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1、1087APPARENTINTRINSICDISSOLUTION—DISSOLUTIONTESTINGPROCEDURESFORROTATINGDISKANDSTATIONARYDISKThisgeneralinformationchapterApparentIntrinsicDissolution—DissolutionTestingProceduresforRotatingDiskandStationaryDisk1087discussesthedeterminationofdissolutionr
2、atesfromnondisintegratingcompactsexposingafixedsurfaceareatoagivensolventmedium.Compact,asusedhere,isanondisintegratingmassresultingfromcompressionofthematerialundertestusingappropriatepressureconditions.Asinglesurfacehavingspecifiedphysicaldimensionsisp
3、resentedfordissolution.Determinationoftherateofdissolutioncanbeimportantduringthecourseofthedevelopmentofnewchemicalentitiesbecauseitsometimespermitspredictionofpotentialbioavailabilityproblemsandmayalsobeusefultocharacterizecompendialarticlessuchasexcip
4、ientsordrugsubstances.Intrinsicdissolutionstudiesarecharacterizationstudiesandarenotreferencedinindividualmonographs.Informationprovidedinthisgeneralinformationchapterisintendedtobeadaptedviaaspecificprotocolappropriatetoaspecifiedmaterial.–1Dissolutionr
5、ategenerallyisexpressedasthemassofsoluteappearinginthedissolutionmediumperunittime(e.g.,masssec),–2–1butdissolutionfluxisexpressedastherateperunitarea(e.g.,masscmsec).Reportingdissolutionfluxispreferredbecauseitisnormalizedforsurfacearea,andforapuredrugs
6、ubstanceiscommonlycalledintrinsicdissolutionrate.Dissolutionrateisinfluencedbyintrinsicsolid-statepropertiessuchascrystallinestate,includingpolymorphsandsolvates,aswellasdegreeofnoncrystallinity.Numerousproceduresareavailableformodifyingthephysicochemica
7、lpropertiesofchemicalentitiessothattheirsolubilityanddissolutionpropertiesareenhanced.Amongthesearecoprecipitatesandtheuseofracematesandenantiomericmixtures.Theeffectofimpuritiesassociatedwithamaterialcanalsosignificantlyalteritsdissolutionproperties.Dis
8、solutionpropertiesarealsoinfluencedbyextrinsicfactorssuchassurfacearea,hydrodynamics,anddissolutionmediumproperties,includingsolvent(typicallywater),presenceofsurfactants,temperature,fluidviscosity,pH,buffertype,andbuffers
