Recrystallization of Commercial Carbamazepine Samples—A Strategy to Control Dissolution Variability 英文参考文献.docVIP

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Recrystallization of Commercial Carbamazepine Samples—A Strategy to Control Dissolution Variability 英文参考文献.doc

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Recrystallization of Commercial Carbamazepine Samples—A Strategy to Control Dissolution Variability 英文参考文献

Pharmaceutics2012,4,58-70;doi:10.3390/pharmaceutics4010058 OPENACCESS pharmaceutics ISSN1999-4923 /journal/pharmaceutics Article RecrystallizationofCommercialCarbamazepineSamples—A StrategytoControlDissolutionVariability FeliciaFlicker,VeronikaA.EberleandGabrieleBetz* IndustrialPharmacyLab,UniversityofBasel,M¨ulhauserstrasse51,Basel4056,Switzerland *Authortowhomcorrespondenceshouldbeaddressed;E-Mail:gabriele.betz@unibas.ch; Tel.:+41-61-381-07-20;Fax:+41-61-381-04-30. Received:5December2011;inrevisedform:9January2012/Accepted:10January2012/ Published:13January2012 Abstract: Physical properties of commercial carbamazepine (CBZ) samples can signi?cantlyin?uencedrugreleaseandtherebyjeopardizebioequivalenceofthe?naldosage form. The aim of this study was to reduce variability in commercial CBZ samples by recrystallization. CBZ samples of four different suppliers were recrystallized in ethanol solutioncontaining1%polyvinylpyrrolidone(PVP).CBZsampleswereanalyzedbydisk intrinsicdissolutionrate(DIDR),X-raypowderdiffraction(XRPD),differentialscanning calorimetry(DSC),andscanningelectronmicroscopy(SEM).RecrystallizedCBZsamples showed strongly reduced variability in DIDR compared to the untreated CBZ samples. Moreover, transformation process to CBZ dihydrate was inhibited; no dihydrate crystals werevisibleoncompactsurfacesafter8hintrinsicdissolutionmeasurement.Recrystallized CBZ samples showed no change in polymorphic form, however, particle size and shape wasinhomogenous. Inbinarymixtureswithmicrocrystallinecellulose,recrystallizedCBZ samplesagainshoweddifferenceindrugrelease. Thisdifferencewasassociatedwiththe inhomogenous particle size in the recrystallized CBZ samples. The results show that a controlledgrindingstepisrequiredafterrecrystallization.Wesuggesttherecrystallizationin presenceof1%PVPfollowedbyacontrolledgrindingstepasastrategytoreducedissolution variabilityincommercialCBZsamples. Keywords: polyvinylpyrrolidone; polymer; intrinsic dissolution; polymorphism