无定型固体分散体制剂的处方、工艺与质量控制策略
Formulation,Process and Quality Control Strategies for Amorphous Solid Dispersion-based Preparations
杨茜 1李慧义1
作者信息
摘要
无定型固体分散体是提高难溶性药物口服生物利用度的有效策略之一,应用前景广泛.但由于存在固态物理稳定性,即"老化"的问题,会影响药物的体外溶出和体内吸收,给无定型固体分散体制剂的开发带来了较大挑战.固态物理稳定性易受处方组成、制备工艺和贮存条件等多种因素的影响.文章讨论了无定型固体分散体制剂的处方组成、制备工艺和质量控制,以期为其研究和开发提供参考.
Abstract
Amorphous solid dispersion is one of the most effective formulation approaches to enhance the oral bioavailability of poorly water-soluble drugs with wide application prospects.However,due to the"aging",a solid state physical stability problem,which affects the dissolution in vitro and absorption in vivo,the development of amorphous solid dispersion-based preparations faces great challenges.The solid state physical stability is affected by many factors such as formulation composition,preparation process and storage conditions.In this paper,formulation composition,preparation process and quality control of amorphous solid dispersion-based preparations are summarized in order to provide the guidance for the development of amorphous solid dispersion-based preparations.
关键词
无定型固体分散体/处方/制备工艺/物理稳定性/质量控制Key words
amorphous solid dispersion/formulation/preparation process/physical stability/quality control引用本文复制引用
出版年
2024
NETL
NSTL
万方数据