包衣处方对盐酸文拉法辛微孔渗透泵型控释片体外释药的影响

Effects of coating on the in vitro release character of venlafaxine hydrochloride microporous membrane osmotic pump tablets

目的考察包衣处方对盐酸文拉法辛口服微孔渗透泵控释片体外释药的影响,并优选最佳包衣处方。方法考察聚乙二醇400(PEG400)的用量、包衣增量、邻苯二甲酸二丁酯(DBP)的种类和用量4个因素对释放的影响,并通过正交设计优化包衣处方。结果盐酸文拉法辛微孔渗透泵控释片的体外释药符合零级释放规律,释药速率受致孔剂、增塑剂、衣膜厚度的影响均较大。结论通过对包衣处方的优化,盐酸文拉法辛口服微孔渗透泵控释片能够恒速释药。

Objective To investigate the effects of coating on venlafaxine hydrochloride microporous mem- brane osmotic pump tablets in vitro release and optimize the formulation of coating membrane. Methods The factors influencing the drug release were selected by the single factor investigation （such as PEG content, DBP varieties, DBP content and membrane weight）. And the optimal formulation of microporous membrane was selected by the orthogonal design. Results Venlafaxine hydrochloride microporous membrane osmotic pump tablets with optimized coating membrane formulation could achieve the desired zero-order release profile in 12 hours, the channeling agent, plasticizer and coating thickness were all found to have great effects on the in vitro release of drug. Conclusions The constant release of venlafaxine hydrochloride oral MPOP tablets can be achieved through adjusting the coating formulation.