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Excipients

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RetaLac^®

MEGGLEs 的共加工辅料RetaLac^®外观为白色无味的粉末 , 能够很好地流动并部分溶于冷水。它含有相同含量的羟丙基甲基纤维素 (type 2208, a.k.a. “K-type”) 粘度为4000 mPa·s和一水乳糖，两者均为药用级别的物料.通过喷雾制粒得到的具有特别结构的颗粒的粒度分布D50大约是100微米到200微米,典型值为125微米，适合直接压片的工艺。
乳糖的性质鉴定参考欧洲药典相关章节，方法C：产生红色溶液。羟丙基甲基纤维素的鉴定参加欧洲药典方法:温度在50°C时溶液呈明胶状.

Shelf life / Retest:
24 months

Standard Packaging:
12 kg - Plastic Drum with PE-EVOH-PE Inliner

粒度分布
[Mechanical sieve shaker]

<63 µm: NMT 25%
<250 µm: NLT 80%

典型值

堆密度 [g/l]: 340
振实密度 [g/l]: 460
豪森指数 1.35
卡尔指数： 26.09 %

HPMC Hypromellose Lactose_Sustained Release_modified release_direct compression

好处

缓控释制剂的直接压片
相对于湿法制粒或物理混合物更好的可加工性
符合法规要求
扩散理论控制的药物释放
溶出释放不依赖于PH值( pH 1 到 7)
药物的释放和片剂的几何尺寸有关
更简洁的工艺
相对于单纯羟丙基甲基纤维素更好地润湿行为

用途

直接压片，可用于多颗粒系统和微片
干法制粒压片
混悬剂
挤出滚圆

典型粒径分布something new

EXCiPACT Certificate

Shelf life - Retest Date

Sustainability Statement

Sustainability Whitepaper

14001_eng_2016-2018.pdf

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