Formulation Optimization and Evaluation of Push Pull Osmotic Pump Tablet of Vildagliptin

Abstract

Purpose- The present study was to develop an oral push-pull osmotic pump tablet of vildagliptin, DPP-IV inhibitor drug; which is BCS class I drug. Method- The tablets were prepared by the wet granulation method using polyox and osmotic agent NaCl. The granules were compressed into bilayered tablet by conventional compression machine. The bilayered core osmotic tablets were coated with cellulose acetate in a conventional pan coating. In-vitro dissolution was evaluated using USP dissolution apparatus II in 0.1 N HCl pH 1.2 buffers for 2 hrs and phosphate buffer pH 7.5 for 22 hrs respectively. The formulated optimized batch VP1 were kept to stability studies for 3 months. Result- The formulated optimized batch VP1 of PPOP tablet shows 2hrs lag time with zero order release kinetic. In –vitro drug release was obtained 91.45 % up to 22hrs respectively. Polyox in push-pull layer along with osmotic agent and cellulose acetate controlled the drug release pattern from formulated PPOP tablet. No significant changes were observed upto the period of 3 months of storage during stability study. Conclusion- The PPOP tablet of vildagliptin was able to deliver the drug in controlled pattern over a long period of time by the process of osmosis. Conventional compression and pan coating method can be used to prepare PPOP tablet successfully.