application of polymer in hot melt extrusion

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1、PharmaceuticalPolymerforHotMeltExtrusionMingLuApril7,2017HotmeltextrusionAPIPolymerFormulationdevelopmentCasestudiesBackgroundFoodPlastic&RubberPharmaceuticstheMid-19th1930’sHistoryofHME1970’sWilliamIIIRobertZhangFengRepkaAMichealMississipiUniversity黄思远刘旭冯鑫4%Germany4011%3528%US30

2、Patents5%Japan255%France2015UK1019%otherTheNumberofPatents5European28%OtherAsian0198319881993199820032008DistriputionofpatentsYearNuvaRing®TheKaletra®TabletsTheImplanon®Implant2010年以后，HME:Spraydrying=3:4HotMeltExtrusion(HME)AmorphoussoliddispersionAPI增溶增溶缓释掩味CrystallinePolymersoliddis

3、persionHMEsystem•Temperature•Screwspeed•Torque•Pressure•ViscosityFeedingsystemScrewandbarrelDieTwinScrewExtruder(CourtesyofAmericanLeistritzCo.,Somerville,NJ)ScrewsandbarrelFeedersystemDiesystemSolidrMeltingMeltegionregionregionPhysicalstateofmaterialinbarrel•Co-rotatingtwin-screwCoun

4、ter-rotatingtwin-screwMiniCTW(Thermofisher,Germany)DownstreamsystemApelletizerusedtochoprodshapedextrudatesintopelletsorgranules.(CourtesyofRandcastleextrusionsystemsInc.,NJ).ChillrollerflakeunitScrewandbarrelFeedersystemDiesystemIllustrationofahot-meltextrusionfilmassembly.Courtesyof

5、ThermoElectronCorporation,MA.FinalproductAPIPolymerPlasticizerOtheringredientGranulesDieandPelletsdownstreamsystemFilmsImplantsTabletsCasestudiesMarketedZithromax®（希舒美）API：Azithromycin（阿奇霉素）Polymer：HPMCManufacture：PfizerMarketed:1990(UK)1991(USA)1996(China)CasestudiesMarketedSoliddisp

6、ersionforsolubilization•Amorphoussoliddispersion(ASD)——mostconsiderablefordissolutionenhancement•Crystallinesoliddisperison(CSD)Threecasestoprepareit:1.Thesufficientlyphysically/chemicallystableamorphousformcannotbegenerated.2.Thelatticeenergyislowerenoughthatdissolutionisnothinderedb

7、ythecrystallinestructure.SuccessfulextrusionofASDT>Tprocessmeltingpointofpuredrug挤出温度高于药物熔点很多药物对热敏感，熔融即分解。010080-2DSCTGA60-4Weight(%)40-6Tm=215oC20HeatFlow(mW/mg,exoup)100200300oTemperature(C)富马酸喹硫平卡马西平二氟尼柳（抗抑郁）（抗癫痫）(解热镇痛)AmorphousSolidDispersion利托那韦片剂PVPVA64克立芝(利托那韦/洛匹那韦/PVPVA64))HM

8、EGCry