【摘要】 药物的固体形态直接影响其安全性与有效性,共晶和盐作为两种不同的固体形态,可有效改善药物的理化性质,是目前制药工业领域的研究热点。本文归纳并总结了共晶和盐的研究现状,结合FDA最新发布的《药物共晶监管分类指南》,根据各自的物理结构差异,阐明了共晶和盐的不同定义,讨论了两者在提高药物溶解度、稳定性和生物利用度等方面的作用和可能存在的问题,介绍了一些重要的鉴别共晶与盐的现代分析方法。更多还原

【Abstract】 New solid forms with modified physicochemical and biopharmaceutical properties can be obtained by introducing different guest molecules to form cocrystals or salts.This approach appears to be an advantageous alternative for pharmaceutical research and development.Inspired by the newly released Guidance for Industry:Regulatory Classification of Pharmaceutical Cocrystals,we reviewed the differences between cocrystals and salts in their definition,structure,characterization,regulatory issues and physicochemical properties such as solubility,stability as well as bioavailability.In addition,some newly developed techniques for characterizing cocrystals or salts are also introduced.更多还原