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美国KERRY医药

Excipient Product Offering 可提供的药用辅料
Lactose Excipients 乳糖系列
Monohydrate Spray Dried Cryst/Amorph Fluid Bed Crystalline Drum Dried Crystalline Inhalation Grade Gastric Clear Colored Standard Custom Match Modified Release Anhydrous Roller Dried Inhalation Grade
Coating Systems 包衣系列
Enteric Clear Colored Standard Custom Match Modified Release
Tabletting Systems Excipients 复配辅料系列 Flavor Compounds香精
ODT LubriTose AN&SD Disintequik Disintequik MCC Custom Co-Excipients Liquid Powders Crystals Flavor Modulation Technology Myvacet? Myverol? Myvaplex? Admuls?
Glycerides 甘油脂乳化剂
1
A Kerry Group Business

Market Applications市场应用
Hydrous or anhydrous Lactose, coatings, glycerides, ODT Systems and flavors 无水乳糖或一水乳糖，包衣，甘油酯，口溶片剂和香精 Non active Ingredients to produce tablets,capsules, sachets, inhalation systems, syrups, injectables and creams. 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
Animal or non animal protein hydrolysates, yeast extracts and protein systems 动物或非动物蛋白水解物，酵母抽提物和蛋白
Media ingredients to produce vaccines,therapeutic drugs, antibiotics, starter cultures, organic acids, vitamins or amino acids 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 Media ingredients to produce vaccines and therapeutic drugs. Media ingredients to produce diagnostic bacterial sterility and identification systems 用于生产诊断细菌的无菌鉴别培养基
2
A Kerry Group Business

Sheffield 药用辅料
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
乳化剂: Admul T 80 & 60 V NF Admul S 60 K NF Myvacet 9-45, 9-08 & 7-07 K NF 润滑剂: Myverol 18-06 & 18-04 P K DMG 95 NF Admul MG 40-04 P K MDG 40-55 NF
药用香精(具有DMF号),天然香精
A Kerry Group Business

Sheffield 药用辅料
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Sheffield Anhydrous Lactose DT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
Sheffield TM 片剂复配辅料 Lubritose AN & SD Sheffield TM 片剂复配辅料ODT Sheffield TM 片剂复配辅料Disitequik Sheffield TM 片剂复配辅料Disitequik MCC
A Kerry Group Business

生物科学细胞营养产品及应用
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Sheffield Hy Pep 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
A Kerry Group Business

LubriTose Tabletting Systems
A business building solution for improved Tabletting Manufacturing
改良片剂制造的有效方法
A Kerry Group Business

LubriTose Tabletting Systems
overview综述
? Integrated co-processed directly compressible excipients ? ? ? 综合复配辅料用于直压片剂工艺将可压乳糖与润滑剂结合在一起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 ? Combine a compressible lactose with a lubricant ? Self-lubricating properties simplify final dose manufacturing
? 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干混过程无需精确控制,过度搅拌无妨 ? Eliminate precisely controlled blending requirements ? 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.
A Kerry Group Business

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
A Kerry Group Business

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
A Kerry Group Business

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)
A Kerry Group Business

Product Benefits产品的好处
ensures adequate lubrication Every Time, All the Time 每时每刻确保适度的润滑
? Increases efficiencies in direct compression operations提升直压生产效率 ? ? ? ? ? ? ? ? Does not film coat equipment – extends run times and reduces cleaning cycles 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 Reduces raw material QC testing, manufacturing steps and process validation 减少QC对原料的检测时间,减少生产步骤和工艺的验证 Can increase speed of tablet press operation up to 25% higher with 20% lower compaction forces (may vary with formulation) 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) Can extend tablet press tooling life 可延长压片机的使用寿命
A Kerry Group Business

LubriTose AN: Overview 综述
? LubriTose AN is a Patent Pending, integrated co-processed excipient system that eliminates manufacturing issues typically encountered with using Magnesium Stearate as a lubricant. ? 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 ? LubriTose AN consists of:组成 ? ? ? NF/EP/JP compliant Anhydrous Lactose and 无水乳糖与 NF compliant distilled Glyceryl Monostearate 蒸馏的单硬脂酸甘油酯 The chemical attributes of both products are preserved 各组份的产品特性均被保持
? Specifically designed for use in direct compression, high speed tabletting operations where consistency, production efficiency and cost are paramount ? 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． ? The monograph compliant ingredients and DMF registration assure acceptance by all major global regulatory agencies ? 符合专论和ＤＭＦ注册的原料保证能符合世界各国法规 ? Both materials are listed in the FDA Inactive Ingredients Database, meaning that the ingredients are present in currently approved FDA drug products ? 上述原料可见于ＦＤＡ批准的可用于药品生产的非活性组分的数据库． ? Provide assurance of an inert material with no effect on most active ingredients and no toxicological concerns. ? 可确保对活性药物的活性无任何影响，决无任何毒性．
A Kerry Group Business

LubriTose AN
? Delivering Greater Value更大的产值 ? ? ? ? ? ? Replacement for magnesium stearate 可替代硬脂酸镁 Leverages Kerry Ingredients & Flavours Technologies to deliver innovative new solution to lubrication of tabletting machines 综合Kerry Ingredients & Flavours 的技术资源不断开创新技术，提供来改进制片用的润滑剂 Delivers greater value for tabletting manufactures 提升片剂制造的产值
? Improved Results改进效果 ? ? ? ? ? ? ? ? ? ? Ability to run at higher production speeds (up to 25%) 制片速度可大幅提高（２５％以上） Eliminates physical rejection issues related to over-blending 消除与过度混合有关的物理性不合格． Improves tablet hardness and disintegration time consistency 片剂的硬度和崩解速率得到改善 Reduce compaction force and overall wear on production equipment (dies, punches, tools) 可降低压片机械的冲压力 Reduce Quality Control testing and validation 减低ＱＣ测试和验证的频率．
A Kerry Group Business

LubriTose Tabletting Systems
LubriTose AN
Lactose Anhydrous NF And Distilled Monoglyceride
LubriTose SD
Lactose Spray Dried NF And Distilled Monoglyceride
A Kerry Group Business

LubriTose AN
equal in lubrication performance to Mag. Stearate 润滑作用与硬脂酸镁相当
Compression force vs Ejection force
21 19 17 15 13 11 9 7 5 600
Ejection Force (lbs)
800
1000
1200
1400
1600
Compression Force (lbs) Lubritose AN DT 1% mag stear.
A Kerry Group Business

LubriTose SD
equal in lubrication performance to Mag. Stearate 润滑作用与硬脂酸镁相当
Compression Force vs Ejection Force
92 90 88 86 84 82 80 78 500 Ejection Force (lbs)
700
900
1100
1300
1500
Compression Force (lbs) LubriTose SD 316/1% mag stear.
A Kerry Group Business

Magnesium Stearate硬脂酸镁
overblending increases tablet disintegration 过度混搅会使增加片剂崩解时间
Lactose/Mg Stearate Hardness vs Disintegration
Disintegration Tim e (sec) 3000 2500 2000 1500 1000 500 0 0 10 20 30 40 50 60 70 Tablet Hardness (N) 2 Minute Blend 30 Minute Blend
A Kerry Group Business

LubriTose AN
overblending does not affect disintegration
过度混搅不影响药片的崩解
LubriTose AN Hardness vs Disintegration
Disintegration Tim e (sec) 1600 1400 1200 1000 800 600 400 200 0 0 10 20 30 40 50 60 70 Tablet Hardness (N) Blended for 2 minutes Blended for 60 minutes
A Kerry Group Business

LubriTose SD
overblending does not affect disintegration
过度混搅不影响药片的崩解
LubriTose SD Hardness vs Disintegration
1500 1300 1100 900 700 500 0 10 20 30 40 50 60 Tablet Hardness (N) Blended for 2 minutes Blended for 60 minutes
Disintegration Tim e (sec)
A Kerry Group Business

Magnesium Stearate
overblending decreases tablet hardness 过度混搅会降低片剂的硬度
Lactose/Mg Stearate Compression vs Hardness
70 60 50 40 30 20 10 0 400 Tablet Hardness (N)
600
800
1000
1200
1400
1600
Compression Force (lbs) 2 Minute Blend 30 Minute Blend
A Kerry Group Business