Abstract
Diabetes mellitus (DM), especially type II, is one of the most common chronic diseases. Its firstline oral treatment is metformin, but in now a days some other drugs are also used for the treatment of typeII Diabetes mellitus. In present study wet granulation technique is used for preparing immediate release matrix tablet of DPP-4 inhibitor with the help of superdisintegrants. Formulation optimization was done in three steps. In first step, amount of pregelatinized starch was optimized by preparing four trial batches. Prepared blend of granules and the pre and the formulations were evaluated for pre and post compression parameters. Amount of pregelatinized starch was optimized to 24 mg. In the next step, amount of SLS was optimized in the same way to 1 %. Finally amount of superdisintegrant- croscarmellose was optimized by preparing four batches and evaluating them for pre and post compression parameters. In-vitro drug release study of prepared formulation compare with the marketed formulation. It was observed that drug release from batch I10 and I11 batches was comparable with 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 in formulation of immediate release matrix tablet of DPP-4 inhibitor i.e. vildagliptin. The drug improve the glycaemic control and inhibition of DPP-4 results in increased fasting and postprandial endogenous level of incretin hormones. After meal it will maintain the blood glucose level.
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