Abstract

DEVELOPMENT OF FAST DISSOLVING SUBLINGUAL WAFERS OF SITAGLIPTIN BY FILM FORMER

Sachin Dangi*, Ravi Kumar, Dr. R. B. Goswami and Priyanka Chaturvedi

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Abstract

Sitagliptin, A DPP-4 inhibitor, is commonly used in the treatment of diabetes mellitus. But, due to its late onset and adverse effect on kidney, its hyperglycemic activity is drastically changed. Hence, the present investigation was concluded with an attempt to design fast dissolving oral films of Sitagliptin phosphate using various polymers and plasticizers. The present research aimed to formulate fast dissolving oral films using various polymers and plasticizers using the solvent casting method. Preformulation studies were conducted to check the compatibility between the drug and the excipients. Nine batches were prepared and were put through various evaluations parameters like % elongation, thickness, weight variation, in-vitro drug dissolution, strength, drug content, assay, and SEM analysis. Based on the results, F3 was found to be an optimized batch. A comparative in-vitro drug dissolution study was conducted between the marketed product and the film. Stability studies of optimized batch F3 were conducted and found to have no physicochemical changes and no significant changes in the drug release study. The study concluded that oral fast dissolving film of sitagliptin phosphate improved the onset time of the drug and reduces the adverse effects compared to the traditional oral dosage form and can facilitate the reduction in symptoms of hyperglycemia.

Keywords: Fast-dissolving film, Diabetes mellitus, Sitagliptin, plasticizers, in-vitro drug dissolution study, & Tensile strength.