非诺贝特双层渗透泵制剂的处方优化

Formulation optimization of fenofibrate bi-layer osmotic pump tablets

目的优化非诺贝特双层渗透泵的处方,制备日服一次的非诺贝特双层渗透泵。方法采用星点设计-效应面法,以累计释放量、释放曲线的线性和综合指标OD值作为考察指标,以含药层氯化钠与聚氧乙烯的比例、包衣增重、包衣膜中聚乙二醇4000用量作为考察因素,对非诺贝特双层渗透泵片处方进行优化。结果自制样品的药物释放曲线结果与理论释药曲线基本一致。结论星点设计-效应面法优化非诺贝特双层渗透泵处方具有很好的预测性与实用性。

Objective To prepare once daily fenofibrate controlled-release tablets and optimize the formulation with central composite design-response surface methodology. Method Using accumulative drug release and linearity of the release curve as dependent variables,ratio of sodium chloride and polyoxyethylene in drug layer,weight gain in coating and amount of macrogol in coating solution as independent variables,central composite design-response surface methodology was applied to optimize fenofibrate double-layer osmotic pump tablets formulation. Result The dissolution profiles of the self-made osmotic pump tablets were similar to the target profile. Conclusion Central composite design-response surface methodology can be used to optimize the formulation of fenofibrate bi-layer osmotic pump tablets and the models are proved to be predictable and feasible.