Optimization of Propafenone Hydrochloride Sustained-release Tablets by Central Composite Design and Response Surface Methodology

OBJECTIVE To optimize the formulation of propafenone hydrochloride sustained-release tablets by central composite design/response surface methodology. METHODS The formulation of propafenone hydrochloride sustained-release tablets was optimized using the amount of HPMC and lactose as factors and with accumulative release rate as index. The optimized results were validated. RESULTS Optimized formulation was 31.19%-32.16% by HPMC and 8.67%-14.7% by lactose. Bias between the observed and predicted values was within 6%. CONCLUSION The model developed by central composite design/response surface methodology can be used for the optimization of propafenone hydrochloride sustained-release tablets formulation. Established model has good predictive accuracy.