美国KERRY医药辅料介绍

AKerryGroupBusiness1ExcipientProductOffering可提供的药用辅料MonohydrateSprayDriedCryst/AmorphFluidBedCrystallineDrumDriedCrystallineInhalationGradeAnhydrousRollerDriedInhalationGradeLactoseExcipients乳糖系列GastricClearColoredStandardCustomMatchModifiedReleaseEntericClearColoredStandardCustomMatchModifiedReleaseCoatingSystems包衣系列ODTLubriToseAN&SDDisintequikDisintequikMCCCustomCo-ExcipientsTablettingSystemsExcipients复配辅料系列LiquidPowdersCrystalsFlavorModulationTechnologyFlavorCompounds香精Myvacet™Myverol™Myvaplex™Admuls™Glycerides甘油脂乳化剂AKerryGroupBusiness2MarketApplications市场应用Mediaingredientstoproducevaccines,therapeuticdrugs,antibiotics,startercultures,organicacids,vitaminsoraminoacids用于生产疫苗，制疗药，抗生素，细胞培养，有机酸，维生素或氨基酸的介质组份Mediaingredientstoproducevaccinesandtherapeuticdrugs.Mediaingredientstoproducediagnosticbacterialsterilityandidentificationsystems用于生产诊断细菌的无菌鉴别培养基Animalornonanimalproteinhydrolysates,yeastextractsandproteinsystems动物或非动物蛋白水解物，酵母抽提物和蛋白HydrousoranhydrousLactose,coatings,glycerides,ODTSystemsandflavors无水乳糖或一水乳糖，包衣，甘油酯，口溶片剂和香精NonactiveIngredientstoproducetablets,capsules,sachets,inhalationsystems,syrups,injectablesandcreams.用于片剂，胶囊，小袋，吸入制剂，糖浆，注射剂和霜剂的非活性组份AKerryGroupBusiness复配包衣产品水晶包衣粉彩色包衣粉肠溶包衣粉乳化剂和润滑剂药用香精(具有DMF号),天然香精乳化剂:AdmulT80&60VNFAdmulS60KNFMyvacet9-45,9-08&7-07KNF润滑剂:Myverol18-06&18-04PKDMG95NFAdmulMG40-04PKMDG40-55NFSheffield药用辅料AKerryGroupBusiness乳糖Foremost一水结晶乳糖310,312,313,314WG和喷雾干燥乳糖315,316无水直压乳糖SheffieldAnhydrousLactoseDT和DTHV吸入乳糖其中Sheffield无水直压乳糖,在美国最初申请专利,在制药行业被作为比较无水直压乳糖的标准片剂复配辅料SheffieldTM片剂复配辅料LubritoseAN&SDSheffieldTM片剂复配辅料ODTSheffieldTM片剂复配辅料DisitequikSheffieldTM片剂复配辅料DisitequikMCCSheffield药用辅料AKerryGroupBusiness全球主要的培养基成分生产者,提供以水解蛋白和酵母提取物为特色的产品用于细胞营养,适用于以下领域:细胞培养诊断用培养基微生物发酵大规模发酵其中SheffieldHyPep植物蛋白水解物系列产品,对细胞培养基中血清的成功替代生物科学细胞营养产品及应用AKerryGroupBusinessLubriToseTablettingSystemsAbusinessbuildingsolutionforimprovedTablettingManufacturing改良片剂制造的有效方法AKerryGroupBusinessLubriToseTablettingSystemsoverview综述•Integratedco-processeddirectlycompressibleexcipients•综合复配辅料用于直压片剂工艺•Combineacompressiblelactosewithalubricant•将可压乳糖与润滑剂结合在一起•Self-lubricatingpropertiessimplifyfinaldosemanufacturing•润滑特性简化了片剂的制造加工•Doesnotrequiretheadditionofmagnesiumstearate,binderordistinegrant•无须添加硬脂酸镁或其他粘合剂或崩解剂•Free-flowing,highlycompressiblewithlowdustingproperties•具有快速流动性,极高的可压缩性同时具有很低的扬尘性•Eliminatepreciselycontrolledblendingrequirements•干混过程无需精确控制,过度搅拌无妨•Improvecontentuniformityandreducerejections•药片成份的均一性得到提升,不合格率降低.•Canextendtabletpressruntimesandincreasetabletspeeds•压片机可长时间连续运转,提高压片速度.AKerryGroupBusinessProductFeatures产品特性optimizingdirectcompression优化直压工艺•Specificallydesignedfordirectcompression,highspeedtablettingoperationswhereconsistency,productionefficiencyandcostareparamount•特为直压工艺高速压片生产设计,压片质量的连贯性,制造效率和成本是极为重要的考量•AllmaterialsincludedinFDAInactiveIngredientsGuideandcurrentlyusedinapprovedFDAdrugproducts•所用原料均符合FDA规范要求.•Lactosebased–compatiblewithawiderangeofAPIs•以乳糖为基体可与API广泛兼容•DMFregistrations•经DMF(DrugMasterFile)注册AKerryGroupBusinessProductBenefits产品的好处ensuresadequatelubricationEveryTime,AlltheTime确保适度的润滑,每时每刻•Eliminatesanyissueswithover-blendingorunder-blending•可消除因过度混合或搅拌不足所引发的质量缺陷事故•Particlesheathing颗粒状盖帽•Dryformulationoverblending过度搅拌使配方失水变干•Feed-frameoverblending过度搅拌使灌料管道不畅•Friability&tablethardnessrejections片剂的脆碎度和硬度不达标•Chippingandcappingissues片碎裂和叠帽AKerryGroupBusinessProductBenefits产品的好处ensuresadequatelubricationEveryTime,AlltheTime确保适度的润滑,每时每刻•ImprovesPerformance改善片剂的质量•Reducesdissolutionrateinconsistency减少了与溶出率的矛盾•Improvestabletweightconsistency提高了片重的一致性•Improvesflowabilityandcontentuniformityduringdirectcompression•改进了在制片过程中物料的流动性和片成份的均一性•Reduces“yellowing”fromalkalineingredients•降低了片剂的泛黄情况(因碱性组分的影响所致)AKerryGroupBusinessProductBenefits产品的好处ensuresadequatelubricationEveryTime,AlltheTime每时每刻确保适度的润滑•Increasesefficienciesindirectcompressionoperations提升直压生产效率•Doesnotfilmcoatequipment–extendsruntimesandreducescleaningcycles•不会在压片模表面形成膜-----可延长压片机运行时间,减少停机清洁时间•ReducesrawmaterialQCtesting,manufacturingstepsandprocessvalidation•减少QC对原料的检测时间,减少生产步骤和工艺的验证•Canincreasespeedoftabletpressoperationupto25%higherwith20%lowercompactionforces(mayvarywithformulation)•可有效地提高压片速度25%以上,压片力则可降低20%(随配方的变化有所不同)•Canextendtabletpresstoolinglife•可延长压片机的使用寿命AKerryGroupBusiness•LubriToseANisaPatentPending,integratedco-processedexcipientsystemthateliminatesmanufacturingissuestypicallyencounteredwithusingMagnesiumStearateasalubricant.•完整的加工赋形剂系列正在报批专利权,它能消除制造过程的问题,最典型的是能解决在使用硬脂酸镁润滑剂的出现的问题•LubriToseANconsistsof:组成•NF/EP/JPcompliantAnhydrousLactoseand无水乳糖与•NFcompliantdistilledGlycerylMonostearate蒸馏的单硬脂酸甘油酯•Thechemicalattributesofbothproductsarepreserved各组份的产品特性均被保持•Specificallydesignedforuseindirectcompression,highspeedtablettingoperationswhereconsistency,productionefficiencyandcostareparamount•专为直接应用于高速压片工艺所设计，尤为重要的是制造质量的一致性，高效率和成本．•ThemonographcompliantingredientsandDMFregistrationassureacceptancebyallmajorglobalregulatoryagencies•符合专论和ＤＭＦ注册的原料保证能符合世界各国法规•BothmaterialsarelistedintheFDAInactiveIngredientsDatabase,meaningthat