辅料功能性指标对制剂质量的影响-默克

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1、TheinfluenceoffunctionalityparametersonthequalityoffinisheddosagesDr.BhushanThekedarFieldMarketingManager,Asia–PCSOverviewHighFunctionalExcipientsExcipientsforDirectCompressionMannitolforDirectCompressionExcipientforWetGranulationDirectlyCompressibleMagnesiumExcipient

2、forOrallyDisintegratingTabletsLubricantswithAddedValue2B.Thekedar,June2012HighFunctionalExcipients3B.Thekedar,June2012FunctionalParticleEngineeringPhysicalcharacteristicsinadditiontochemistrydeterminethequalityofyourproducts.4B.Thekedar,June2012FlowabilityParticlesize

3、distributionfortheactive(s)intheformulationHygroscopicityCompressibilityDrugloadingcapacityFriabilityStabilityMouthfeelContentuniformityoffinisheddosageDisintegrationtimeoffinaldosageDissolutionofdrugsubstanceFunctionalParticleEngineeringKeyPhysicalCharacteristicsofan

4、SolidFormulationExcipient5B.Thekedar,June2012Filler/matrixpolymerGlidantBinderDisintegrantAPILubricantFunctionalExcipientsofTablets6B.Thekedar,June2012GlidantMultifunctionalDC-excipientAPILubricantMultifunctionalDC-Excipients7B.Thekedar,June2012PropertiesofanidealDC-e

5、xcipient...ItshouldhaveaoutstandingflowabilityItshouldhaveaparticlesizedistributionappropriatefortheactive(s)intheformulationItshouldbenot/littlehygroscopicItshouldhaveahighcompressibilityItsholdhaveahighdrugloadingcapacityItshouldhaveanexcellentpressure-hardnessprofi

6、leItshouldresultintabletswithlowfriabilityItshouldformtabletswithshortdisintegrationtimeandfastdrugdissolutionItshouldresultintabletswithexcellentcontentuniformityItshouldbeunsusceptibletolubricantsItshouldbephysiologicallyinertItshouldbecompatiblewithalltypesofingred

7、ientsItshouldbestabletoair,moistureandheatItmustnotshowanyphysicalorchemicalchangeonagingItshouldbecolourlessandtastelessItshouldacceptcolourantsuniformlyItshouldbeinexpensiveItshouldpocessapropermouthfeelItshouldnotinterferewiththebiologicalavailabilityofactivesItsho

8、uldbereworkablewithoutlossofflowandcompressibilityItshouldmakethevalidationofthetablettingprocesseasy8B.Thekedar,June2012Exc