Influence of preparation methods on amorphous cinacalcet hydrochloride
10.11665/j.issn.1000-5048.20160312
- VernacularTitle:制备方法对无定形盐酸西那卡塞的影响
- Author:
Shanshan WANG
1
;
Weiming FAN
;
Juan CHEN
;
Yuan GAO
Author Information
1. 中国药科大学中药制剂教研室
- Publication Type:Journal Article
- Keywords:
cinacalcet hydrochloride;
amorphis;
dissolution;
stability;
preparation
- From:
Journal of China Pharmaceutical University
2016;47(3):317-323
- CountryChina
- Language:Chinese
-
Abstract:
In the present study, amorphous cinacalcet hydrochloride was prepared by three different approaches including rotary evaporation, quench-cooling and lyophilization. Physicochemical properties of prepared amorphous cinacalcet hydrochloride such as thermal behavior, dissolution and stability were investigated. Results showed that there was no difference in dissolution and chemical stability for amorphous cinacalcet hydrochloride prepared by these three different methods; however, these amorphous materials exhibited significant difference in thermodynamic behavior and physical stability: (1)They had similar Tg but with significant difference in Tc(135. 2, 129. 6 and 153. 9 °C for the amorphous products prepared by rotary evaporation, lyophilization and quench-cooling, respectively); (2)These amorphous products were easy to recrystallize under an environment with high temperature and humidity, especially that prepared by quench-cooling. This study provides an experimental basis for screening preparation methods of amorphous materials.
