化学仿制药制剂开发中晶型研究思路探讨
Discussion on Crystal Type Research in the Development of Chemical Generic Drugs
翟允耀 1章晓骅1
作者信息
- 1. 南京正大天晴制药有限公司,江苏 南京 210046
- 折叠
摘要
目的 讨论化学仿制药制剂工艺开发和稳定性期间晶型研究和控制策略.方法 基于质量源于设计的理念,对药物制剂中出现的原料药晶型进行分类讨论.结果 药物制剂中不同晶型情况需要不同的控制策略,保持晶型稳定是药物安全性和有效性的重要基础之一.良好的晶型控制策略能够保证药品质量批次间的重现性.结论 制剂开发中,除了常规粉末X射线衍射法(PXRD)以外,尤其对于溶解度差异较大的晶型情况,替代方法(如溶出度)也可以作为晶型控制的手段.
Abstract
Objective To discuss crystal type studies and control strategies during preparations process and stability of chemical generic drug.Methods Based on the idea that the quality by design,discuss the types of drug substance crystal patterns present in the pharmaceutical preparation.Results Different crystal forms in pharmaceutical preparations require different control strategies,and maintaining crystal form stability is one of the important bases for drug safety and effectiveness.Good crystal control strategy can ensure the quality reproducibility.Conclusion During the formulation development process,in addition to the conventional powder X-ray diffraction method(PXRD),alternative methods(such as dissolution)can also be used as a means of crystal control which especially for the solubility varies widely between different crystal forms.
关键词
化学仿制药/药物制剂/晶型研究Key words
Chemical generic drug/Pharmaceutic preparation/Crystal type research引用本文复制引用
出版年
2024
NETL
NSTL
万方数据