Optimization on Formulation of Controlled-onset Extended-release Tablets of Nicorandil by Central Composite Design-response Surface Method / 医药导报

ABSTRACT

Objective To optimize the formulation of controlled-onset extended-release tablets of nicorandilby central composite design-response surface method. Methods The tablets containing nicorandil were prepared bydry-compression coating technique.The influence factors included the amount of HPMC, the amount of EC, and the ratio of lactose/MCC in coating film. The evaluation parameter was Q4 h and Q5 h . The possibly optimal formulation was predicted by response surface method. Results The OD was simulated using second-order polynomial equation and the r2was 0.970 1.Optimal prescription was as followsHPMC 89.96 mg, EC 46.21 mg, Lactose/MCC 1.87.Bias between the observed and predicted values of the OD was within 0.43%. Conclusion The controlled-onset extended-release tablets of nicorandil can release drug quickly in vitro at the predetermined time.Central composite design-response surface method can be used to optimize the formulation and the model developed in this study was proved highly predictable.