About OMICS Group OMICS Group is an amalgamation of Open Access Publications and worldwide international science conferences and events. Established in the year 2007 with the sole aim of making the information on Sciences and technology ‘Open Access’, OMICS Group publishes 700+ online open access scholarly journals in all aspects of Science, Engineering, Management and Technology journals. OMICS Group has been instrumental in taking the knowledge on Science & technology to the doorsteps of ordinary men and women. Research Scholars, Students, Libraries, Educational Institutions, Research centers and the industry are main stakeholders that benefitted greatly from this knowledge dissemination. OMICS Group also organizes 1000+ International conferences annually across the globe, where knowledge transfer takes place through debates, round table discussions, poster presentations, workshops, symposia and exhibitions.
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About OMICS Group...Parenteral Drug Nanodispersions : Manufacturing, Characterization and In Vitro/In Vivo Performance Evaluation Panayiotis P. Constantinides, Ph.D Biopharmaceutical
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About OMICS Group
OMICS Group is an amalgamation of Open Access Publications and worldwide international science conferences and events. Established in the year 2007 with the sole aim of making the information on Sciences and technology ‘Open Access’, OMICS Group publishes 700+ online open access scholarly journals in all aspects of Science, Engineering, Management and Technology journals. OMICS Group has been instrumental in taking the knowledge on Science & technology to the doorsteps of ordinary men and women. Research Scholars, Students, Libraries, Educational Institutions, Research centers and the industry are main stakeholders that benefitted greatly from this knowledge dissemination. OMICS Group also organizes 1000+ International conferences annually across the globe, where knowledge transfer takes place through debates, round table discussions, poster presentations, workshops, symposia and exhibitions.
OMICS International is a pioneer and leading science event organizer, which publishes around 700+ open access journals and conducts over 500 Medical, Clinical, Engineering, Life Sciences, Pharma scientific conferences all over the globe annually with the support of more than 1000 scientific associations and 30,000 editorial board members and 3.5 million followers to its credit. OMICS Group has organized 1000+ conferences, workshops and national symposiums across the major cities including San Francisco, Las Vegas, San Antonio, Omaha, Orlando, Raleigh, Santa Clara, Chicago, Philadelphia, Baltimore, United Kingdom, Valencia, Dubai, Beijing, Hyderabad, Bengaluru and Mumbai.
Parenteral Drug Nanodispersions :
Manufacturing, Characterization and In
Vitro/In Vivo Performance Evaluation
Panayiotis P. Constantinides, Ph.D
Biopharmaceutical & Drug Delivery Consulting, LLC
Gurnee, Illinois, USA
Parenterals- 2015, August 17-19, 2015, Chicago, IL
OUTLINE PART I : Overview of Parenteral Drug Nanodispersions
• Particle Size Considerations
• Drug Products on the Market (Doxil® and Abraxane®)
• Engineering and Manufacturing : Impact on Drug Loading
• The particle size of these “nanoparticulate” drug products, is in the
range of approx. 100 - 1000 nm and thus above the defined
nanorange (1-100 nm) …..
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((HSPC, CHOL
Nanoparticle Properties and Inter-relationships
Nanoparticles
Morphology Solubility Alterability Bioactivity
Surface Chemistry Charge Biocompatibility
Shape Size Hydrophobicity
Film Forming
Ability Deformability
Toxicity
Dispersed
State Stability
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Nanoparticle Manufacturing Methods
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To
p-D
ow
n
Bo
tto
m-U
p
Energy
Precipitation
Solvent Evaporation
Emulsion-Diffusion
NANOPARTICLES
BULK
SOLUTION
Homogenization Milling
Cryogenic Approaches
• Super-Critical Fluid Technologies
• Spray Freezing into Liquid
• Ultra-rapid Freezing
Growth
Nanoparticle Engineering and Manufacturing and
Impact on Drug Loading and Release
10
Drug
CarrierPreparation
Drug loading
Release
(Release medium)
Solvent, pH, Temperature
Sequence of adding excipients
Loading during or after nanoparticle formation
Type of nanoparticle
Type of polymer/copolymer (MW, functional groups on polymers, charge)
Ratio liquid/solid lipid (SLN)
Nominal drug loading
Type (base vs salt)
Lipophilicity
Functional groups
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Lipid Polymorphism with Glycerides : Implications for SLN Mehnert, W. and Mӓder, K. (2001) Adv. Drug Del. Rev. 47 : 165-196; Uner, M. (2006) Pharmazie 61 : 380
tissue sections of A549 xenograft Quantification of cell apoptosis
Tumor Growth
Inhibition
Induction of oxidative stress
Tumor Targeting Mitochondria
Targeting
Conclusions and Future Perspectives
• Parenteral nanodispersions such as liposomes, nanoemulsions, polymeric micelles, and solid lipid nanoparticles: – Constitute enabled formulations of approved drugs or NMEs
with liposomal and nanosuspension drug products on the market (Doxil® and Abraxane®)
• Recent advances with these drug nanocarriers include:
– Improvements in manufacturing and characterization methods, drug product quality and performance.
– At least same efficacy and better tolerance than the earlier systems.
– Enhanced drug loading/release and targeting
• Drivers for future growth and commercialization include :
– funding, patent landscape
– better understanding of stability issues, particularly with
parenteral nanosuspensions and solid lipid nanoparticles
– ongoing need for novel safe drugs and therapies
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Acknowledgements
Liposomes/Polymeric Micelles
Phospho-Ibuprofen (P-I)
Solid Lipid Nanoparticles
Phospho-Sulindac (P-S)
Dr. Basil Rigas and laboratory staff, Stony Brook
University, Medical School, Division of Cancer
Prevention and Medicon Pharmaceuticals,
Setauket, NY
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Thank You !
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IVIV Performance
Drug Product Quality
Formulation and Process
Parenteral Drug Nanodispersions
Let us meet again..
We welcome you all to our future conferences of OMICS International
2nd International Conference and Expo on
Parenterals and Injectables
On
October 24-26, 2016 at Istanbul, Turkey http://parenterals-