Design, Development and Characterization of Immediate Release Matrix Tablet of Vildagliptin

Abstract

In the present study, an immediate-release tablet of vildagliptin is prepared by wet granulation using superdisintegrants. Optimization of the formulation was done in three steps. In the first step, the amount of pregelatinized starch was optimized by preparing four trial batches. A prepared blend of granules and formulations pre and post-compression parameters were evaluated. The amount of pregelatinized starch was optimized to 24 mg. In the next step, the amount of Sjogren-Larsson syndrome (SLS) was optimized in the same way to 1%. Finally, the amount of superdisintegrant-croscarmellose was optimized by preparing four batches and evaluating them for pre and post-compression parameters. The formulation was evaluated for drug release study in comparison with the marketed formulation. It was observed that drug release from batch I10 and I11 batches was comparable with the marketed product. Tablet formulation I11 showed higher disintegration time as compared to I10. Formulation I10 was selected as optimum formulation and evaluated for stability. Croscarmellose sodium was found effective superdisintegrant to formulate immediate release matrix tablets.