Preparation and Preliminary Stability of Candesartan Cilexetil Tablets
- VernacularTitle:坎地沙坦酯片的制备及初步稳定性研究
- Author:
Xiangyang XIE
;
Yang LI
;
Wen LIN
;
Chen CHEN
;
Xiangru LIAO
;
Ying CHEN
- Publication Type:Journal Article
- Keywords:
Candesartan cilexetil;
Box-Behnken experiment design;
Friability;
Disintegration time;
Dissolution
- From:
China Pharmacist
2015;(4):664-668
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To prepare and optimize candesartan cilexetil tablets,and study the stability preliminarily. Methods:The formula was optimized by Box-Behnken experiment design,the ratio of lactose to pregelatinized starch( X1 ),the amount of disintegrant ( X2 ,%)and the amount of lubricant( X3 ,%)were selected as the independent variables,and weight difference( Y1 ,%),friability ( Y2 ,%),disintegration time( Y3 ,%)and candesartan cilexetil dissolution( Y4 ,%)were the dependent variables. The release rate of candesartan cilexetil tablets and the reference tablets were compared by similarity factor( f2 value). Preliminary stability was studied by high-temperature test,high-humidity test and illumination test. Results:The optimal formula of the tablets was as follows:the ratio of lactose to pregelatinized starch was 7:1,the amount of disintegrant was 5. 5%,and the amount of lubricant was 0. 5%. The f2 for the candesartan cilexetil tablets and the reference tablets in different dissolution meda was 60. 62,73. 34,66. 95 and 68. 60,respec-tively. Conclusion:The formula design is reasonable,the preparation process is feasible and the quality can be controlled.
