Optimization of Preparation Technology and Formulation of Ginkgolides Osmotic Pump Controlled Release Tablets by Central Composite Design and Response Surface Method

OBJECTIVE:OBJECTIVE:To optimize the preparation technology and formulation of Ginkgolides osmotic pump controlled release tablets. METHODS:The extraction technology was optimized by single factor test with the contents of ginkgolide A(GA)and ginkgolide B(GB)as index,using amount of polyoxyethylene(PEO)in drug layer,mount of PEG4000,type of penetrating agent,the amount of PEO and penetrating agent in push-layer,coating formulation,coating weight as factors. The extraction technology was optimized by response surface method with accumulative rate of GA and GB within 14 h and correlation coefficient of release curves as index using the amount of PEO in drug layer and PEG 4000 in coating solution,weight gain of coating film as factors. RESULTS:The optimized formulation was as follows:PEO 211.2 mg,PEG4000 5.9 g and weight gain of coating film8.9%. The release rate of GA and GB were synchronous;the cumulative release of the optimal osmotic pump tablet was 90% within 14 h. There was no significant difference between measured value and the predicted one. CONCLUSIONS:The technology is reasonable and feasible,and can be used for the preparation of Ginkgolides osmotic pump controlled release tablets.