Abstract

DESIGN AND EVALUATION OF DUAL RELEASE GLICLAZIDE AND SITAGLIPTIN PHOSPHATE INLAY TABLET

Rubina Reichal C.* and Gopal Rao M.

ABSTRACT

The objective of the present study is to design an inlay tablet of Sitagliptin Phosphate (core tablet) as immediate release and Gliclazide (cup portion) as sustained release, where in the dual modified release are selected for Type-II Diabetes Mellitus. The immediate release layer was prepared by direct compression method using different superdisintegrants and the sustained release layer was prepared by wet granulation method. The powder blend and the prepared tablets were evaluated for pre and post compression evaluation studies. The results found were within the pharmacopoeial limit. The in vitro dissolution study of the optimized formulation showed maximum percentage of release. The release kinetics studies revealed that the drug release of formulation 5 (FG5) followed Zero Order kinetics and showed high linearity (R2=0.989) and which the release mechanism followed by Fickian Diffusion. This study concluded that the inlayered tablets of Gliclazide and Sitagliptin Phosphate were the novel approach for the management of Type-II Diabetes Mellitus.

Keywords: Inlay tablet, Gliclazide, Sitagliptin Phosphate, Type-II Diabetes Mellitus.