Reservoir-based drug delivery systemsutilizing microtechnology Adv Drug Deliv Rev 64 (14) (2012) 1590ndash1602
[132] RA Receveur FW Lindemans NF de Rooij Microsystem technologies forimplantable applications J Micromech Microeng 17 (5) (2007) R50
[133] AC Richards Grayson et al Electronic MEMS for triggered delivery Adv DrugDeliv Rev 56 (2) (2004) 173ndash184
[134] HowOzurdex(R) Works(March11 2014) Available fromhttpwwwozurdexcom HowItWorksaspx
[135] A Giese et al Pattern of recurrencefollowinglocal chemotherapy with biodegrad-able carmustine (BCNU) implants in patients with glioblastoma J Neurooncol 66(3) (2004) 351ndash360
[136] EL Weber EA Goebel Cerebral edema associated with Gliadel wafers two casestudies Neuro Oncol 7 (1) (2005) 84ndash89
[137] JT Santini Jr MJ Cima R Langer A controlled-release microchip Nature 397(6717) (1999) 335ndash338
[138] R Farra et al First-in-human testing of a wirelessly controlled drug deliverymicrochip Sci Transl Med 4 (122) (2012) 122ra21
[139] B Hughes Antibodyndash
drug conjugates for cancer poised to deliver Nat Rev DrugDiscov 9 (9) (2010) 665ndash667
[140] JR Junutula et al Site-speci1047297c conjugation of a cytotoxic drug to an antibodyimproves the therapeutic index Nat Biotechnol 26 (8) (2008) 925ndash932
[141] S Verma et al Trastuzumab emtansinefor HER2-positive advanced breast cancerN Engl J Med 367 (19) (2012) 1783ndash1791
[142] ImmunoGen Inc Reports First Quarter Fiscal Year 2014 Financial Results andProvides Quarterly Update (February 9 2014 Published October 25 2013) Avail-able from httpinvestorimmunogencomreleasedetailcfmReleaseID=800370
[143] P Chames et al Therapeutic antibodies successes limit ations and hopes for thefuture Br J Pharmacol 157 (2) (2009) 220ndash233
[144] CF McDonagh et al Engineered antibodyndashdrugconjugateswith de1047297ned sites andstoichiometries of drug attachment Protein Eng Des Sel 19 (7) (2006) 299ndash307
[145] JY Axup et al Synthesis of site-speci1047297c antibodyndashdrug conjugates using unnatu-ral amino acids Proc Natl Acad Sci U S A 109 (40) (2012) 16101ndash16106
[146] SCAlleyNM Okeley PD Senter Antibodyndashdrug conjugates targeted drug deliveryfor cancer Curr Opin Chem Biol 14 (4) (2010) 529ndash537
[147] JM Lambert Drug-conjugated antibodies for the treatment of cancer Br J ClinPharmacol 76 (2) (2013) 248ndash262
27 AC Anselmo S Mitragotri Journal of Controlled Release 190 (2014) 15ndash 28
8152019 Revision sobre formas farmaceuticas nuevas
[149] A Younes et al Brentuximab vedotin (SGN-35) for relapsed CD30-positive lym-phomas N Engl J Med 363 (19) (2010) 1812ndash1821
[150] RS Zolot S Basu RP Million Antibodyndashdrugconjugates Nat Rev Drug Discov12(4) (2013) 259ndash260
[151] FDA P1047297zer Voluntarily Withdraws Cancer Treatment Mylotarg from US Market(February 9 2014 Published June 21 2010) Available from httpwwwfdagov NewsEventsNewsroomPressAnnouncementsucm216448htm
[152] AM Wu PD Senter Arming antibodies prospects and challenges forimmunoconjugates Nat Biotechnol 23 (9) (2005) 1137ndash1146
[153] AK Burnett et al The addition of gemtuzumab ozogamicin to intensive chemo-therapy in older patients with AML produces a signi1047297cant improvement in overallsurvival results of the UK NCRI AML16 randomizedtrial Blood 2011 (AMER SOCHEMATOLOGY 1900 M STREET NW SUITE 200 WASHINGTON DC 20036 USA)
[154] R Langer A personal account of translating discoveries in an academic lab NatBiotechnol 31 (6) (2013) 487ndash489
[155] US Pharmaceutical Sales mdash 2013 (January 17 2014) Available from httpwwwdrugscomstatstop1002013sales
28 AC Anselmo S Mitragotri Journal of Controlled Release 190 (2014) 15ndash 28
8152019 Revision sobre formas farmaceuticas nuevas
[1] M Kermode Unsafe injections in low-income country health settings need forinjection safety promotion to prevent the spread of blood-borne viruses HealthPromot Int 19 (1) (2004) 95ndash103
[2] M Goldberg I Gomez-Orellana Challenges for the oral delivery of macromole-cules Nat Rev Drug Discov 2 (4) (2003) 289ndash295
[3] JS Patton PR ByronInhalingmedicinesdelivering drugs to thebodythroughthelungs Nat Rev Drug Discov 6 (1) (2007) 67ndash74
[4] MR Prausnitz R Langer Transdermal drug delivery Nat Biotechnol 26 (11)(2008) 1261ndash1268
[5] R Gaudana et al Ocular drug delivery AAPS J 12 (3) (2010) 348ndash360[6] L Illum Nasal drug deliverynew developments andstrategiesDrugDiscov Today
7 (23) (2002) 1184ndash1189[7] JE Talmadge The pharmaceutics and delivery of therapeutic polypeptides and
proteins Adv Drug Deliv Rev 10 (2) (1993) 247ndash299[8] RLanger Controlledrelease of a therapeuticproteinNat Med 2 (7)(1996)742ndash743[9] R Langer J Folkman Polymers for the sustained release of proteins and other
macromolecules Nature 263 (5580) (1976) 797ndash800[10] JC Wright AS Hoffman Historical overview of long acting injections and
implants Long Acting Injections and Implants Springer 2012 pp 11ndash24[11] M Chaubal Polylactidesglycolidesmdashexcipients for injectable drug delivery and
beyond Drug Deliv Technol 2 (2002) 34ndash36[12] G Zhu SR Mallery SP Schwendeman Stabilization of proteins encapsulated in
injectable poly (lactide-co-glycolide) Nat Biotechnol 18 (1) (2000) 52ndash57[13] V Sinha A Trehan Biodegradable microspheres for protein delivery J Control
Release 90 (3) (2003) 261ndash280[14] M van de Weert WE Hennink W Jiskoot Protein instability in poly (lactic-co-
glycolic acid) microparticles Pharm Res 17 (10) (2000) 1159ndash1167[15] OL Johnson et al A month-longeffect froma single injection of microencapsulated
human growth hormone Nat Med 2 (7) (1996) 795ndash799[16] W Jianget al Biodegradable poly(lactic-co-glycolic acid) microparticles for inject-
able delivery of vaccine antigens Adv Drug Deliv Rev 57 (3) (2005) 391 ndash410[17] F Jordan et al Sustained release hGH microsphere formulation produced by a
novel supercritical 1047298uid technology in vivo studies J Control Release 141 (2)(2010) 153ndash160
[18] MA Tracy Development and scale-up of a microsphere protein delivery systemBiotechnol Prog 14 (1) (1998) 108ndash115
[20] Johnson amp Johnson Annual Report 2012 (February 9 2014) Available fromhttpswwwjnjcomsitesdefault 1047297lespdfJNJ2012annualreportpdf
[21] TM Allen PR Cullis Drug delivery systems entering themainstreamScience303(5665) (2004) 1818ndash1822
[22] T Allen A Chonn Large unilamellar liposomes with low uptake into the reticulo-endothelial system FEBS Lett 223 (1) (1987) 42ndash46
[23] Y Matsumura H Maeda A new concept for macromolecular therapeuticsin cancer chemotherapy mechanism of tumoritropic accumulation of
proteins and the antitumor agent smancs Cancer Res 46 (12 Part 1) (1986)6387ndash6392[24] G Haran et al Transmembrane ammonium sulfate gradients in liposomes
produce ef 1047297cient and stable entrapment of amphipathic weak bases BiochimBiophys Acta (BBA)mdashBiomembr 1151 (2) (1993) 201ndash215
[25] AT Horowitz Y Barenholz AA Gabizon In vitro cytotoxicity of liposome-encapsulated doxorubicin dependence on liposome composition anddrug release Biochim Biophys Acta (BBA)mdashBiomembr 1109 (2) (1992)203ndash209
[26] AA Gabizon Y Barenholz M Bialer Prolongation of the circulation time of doxo-rubicin encapsulated in liposomes containing a polyethylene glycol-derivatizedphospholipid pharmacokinetic studies in rodents and dogs Pharm Res 10 (5)(1993) 703ndash708
[27] A Gabizon et al Prolonged circulation time and enhanced accumulation in malig-nant exudates of doxorubicin encapsulated in polyethylene-glycol coated lipo-somes Cancer Res 54 (4) (1994) 987ndash992
[28] H Maedaet alTumorvascularpermeabilityand theEPR effectin macromoleculartherapeutics a review J Control Release 65 (1) (2000) 271ndash284
[29] Important Update Regarding Supply Outage of DOXILreg Available from http
wwwdoxilcomdoxil-supply-shortage February 9 2014[30] D Peer et al Nanocarriers as an emerging platform for cancer therapy Nat
Nanotechnol 2 (12) (2007) 751ndash760[31] E Ruoslahti Peptides as targeting elements and tissue penetration devices for
nanoparticles Adv Mater 24 (28) (2012) 3747ndash3756[32] PL Rodriguez et al Minimal ldquoself rdquo peptides that inhibit phagocytic clearance and
enhance delivery of nanoparticles Science 339 (6122) (2013) 971ndash975[33] SM Moghimi AC Hunter JC Murray Long-circulating and target-speci1047297c
nanoparticles theory to practice Pharmacol Rev 53 (2) (2001) 283ndash318[34] JP Rolland et al Direct fabrication and harvesting of monodisperse shape-
speci1047297c nanobiomaterials J Am Chem Soc 127 (28) (2005) 10096ndash10100[35] SW Morton et al Scalable manufacture of built-to-order nanomedicine spray-
assisted layer-by-layer functionalization of PRINT nanoparticles Adv Mater 25(34) (2013) 4707ndash4713
[36] M Ferrari Cancer nanotechnology opportunities and challenges Nat Rev Cancer5 (3) (2005) 161ndash171
[37] WJ Gradishar et al Phase III trial of nanoparticle albumin-bound paclitaxel com-pared with polyethylated castor oil-based paclitaxel in women with breast cancer
J Clin Oncol 23 (31) (2005) 7794ndash7803
[38] M Green et al Abraxanereg a novel Cremophorreg-free albumin-bound particleform of paclitaxel for the treatment of advanced non-small-cell lung cancer AnnOncol 17 (8) (2006) 1263ndash1268
[39] DW Nymanet alPhaseI andpharmacokinetics trial of ABI-007 a novel nanopar-ticle formulation of paclitaxel in patients with advanced nonhematologic malig-nancies J Clin Oncol 23 (31) (2005) 7785ndash7793
[40] Celgene Corporation Announces 2014 Financial Outlook and Preliminary 2013Results (February 9 2014) Available from httpircelgenecomreleasedetailcfmReleaseID=821044
[41] J Hrkach et al Preclinical development and clinical translation of a PSMA-targeteddocetaxel nanoparticle with a differentiated pharmacological pro1047297le Sci Transl
Med 4 (128) (2012) 128ra39[42] S Svenson et al Preclinical to clinical development of the novel camptothecin
nanopharmaceutical CRLX101 J Control Release 153 (1) (2011) 49ndash55[43] S Eliasof et al Correlating preclinical animal studies and human clinical trials of a
multifunctional polymeric nanoparticle Proc Natl Acad Sci U S A 110 (37)(2013) 15127ndash15132
[44] ME Davis et al Evidence of RNAi in humans from systemically administeredsiRNA via targeted nanoparticles Nature 464 (7291) (2010) 1067ndash1070
[45] AZ Wang R Langer OC Farokhzad Nanoparticle delivery of cancer drugs AnnuRev Med 63 (2012) 185ndash198
[46] Y Matsumura K Kataoka Preclinical and clinical studies of anticancer agent-incorporating polymer micelles Cancer Sci 100 (4) (2009) 572ndash579
[47] JD Heidel ME Davis Clinical developments in nanotechnology for cancer thera-py Pharm Res 28 (2) (2011) 187ndash199
[48] B D alby et al Advanced transfection with Lipofectamine 2000 reagent primaryneurons siRNAand high-throughput applicationsMethods 33 (2) (2004)95ndash103
[49] S Venkatraman R Gale Skin adhesives and skin adhesion 1 Transdermal drugdelivery systems Biomaterials 19 (13) (1998) 1119ndash1136
[50] AC Watkinson A commentary on transdermal drug delivery systems in clinicaltrials J Pharm Sci 102 (9) (2013) 3082ndash3088
[51] TH Stanley Fentanyl J Pain Symptom Manage 29 (5 Suppl) (2005) S67ndashS71[52] TH Stanley The history and development of the fentanyl series J Pain Symptom
Manage 7 (3 Suppl) (1992) S3ndashS7[53] Lidoderm Sales Data (February 9 2014) Available from httpwwwdrugscom
statslidoderm[54] S Mitragotri Healingsound theuse of ultrasoundin drug delivery andotherther-
apeutic applications Nat Rev Drug Discov 4 (3) (2005) 255ndash260[55] P Karande A Jain S Mitragotri Insights into synergistic interactions in binary
mixtures of chemical permeation enhancers for transdermal drug delivery J Control Release 115 (1) (2006) 85ndash93
[56] MR Prausnitz Microneedles for transdermal drug delivery Adv Drug Deliv Rev56 (5) (2004) 581ndash587
[57] YN Kalia et al Iontophoretic drug delivery Adv Drug Deliv Rev 56 (5) (2004)619ndash658
[58] P Karande A Jain S Mitragotri Discovery of transdermal penetration enhancersby high-throughput screening Nat Biotechnol 22 (2) (2004) 192ndash197
[59] MA Ashburn et al Iontophoretic delivery of morphinefor postoperative analgesia
J Pain Symptom Manage 7 (1) (1992) 27ndash
33[60] R van der Geest et al Iontophoretic delivery of apomorphine II An in vivo studyin patients with Parkinsons disease Pharm Res 14 (12) (1997) 1804ndash1810
[61] M Cormier et al Effect of transdermal iontophoresis codelivery of hydrocortisoneon metoclopramide pharmacokinetics and skin-induced reactions in humansubjects J Pharm Sci 88 (10) (1999) 1030ndash1035
[62] MP James RM Graham J English Percutaneous iontophoresis of prednisolonemdashapharmacokinetic study Clin Exp Dermatol 11 (1) (1986) 54ndash61
[63] PG Green Iontophoretic delivery of peptide drugs J Control Release 41 (1)(1996) 33ndash48
[64] EL Spierings JA Brevard NP Katz Two‐minute skin anesthesia through ultra-sound pretreatment and iontophoretic delivery of a topical anesthetic a feasibilitystudy Pain Med 9 (1) (2008) 55ndash59
[65] P SantoiannI M Nino G Calabro Intradermal Drug Delivery by Low FrequencySonophoresis (25 kHz) 2004
[66] BE Polat et al Ultrasound-mediated transdermal drug delivery mechanismsscope and emerging trends J Control Release 152 (3) (2011) 330ndash348
[67] JJ Norman et al Faster pharmacokinetics and increased patient acceptance of intradermal insulin delivery using a single hollow microneedle in children and
adolescents with type 1 diabetes Pediatr Diabetes 14 (6) (2013) 459 ndash465[68] J Gupta EI Felner MR Prausnitz Rapid pharmacokinetics of intradermal insulin
administered using microneedles in type 1 diabetes subjects Diabetes TechnolTher 13 (4) (2011) 451ndash456
[69] J Gupta EI Felner MR Prausnitz Minimally invasive insulin delivery in subjectswith type 1 diabetes using hollow microneedles Diabetes Technol Ther 11 (6)(2009) 329ndash337
[70] J Gupta et al Rapid local anesthesia in humans using minimally invasivemicroneedles Clin J Pain 28 (2) (2012) 129ndash135
[72] M Ameri SC Fan YF Maa Parathyroid hormone PTH(1ndash34) formulation thatenables uniform coating on a novel transdermal microprojection delivery systemPharm Res 27 (2) (2010) 303ndash313
[73] PE Daddona et al Parathyroid hormone (1ndash34)-coated microneedle patchsystem clinical pharmacokinetics and pharmacodynamics for treatment of osteo-porosis Pharm Res 28 (1) (2011) 159ndash165
[74] A Arora MR Prausnitz S Mitragotri Micro-scale devices for transdermal drugdelivery Int J Pharm 364 (2) (2008) 227ndash236
26 AC Anselmo S Mitragotri Journal of Controlled Release 190 (2014) 15ndash 28
8152019 Revision sobre formas farmaceuticas nuevas
[75] S Mayes M Ferrone Fentanyl HCl patient-controlled iontophoretic transdermalsystem for the management of acute postoperative pain Ann Pharmacother 40(12) (2006) 2178ndash2186
[76] WT Zempsky et al Evaluation of a low-dose lidocaine iontophoresis system fortopical anesthesia in adults and children a randomized controlled trial ClinTher 26 (7) (2004) 1110ndash1119
[77] BM Becker et al Ultrasound with topical anesthetic rapidly decreases pain of intravenous cannulation Acad Emerg Med 12 (4) (2005) 289ndash295
[78] SK Vashist Non-invasive glucose monitoring technology in diabetes managementa review Anal Chim Acta 750 (2012) 16ndash27
[79] H Chuang et al Pilot studies of transdermal continuous glucose measurement
in outpatient diabetic patients and in patients during and after cardiac surgery J Diabetes Sci Technol 2 (4) (2008) 595ndash602[80] S Rose JF Nelson A continuous long-term injector Aust J Exp Biol Med Sci 33
(4) (1955) 415ndash419[81] F Theeuwes Elementary osmotic pump J Pharm Sci 64 (12) (1975) 1987ndash1991[82] V Malaterre et al Oral osmotically driven systems 30 years of development and
clinical use Eur J Pharm Biopharm 73 (3) (2009) 311ndash323[83] E Rosenthal The Soaring Cost of a Simple Breath (February 9 2014) Published
October 12 2013] Available from httpwwwnytimescom20131013usthe-soaring-cost-of-a-simple-breathhtml_r=0
[84] F Theeuwes Orososmotic system development Drug Dev Ind Pharm 9 (7)(1983) 1331ndash1357
[85] CG Park et al A nano1047297brous sheet-based system for linear delivery of nifedipine J Control Release 149 (3) (2011) 250ndash257
[86] DM Bass M Prevo DS Waxman Gastrointestinal safety of an extended-releasenondeformable oral dosage form (OROS) a retrospective study Drug Saf 25(14) (2002) 1021ndash1033
[87] GA Agyilirah GS Banker Polymers for Enteric Coating Applications Polymers forControlled Drug Delivery CRC Press Boca Raton 1991 39ndash66
[88] G Ponchel J-M Irache Speci1047297c and non-speci1047297c bioadhesive particulate systemsfor oral delivery to the gastrointestinal tract Adv Drug Deliv Rev 34 (2) (1998)191ndash219
[89] M Morishita NA Peppas Is the oral route possible for peptide and protein drugdelivery Drug Discov Today 11 (19) (2006) 905ndash910
[90] A Bernkop-Schnuumlrch The use of inhibitory agents to overcome the enzymatic bar-rier to perorally administered therapeuticpeptides and proteins J Control Release52 (1) (1998) 1ndash16
[91] LM Ensign R Cone J HanesOral drug delivery with polymeric nanoparticles thegastrointestinal mucus barriers Adv Drug Deliv Rev 64 (6) (2012) 557ndash570
[92] E Mathiowitz et al Biologically erodable microspheres as potential oral drugdelivery systems Nature 386 (6623) (1997) 410ndash414
[93] V Gupta et alMucoadhesiveintestinaldevices fororal delivery of salmon calcitonin J Control Release 172 (3) (2013) 753ndash762
[95] PW Swaan Recent advances in intestinal macromolecular drug delivery viareceptor-mediated transport pathways Pharm Res 15 (6) (1998) 826ndash834
[96] R Eldor et al Glucose-reducing effect of the ORMD-0801 oral insulin preparationin patients with uncontrolled type 1 diabetes a pilot study PLoS One 8 (4) (2013)e59524
[97] TheEligenreg Library(February9 2014) Available from httpwwwemispherecom eligen_libraryhtml
[98] MC Castelli et al Comparing the ef 1047297cacy and tolerability of a new daily oral vita-min B12 formulation and intermittent intramuscular vitamin B12 in normalizinglow cobalamin levels a randomized open-label parallel-group study Clin Ther33 (3) (2011) 358ndash371 (e2)
[99] K Whitehead Z Shen S Mitragotri Oraldelivery of macromoleculesusing intestinalpatches applications for insulin delivery J Control Release 98 (1) (2004) 37ndash45
[100] EM Pridgen et al Transepithelial transport of fc-targeted nanoparticles by theneonatal fc receptor for oral delivery Sci Transl Med 5 (213) (2013) 213ra167
[101] M Torres‐Lugo et al pH‐sensitive hydrogels as gastrointestinal tract absorptionenhancers transport mechanisms of salmoncalcitoninand other modelmoleculesusing the Caco‐2 cell model Biotechnol Prog 18 (3) (2002) 612ndash616
[102] M Torres-Lugo et al Physicochemical behavior and cytotoxic effects of p (methacrylic acidndashg-ethylene glycol) nanospheres for oral delivery of proteins
J Control Release 80 (1) (2002) 197ndash
205[103] RU Agu et alThe lung as a route forsystemicdeliveryof therapeuticproteins and
peptides Respir Res 2 (4) (2001) 198[104] R Dalby J Suman Inhalation therapy technological milestones in asthma treat-
ment Adv Drug Deliv Rev 55 (7) (2003) 779ndash791[105] PJ Anderson History of aerosol therapy liquid nebulization to MDIs to DPIs
Respir Care 50 (9) (2005) 1139ndash1150[106] JB Fink BK Rubin Problems with inhaler use a call for improved clinician and
patient education Respir Care 50 (10) (2005) 1360ndash1375[107] MJ Telko AJ Hickey Dry powder inhaler formulation Respir Care 50 (9) (2005)
1209ndash1227[108] DAEdwardsA Ben-Jebria R Langer Recentadvances in pulmonary drug delivery
using large porous inhaled particles J Appl Physiol 85 (2) (1998) 379ndash385[109] MB DolovichR DhandAerosol drug deliverydevelopments in devicedesign and
clinical use Lancet 377 (9770) (2011) 1032ndash1045[110] A Hussain et al Absorption enhancers in pulmonary protein delivery J Control
Release 94 (1) (2004) 15ndash24[111] J L Cleland A Daugherty R Mrsny Emerging protein delivery methods Curr
Opin Biotechnol 12 (2) (2001) 212ndash219
[112] JS Patton J Bukar S Nagarajan Inhaled insulin Adv Drug Deliv Rev 35 (2ndash3)(1999) 235ndash247
[113] FDA to Complete Phase-out of Chloro1047298uorocarbon Inhalers (February 9 2014Published October 23 2013) Available from httpwwwfdagovnewsevents newsroompressannouncementsucm371901htm
[114] Drug Treatments for Asthma and Chronic Obstructive Pulmonary Disease ThatDo Not Use Chloro1047298uorocarbons (February 9 2014) Available from http wwwfdagovDrugsDrugSafetyInformationbyDrugClassucm082370htm
[115] AJ Hickey Back to the future inhaled drug products J Pharm Sci 102 (4) (2013)1165ndash1172
[116] S White et al EXUBERA pharmaceutical development of a novel product for
906[117] T Quattrin et al Ef 1047297cacy and safety of inhaled insulin (Exubera) compared withsubcutaneous insulin therapy in patients with type 1 diabetes results of a 6-month randomized comparative trial Diabetes Care 27 (11) (2004) 2622ndash2627
[118] PA Hollander etal Ef 1047297cacyand safety of inhaled insulin (exubera)comparedwithsubcutaneousinsulin therapy in patients with type 2 diabetesresults of a 6-monthrandomized comparative trial Diabetes Care 27 (10) (2004) 2356ndash2362
[119] C Black et al The clinical effectiveness and cost-effectiveness of inhaled insulin indiabetes mellitus a systematic review and economic evaluation Health TechnolAssess 11 (33) (2007) 1ndash126
[120] A Opar Another blowfor inhaled protein therapeutics Nat Rev Drug Discov 7 (3)(2008) 189ndash190
[121] J Kling Dreamboat sinks prospects for fast approval of inhaled insulin NatBiotechnol 29 (3) (2011) 175ndash176
[122] Press Releases MannKind Reports Positive Data from a Phase 3 Clinical Study of AFREZZA in Patients with Type 1 Diabetes (February 9 2014 Published August14 2013) Available from httpwwwnewsmannkindcorpcomphoenixzhtmlc=147953ampp=irol-newsArticleampID=1847441amphighlight=
[123] Available from httpwwwcivitastherapeuticscomCVT-301html
[124] Cardeas Pharma Announces that FDA Grants QIDP Designation and Fast TrackReview for the Companys Antibiotic Combination Product (February 9 2014Published January 8 2014) Available from httpcardeaspharmacom press-releasescardeas-pharma-announces-that-fda-grants-qidp-designation-and-fast-track-review-for-the-companys-antibiotic-combination-product
[125] M Staples et al Application of micro- and nano-electromechanical devices todrug delivery Pharm Res 23 (5) (2006) 847ndash863
[126] TJ Smith et al Intravitreal sustained-release ganciclovir Arch Ophthalmol 110(2) (1992) 255ndash258
[127] GE Sanborn et al Sustained-release ganciclovir therapy for treatment of cyto-megalovirus retinitis Use of an intravitreal device Arch Ophthalmol 110 (2)(1992) 188ndash195
[128] G Velez SM Whitcup New developments in sustained release drug deliveryfor the treatment of intraocular disease Br J Ophthalmol 83 (11) (1999)1225ndash1229
[129] DH Geroski HF Edelhauser Drug delivery for posterior segment eye diseaseInvest Ophthalmol Vis Sci 41 (5) (2000) 961ndash964
[130] DC Musch et al Treatment of cytomegalovirus retinitis with a sustained-releaseganciclovir implant The Ganciclovir Implant Study Group N Engl J Med 337 (2)(1997) 83ndash90
[131] CL Stevenson JT Santini Jr R Langer Reservoir-based drug delivery systemsutilizing microtechnology Adv Drug Deliv Rev 64 (14) (2012) 1590ndash1602
[132] RA Receveur FW Lindemans NF de Rooij Microsystem technologies forimplantable applications J Micromech Microeng 17 (5) (2007) R50
[133] AC Richards Grayson et al Electronic MEMS for triggered delivery Adv DrugDeliv Rev 56 (2) (2004) 173ndash184
[134] HowOzurdex(R) Works(March11 2014) Available fromhttpwwwozurdexcom HowItWorksaspx
[135] A Giese et al Pattern of recurrencefollowinglocal chemotherapy with biodegrad-able carmustine (BCNU) implants in patients with glioblastoma J Neurooncol 66(3) (2004) 351ndash360
[136] EL Weber EA Goebel Cerebral edema associated with Gliadel wafers two casestudies Neuro Oncol 7 (1) (2005) 84ndash89
[137] JT Santini Jr MJ Cima R Langer A controlled-release microchip Nature 397(6717) (1999) 335ndash338
[138] R Farra et al First-in-human testing of a wirelessly controlled drug deliverymicrochip Sci Transl Med 4 (122) (2012) 122ra21
[139] B Hughes Antibodyndash
drug conjugates for cancer poised to deliver Nat Rev DrugDiscov 9 (9) (2010) 665ndash667
[140] JR Junutula et al Site-speci1047297c conjugation of a cytotoxic drug to an antibodyimproves the therapeutic index Nat Biotechnol 26 (8) (2008) 925ndash932
[141] S Verma et al Trastuzumab emtansinefor HER2-positive advanced breast cancerN Engl J Med 367 (19) (2012) 1783ndash1791
[142] ImmunoGen Inc Reports First Quarter Fiscal Year 2014 Financial Results andProvides Quarterly Update (February 9 2014 Published October 25 2013) Avail-able from httpinvestorimmunogencomreleasedetailcfmReleaseID=800370
[143] P Chames et al Therapeutic antibodies successes limit ations and hopes for thefuture Br J Pharmacol 157 (2) (2009) 220ndash233
[144] CF McDonagh et al Engineered antibodyndashdrugconjugateswith de1047297ned sites andstoichiometries of drug attachment Protein Eng Des Sel 19 (7) (2006) 299ndash307
[145] JY Axup et al Synthesis of site-speci1047297c antibodyndashdrug conjugates using unnatu-ral amino acids Proc Natl Acad Sci U S A 109 (40) (2012) 16101ndash16106
[146] SCAlleyNM Okeley PD Senter Antibodyndashdrug conjugates targeted drug deliveryfor cancer Curr Opin Chem Biol 14 (4) (2010) 529ndash537
[147] JM Lambert Drug-conjugated antibodies for the treatment of cancer Br J ClinPharmacol 76 (2) (2013) 248ndash262
27 AC Anselmo S Mitragotri Journal of Controlled Release 190 (2014) 15ndash 28
8152019 Revision sobre formas farmaceuticas nuevas
[149] A Younes et al Brentuximab vedotin (SGN-35) for relapsed CD30-positive lym-phomas N Engl J Med 363 (19) (2010) 1812ndash1821
[150] RS Zolot S Basu RP Million Antibodyndashdrugconjugates Nat Rev Drug Discov12(4) (2013) 259ndash260
[151] FDA P1047297zer Voluntarily Withdraws Cancer Treatment Mylotarg from US Market(February 9 2014 Published June 21 2010) Available from httpwwwfdagov NewsEventsNewsroomPressAnnouncementsucm216448htm
[152] AM Wu PD Senter Arming antibodies prospects and challenges forimmunoconjugates Nat Biotechnol 23 (9) (2005) 1137ndash1146
[153] AK Burnett et al The addition of gemtuzumab ozogamicin to intensive chemo-therapy in older patients with AML produces a signi1047297cant improvement in overallsurvival results of the UK NCRI AML16 randomizedtrial Blood 2011 (AMER SOCHEMATOLOGY 1900 M STREET NW SUITE 200 WASHINGTON DC 20036 USA)
[154] R Langer A personal account of translating discoveries in an academic lab NatBiotechnol 31 (6) (2013) 487ndash489
[155] US Pharmaceutical Sales mdash 2013 (January 17 2014) Available from httpwwwdrugscomstatstop1002013sales
28 AC Anselmo S Mitragotri Journal of Controlled Release 190 (2014) 15ndash 28
8152019 Revision sobre formas farmaceuticas nuevas
[1] M Kermode Unsafe injections in low-income country health settings need forinjection safety promotion to prevent the spread of blood-borne viruses HealthPromot Int 19 (1) (2004) 95ndash103
[2] M Goldberg I Gomez-Orellana Challenges for the oral delivery of macromole-cules Nat Rev Drug Discov 2 (4) (2003) 289ndash295
[3] JS Patton PR ByronInhalingmedicinesdelivering drugs to thebodythroughthelungs Nat Rev Drug Discov 6 (1) (2007) 67ndash74
[4] MR Prausnitz R Langer Transdermal drug delivery Nat Biotechnol 26 (11)(2008) 1261ndash1268
[5] R Gaudana et al Ocular drug delivery AAPS J 12 (3) (2010) 348ndash360[6] L Illum Nasal drug deliverynew developments andstrategiesDrugDiscov Today
7 (23) (2002) 1184ndash1189[7] JE Talmadge The pharmaceutics and delivery of therapeutic polypeptides and
proteins Adv Drug Deliv Rev 10 (2) (1993) 247ndash299[8] RLanger Controlledrelease of a therapeuticproteinNat Med 2 (7)(1996)742ndash743[9] R Langer J Folkman Polymers for the sustained release of proteins and other
macromolecules Nature 263 (5580) (1976) 797ndash800[10] JC Wright AS Hoffman Historical overview of long acting injections and
implants Long Acting Injections and Implants Springer 2012 pp 11ndash24[11] M Chaubal Polylactidesglycolidesmdashexcipients for injectable drug delivery and
beyond Drug Deliv Technol 2 (2002) 34ndash36[12] G Zhu SR Mallery SP Schwendeman Stabilization of proteins encapsulated in
injectable poly (lactide-co-glycolide) Nat Biotechnol 18 (1) (2000) 52ndash57[13] V Sinha A Trehan Biodegradable microspheres for protein delivery J Control
Release 90 (3) (2003) 261ndash280[14] M van de Weert WE Hennink W Jiskoot Protein instability in poly (lactic-co-
glycolic acid) microparticles Pharm Res 17 (10) (2000) 1159ndash1167[15] OL Johnson et al A month-longeffect froma single injection of microencapsulated
human growth hormone Nat Med 2 (7) (1996) 795ndash799[16] W Jianget al Biodegradable poly(lactic-co-glycolic acid) microparticles for inject-
able delivery of vaccine antigens Adv Drug Deliv Rev 57 (3) (2005) 391 ndash410[17] F Jordan et al Sustained release hGH microsphere formulation produced by a
novel supercritical 1047298uid technology in vivo studies J Control Release 141 (2)(2010) 153ndash160
[18] MA Tracy Development and scale-up of a microsphere protein delivery systemBiotechnol Prog 14 (1) (1998) 108ndash115
[20] Johnson amp Johnson Annual Report 2012 (February 9 2014) Available fromhttpswwwjnjcomsitesdefault 1047297lespdfJNJ2012annualreportpdf
[21] TM Allen PR Cullis Drug delivery systems entering themainstreamScience303(5665) (2004) 1818ndash1822
[22] T Allen A Chonn Large unilamellar liposomes with low uptake into the reticulo-endothelial system FEBS Lett 223 (1) (1987) 42ndash46
[23] Y Matsumura H Maeda A new concept for macromolecular therapeuticsin cancer chemotherapy mechanism of tumoritropic accumulation of
proteins and the antitumor agent smancs Cancer Res 46 (12 Part 1) (1986)6387ndash6392[24] G Haran et al Transmembrane ammonium sulfate gradients in liposomes
produce ef 1047297cient and stable entrapment of amphipathic weak bases BiochimBiophys Acta (BBA)mdashBiomembr 1151 (2) (1993) 201ndash215
[25] AT Horowitz Y Barenholz AA Gabizon In vitro cytotoxicity of liposome-encapsulated doxorubicin dependence on liposome composition anddrug release Biochim Biophys Acta (BBA)mdashBiomembr 1109 (2) (1992)203ndash209
[26] AA Gabizon Y Barenholz M Bialer Prolongation of the circulation time of doxo-rubicin encapsulated in liposomes containing a polyethylene glycol-derivatizedphospholipid pharmacokinetic studies in rodents and dogs Pharm Res 10 (5)(1993) 703ndash708
[27] A Gabizon et al Prolonged circulation time and enhanced accumulation in malig-nant exudates of doxorubicin encapsulated in polyethylene-glycol coated lipo-somes Cancer Res 54 (4) (1994) 987ndash992
[28] H Maedaet alTumorvascularpermeabilityand theEPR effectin macromoleculartherapeutics a review J Control Release 65 (1) (2000) 271ndash284
[29] Important Update Regarding Supply Outage of DOXILreg Available from http
wwwdoxilcomdoxil-supply-shortage February 9 2014[30] D Peer et al Nanocarriers as an emerging platform for cancer therapy Nat
Nanotechnol 2 (12) (2007) 751ndash760[31] E Ruoslahti Peptides as targeting elements and tissue penetration devices for
nanoparticles Adv Mater 24 (28) (2012) 3747ndash3756[32] PL Rodriguez et al Minimal ldquoself rdquo peptides that inhibit phagocytic clearance and
enhance delivery of nanoparticles Science 339 (6122) (2013) 971ndash975[33] SM Moghimi AC Hunter JC Murray Long-circulating and target-speci1047297c
nanoparticles theory to practice Pharmacol Rev 53 (2) (2001) 283ndash318[34] JP Rolland et al Direct fabrication and harvesting of monodisperse shape-
speci1047297c nanobiomaterials J Am Chem Soc 127 (28) (2005) 10096ndash10100[35] SW Morton et al Scalable manufacture of built-to-order nanomedicine spray-
assisted layer-by-layer functionalization of PRINT nanoparticles Adv Mater 25(34) (2013) 4707ndash4713
[36] M Ferrari Cancer nanotechnology opportunities and challenges Nat Rev Cancer5 (3) (2005) 161ndash171
[37] WJ Gradishar et al Phase III trial of nanoparticle albumin-bound paclitaxel com-pared with polyethylated castor oil-based paclitaxel in women with breast cancer
J Clin Oncol 23 (31) (2005) 7794ndash7803
[38] M Green et al Abraxanereg a novel Cremophorreg-free albumin-bound particleform of paclitaxel for the treatment of advanced non-small-cell lung cancer AnnOncol 17 (8) (2006) 1263ndash1268
[39] DW Nymanet alPhaseI andpharmacokinetics trial of ABI-007 a novel nanopar-ticle formulation of paclitaxel in patients with advanced nonhematologic malig-nancies J Clin Oncol 23 (31) (2005) 7785ndash7793
[40] Celgene Corporation Announces 2014 Financial Outlook and Preliminary 2013Results (February 9 2014) Available from httpircelgenecomreleasedetailcfmReleaseID=821044
[41] J Hrkach et al Preclinical development and clinical translation of a PSMA-targeteddocetaxel nanoparticle with a differentiated pharmacological pro1047297le Sci Transl
Med 4 (128) (2012) 128ra39[42] S Svenson et al Preclinical to clinical development of the novel camptothecin
nanopharmaceutical CRLX101 J Control Release 153 (1) (2011) 49ndash55[43] S Eliasof et al Correlating preclinical animal studies and human clinical trials of a
multifunctional polymeric nanoparticle Proc Natl Acad Sci U S A 110 (37)(2013) 15127ndash15132
[44] ME Davis et al Evidence of RNAi in humans from systemically administeredsiRNA via targeted nanoparticles Nature 464 (7291) (2010) 1067ndash1070
[45] AZ Wang R Langer OC Farokhzad Nanoparticle delivery of cancer drugs AnnuRev Med 63 (2012) 185ndash198
[46] Y Matsumura K Kataoka Preclinical and clinical studies of anticancer agent-incorporating polymer micelles Cancer Sci 100 (4) (2009) 572ndash579
[47] JD Heidel ME Davis Clinical developments in nanotechnology for cancer thera-py Pharm Res 28 (2) (2011) 187ndash199
[48] B D alby et al Advanced transfection with Lipofectamine 2000 reagent primaryneurons siRNAand high-throughput applicationsMethods 33 (2) (2004)95ndash103
[49] S Venkatraman R Gale Skin adhesives and skin adhesion 1 Transdermal drugdelivery systems Biomaterials 19 (13) (1998) 1119ndash1136
[50] AC Watkinson A commentary on transdermal drug delivery systems in clinicaltrials J Pharm Sci 102 (9) (2013) 3082ndash3088
[51] TH Stanley Fentanyl J Pain Symptom Manage 29 (5 Suppl) (2005) S67ndashS71[52] TH Stanley The history and development of the fentanyl series J Pain Symptom
Manage 7 (3 Suppl) (1992) S3ndashS7[53] Lidoderm Sales Data (February 9 2014) Available from httpwwwdrugscom
statslidoderm[54] S Mitragotri Healingsound theuse of ultrasoundin drug delivery andotherther-
apeutic applications Nat Rev Drug Discov 4 (3) (2005) 255ndash260[55] P Karande A Jain S Mitragotri Insights into synergistic interactions in binary
mixtures of chemical permeation enhancers for transdermal drug delivery J Control Release 115 (1) (2006) 85ndash93
[56] MR Prausnitz Microneedles for transdermal drug delivery Adv Drug Deliv Rev56 (5) (2004) 581ndash587
[57] YN Kalia et al Iontophoretic drug delivery Adv Drug Deliv Rev 56 (5) (2004)619ndash658
[58] P Karande A Jain S Mitragotri Discovery of transdermal penetration enhancersby high-throughput screening Nat Biotechnol 22 (2) (2004) 192ndash197
[59] MA Ashburn et al Iontophoretic delivery of morphinefor postoperative analgesia
J Pain Symptom Manage 7 (1) (1992) 27ndash
33[60] R van der Geest et al Iontophoretic delivery of apomorphine II An in vivo studyin patients with Parkinsons disease Pharm Res 14 (12) (1997) 1804ndash1810
[61] M Cormier et al Effect of transdermal iontophoresis codelivery of hydrocortisoneon metoclopramide pharmacokinetics and skin-induced reactions in humansubjects J Pharm Sci 88 (10) (1999) 1030ndash1035
[62] MP James RM Graham J English Percutaneous iontophoresis of prednisolonemdashapharmacokinetic study Clin Exp Dermatol 11 (1) (1986) 54ndash61
[63] PG Green Iontophoretic delivery of peptide drugs J Control Release 41 (1)(1996) 33ndash48
[64] EL Spierings JA Brevard NP Katz Two‐minute skin anesthesia through ultra-sound pretreatment and iontophoretic delivery of a topical anesthetic a feasibilitystudy Pain Med 9 (1) (2008) 55ndash59
[65] P SantoiannI M Nino G Calabro Intradermal Drug Delivery by Low FrequencySonophoresis (25 kHz) 2004
[66] BE Polat et al Ultrasound-mediated transdermal drug delivery mechanismsscope and emerging trends J Control Release 152 (3) (2011) 330ndash348
[67] JJ Norman et al Faster pharmacokinetics and increased patient acceptance of intradermal insulin delivery using a single hollow microneedle in children and
adolescents with type 1 diabetes Pediatr Diabetes 14 (6) (2013) 459 ndash465[68] J Gupta EI Felner MR Prausnitz Rapid pharmacokinetics of intradermal insulin
administered using microneedles in type 1 diabetes subjects Diabetes TechnolTher 13 (4) (2011) 451ndash456
[69] J Gupta EI Felner MR Prausnitz Minimally invasive insulin delivery in subjectswith type 1 diabetes using hollow microneedles Diabetes Technol Ther 11 (6)(2009) 329ndash337
[70] J Gupta et al Rapid local anesthesia in humans using minimally invasivemicroneedles Clin J Pain 28 (2) (2012) 129ndash135
[72] M Ameri SC Fan YF Maa Parathyroid hormone PTH(1ndash34) formulation thatenables uniform coating on a novel transdermal microprojection delivery systemPharm Res 27 (2) (2010) 303ndash313
[73] PE Daddona et al Parathyroid hormone (1ndash34)-coated microneedle patchsystem clinical pharmacokinetics and pharmacodynamics for treatment of osteo-porosis Pharm Res 28 (1) (2011) 159ndash165
[74] A Arora MR Prausnitz S Mitragotri Micro-scale devices for transdermal drugdelivery Int J Pharm 364 (2) (2008) 227ndash236
26 AC Anselmo S Mitragotri Journal of Controlled Release 190 (2014) 15ndash 28
8152019 Revision sobre formas farmaceuticas nuevas
[75] S Mayes M Ferrone Fentanyl HCl patient-controlled iontophoretic transdermalsystem for the management of acute postoperative pain Ann Pharmacother 40(12) (2006) 2178ndash2186
[76] WT Zempsky et al Evaluation of a low-dose lidocaine iontophoresis system fortopical anesthesia in adults and children a randomized controlled trial ClinTher 26 (7) (2004) 1110ndash1119
[77] BM Becker et al Ultrasound with topical anesthetic rapidly decreases pain of intravenous cannulation Acad Emerg Med 12 (4) (2005) 289ndash295
[78] SK Vashist Non-invasive glucose monitoring technology in diabetes managementa review Anal Chim Acta 750 (2012) 16ndash27
[79] H Chuang et al Pilot studies of transdermal continuous glucose measurement
in outpatient diabetic patients and in patients during and after cardiac surgery J Diabetes Sci Technol 2 (4) (2008) 595ndash602[80] S Rose JF Nelson A continuous long-term injector Aust J Exp Biol Med Sci 33
(4) (1955) 415ndash419[81] F Theeuwes Elementary osmotic pump J Pharm Sci 64 (12) (1975) 1987ndash1991[82] V Malaterre et al Oral osmotically driven systems 30 years of development and
clinical use Eur J Pharm Biopharm 73 (3) (2009) 311ndash323[83] E Rosenthal The Soaring Cost of a Simple Breath (February 9 2014) Published
October 12 2013] Available from httpwwwnytimescom20131013usthe-soaring-cost-of-a-simple-breathhtml_r=0
[84] F Theeuwes Orososmotic system development Drug Dev Ind Pharm 9 (7)(1983) 1331ndash1357
[85] CG Park et al A nano1047297brous sheet-based system for linear delivery of nifedipine J Control Release 149 (3) (2011) 250ndash257
[86] DM Bass M Prevo DS Waxman Gastrointestinal safety of an extended-releasenondeformable oral dosage form (OROS) a retrospective study Drug Saf 25(14) (2002) 1021ndash1033
[87] GA Agyilirah GS Banker Polymers for Enteric Coating Applications Polymers forControlled Drug Delivery CRC Press Boca Raton 1991 39ndash66
[88] G Ponchel J-M Irache Speci1047297c and non-speci1047297c bioadhesive particulate systemsfor oral delivery to the gastrointestinal tract Adv Drug Deliv Rev 34 (2) (1998)191ndash219
[89] M Morishita NA Peppas Is the oral route possible for peptide and protein drugdelivery Drug Discov Today 11 (19) (2006) 905ndash910
[90] A Bernkop-Schnuumlrch The use of inhibitory agents to overcome the enzymatic bar-rier to perorally administered therapeuticpeptides and proteins J Control Release52 (1) (1998) 1ndash16
[91] LM Ensign R Cone J HanesOral drug delivery with polymeric nanoparticles thegastrointestinal mucus barriers Adv Drug Deliv Rev 64 (6) (2012) 557ndash570
[92] E Mathiowitz et al Biologically erodable microspheres as potential oral drugdelivery systems Nature 386 (6623) (1997) 410ndash414
[93] V Gupta et alMucoadhesiveintestinaldevices fororal delivery of salmon calcitonin J Control Release 172 (3) (2013) 753ndash762
[95] PW Swaan Recent advances in intestinal macromolecular drug delivery viareceptor-mediated transport pathways Pharm Res 15 (6) (1998) 826ndash834
[96] R Eldor et al Glucose-reducing effect of the ORMD-0801 oral insulin preparationin patients with uncontrolled type 1 diabetes a pilot study PLoS One 8 (4) (2013)e59524
[97] TheEligenreg Library(February9 2014) Available from httpwwwemispherecom eligen_libraryhtml
[98] MC Castelli et al Comparing the ef 1047297cacy and tolerability of a new daily oral vita-min B12 formulation and intermittent intramuscular vitamin B12 in normalizinglow cobalamin levels a randomized open-label parallel-group study Clin Ther33 (3) (2011) 358ndash371 (e2)
[99] K Whitehead Z Shen S Mitragotri Oraldelivery of macromoleculesusing intestinalpatches applications for insulin delivery J Control Release 98 (1) (2004) 37ndash45
[100] EM Pridgen et al Transepithelial transport of fc-targeted nanoparticles by theneonatal fc receptor for oral delivery Sci Transl Med 5 (213) (2013) 213ra167
[101] M Torres‐Lugo et al pH‐sensitive hydrogels as gastrointestinal tract absorptionenhancers transport mechanisms of salmoncalcitoninand other modelmoleculesusing the Caco‐2 cell model Biotechnol Prog 18 (3) (2002) 612ndash616
[102] M Torres-Lugo et al Physicochemical behavior and cytotoxic effects of p (methacrylic acidndashg-ethylene glycol) nanospheres for oral delivery of proteins
J Control Release 80 (1) (2002) 197ndash
205[103] RU Agu et alThe lung as a route forsystemicdeliveryof therapeuticproteins and
peptides Respir Res 2 (4) (2001) 198[104] R Dalby J Suman Inhalation therapy technological milestones in asthma treat-
ment Adv Drug Deliv Rev 55 (7) (2003) 779ndash791[105] PJ Anderson History of aerosol therapy liquid nebulization to MDIs to DPIs
Respir Care 50 (9) (2005) 1139ndash1150[106] JB Fink BK Rubin Problems with inhaler use a call for improved clinician and
patient education Respir Care 50 (10) (2005) 1360ndash1375[107] MJ Telko AJ Hickey Dry powder inhaler formulation Respir Care 50 (9) (2005)
1209ndash1227[108] DAEdwardsA Ben-Jebria R Langer Recentadvances in pulmonary drug delivery
using large porous inhaled particles J Appl Physiol 85 (2) (1998) 379ndash385[109] MB DolovichR DhandAerosol drug deliverydevelopments in devicedesign and
clinical use Lancet 377 (9770) (2011) 1032ndash1045[110] A Hussain et al Absorption enhancers in pulmonary protein delivery J Control
Release 94 (1) (2004) 15ndash24[111] J L Cleland A Daugherty R Mrsny Emerging protein delivery methods Curr
Opin Biotechnol 12 (2) (2001) 212ndash219
[112] JS Patton J Bukar S Nagarajan Inhaled insulin Adv Drug Deliv Rev 35 (2ndash3)(1999) 235ndash247
[113] FDA to Complete Phase-out of Chloro1047298uorocarbon Inhalers (February 9 2014Published October 23 2013) Available from httpwwwfdagovnewsevents newsroompressannouncementsucm371901htm
[114] Drug Treatments for Asthma and Chronic Obstructive Pulmonary Disease ThatDo Not Use Chloro1047298uorocarbons (February 9 2014) Available from http wwwfdagovDrugsDrugSafetyInformationbyDrugClassucm082370htm
[115] AJ Hickey Back to the future inhaled drug products J Pharm Sci 102 (4) (2013)1165ndash1172
[116] S White et al EXUBERA pharmaceutical development of a novel product for
906[117] T Quattrin et al Ef 1047297cacy and safety of inhaled insulin (Exubera) compared withsubcutaneous insulin therapy in patients with type 1 diabetes results of a 6-month randomized comparative trial Diabetes Care 27 (11) (2004) 2622ndash2627
[118] PA Hollander etal Ef 1047297cacyand safety of inhaled insulin (exubera)comparedwithsubcutaneousinsulin therapy in patients with type 2 diabetesresults of a 6-monthrandomized comparative trial Diabetes Care 27 (10) (2004) 2356ndash2362
[119] C Black et al The clinical effectiveness and cost-effectiveness of inhaled insulin indiabetes mellitus a systematic review and economic evaluation Health TechnolAssess 11 (33) (2007) 1ndash126
[120] A Opar Another blowfor inhaled protein therapeutics Nat Rev Drug Discov 7 (3)(2008) 189ndash190
[121] J Kling Dreamboat sinks prospects for fast approval of inhaled insulin NatBiotechnol 29 (3) (2011) 175ndash176
[122] Press Releases MannKind Reports Positive Data from a Phase 3 Clinical Study of AFREZZA in Patients with Type 1 Diabetes (February 9 2014 Published August14 2013) Available from httpwwwnewsmannkindcorpcomphoenixzhtmlc=147953ampp=irol-newsArticleampID=1847441amphighlight=
[123] Available from httpwwwcivitastherapeuticscomCVT-301html
[124] Cardeas Pharma Announces that FDA Grants QIDP Designation and Fast TrackReview for the Companys Antibiotic Combination Product (February 9 2014Published January 8 2014) Available from httpcardeaspharmacom press-releasescardeas-pharma-announces-that-fda-grants-qidp-designation-and-fast-track-review-for-the-companys-antibiotic-combination-product
[125] M Staples et al Application of micro- and nano-electromechanical devices todrug delivery Pharm Res 23 (5) (2006) 847ndash863
[126] TJ Smith et al Intravitreal sustained-release ganciclovir Arch Ophthalmol 110(2) (1992) 255ndash258
[127] GE Sanborn et al Sustained-release ganciclovir therapy for treatment of cyto-megalovirus retinitis Use of an intravitreal device Arch Ophthalmol 110 (2)(1992) 188ndash195
[128] G Velez SM Whitcup New developments in sustained release drug deliveryfor the treatment of intraocular disease Br J Ophthalmol 83 (11) (1999)1225ndash1229
[129] DH Geroski HF Edelhauser Drug delivery for posterior segment eye diseaseInvest Ophthalmol Vis Sci 41 (5) (2000) 961ndash964
[130] DC Musch et al Treatment of cytomegalovirus retinitis with a sustained-releaseganciclovir implant The Ganciclovir Implant Study Group N Engl J Med 337 (2)(1997) 83ndash90
[131] CL Stevenson JT Santini Jr R Langer Reservoir-based drug delivery systemsutilizing microtechnology Adv Drug Deliv Rev 64 (14) (2012) 1590ndash1602
[132] RA Receveur FW Lindemans NF de Rooij Microsystem technologies forimplantable applications J Micromech Microeng 17 (5) (2007) R50
[133] AC Richards Grayson et al Electronic MEMS for triggered delivery Adv DrugDeliv Rev 56 (2) (2004) 173ndash184
[134] HowOzurdex(R) Works(March11 2014) Available fromhttpwwwozurdexcom HowItWorksaspx
[135] A Giese et al Pattern of recurrencefollowinglocal chemotherapy with biodegrad-able carmustine (BCNU) implants in patients with glioblastoma J Neurooncol 66(3) (2004) 351ndash360
[136] EL Weber EA Goebel Cerebral edema associated with Gliadel wafers two casestudies Neuro Oncol 7 (1) (2005) 84ndash89
[137] JT Santini Jr MJ Cima R Langer A controlled-release microchip Nature 397(6717) (1999) 335ndash338
[138] R Farra et al First-in-human testing of a wirelessly controlled drug deliverymicrochip Sci Transl Med 4 (122) (2012) 122ra21
[139] B Hughes Antibodyndash
drug conjugates for cancer poised to deliver Nat Rev DrugDiscov 9 (9) (2010) 665ndash667
[140] JR Junutula et al Site-speci1047297c conjugation of a cytotoxic drug to an antibodyimproves the therapeutic index Nat Biotechnol 26 (8) (2008) 925ndash932
[141] S Verma et al Trastuzumab emtansinefor HER2-positive advanced breast cancerN Engl J Med 367 (19) (2012) 1783ndash1791
[142] ImmunoGen Inc Reports First Quarter Fiscal Year 2014 Financial Results andProvides Quarterly Update (February 9 2014 Published October 25 2013) Avail-able from httpinvestorimmunogencomreleasedetailcfmReleaseID=800370
[143] P Chames et al Therapeutic antibodies successes limit ations and hopes for thefuture Br J Pharmacol 157 (2) (2009) 220ndash233
[144] CF McDonagh et al Engineered antibodyndashdrugconjugateswith de1047297ned sites andstoichiometries of drug attachment Protein Eng Des Sel 19 (7) (2006) 299ndash307
[145] JY Axup et al Synthesis of site-speci1047297c antibodyndashdrug conjugates using unnatu-ral amino acids Proc Natl Acad Sci U S A 109 (40) (2012) 16101ndash16106
[146] SCAlleyNM Okeley PD Senter Antibodyndashdrug conjugates targeted drug deliveryfor cancer Curr Opin Chem Biol 14 (4) (2010) 529ndash537
[147] JM Lambert Drug-conjugated antibodies for the treatment of cancer Br J ClinPharmacol 76 (2) (2013) 248ndash262
27 AC Anselmo S Mitragotri Journal of Controlled Release 190 (2014) 15ndash 28
8152019 Revision sobre formas farmaceuticas nuevas
[149] A Younes et al Brentuximab vedotin (SGN-35) for relapsed CD30-positive lym-phomas N Engl J Med 363 (19) (2010) 1812ndash1821
[150] RS Zolot S Basu RP Million Antibodyndashdrugconjugates Nat Rev Drug Discov12(4) (2013) 259ndash260
[151] FDA P1047297zer Voluntarily Withdraws Cancer Treatment Mylotarg from US Market(February 9 2014 Published June 21 2010) Available from httpwwwfdagov NewsEventsNewsroomPressAnnouncementsucm216448htm
[152] AM Wu PD Senter Arming antibodies prospects and challenges forimmunoconjugates Nat Biotechnol 23 (9) (2005) 1137ndash1146
[153] AK Burnett et al The addition of gemtuzumab ozogamicin to intensive chemo-therapy in older patients with AML produces a signi1047297cant improvement in overallsurvival results of the UK NCRI AML16 randomizedtrial Blood 2011 (AMER SOCHEMATOLOGY 1900 M STREET NW SUITE 200 WASHINGTON DC 20036 USA)
[154] R Langer A personal account of translating discoveries in an academic lab NatBiotechnol 31 (6) (2013) 487ndash489
[155] US Pharmaceutical Sales mdash 2013 (January 17 2014) Available from httpwwwdrugscomstatstop1002013sales
28 AC Anselmo S Mitragotri Journal of Controlled Release 190 (2014) 15ndash 28
8152019 Revision sobre formas farmaceuticas nuevas
[1] M Kermode Unsafe injections in low-income country health settings need forinjection safety promotion to prevent the spread of blood-borne viruses HealthPromot Int 19 (1) (2004) 95ndash103
[2] M Goldberg I Gomez-Orellana Challenges for the oral delivery of macromole-cules Nat Rev Drug Discov 2 (4) (2003) 289ndash295
[3] JS Patton PR ByronInhalingmedicinesdelivering drugs to thebodythroughthelungs Nat Rev Drug Discov 6 (1) (2007) 67ndash74
[4] MR Prausnitz R Langer Transdermal drug delivery Nat Biotechnol 26 (11)(2008) 1261ndash1268
[5] R Gaudana et al Ocular drug delivery AAPS J 12 (3) (2010) 348ndash360[6] L Illum Nasal drug deliverynew developments andstrategiesDrugDiscov Today
7 (23) (2002) 1184ndash1189[7] JE Talmadge The pharmaceutics and delivery of therapeutic polypeptides and
proteins Adv Drug Deliv Rev 10 (2) (1993) 247ndash299[8] RLanger Controlledrelease of a therapeuticproteinNat Med 2 (7)(1996)742ndash743[9] R Langer J Folkman Polymers for the sustained release of proteins and other
macromolecules Nature 263 (5580) (1976) 797ndash800[10] JC Wright AS Hoffman Historical overview of long acting injections and
implants Long Acting Injections and Implants Springer 2012 pp 11ndash24[11] M Chaubal Polylactidesglycolidesmdashexcipients for injectable drug delivery and
beyond Drug Deliv Technol 2 (2002) 34ndash36[12] G Zhu SR Mallery SP Schwendeman Stabilization of proteins encapsulated in
injectable poly (lactide-co-glycolide) Nat Biotechnol 18 (1) (2000) 52ndash57[13] V Sinha A Trehan Biodegradable microspheres for protein delivery J Control
Release 90 (3) (2003) 261ndash280[14] M van de Weert WE Hennink W Jiskoot Protein instability in poly (lactic-co-
glycolic acid) microparticles Pharm Res 17 (10) (2000) 1159ndash1167[15] OL Johnson et al A month-longeffect froma single injection of microencapsulated
human growth hormone Nat Med 2 (7) (1996) 795ndash799[16] W Jianget al Biodegradable poly(lactic-co-glycolic acid) microparticles for inject-
able delivery of vaccine antigens Adv Drug Deliv Rev 57 (3) (2005) 391 ndash410[17] F Jordan et al Sustained release hGH microsphere formulation produced by a
novel supercritical 1047298uid technology in vivo studies J Control Release 141 (2)(2010) 153ndash160
[18] MA Tracy Development and scale-up of a microsphere protein delivery systemBiotechnol Prog 14 (1) (1998) 108ndash115
[20] Johnson amp Johnson Annual Report 2012 (February 9 2014) Available fromhttpswwwjnjcomsitesdefault 1047297lespdfJNJ2012annualreportpdf
[21] TM Allen PR Cullis Drug delivery systems entering themainstreamScience303(5665) (2004) 1818ndash1822
[22] T Allen A Chonn Large unilamellar liposomes with low uptake into the reticulo-endothelial system FEBS Lett 223 (1) (1987) 42ndash46
[23] Y Matsumura H Maeda A new concept for macromolecular therapeuticsin cancer chemotherapy mechanism of tumoritropic accumulation of
proteins and the antitumor agent smancs Cancer Res 46 (12 Part 1) (1986)6387ndash6392[24] G Haran et al Transmembrane ammonium sulfate gradients in liposomes
produce ef 1047297cient and stable entrapment of amphipathic weak bases BiochimBiophys Acta (BBA)mdashBiomembr 1151 (2) (1993) 201ndash215
[25] AT Horowitz Y Barenholz AA Gabizon In vitro cytotoxicity of liposome-encapsulated doxorubicin dependence on liposome composition anddrug release Biochim Biophys Acta (BBA)mdashBiomembr 1109 (2) (1992)203ndash209
[26] AA Gabizon Y Barenholz M Bialer Prolongation of the circulation time of doxo-rubicin encapsulated in liposomes containing a polyethylene glycol-derivatizedphospholipid pharmacokinetic studies in rodents and dogs Pharm Res 10 (5)(1993) 703ndash708
[27] A Gabizon et al Prolonged circulation time and enhanced accumulation in malig-nant exudates of doxorubicin encapsulated in polyethylene-glycol coated lipo-somes Cancer Res 54 (4) (1994) 987ndash992
[28] H Maedaet alTumorvascularpermeabilityand theEPR effectin macromoleculartherapeutics a review J Control Release 65 (1) (2000) 271ndash284
[29] Important Update Regarding Supply Outage of DOXILreg Available from http
wwwdoxilcomdoxil-supply-shortage February 9 2014[30] D Peer et al Nanocarriers as an emerging platform for cancer therapy Nat
Nanotechnol 2 (12) (2007) 751ndash760[31] E Ruoslahti Peptides as targeting elements and tissue penetration devices for
nanoparticles Adv Mater 24 (28) (2012) 3747ndash3756[32] PL Rodriguez et al Minimal ldquoself rdquo peptides that inhibit phagocytic clearance and
enhance delivery of nanoparticles Science 339 (6122) (2013) 971ndash975[33] SM Moghimi AC Hunter JC Murray Long-circulating and target-speci1047297c
nanoparticles theory to practice Pharmacol Rev 53 (2) (2001) 283ndash318[34] JP Rolland et al Direct fabrication and harvesting of monodisperse shape-
speci1047297c nanobiomaterials J Am Chem Soc 127 (28) (2005) 10096ndash10100[35] SW Morton et al Scalable manufacture of built-to-order nanomedicine spray-
assisted layer-by-layer functionalization of PRINT nanoparticles Adv Mater 25(34) (2013) 4707ndash4713
[36] M Ferrari Cancer nanotechnology opportunities and challenges Nat Rev Cancer5 (3) (2005) 161ndash171
[37] WJ Gradishar et al Phase III trial of nanoparticle albumin-bound paclitaxel com-pared with polyethylated castor oil-based paclitaxel in women with breast cancer
J Clin Oncol 23 (31) (2005) 7794ndash7803
[38] M Green et al Abraxanereg a novel Cremophorreg-free albumin-bound particleform of paclitaxel for the treatment of advanced non-small-cell lung cancer AnnOncol 17 (8) (2006) 1263ndash1268
[39] DW Nymanet alPhaseI andpharmacokinetics trial of ABI-007 a novel nanopar-ticle formulation of paclitaxel in patients with advanced nonhematologic malig-nancies J Clin Oncol 23 (31) (2005) 7785ndash7793
[40] Celgene Corporation Announces 2014 Financial Outlook and Preliminary 2013Results (February 9 2014) Available from httpircelgenecomreleasedetailcfmReleaseID=821044
[41] J Hrkach et al Preclinical development and clinical translation of a PSMA-targeteddocetaxel nanoparticle with a differentiated pharmacological pro1047297le Sci Transl
Med 4 (128) (2012) 128ra39[42] S Svenson et al Preclinical to clinical development of the novel camptothecin
nanopharmaceutical CRLX101 J Control Release 153 (1) (2011) 49ndash55[43] S Eliasof et al Correlating preclinical animal studies and human clinical trials of a
multifunctional polymeric nanoparticle Proc Natl Acad Sci U S A 110 (37)(2013) 15127ndash15132
[44] ME Davis et al Evidence of RNAi in humans from systemically administeredsiRNA via targeted nanoparticles Nature 464 (7291) (2010) 1067ndash1070
[45] AZ Wang R Langer OC Farokhzad Nanoparticle delivery of cancer drugs AnnuRev Med 63 (2012) 185ndash198
[46] Y Matsumura K Kataoka Preclinical and clinical studies of anticancer agent-incorporating polymer micelles Cancer Sci 100 (4) (2009) 572ndash579
[47] JD Heidel ME Davis Clinical developments in nanotechnology for cancer thera-py Pharm Res 28 (2) (2011) 187ndash199
[48] B D alby et al Advanced transfection with Lipofectamine 2000 reagent primaryneurons siRNAand high-throughput applicationsMethods 33 (2) (2004)95ndash103
[49] S Venkatraman R Gale Skin adhesives and skin adhesion 1 Transdermal drugdelivery systems Biomaterials 19 (13) (1998) 1119ndash1136
[50] AC Watkinson A commentary on transdermal drug delivery systems in clinicaltrials J Pharm Sci 102 (9) (2013) 3082ndash3088
[51] TH Stanley Fentanyl J Pain Symptom Manage 29 (5 Suppl) (2005) S67ndashS71[52] TH Stanley The history and development of the fentanyl series J Pain Symptom
Manage 7 (3 Suppl) (1992) S3ndashS7[53] Lidoderm Sales Data (February 9 2014) Available from httpwwwdrugscom
statslidoderm[54] S Mitragotri Healingsound theuse of ultrasoundin drug delivery andotherther-
apeutic applications Nat Rev Drug Discov 4 (3) (2005) 255ndash260[55] P Karande A Jain S Mitragotri Insights into synergistic interactions in binary
mixtures of chemical permeation enhancers for transdermal drug delivery J Control Release 115 (1) (2006) 85ndash93
[56] MR Prausnitz Microneedles for transdermal drug delivery Adv Drug Deliv Rev56 (5) (2004) 581ndash587
[57] YN Kalia et al Iontophoretic drug delivery Adv Drug Deliv Rev 56 (5) (2004)619ndash658
[58] P Karande A Jain S Mitragotri Discovery of transdermal penetration enhancersby high-throughput screening Nat Biotechnol 22 (2) (2004) 192ndash197
[59] MA Ashburn et al Iontophoretic delivery of morphinefor postoperative analgesia
J Pain Symptom Manage 7 (1) (1992) 27ndash
33[60] R van der Geest et al Iontophoretic delivery of apomorphine II An in vivo studyin patients with Parkinsons disease Pharm Res 14 (12) (1997) 1804ndash1810
[61] M Cormier et al Effect of transdermal iontophoresis codelivery of hydrocortisoneon metoclopramide pharmacokinetics and skin-induced reactions in humansubjects J Pharm Sci 88 (10) (1999) 1030ndash1035
[62] MP James RM Graham J English Percutaneous iontophoresis of prednisolonemdashapharmacokinetic study Clin Exp Dermatol 11 (1) (1986) 54ndash61
[63] PG Green Iontophoretic delivery of peptide drugs J Control Release 41 (1)(1996) 33ndash48
[64] EL Spierings JA Brevard NP Katz Two‐minute skin anesthesia through ultra-sound pretreatment and iontophoretic delivery of a topical anesthetic a feasibilitystudy Pain Med 9 (1) (2008) 55ndash59
[65] P SantoiannI M Nino G Calabro Intradermal Drug Delivery by Low FrequencySonophoresis (25 kHz) 2004
[66] BE Polat et al Ultrasound-mediated transdermal drug delivery mechanismsscope and emerging trends J Control Release 152 (3) (2011) 330ndash348
[67] JJ Norman et al Faster pharmacokinetics and increased patient acceptance of intradermal insulin delivery using a single hollow microneedle in children and
adolescents with type 1 diabetes Pediatr Diabetes 14 (6) (2013) 459 ndash465[68] J Gupta EI Felner MR Prausnitz Rapid pharmacokinetics of intradermal insulin
administered using microneedles in type 1 diabetes subjects Diabetes TechnolTher 13 (4) (2011) 451ndash456
[69] J Gupta EI Felner MR Prausnitz Minimally invasive insulin delivery in subjectswith type 1 diabetes using hollow microneedles Diabetes Technol Ther 11 (6)(2009) 329ndash337
[70] J Gupta et al Rapid local anesthesia in humans using minimally invasivemicroneedles Clin J Pain 28 (2) (2012) 129ndash135
[72] M Ameri SC Fan YF Maa Parathyroid hormone PTH(1ndash34) formulation thatenables uniform coating on a novel transdermal microprojection delivery systemPharm Res 27 (2) (2010) 303ndash313
[73] PE Daddona et al Parathyroid hormone (1ndash34)-coated microneedle patchsystem clinical pharmacokinetics and pharmacodynamics for treatment of osteo-porosis Pharm Res 28 (1) (2011) 159ndash165
[74] A Arora MR Prausnitz S Mitragotri Micro-scale devices for transdermal drugdelivery Int J Pharm 364 (2) (2008) 227ndash236
26 AC Anselmo S Mitragotri Journal of Controlled Release 190 (2014) 15ndash 28
8152019 Revision sobre formas farmaceuticas nuevas
[75] S Mayes M Ferrone Fentanyl HCl patient-controlled iontophoretic transdermalsystem for the management of acute postoperative pain Ann Pharmacother 40(12) (2006) 2178ndash2186
[76] WT Zempsky et al Evaluation of a low-dose lidocaine iontophoresis system fortopical anesthesia in adults and children a randomized controlled trial ClinTher 26 (7) (2004) 1110ndash1119
[77] BM Becker et al Ultrasound with topical anesthetic rapidly decreases pain of intravenous cannulation Acad Emerg Med 12 (4) (2005) 289ndash295
[78] SK Vashist Non-invasive glucose monitoring technology in diabetes managementa review Anal Chim Acta 750 (2012) 16ndash27
[79] H Chuang et al Pilot studies of transdermal continuous glucose measurement
in outpatient diabetic patients and in patients during and after cardiac surgery J Diabetes Sci Technol 2 (4) (2008) 595ndash602[80] S Rose JF Nelson A continuous long-term injector Aust J Exp Biol Med Sci 33
(4) (1955) 415ndash419[81] F Theeuwes Elementary osmotic pump J Pharm Sci 64 (12) (1975) 1987ndash1991[82] V Malaterre et al Oral osmotically driven systems 30 years of development and
clinical use Eur J Pharm Biopharm 73 (3) (2009) 311ndash323[83] E Rosenthal The Soaring Cost of a Simple Breath (February 9 2014) Published
October 12 2013] Available from httpwwwnytimescom20131013usthe-soaring-cost-of-a-simple-breathhtml_r=0
[84] F Theeuwes Orososmotic system development Drug Dev Ind Pharm 9 (7)(1983) 1331ndash1357
[85] CG Park et al A nano1047297brous sheet-based system for linear delivery of nifedipine J Control Release 149 (3) (2011) 250ndash257
[86] DM Bass M Prevo DS Waxman Gastrointestinal safety of an extended-releasenondeformable oral dosage form (OROS) a retrospective study Drug Saf 25(14) (2002) 1021ndash1033
[87] GA Agyilirah GS Banker Polymers for Enteric Coating Applications Polymers forControlled Drug Delivery CRC Press Boca Raton 1991 39ndash66
[88] G Ponchel J-M Irache Speci1047297c and non-speci1047297c bioadhesive particulate systemsfor oral delivery to the gastrointestinal tract Adv Drug Deliv Rev 34 (2) (1998)191ndash219
[89] M Morishita NA Peppas Is the oral route possible for peptide and protein drugdelivery Drug Discov Today 11 (19) (2006) 905ndash910
[90] A Bernkop-Schnuumlrch The use of inhibitory agents to overcome the enzymatic bar-rier to perorally administered therapeuticpeptides and proteins J Control Release52 (1) (1998) 1ndash16
[91] LM Ensign R Cone J HanesOral drug delivery with polymeric nanoparticles thegastrointestinal mucus barriers Adv Drug Deliv Rev 64 (6) (2012) 557ndash570
[92] E Mathiowitz et al Biologically erodable microspheres as potential oral drugdelivery systems Nature 386 (6623) (1997) 410ndash414
[93] V Gupta et alMucoadhesiveintestinaldevices fororal delivery of salmon calcitonin J Control Release 172 (3) (2013) 753ndash762
[95] PW Swaan Recent advances in intestinal macromolecular drug delivery viareceptor-mediated transport pathways Pharm Res 15 (6) (1998) 826ndash834
[96] R Eldor et al Glucose-reducing effect of the ORMD-0801 oral insulin preparationin patients with uncontrolled type 1 diabetes a pilot study PLoS One 8 (4) (2013)e59524
[97] TheEligenreg Library(February9 2014) Available from httpwwwemispherecom eligen_libraryhtml
[98] MC Castelli et al Comparing the ef 1047297cacy and tolerability of a new daily oral vita-min B12 formulation and intermittent intramuscular vitamin B12 in normalizinglow cobalamin levels a randomized open-label parallel-group study Clin Ther33 (3) (2011) 358ndash371 (e2)
[99] K Whitehead Z Shen S Mitragotri Oraldelivery of macromoleculesusing intestinalpatches applications for insulin delivery J Control Release 98 (1) (2004) 37ndash45
[100] EM Pridgen et al Transepithelial transport of fc-targeted nanoparticles by theneonatal fc receptor for oral delivery Sci Transl Med 5 (213) (2013) 213ra167
[101] M Torres‐Lugo et al pH‐sensitive hydrogels as gastrointestinal tract absorptionenhancers transport mechanisms of salmoncalcitoninand other modelmoleculesusing the Caco‐2 cell model Biotechnol Prog 18 (3) (2002) 612ndash616
[102] M Torres-Lugo et al Physicochemical behavior and cytotoxic effects of p (methacrylic acidndashg-ethylene glycol) nanospheres for oral delivery of proteins
J Control Release 80 (1) (2002) 197ndash
205[103] RU Agu et alThe lung as a route forsystemicdeliveryof therapeuticproteins and
peptides Respir Res 2 (4) (2001) 198[104] R Dalby J Suman Inhalation therapy technological milestones in asthma treat-
ment Adv Drug Deliv Rev 55 (7) (2003) 779ndash791[105] PJ Anderson History of aerosol therapy liquid nebulization to MDIs to DPIs
Respir Care 50 (9) (2005) 1139ndash1150[106] JB Fink BK Rubin Problems with inhaler use a call for improved clinician and
patient education Respir Care 50 (10) (2005) 1360ndash1375[107] MJ Telko AJ Hickey Dry powder inhaler formulation Respir Care 50 (9) (2005)
1209ndash1227[108] DAEdwardsA Ben-Jebria R Langer Recentadvances in pulmonary drug delivery
using large porous inhaled particles J Appl Physiol 85 (2) (1998) 379ndash385[109] MB DolovichR DhandAerosol drug deliverydevelopments in devicedesign and
clinical use Lancet 377 (9770) (2011) 1032ndash1045[110] A Hussain et al Absorption enhancers in pulmonary protein delivery J Control
Release 94 (1) (2004) 15ndash24[111] J L Cleland A Daugherty R Mrsny Emerging protein delivery methods Curr
Opin Biotechnol 12 (2) (2001) 212ndash219
[112] JS Patton J Bukar S Nagarajan Inhaled insulin Adv Drug Deliv Rev 35 (2ndash3)(1999) 235ndash247
[113] FDA to Complete Phase-out of Chloro1047298uorocarbon Inhalers (February 9 2014Published October 23 2013) Available from httpwwwfdagovnewsevents newsroompressannouncementsucm371901htm
[114] Drug Treatments for Asthma and Chronic Obstructive Pulmonary Disease ThatDo Not Use Chloro1047298uorocarbons (February 9 2014) Available from http wwwfdagovDrugsDrugSafetyInformationbyDrugClassucm082370htm
[115] AJ Hickey Back to the future inhaled drug products J Pharm Sci 102 (4) (2013)1165ndash1172
[116] S White et al EXUBERA pharmaceutical development of a novel product for
906[117] T Quattrin et al Ef 1047297cacy and safety of inhaled insulin (Exubera) compared withsubcutaneous insulin therapy in patients with type 1 diabetes results of a 6-month randomized comparative trial Diabetes Care 27 (11) (2004) 2622ndash2627
[118] PA Hollander etal Ef 1047297cacyand safety of inhaled insulin (exubera)comparedwithsubcutaneousinsulin therapy in patients with type 2 diabetesresults of a 6-monthrandomized comparative trial Diabetes Care 27 (10) (2004) 2356ndash2362
[119] C Black et al The clinical effectiveness and cost-effectiveness of inhaled insulin indiabetes mellitus a systematic review and economic evaluation Health TechnolAssess 11 (33) (2007) 1ndash126
[120] A Opar Another blowfor inhaled protein therapeutics Nat Rev Drug Discov 7 (3)(2008) 189ndash190
[121] J Kling Dreamboat sinks prospects for fast approval of inhaled insulin NatBiotechnol 29 (3) (2011) 175ndash176
[122] Press Releases MannKind Reports Positive Data from a Phase 3 Clinical Study of AFREZZA in Patients with Type 1 Diabetes (February 9 2014 Published August14 2013) Available from httpwwwnewsmannkindcorpcomphoenixzhtmlc=147953ampp=irol-newsArticleampID=1847441amphighlight=
[123] Available from httpwwwcivitastherapeuticscomCVT-301html
[124] Cardeas Pharma Announces that FDA Grants QIDP Designation and Fast TrackReview for the Companys Antibiotic Combination Product (February 9 2014Published January 8 2014) Available from httpcardeaspharmacom press-releasescardeas-pharma-announces-that-fda-grants-qidp-designation-and-fast-track-review-for-the-companys-antibiotic-combination-product
[125] M Staples et al Application of micro- and nano-electromechanical devices todrug delivery Pharm Res 23 (5) (2006) 847ndash863
[126] TJ Smith et al Intravitreal sustained-release ganciclovir Arch Ophthalmol 110(2) (1992) 255ndash258
[127] GE Sanborn et al Sustained-release ganciclovir therapy for treatment of cyto-megalovirus retinitis Use of an intravitreal device Arch Ophthalmol 110 (2)(1992) 188ndash195
[128] G Velez SM Whitcup New developments in sustained release drug deliveryfor the treatment of intraocular disease Br J Ophthalmol 83 (11) (1999)1225ndash1229
[129] DH Geroski HF Edelhauser Drug delivery for posterior segment eye diseaseInvest Ophthalmol Vis Sci 41 (5) (2000) 961ndash964
[130] DC Musch et al Treatment of cytomegalovirus retinitis with a sustained-releaseganciclovir implant The Ganciclovir Implant Study Group N Engl J Med 337 (2)(1997) 83ndash90
[131] CL Stevenson JT Santini Jr R Langer Reservoir-based drug delivery systemsutilizing microtechnology Adv Drug Deliv Rev 64 (14) (2012) 1590ndash1602
[132] RA Receveur FW Lindemans NF de Rooij Microsystem technologies forimplantable applications J Micromech Microeng 17 (5) (2007) R50
[133] AC Richards Grayson et al Electronic MEMS for triggered delivery Adv DrugDeliv Rev 56 (2) (2004) 173ndash184
[134] HowOzurdex(R) Works(March11 2014) Available fromhttpwwwozurdexcom HowItWorksaspx
[135] A Giese et al Pattern of recurrencefollowinglocal chemotherapy with biodegrad-able carmustine (BCNU) implants in patients with glioblastoma J Neurooncol 66(3) (2004) 351ndash360
[136] EL Weber EA Goebel Cerebral edema associated with Gliadel wafers two casestudies Neuro Oncol 7 (1) (2005) 84ndash89
[137] JT Santini Jr MJ Cima R Langer A controlled-release microchip Nature 397(6717) (1999) 335ndash338
[138] R Farra et al First-in-human testing of a wirelessly controlled drug deliverymicrochip Sci Transl Med 4 (122) (2012) 122ra21
[139] B Hughes Antibodyndash
drug conjugates for cancer poised to deliver Nat Rev DrugDiscov 9 (9) (2010) 665ndash667
[140] JR Junutula et al Site-speci1047297c conjugation of a cytotoxic drug to an antibodyimproves the therapeutic index Nat Biotechnol 26 (8) (2008) 925ndash932
[141] S Verma et al Trastuzumab emtansinefor HER2-positive advanced breast cancerN Engl J Med 367 (19) (2012) 1783ndash1791
[142] ImmunoGen Inc Reports First Quarter Fiscal Year 2014 Financial Results andProvides Quarterly Update (February 9 2014 Published October 25 2013) Avail-able from httpinvestorimmunogencomreleasedetailcfmReleaseID=800370
[143] P Chames et al Therapeutic antibodies successes limit ations and hopes for thefuture Br J Pharmacol 157 (2) (2009) 220ndash233
[144] CF McDonagh et al Engineered antibodyndashdrugconjugateswith de1047297ned sites andstoichiometries of drug attachment Protein Eng Des Sel 19 (7) (2006) 299ndash307
[145] JY Axup et al Synthesis of site-speci1047297c antibodyndashdrug conjugates using unnatu-ral amino acids Proc Natl Acad Sci U S A 109 (40) (2012) 16101ndash16106
[146] SCAlleyNM Okeley PD Senter Antibodyndashdrug conjugates targeted drug deliveryfor cancer Curr Opin Chem Biol 14 (4) (2010) 529ndash537
[147] JM Lambert Drug-conjugated antibodies for the treatment of cancer Br J ClinPharmacol 76 (2) (2013) 248ndash262
27 AC Anselmo S Mitragotri Journal of Controlled Release 190 (2014) 15ndash 28
8152019 Revision sobre formas farmaceuticas nuevas
[149] A Younes et al Brentuximab vedotin (SGN-35) for relapsed CD30-positive lym-phomas N Engl J Med 363 (19) (2010) 1812ndash1821
[150] RS Zolot S Basu RP Million Antibodyndashdrugconjugates Nat Rev Drug Discov12(4) (2013) 259ndash260
[151] FDA P1047297zer Voluntarily Withdraws Cancer Treatment Mylotarg from US Market(February 9 2014 Published June 21 2010) Available from httpwwwfdagov NewsEventsNewsroomPressAnnouncementsucm216448htm
[152] AM Wu PD Senter Arming antibodies prospects and challenges forimmunoconjugates Nat Biotechnol 23 (9) (2005) 1137ndash1146
[153] AK Burnett et al The addition of gemtuzumab ozogamicin to intensive chemo-therapy in older patients with AML produces a signi1047297cant improvement in overallsurvival results of the UK NCRI AML16 randomizedtrial Blood 2011 (AMER SOCHEMATOLOGY 1900 M STREET NW SUITE 200 WASHINGTON DC 20036 USA)
[154] R Langer A personal account of translating discoveries in an academic lab NatBiotechnol 31 (6) (2013) 487ndash489
[155] US Pharmaceutical Sales mdash 2013 (January 17 2014) Available from httpwwwdrugscomstatstop1002013sales
28 AC Anselmo S Mitragotri Journal of Controlled Release 190 (2014) 15ndash 28
8152019 Revision sobre formas farmaceuticas nuevas
[75] S Mayes M Ferrone Fentanyl HCl patient-controlled iontophoretic transdermalsystem for the management of acute postoperative pain Ann Pharmacother 40(12) (2006) 2178ndash2186
[76] WT Zempsky et al Evaluation of a low-dose lidocaine iontophoresis system fortopical anesthesia in adults and children a randomized controlled trial ClinTher 26 (7) (2004) 1110ndash1119
[77] BM Becker et al Ultrasound with topical anesthetic rapidly decreases pain of intravenous cannulation Acad Emerg Med 12 (4) (2005) 289ndash295
[78] SK Vashist Non-invasive glucose monitoring technology in diabetes managementa review Anal Chim Acta 750 (2012) 16ndash27
[79] H Chuang et al Pilot studies of transdermal continuous glucose measurement
in outpatient diabetic patients and in patients during and after cardiac surgery J Diabetes Sci Technol 2 (4) (2008) 595ndash602[80] S Rose JF Nelson A continuous long-term injector Aust J Exp Biol Med Sci 33
(4) (1955) 415ndash419[81] F Theeuwes Elementary osmotic pump J Pharm Sci 64 (12) (1975) 1987ndash1991[82] V Malaterre et al Oral osmotically driven systems 30 years of development and
clinical use Eur J Pharm Biopharm 73 (3) (2009) 311ndash323[83] E Rosenthal The Soaring Cost of a Simple Breath (February 9 2014) Published
October 12 2013] Available from httpwwwnytimescom20131013usthe-soaring-cost-of-a-simple-breathhtml_r=0
[84] F Theeuwes Orososmotic system development Drug Dev Ind Pharm 9 (7)(1983) 1331ndash1357
[85] CG Park et al A nano1047297brous sheet-based system for linear delivery of nifedipine J Control Release 149 (3) (2011) 250ndash257
[86] DM Bass M Prevo DS Waxman Gastrointestinal safety of an extended-releasenondeformable oral dosage form (OROS) a retrospective study Drug Saf 25(14) (2002) 1021ndash1033
[87] GA Agyilirah GS Banker Polymers for Enteric Coating Applications Polymers forControlled Drug Delivery CRC Press Boca Raton 1991 39ndash66
[88] G Ponchel J-M Irache Speci1047297c and non-speci1047297c bioadhesive particulate systemsfor oral delivery to the gastrointestinal tract Adv Drug Deliv Rev 34 (2) (1998)191ndash219
[89] M Morishita NA Peppas Is the oral route possible for peptide and protein drugdelivery Drug Discov Today 11 (19) (2006) 905ndash910
[90] A Bernkop-Schnuumlrch The use of inhibitory agents to overcome the enzymatic bar-rier to perorally administered therapeuticpeptides and proteins J Control Release52 (1) (1998) 1ndash16
[91] LM Ensign R Cone J HanesOral drug delivery with polymeric nanoparticles thegastrointestinal mucus barriers Adv Drug Deliv Rev 64 (6) (2012) 557ndash570
[92] E Mathiowitz et al Biologically erodable microspheres as potential oral drugdelivery systems Nature 386 (6623) (1997) 410ndash414
[93] V Gupta et alMucoadhesiveintestinaldevices fororal delivery of salmon calcitonin J Control Release 172 (3) (2013) 753ndash762
[95] PW Swaan Recent advances in intestinal macromolecular drug delivery viareceptor-mediated transport pathways Pharm Res 15 (6) (1998) 826ndash834
[96] R Eldor et al Glucose-reducing effect of the ORMD-0801 oral insulin preparationin patients with uncontrolled type 1 diabetes a pilot study PLoS One 8 (4) (2013)e59524
[97] TheEligenreg Library(February9 2014) Available from httpwwwemispherecom eligen_libraryhtml
[98] MC Castelli et al Comparing the ef 1047297cacy and tolerability of a new daily oral vita-min B12 formulation and intermittent intramuscular vitamin B12 in normalizinglow cobalamin levels a randomized open-label parallel-group study Clin Ther33 (3) (2011) 358ndash371 (e2)
[99] K Whitehead Z Shen S Mitragotri Oraldelivery of macromoleculesusing intestinalpatches applications for insulin delivery J Control Release 98 (1) (2004) 37ndash45
[100] EM Pridgen et al Transepithelial transport of fc-targeted nanoparticles by theneonatal fc receptor for oral delivery Sci Transl Med 5 (213) (2013) 213ra167
[101] M Torres‐Lugo et al pH‐sensitive hydrogels as gastrointestinal tract absorptionenhancers transport mechanisms of salmoncalcitoninand other modelmoleculesusing the Caco‐2 cell model Biotechnol Prog 18 (3) (2002) 612ndash616
[102] M Torres-Lugo et al Physicochemical behavior and cytotoxic effects of p (methacrylic acidndashg-ethylene glycol) nanospheres for oral delivery of proteins
J Control Release 80 (1) (2002) 197ndash
205[103] RU Agu et alThe lung as a route forsystemicdeliveryof therapeuticproteins and
peptides Respir Res 2 (4) (2001) 198[104] R Dalby J Suman Inhalation therapy technological milestones in asthma treat-
ment Adv Drug Deliv Rev 55 (7) (2003) 779ndash791[105] PJ Anderson History of aerosol therapy liquid nebulization to MDIs to DPIs
Respir Care 50 (9) (2005) 1139ndash1150[106] JB Fink BK Rubin Problems with inhaler use a call for improved clinician and
patient education Respir Care 50 (10) (2005) 1360ndash1375[107] MJ Telko AJ Hickey Dry powder inhaler formulation Respir Care 50 (9) (2005)
1209ndash1227[108] DAEdwardsA Ben-Jebria R Langer Recentadvances in pulmonary drug delivery
using large porous inhaled particles J Appl Physiol 85 (2) (1998) 379ndash385[109] MB DolovichR DhandAerosol drug deliverydevelopments in devicedesign and
clinical use Lancet 377 (9770) (2011) 1032ndash1045[110] A Hussain et al Absorption enhancers in pulmonary protein delivery J Control
Release 94 (1) (2004) 15ndash24[111] J L Cleland A Daugherty R Mrsny Emerging protein delivery methods Curr
Opin Biotechnol 12 (2) (2001) 212ndash219
[112] JS Patton J Bukar S Nagarajan Inhaled insulin Adv Drug Deliv Rev 35 (2ndash3)(1999) 235ndash247
[113] FDA to Complete Phase-out of Chloro1047298uorocarbon Inhalers (February 9 2014Published October 23 2013) Available from httpwwwfdagovnewsevents newsroompressannouncementsucm371901htm
[114] Drug Treatments for Asthma and Chronic Obstructive Pulmonary Disease ThatDo Not Use Chloro1047298uorocarbons (February 9 2014) Available from http wwwfdagovDrugsDrugSafetyInformationbyDrugClassucm082370htm
[115] AJ Hickey Back to the future inhaled drug products J Pharm Sci 102 (4) (2013)1165ndash1172
[116] S White et al EXUBERA pharmaceutical development of a novel product for
906[117] T Quattrin et al Ef 1047297cacy and safety of inhaled insulin (Exubera) compared withsubcutaneous insulin therapy in patients with type 1 diabetes results of a 6-month randomized comparative trial Diabetes Care 27 (11) (2004) 2622ndash2627
[118] PA Hollander etal Ef 1047297cacyand safety of inhaled insulin (exubera)comparedwithsubcutaneousinsulin therapy in patients with type 2 diabetesresults of a 6-monthrandomized comparative trial Diabetes Care 27 (10) (2004) 2356ndash2362
[119] C Black et al The clinical effectiveness and cost-effectiveness of inhaled insulin indiabetes mellitus a systematic review and economic evaluation Health TechnolAssess 11 (33) (2007) 1ndash126
[120] A Opar Another blowfor inhaled protein therapeutics Nat Rev Drug Discov 7 (3)(2008) 189ndash190
[121] J Kling Dreamboat sinks prospects for fast approval of inhaled insulin NatBiotechnol 29 (3) (2011) 175ndash176
[122] Press Releases MannKind Reports Positive Data from a Phase 3 Clinical Study of AFREZZA in Patients with Type 1 Diabetes (February 9 2014 Published August14 2013) Available from httpwwwnewsmannkindcorpcomphoenixzhtmlc=147953ampp=irol-newsArticleampID=1847441amphighlight=
[123] Available from httpwwwcivitastherapeuticscomCVT-301html
[124] Cardeas Pharma Announces that FDA Grants QIDP Designation and Fast TrackReview for the Companys Antibiotic Combination Product (February 9 2014Published January 8 2014) Available from httpcardeaspharmacom press-releasescardeas-pharma-announces-that-fda-grants-qidp-designation-and-fast-track-review-for-the-companys-antibiotic-combination-product
[125] M Staples et al Application of micro- and nano-electromechanical devices todrug delivery Pharm Res 23 (5) (2006) 847ndash863
[126] TJ Smith et al Intravitreal sustained-release ganciclovir Arch Ophthalmol 110(2) (1992) 255ndash258
[127] GE Sanborn et al Sustained-release ganciclovir therapy for treatment of cyto-megalovirus retinitis Use of an intravitreal device Arch Ophthalmol 110 (2)(1992) 188ndash195
[128] G Velez SM Whitcup New developments in sustained release drug deliveryfor the treatment of intraocular disease Br J Ophthalmol 83 (11) (1999)1225ndash1229
[129] DH Geroski HF Edelhauser Drug delivery for posterior segment eye diseaseInvest Ophthalmol Vis Sci 41 (5) (2000) 961ndash964
[130] DC Musch et al Treatment of cytomegalovirus retinitis with a sustained-releaseganciclovir implant The Ganciclovir Implant Study Group N Engl J Med 337 (2)(1997) 83ndash90
[131] CL Stevenson JT Santini Jr R Langer Reservoir-based drug delivery systemsutilizing microtechnology Adv Drug Deliv Rev 64 (14) (2012) 1590ndash1602
[132] RA Receveur FW Lindemans NF de Rooij Microsystem technologies forimplantable applications J Micromech Microeng 17 (5) (2007) R50
[133] AC Richards Grayson et al Electronic MEMS for triggered delivery Adv DrugDeliv Rev 56 (2) (2004) 173ndash184
[134] HowOzurdex(R) Works(March11 2014) Available fromhttpwwwozurdexcom HowItWorksaspx
[135] A Giese et al Pattern of recurrencefollowinglocal chemotherapy with biodegrad-able carmustine (BCNU) implants in patients with glioblastoma J Neurooncol 66(3) (2004) 351ndash360
[136] EL Weber EA Goebel Cerebral edema associated with Gliadel wafers two casestudies Neuro Oncol 7 (1) (2005) 84ndash89
[137] JT Santini Jr MJ Cima R Langer A controlled-release microchip Nature 397(6717) (1999) 335ndash338
[138] R Farra et al First-in-human testing of a wirelessly controlled drug deliverymicrochip Sci Transl Med 4 (122) (2012) 122ra21
[139] B Hughes Antibodyndash
drug conjugates for cancer poised to deliver Nat Rev DrugDiscov 9 (9) (2010) 665ndash667
[140] JR Junutula et al Site-speci1047297c conjugation of a cytotoxic drug to an antibodyimproves the therapeutic index Nat Biotechnol 26 (8) (2008) 925ndash932
[141] S Verma et al Trastuzumab emtansinefor HER2-positive advanced breast cancerN Engl J Med 367 (19) (2012) 1783ndash1791
[142] ImmunoGen Inc Reports First Quarter Fiscal Year 2014 Financial Results andProvides Quarterly Update (February 9 2014 Published October 25 2013) Avail-able from httpinvestorimmunogencomreleasedetailcfmReleaseID=800370
[143] P Chames et al Therapeutic antibodies successes limit ations and hopes for thefuture Br J Pharmacol 157 (2) (2009) 220ndash233
[144] CF McDonagh et al Engineered antibodyndashdrugconjugateswith de1047297ned sites andstoichiometries of drug attachment Protein Eng Des Sel 19 (7) (2006) 299ndash307
[145] JY Axup et al Synthesis of site-speci1047297c antibodyndashdrug conjugates using unnatu-ral amino acids Proc Natl Acad Sci U S A 109 (40) (2012) 16101ndash16106
[146] SCAlleyNM Okeley PD Senter Antibodyndashdrug conjugates targeted drug deliveryfor cancer Curr Opin Chem Biol 14 (4) (2010) 529ndash537
[147] JM Lambert Drug-conjugated antibodies for the treatment of cancer Br J ClinPharmacol 76 (2) (2013) 248ndash262
27 AC Anselmo S Mitragotri Journal of Controlled Release 190 (2014) 15ndash 28
8152019 Revision sobre formas farmaceuticas nuevas
[149] A Younes et al Brentuximab vedotin (SGN-35) for relapsed CD30-positive lym-phomas N Engl J Med 363 (19) (2010) 1812ndash1821
[150] RS Zolot S Basu RP Million Antibodyndashdrugconjugates Nat Rev Drug Discov12(4) (2013) 259ndash260
[151] FDA P1047297zer Voluntarily Withdraws Cancer Treatment Mylotarg from US Market(February 9 2014 Published June 21 2010) Available from httpwwwfdagov NewsEventsNewsroomPressAnnouncementsucm216448htm
[152] AM Wu PD Senter Arming antibodies prospects and challenges forimmunoconjugates Nat Biotechnol 23 (9) (2005) 1137ndash1146
[153] AK Burnett et al The addition of gemtuzumab ozogamicin to intensive chemo-therapy in older patients with AML produces a signi1047297cant improvement in overallsurvival results of the UK NCRI AML16 randomizedtrial Blood 2011 (AMER SOCHEMATOLOGY 1900 M STREET NW SUITE 200 WASHINGTON DC 20036 USA)
[154] R Langer A personal account of translating discoveries in an academic lab NatBiotechnol 31 (6) (2013) 487ndash489
[155] US Pharmaceutical Sales mdash 2013 (January 17 2014) Available from httpwwwdrugscomstatstop1002013sales
28 AC Anselmo S Mitragotri Journal of Controlled Release 190 (2014) 15ndash 28
8152019 Revision sobre formas farmaceuticas nuevas
[149] A Younes et al Brentuximab vedotin (SGN-35) for relapsed CD30-positive lym-phomas N Engl J Med 363 (19) (2010) 1812ndash1821
[150] RS Zolot S Basu RP Million Antibodyndashdrugconjugates Nat Rev Drug Discov12(4) (2013) 259ndash260
[151] FDA P1047297zer Voluntarily Withdraws Cancer Treatment Mylotarg from US Market(February 9 2014 Published June 21 2010) Available from httpwwwfdagov NewsEventsNewsroomPressAnnouncementsucm216448htm
[152] AM Wu PD Senter Arming antibodies prospects and challenges forimmunoconjugates Nat Biotechnol 23 (9) (2005) 1137ndash1146
[153] AK Burnett et al The addition of gemtuzumab ozogamicin to intensive chemo-therapy in older patients with AML produces a signi1047297cant improvement in overallsurvival results of the UK NCRI AML16 randomizedtrial Blood 2011 (AMER SOCHEMATOLOGY 1900 M STREET NW SUITE 200 WASHINGTON DC 20036 USA)
[154] R Langer A personal account of translating discoveries in an academic lab NatBiotechnol 31 (6) (2013) 487ndash489
[155] US Pharmaceutical Sales mdash 2013 (January 17 2014) Available from httpwwwdrugscomstatstop1002013sales
28 AC Anselmo S Mitragotri Journal of Controlled Release 190 (2014) 15ndash 28