11/10/2014 PHARMACOLOGY - Microsoft OneNote Online DOSAGE FORMS I. Introduction Pharmaceutical Dosage Forms ‐ Drug product or preparing containing the: ‐ Drug/active ingredient ‐ Excipients/additive/adjuncts Drug Any article or agent that is used for the diagnosis, mitigation, treatment, prevent ion & cure of diseases in man and animals ‐ Agents used to affect the structure & any function of the body of man & o ther animals Excipients ‐ Agents that are used to solubilize, suspend, thicken, dilute, emulsify, stabilize, preserve, color, & flavor medicinal agents into appealing & efficacious dosage forms Cosmetics Any substance or preparation intended to be placed in contact with the external par ts of the human body (epidermis, hair system, nails, lips, & external genitals) or with the teeth & the mucous membrane of the oral cavity with a view exclusively or mainly to clean, perfume, changing their appearan ce, correcting body odors &/or protecting them or keeping them in good condition Reasons for formulating Dosage Forms : Stability Improved solubility Improved appearance Ease of administration Palatability SOLID DOSAGE FORMS
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11/10/2014PHARMACOLOGY-MicrosoftOneNoteOnline
DOSAGEFORMSI.IntroductionPharmaceuticalDosageFormsDrugproductorpreparingcontainingthe:Drug/activeingredientExcipients/additive/adjunctsDrugAnyarticleoragentthatisusedforthediagnosis,mitigation,treatment,prevention&cureofdiseasesinmanandanimalsAgentsusedtoaffectthestructure&anyfunctionofthebodyofman&otheranimalsExcipientsAgentsthatareusedtosolubilize,suspend,thicken,dilute,emulsify,stabilize,preserve,color,&flavormedicinalagentsintoappealing&efficaciousdosageformsCosmeticsAnysubstanceorpreparationintendedtobeplacedincontactwiththeexternalpartsofthehumanbody(epidermis,hairsystem,nails,lips,&externalgenitals)orwiththeteeth&themucousmembraneoftheoralcavitywithaviewexclusivelyormainlytoclean,perfume,changingtheirappearance,correctingbodyodors&/orprotectingthemorkeepingthemingoodcondition
ReasonsforformulatingDosageForms:
StabilityImprovedsolubilityImprovedappearanceEaseofadministrationPalatability
SOLIDDOSAGEFORMSA.PowdersIntimatemixtureoffinelydivideddrugsorchemicals,whichareintendedforexternal&internalusehttps://onedrive.live.com/view.aspx?resid=1D42BCCE5A613DB7!113&app=OneNote&authkey=!ANAzyWiE6fJMRec1/25
11/10/2014PHARMACOLOGY-MicrosoftOneNoteOnlineAdvantagesflexibilityincompoundingdevoidofmixturerelativelystableDisadvantagesInaccuracyofdoseNoteasilywetted(lowabsorption)NotsuitablefordispensingSomepowdersarehygroscopicanddeliquescent>Hygroscopicabsorbsmoisturebutdoesnotliquefy>Deliquescentabsorbsmoisture&liquefiesPARTICLESIZEANALYSISObtainquantitativedataforsize,shape,&distributionofdrugparticles&othercomponentstobeusedintheformulationFACTORSINFLUENCEDBYPARTICLESIZE1.DissolutionParticlesizeRateofdissolutionex.Micronization1.SuspendabilityImportantforredispersingsuspenoidsinsuspensionsSedimentationvolume,thebetterthesuspension2.UniformityContentuniformityWeightvariation3.Penetrability
4.Feel
ImportantforinhalationalParticlesize,fasterpenetration
Particlesize,betterskinfeelPreventgrittiness>Comminutionprocessofparticlesizereduction
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11/10/2014PHARMACOLOGY-MicrosoftOneNoteOnlineSMALLSCALEMETHODSTriturationusemortar&pestle3types1.Glasssmooth,nonporoussurface,solutions,suspensions,&ointmentscoloredsubstances.5.Wedgewoodcrystals6.Porcelainsoftaggregatecrystalsa.LevigationFormingapastebytheadditionofanonsolvent(levigatingpaste)LowerstheparticlesizebutdoesnotdissolvethepowderEx.Mineraloil&glycerinsa.PulverizationbyInterventionAdditionofanonvolatilesubstanceEx.Camphor+MineralOilIodinecrystals+EtherLARGESCALEMETHODS7.MechanicalpulverizersLargemills8.Blendingprocessofmixingpowderedmaterials9.Tumblingmaterialsareenclosedinaconstantlyrotatingchamber(largescale)10.Spatulationuseofspatula,smallscale;ifpowdersarenonpotent11.Siftinguseofsifters;nonpotentpowders12.GeometricDilutionadditionofanEQUALvolumeofdiluenttoapotentsubstanceTypesofPowders13.Bulkpowderslargequantitiesoforalpowdersa.Dentrificesmildabrasive,anticariogenicb.Dustingpowderslocallyapplied,nontoxicc.Douchepowdersstartingmaterialforvaginaldouched.Insufflationsblownintobodycavitybytheuseofinsufflator(ex.forears,nose)e.Triturations10%ofactiveingredient14.Dividedpowderssmallquantities;akachartulaeorindividualizedpowdersTypesofpaperA.Bondpaper:nomoistureresistanceB.Glassine:glazedtransparentpaper;moistureresistantDisadvantagedoesntprotectproductfromphotodegredationC.Vegetableparchment:thin,semiopaque,moistureresistant
https://onedrive.live.com/view.aspx?resid=1D42BCCE5A613DB7!113&app=OneNote&authkey=!ANAzyWiE6fJMRec3/2511/10/2014PHARMACOLOGY-MicrosoftOneNoteOnlineD.Waxedpaper:suitableforhygroscopic&deliquescentpowders,waterproofB.GranulesPreparedagglomeratesofpowdersSievesize:No412Fortabletpreparation:No1220MethodsofPreparationWetgranulation:mostcommon;usesgranulatingfluidssuchaswater,ethanol,&isopropylalcohol**dryingstep(dryinsidetheoven)Drygranulation:usedifmaterialismoisturesensitive&/orheatlabilea.Sluggingproducesslugs**slugslargeflattabletsabout1inchindiameterwhicharebrokendownintogranulesb.Rollercompaction:producessheetsEffervescentGranulesReleasesCO2tomaskthedisagreeabletasteofdrugComponents:NAHCO3Citricacid(C6H8O7)ifalone,ityieldsastickymixtureTartaricacid(C4H4O6)ifalone,iteasilycrumbles**Shouldhavebothcitric&tartaricC.TabletsSoliddosageformsthatarepreparedbymoldingorcompression.TYPESOFTABLETS:1.MoldedtabletsSoft2.CompressedtabletsHardA.CompressesTablets1layerB.MultiCompressedtablet2ormorelayersC.SugarcoatedtabletsUsedtomaskthedisagreeabletasteofthedrugDisadvantages:Addsbulktotheformulation(>50%)TimeconsumingRequiresexpertiseD.FilmCoatedTabletsInvolvestheapplicationofathinplasticlikematerialonthetablet.Advantages:
https://onedrive.live.com/view.aspx?resid=1D42BCCE5A613DB7!113&app=OneNote&authkey=!ANAzyWiE6fJMRec4/2511/10/2014PHARMACOLOGY-MicrosoftOneNoteOnlineDoesnotformbulktotheformulationLesstimeconsumingMoredurableandpliableE.EntericCoatedTabletsMeanttodisintegrateinthesmallintestinewhereinthePHisgreaterthanthePHofthegastricmucosa.Reasons:ToincreaseabsorptionofadrugTopreventgastricirritationToofferprotectionfordrugsdestroyedbyacid.F.ChewableTabletsForthosewhohavedifficultyinswallowingDoesnotneeddisintegrantsUsualdiluentsareMannitolandXylitol(SugarFreepreparations)G.EffervescentTabletsWhenincontactwithwater,ItwillreleaseCO2H.BuccalTabletsTabletsplacedinthebuccalcavity(Betweenthecheeks&gums)Disintegrationtime:4hoursI.SublingualTabletsTabletsplacedunderthetongueFastdisintegrationtimeUsedforemergencydrugs:Clonidine(Catapress)ISMN(Imdur)ISDN(Isordil)J.RapidlyDisintegratingTablets(RDT)ForpatientswithdifficultyinswallowingEX:Risperidone(AntiPsychotics)K.ExtendedRelease/ModifiedReleaseTabletsL.VaginalTablets/InsertsMETHODSOFMANUFACTURINGTABLETS:1.WetGranulation2.DryGranulation3.DirectCompressionFromPowdertoTabletFormaterialswithexcellentflowpropertyandcohesivepropertyEX:NaCl,KClhttps://onedrive.live.com/view.aspx?resid=1D42BCCE5A613DB7!113&app=OneNote&authkey=!ANAzyWiE6fJMRec5/25
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