口服固体制剂粒度和粒度分布相关问题探讨

Discussion on issues related to particle size and its distribution of oral solid preparation

粒度和粒度分布是原辅料以及药物颗粒的关键质量属性,对药物制剂的生产可行性和产品性能有着重要的影响。本文旨在通过对口服固体制剂粒度和粒度分布与生产可行性、产品性能之间的相关性进行剖析,提出粒度和粒度分布分析方法开发和验证过程的关键考虑因素,并探讨如何建立合理的粒度分布控制标准,为药物研发和生产阶段进行粒度和粒度分布研究提供参考。

Particle size and particle size distribution are critical quality attributes of raw materials and drug particles,which have significant impacts on the feasibility of drug formulation production and product performance.This paper aimed to analyze the correlation between particle size and particle size distribution of oral solid dosage forms and the feasibility of production as well as product performance.It proposed key considerations for the development and validation of particle size and particle size distribution analysis methods and discusses how to establish rational control standards for particle size distribution.This study provided references for particle size and particle size distribution research in drug development and production stages.