A reliable crystallization process for the preparation of agomelatine form I
10.11665/j.issn.1000-5048.20160208
- VernacularTitle:稳定的阿戈美拉汀晶型Ⅰ的制备方法
- Author:
Yinrong XU
1
;
Xiaoxia SHENG
Author Information
1. 杭州领业医药科技有限公司
- Publication Type:Journal Article
- Keywords:
agomelatine form I;
polymer;
stability;
preparation;
PVP;
HPMC
- From:
Journal of China Pharmaceutical University
2016;47(2):171-175
- CountryChina
- Language:Chinese
-
Abstract:
A reliable crystallization process was developed for the preparation of stable agomelatine form I. This antisolvent crystallization was explored in ethanol-n-heptane by adding PVP and ethanol-water system by adding HPMC, respectively. Factors such as solvent, polymer, concentration of polymer, and solvent ratio were subjected to detailed examination. Accelerated and long-term stability observations indicates that the presence of polymeric additives in the crystallization process enhances the stability of agomelatine form I.