期刊
JOURNAL OF PHARMACEUTICAL SCIENCES
卷 92, 期 7, 页码 1331-1342出版社
ELSEVIER SCIENCE INC
DOI: 10.1002/jps.10366
关键词
crystallinity; polymorph; solubility; stability; absorption; particle size; profiles
General Pharmaceutics is proposed as the broad study of the biopharmaceutical and physical chemical properties of each potential drug substance. When the first quality bulk lot is delivered, usually the first GMP bulk lot, an extensive profiling of the potential drug substance should commence. This profile should include solid-state characterization as well as thorough analyses of solubility, stability, and absorption properties of the drug substance that could affect the development of a viable medicine. As a result of these studies, a number of initial specifications could be developed: the preferred polymorphic or crystalline form identified, the preferred particle size to optimize absorption/development, and an initial biopharmaceutics classification with a dose limit to identify those cases in which the formulation can be expected to improve absorption and exposure. The broad topic of General Pharmaceutics is discussed in this Minireview including many advances in technology in this field as well as the rationale behind the proposed initial specifications. (C) 2003 Wiley-Liss, Inc. and the American Pharmacists Association.
作者
我是这篇论文的作者
点击您的名字以认领此论文并将其添加到您的个人资料中。
推荐
暂无数据