含有BCS-1类和3类药物口服固体速释剂型的溶出度测试和标准限度工业指南草案-FDA工业指

DraftGuidanceTemp07/29/15DissolutionTestingandSpecificationCriteriaforImmediate-ReleaseSolidOralDosageFormsContainingBiopharmaceuticsClassificationSystemClass1and3DrugsGuidanceforIndustryDRAFTGUIDANCEThisguidancedocumentisbeingdistributedforcommentpurposesonly.Commentsandsuggestionsregardingthisdraftdocumentshouldbesubmittedwithin60daysofpublicationintheFederalRegisterofthenoticeannouncingtheavailabilityofthedraftguidance.Submitelectroniccommentsto(HFA-305),FoodandDrugAdministration,5630FishersLane,rm.1061,Rockville,MD20852.AllcommentsshouldbeidentifiedwiththedocketnumberlistedinthenoticeofavailabilitythatpublishesintheFederalRegister.Forquestionsregardingthisdraftdocumentcontact(CDER)RichardLostrittoat301-796-1667.U.S.DepartmentofHealthandHumanServicesFoodandDrugAdministrationCenterforDrugEvaluationandResearch(CDER)August2015BiopharmaceuticsDissolutionTestingandSpecificationCriteriaforImmediate-ReleaseSolidOralDosageFormsContainingBiopharmaceuticsClassificationSystemClass1and3DrugsGuidanceforIndustryAdditionalcopiesareavailablefrom:OfficeofCommunications,DivisionofDrugInformationCenterforDrugEvaluationandResearchFoodandDrugAdministration10001NewHampshireAve.,HillandaleBldg.,4thFloorSilverSpring,MD20993-0002Phone:[phone]or301-796-3400;Fax:[phone]Email:[e-mail](CDER)August2015BiopharmaceuticsContainsNonbindingRecommendationsDraft—NotforImplementationDraftGuidanceTemp07/29/15iiTABLEOFCONTENTSI.INTRODUCTION.............................................................................................................1II.BACKGROUND...............................................................................................................2III.ELIGIBLEPRODUCTS..................................................................................................3A.DosageForm...................................................................................................................................3B.Solubility.........................................................................................................................................3C.TherapeuticClass...........................................................................................................................3D.TimetoMaximumPlasmaConcentration....................................................................................3E.ManufacturingandTestingHistory..............................................................................................4F.Excipients........................................................................................................................................4IV.STANDARDDISSOLUTIONTESTCONDITIONS...................................................4A.BasketMethod(USPapparatus1)................................................................................................4B.PaddleMethod(USPapparatus2)................................................................................................4V.SPECIFICATION.............................................................................................................5VI.REPLACINGDISSOLUTIONWITHDISINTEGRATION.......................................5VII.REFERENCES..................................................................................................................5ContainsNonbindingRecommendationsDraft—NotforImplementationDraftGuidanceTemp07/29/151DissolutionTestingandSpecificationCriteriaforImmediate-1ReleaseSolidOralDosageFormsContainingBiopharmaceutics2ClassificationSystemClass1and3Drugs3GuidanceforIndustry1456Thisdraftguidance,whenfinalized,willrepresentthecurrentthinkingoftheFoodandDrug7Administration(FDAorAgency)onthistopic.Itdoesnotcreateanyrightsforanypersonandisnot8bindingonFDAorthepublic.Youcanuseanalternativeapproachifitsatisfiestherequirementsofthe9applicablestatutesandregulations.Todiscussanalternativeapproach,contacttheFDAstaffresponsible10forthisguidanceaslistedonthetitlepage.111213I.INTRODUCTION1415Thisguidanceisdevelopedtoprovidemanufacturerswithrecommendationsforsubmissionof16newdrugapplications(NDAs),investigationalnewdrugapplications(INDs),and/or17abbreviatednewdrugapplications(ANDAs),asappropriate,forimmediate-release(IR)tablets18andcapsulesthatcontainhighlysolubledrugsubstances.Theguidanceisintendedtodescribe19whenastandardreleasetestandcriteriamaybeusedinlieuofextensivemethoddevelopment20andspecification-settingexercises.Whenfinal,thisguidancewillsupersedetheguidancefor21industryonDissolutionTestingofImmediateReleaseSolidOralDosageForms(August1997)22forbiopharmaceuticsclassificationsystem(BCS)class1and3drugsubstancesinimmediate-23releasedrugproductsthatmeetthecriteriainthisguidance.2Forclass2and4drugsubstances,24applicantsshouldstillrefertoth