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ID:41219732
大小:4.68 MB
页数:42页
时间:2019-08-19
《PDAMetro Glass delamination》由会员上传分享,免费在线阅读,更多相关内容在学术论文-天天文库。
1、GlassDelamination:Risks,RealityandRegulatoriesPDA:AGlobal.DanieleZuccatoR&DProjectManagementNuovaOMPIAssociation–StevanatoGroupAGENDAIntroductiontoglassdelaminationmechanismSGDelaminationstudies&resultsProtocolforearlydelaminationpredictionVialsvs.SyringesRegulatoryaspects
2、GLASSDELAMINATIONSeparationofthinglasslayers(lamellae)thatappearasshiny,needleshapedparticlesfloatinginthecontactliquidTheformationofasilica-richlayerpoorlybondedtothesubstrateisthefirststageofanextendeddelaminationGlass-liquidinteractionsareresponsiblefortheformationofana
3、lteredlayerGLASS–LIQUIDINTERACTIONSFormationofaalkalidepletedlayerWFIorAcidLeachingIncreasingofthelayerthicknessH+Ca++K+Na+CrackingGlassDetachmentofscalesTYPICALFLAKESASPECTDELAMINATIONOFPHARMACEUTICALGLASSThefirststageisalwaystheformationofanalteredlayerWhenvialsarefilled
4、withtheliquidpreparation,thislayerissubjecttoastrongre-hydrationandswellingDELAMINATIONOFPHARMACEUTICALGLASSGlass-flakesOHSomepreparationsmayfavourdelaminationAlkalinesolutionsstronglyaffectthedissolutionofthesilicalayer.SiOconcentrationinthe2extractionliquidincreasessteep
5、lyFlakesappearanceFACTORSAFFECTINGDELAMINATIONOFPHARMAGLASSES•sulfurtreatmentSurface•siliconizationtreatments•coating•speedofthetransformationprocess•burnersflametemperatureConversion•improperannealingstage,tensilestressesprocess•typeofglass•chemistryofthebuffersupportingt
6、heactiveDrugprincipleformulation&•pH&ionicstrengthofthedrugsolutionpost-•organicacidstreatments•sterilizationprocess•storageconditionsORGANICSACIDS«Neutralsolutionsoforganicacidsbehaveasstronglyalkalinesolutionsfavoringdissolutionofsilica»FrankR.BaconandFrankC.Raggon,Journ
7、aloftheAmericanCeramicSociety,42[4]199-205(1959)OPENQUESTIONS•Howcandelaminationbepredicted?•Whatparameterscanbeusedtoinvestigatedelaminationpropensity?!•AreEPvaluesstillagoodindicatorofdelaminationresistance?•WhichglassTypeismoresuitabletowhichpreparation?AGENDAIntroducti
8、ontoglassdelaminationmechanismSGDelaminationstudies&resultsProtocolforearlydelaminationpr
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