Polymorphism of active pharmaceutical ingredients

被引：115
|
作者：
Karpinski, PH [1 ]
机构：
[1] Novartis Pharmaceut Corp, E Hanover, NJ 07936 USA
来源：
CHEMICAL ENGINEERING & TECHNOLOGY | 2006年 / 29卷 / 02期
关键词：
D O I：
10.1002/ceat.200500397
中图分类号：
TQ [化学工业];
学科分类号：
0817 ;
摘要：
Different polymorphs of the same active pharmaceutical ingredient (API) display distinct physical properties, such as melting point, solubility, dissolution rate, hygroscopicity, or stability. The ability to successfully produce and reproduce specific stable polymorphs is intricately correlated with the efficiency and speed of drug development, the robustness of manufacturing process, and - ultimately - the stability and quality of APIs. This paper focuses on eight case study examples of interesting polymorphic transformations observed in the course of the regular API development process. Through extensive physicochemical characterization, using multiple analytical techniques, the phenomena observed could be elucidated and proper measures recommended to reduce the risk of unexpected polymorphic transformations.
引用
收藏
页码：233 / 237
页数：5
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