Formulation Optimization of Budesonide Sustained-release Tablet by Central Composite Design-response Surface Method
10.6039/j.issn.1001-0408.2017.10.27
- VernacularTitle:星点设计-响应面法优化布地奈德缓释片处方
- Author:
Yuanzhi REN
;
Tao ZHANG
;
Hua HUANG
;
Xiujie LIU
;
Jingsong ZHOU
- Keywords:
Budesonide;
Sustained-release tablet;
Central composite design-response surface method;
Formulation screening
- From:
China Pharmacy
2017;28(10):1395-1398
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE:To optimize the formulation of Budesonide sustained-release tablet. METHODS:Using the cumula-tive releases in 2,4,8 h as investigation indexes,central composite design-response surface method was used to optimize the amount of hydroxypropylcellulose L(HPC-L),amount of soybean phosphatides,and filler(fixed total 200 mg)lactose- micro-crystalline cellulose mass ratio in the formulation of Budesonide sustained-release tablet,and the verification test was conducted. The release behaviors of prepared sustained-release tablet and original preparation in pH 7.2,7.0,6.8 phosphate buffer were com-pared. RESULTS:The optimal formulation was as follow as budesonide of 9 mg,HPC-L of 46.49 mg,soybean phosphatides of 9.23 mg,filler lactose-microcrystalline cellulose mass ratio of 1:2.9;the cumulative releases in 2,4,8 h were 21.9%,50.1%, 99.5%,the relative errors with predicted values (22.0%,50.0%,98.5%) were 0.45%,0.20%,1.02%(n=3),respectively. Compared with cumulative release of original preparation,the f2 was higher than 50. CONCLUSIONS:Budesonide sustained-re-lease tablet is successfully prepared,which shows similar release behavior to original preparations.
