Research progress on characterization of phase separation of amorphous solid dispersion
10.12173/j.issn.2097-4922.202404132
- VernacularTitle:无定型固体分散体相态表征研究进展
- Author:
Ling ZHU
1
;
Huijie WANG
;
Huan WANG
;
Yao LI
;
Yuanyuan ZHAO
;
Hao ZHOU
Author Information
1. 正大天晴药业集团股份有限公司,南京 211100
- Keywords:
Amorphous solid dispersion;
Phase separation;
Characterization techniques;
Stability;
Recrystallization;
Regulatory requirements
- From:
China Pharmacist
2024;28(10):321-330
- CountryChina
- Language:Chinese
-
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.