Formulation Development and Evaluation of Sustained Release Tablets of Anti Diabetic Drug

Abstract

Aim: The present research work was to design and develop the sustained release matrix tablets of vildagliptin. It is having a short biological half-life (1.5 h) so it is considered as a suitable drug for the formulation of sustained release tablets to prolong its therapeutic action. Vildagliptin is an oral antihyperglycemic agent of the new dipeptidyl peptidase-4 inhibitor class of drug.

Materials and Methods: Matrix tablets were prepared by wet granulation technique, using synthetic and natural polymers at different ratios. Granules were prepared and evaluated for bulk density, tapped density, Hausner’s ratio, compressibility index.

Statistical Analysis Used: The Fourier-transform infrared spectra of the vildagliptin and different polymers alone and in a combination show the compatibility of the drug with excipients.

Results: The physicochemical properties of tablets were found within the limits. The prepared tablets were evaluated for weight variation, thickness, hardness, % friability, % drug contents, and in vitro release. In vitro dissolution studies (USP dissolution rate test apparatus II, 50 rpm, 37°C ± 0.5°C) was carried out for the first 2 h in 0.1 N HCl (1.2 pH) and followed 6.8 phosphate buffer for 10 h as a dissolution medium.

Conclusion: The optimized formulation F-8 was shown maximum drug release 97.56 ± 0.72% in 12 h of dissolution. The release kinetic data of formulation F-8 shown zero order (R2 = 9902).

Keywords: Dipeptidyl peptidase-4 inhibitor, kinetics, SR Matrix, vildagliptin, wet granulation.