美国KERRY医药辅料介绍.ppt

LubriTose Tabletting Systemsoverview综述 Integrated co-processed directly compressible excipients 综合复配辅料用于直压片剂工艺 Combine a compressible lactose with a lubricant 将可压乳糖与润滑剂结合在一起 Self-lubricating properties simplify final dose manufacturing 润滑特性简化了片剂的制造加工 Does not require the addition of magnesium stearate, binder or distinegrant 无须添加硬脂酸镁或其他粘合剂或崩解剂 Free-flowing, highly compressible with low dusting properties 具有快速流动性,极高的可压缩性同时具有很低的扬尘性 Eliminate precisely controlled blending requirements 干混过程无需精确控制,过度搅拌无妨 Improve content uniformity and reduce rejections 药片成份的均一性得到提升,不合格率降低. Can extend tablet press run times and increase tablet speeds 压片机可长时间连续运转,提高压片速度. Product Features产品特性 optimizing direct compression优化直压工艺 Specifically designed for direct compression, high speed tabletting operations where consistency, production efficiency and cost are paramount 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 All materials included in FDA Inactive Ingredients Guide and currently used in approved FDA drug products 所用原料均符合FDA规范要求. Lactose based – compatible with a wide range of APIs 以乳糖为基体可与API 广泛兼容 DMF registrations 经DMF (Drug Master File)注册 Product Benefits产品的好处ensures adequate lubrication Every Time, All the Time确保适度的润滑,每时每刻 Eliminates any issues with over-blending or under-blending 可消除因过度混合或搅拌不足所引发的质量缺陷事故 Particle sheathing颗粒状盖帽 Dry formulation over blending过度搅拌使配方失水变干 Feed-frame over blending过度搅拌使灌料管道不畅 Friability tablet hardness rejections片剂的脆碎度和硬度不达标 Chipping and capping issues片碎裂和叠帽 Product Benefits产品的好处ensures adequate lubrication Every Time, All the Time确保适度的润滑,每时每刻 Improves Performance改善片剂的质量 Reduces dissolution rate inconsistency减少了与溶出率的矛盾 Improves tablet weight consistency提高了片重的一致性 Improves flowability and content uniformity during direct compression 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” from alkaline ingredients 降低了片剂的泛黄情况(因碱性组分的影响所致) Product Benefits产品的好处ensures adequate lubrication E