Optimization of the Formulation of Roxatidine Acetate Hydrochloride Sustained-release Tablets by Central Composite Design-response Surface Methodology
10.6039/j.issn.1001-0408.2018.07.15
- VernacularTitle:星点设计-响应面法优化盐酸罗沙替丁醋酸酯缓释片的处方
- Author:
Yishan DUAN
1
;
Juan DU
;
Lu SUN
;
Xueyi LI
;
Ning LIN
Author Information
1. 湖北中医药大学药学院
- Keywords:
Roxatidine acetate hydrochloride;
Sustained-release tablets;
Central composite design-response surface methodology;
Preparation;
Formulation optimization
- From:
China Pharmacy
2018;29(7):927-929
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE:To optimize the formulation of Roxatidine acetate hydrochloride(ROX)sustained-release tablets. METHODS:ROX sustained-release tablets were prepared by direct powder compression method. Central composite design-response surface methodology was used to optimize the formulation with composite index of 1,4,8 h in vitro accumulative release rate as index,using mass ratio of lactose/microcrystalline cellulose(MCC)(m/m),ethyl cellulose(EC)amount and HPMC amount as factors. Validation test was also conducted. RESULTS:The optimal formulation was as follows as ROX 75 mg,lactose 45 mg, MCC 91 mg,EC 65 mg,HPMC 124 mg,micropowder silica gel 2 mg. 1,4,8 h in vitro accumulative release rates of prepared sustained-release tablets were(30.7 ± 0.5)%,(65.8 ± 0.7)%,(89.4 ± 0.6)%,respectively. Related errors of them to predicted value were 0.6%,0.8%,1.2%,respectively. CONCLUSIONS:ROX sustained-release tablets are prepared successfully,and sustained-release effect is consisted with the expected effect.
