Formulation and Optimization of Immediate Release Tablet of Sitagliptin Phosphate using Response Surface Methodology

Abstract: The objective of this study was to design and evaluate Sitagliptin Phosphate immediate release (IR) 50 mg tablet using Response Surface Methodology for the managemant of Type-II diabetes mellitus. Response surface methodology (RSM) computations for this optimization study were performed employing Minitab 16. Different formulations of immediate release were prepared by applying 2 factor 2 level Central Composite Design (CCD) using Minitab 16 which gave 13 formulation for each layer. The amount of Sodium Starch Glycollate (SSG) and Croscarmellose Sodium (CCS) in IR layer were used as independent variables and the percent drug release at 15 minutes were selected as dependent (response) variables for optimization. All the formulation were prepared and evaluated using appropriate analytical technology. Based on the in-vitro dissolution data (dependent variable/response), the composition of formulation with optimum drug release for immediate release were identified and employed to formulate optimized tablets followed by its evaluation. All the physico-chemical parameters of the tablets were found satisfactory.The optimized Sitagliptin Phosphate IR tablet disintegrated in 14 sec and showed an initial release of Sitagliptin 99.072% within 15 minutes.

Keywords: Response Surface Methodology, immediate release, Sitagliptin Phosphate, Type-II diabetes mellitus, Superdisintegrants, excipient