无定型固体分散体相态表征研究进展
Research progress on characterization of phase separation of amorphous solid dispersion
朱玲 1王慧洁 1王欢 1李瑶 1赵媛媛 1周浩1
作者信息
- 1. 正大天晴药业集团股份有限公司,南京 211100
- 折叠
摘要
固体分散体技术是改善难溶性药物溶出度和生物利用度的先进技术.抑制无定型固体分散体(ASD)活性药物成分的重结晶和非晶相分离是保证产品稳定性的关键手段,因此ASD相态的表征至关重要.本文从相分离的原理出发,对各种表征技术的优缺点与适用性进行分析与总结,为ASD的表征及稳定性研究提供有效参考.
Abstract
Solid dispersion technology is an advanced technology to improve the solubility and bioavailability of poorly soluble drugs.Inhibition of the recrystallization and amorphous phase separation of amorphous solid dispersion (ASD) active pharmaceutical ingredients are important to ensure product stability,so the characterization of ASD phase separation is essential.Based on the principle of phase separation,this paper analyzed and summarized the advantages,disadvantages and applicability of the various characterization techniques,in order to provide an efficient reference for the characterization and stability study of ASD.
关键词
无定型固体分散体/相分离/表征技术/稳定性/重结晶/监管要求Key words
Amorphous solid dispersion/Phase separation/Characterization techniques/Stability/Recrystallization/Regulatory requirements引用本文复制引用
出版年
2024
NETL
NSTL
万方数据