Study on Formulation Optimization of Nicorandil Sustained-release Matrix Tablet and Drug Release in vitro
10.6039/j.issn.1001-0408.2016.25.33
- VernacularTitle:尼可地尔骨架型缓释片的处方优化及体外释药研究
- Author:
Guilan JIN
;
Ping LUO
;
Juan DU
;
Ning LIN
;
Jianling TAN
;
Xiangfei XING
- Publication Type:Journal Article
- Keywords:
Nicorandil;
Sustained-release matrix tablet;
Formulation optimization;
Central composite design-response surface method;
Drug release in vitro
- From:
China Pharmacy
2016;27(25):3564-3566
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE:To optimize the formulation optimization of Nicorandil sustained-release matrix tablet,and evaluate its drug release properties in vitro. METHODS:Based on single factor test,powder direct compression method was used,using nicorandil cumulative release rate (Q) in 1,4,8,12 h as evaluation indexes,central composite design-response surface method was adopted to optimize the amount of hydroxypropyl methylcellulose(HPMC)and ethyl cellulose(EC);Q values within 12 h in different pH (1.0,5.0,6.8,7.4) media were compared. RESULTS:The optimized formulation (every tablet) was nicorandil 10 mg,HPMC 150 mg,EC 90 mg,microcrystalline cellulose 80 mg,lactose 60 mg,magnesium stearate 2%. Q1 h,Q4 h,Q8 h and Q12 h of the obtained formulation were 23.6%,51.3%,83.7% and 96.9%,respectively;deviation from the predicted values were 2.1%,1.6%,1.0%,0.2%. Q values were similar in pH 1.0-7.4 at different time points. CONCLUSIONS:The obtained Nicor-andil sustained-release matrix tablet by optimal formulation shows sustained-release effect,and the change of pH 1.0-7.4 has no in-terference in the release characteristics of main drug.
