Investigation of formulation, preparation and stability of rosuvastatin calcium tablets
10.3724/SP.J.1008.2015.01029
- Author:
Yuan GAO
1
Author Information
1. Department of Pharmacy, Changhai Hospital, Second Military Medical University
- Publication Type:Journal Article
- Keywords:
Dissolution;
Drug stability;
Fluid bed;
High sheer mixer;
Pharmaceutical chemistry;
Pharmaceutical technology;
Rosuvastatin calcium
- From:
Academic Journal of Second Military Medical University
2015;36(9):1029-1033
- CountryChina
- Language:Chinese
-
Abstract:
Objective To explore the formulation and preparation technique of rosuvastatin calcium tablets with satisfactory stability and reproducibility. Methods Using suitable formulations, we prepared the rosuvastatin calcium granulates by high shear mixer and fluid bed separately, and compared their influences on the granulate properties, tablet characteristics and dissolution. The reproducibility of formulation and preparation technique was investigated. Furthermore, the factors affecting the formulation were also investigated. Results Compared with the fluid bed, granulation using high sheer mixer was more suitable for preparing rosuvastatin calcium granulates. The selected formulation and preparation technique yielded 3 batches of rosuvastatin calcium tablets which met the quality requirement. The tablets had a comparable dissolution profiles to "Crestor " of AstraZeneca. The stability of rosuvastatin calcium was largely affected by the strong light, high humidity and high temperature. Conclusion The optimized formulation and preparation technique have good reproducibility for preparing rosuvastatin calcium tablets, which have good stability.
