Bayer Aktiengesellschaft, Corporate Quality, Berlin, Germany.
Eli Lilly and Company, Product Research and Development, and Global Quality Laboratories, Indianapolis, Indiana 46285.
J Pharm Sci. 2018 Dec;107(12):2995-3002. doi: 10.1016/j.xphs.2018.08.007. Epub 2018 Aug 25.
Dissolution testing is an important physiochemical test for the development of solid oral dosage forms, tablets, and capsules. As a quality control test, the dissolution test is used for assessment of drug product quality and is specified for batch release and regulatory stability studies. In vitro dissolution test results can often be correlated with the biopharmaceutical behavior of a product.This article provides a summary of views from major global agencies (Europe, Japan, United States), pharmacopoeias, academia, and industry. Based on available guidance and literature, this article summarizes highlights for development and validation of a suitable dissolution method, setting appropriate specifications, in vitro-in vivo comparison, and how to obtain a biowaiver.
溶出度测试是开发固体制剂（片剂和胶囊）的重要物理化学测试。作为质量控制测试，溶出度测试用于评估药物产品的质量，并规定用于批放行和监管稳定性研究。体外溶出度测试结果通常可以与产品的生物制药行为相关联。本文总结了主要全球机构（欧洲、日本、美国）、药典、学术界和行业的观点。基于现有指导原则和文献，本文总结了开发和验证合适的溶出度方法、设定适当的规格、体外-体内相关性以及如何获得生物豁免的要点。
