Due to the sensitivity of the eyes and their unique anatomical and physiological characteristics,ophthalmic preparations require stricter quality control compared to other topical preparations.Through preliminary literature research and daily review,mainly based on the relevant domestic/foreign technical guidelines and regulatory requirements,we discuss the quality research of chemical generic ophthalmic preparations.This mainly included the overall requirements for quality research and other concerns,such as microbiological considerations,drug release/dissolution,and stability design.Through the discussion in this article,we hope to provide some reference for the development of generic ophthalmic preparations,especially complex preparations or for regulatory agencies in China.
关键词
眼用制剂/复杂剂型/质量研究/释放或溶出/微生物学
Key words
Ophthalmic drug products/Complex dosage forms/Quality research/Release or dissolution/Microbiological considerations
维普
万方数据