DESIGN AND CHARACTERIZATION OF INLAY TABLET FOR TYPE 2 DIABETES MELLITUS (T2DM) - A NOVEL APPROACH IN DRUG DELIVERY

Subashini Rajaram*, Ramamani A. R. and Stephen P.

ABSTRACT

Any drug delivery system that enhances the therapeutic effectiveness of incorporated drugs by providing sustained, controlled delivery and / or targeting the drug to desired site is always invitable. Among various route of administration oral route is the most compact, painless, safest and least expensive, it is the one most often used. The present study aimed to develop a novel type of layered tablet consists of sitagliptin phosphate as immediate release layer and metformin hydrochloride as sustained release layer for T2DM. Immediate release layer was prepared by direct compression method using superdisintegrants such as sodium starch glycolate, crospovidone and croscarmellose sodium and sustained release layer of metformin hydrochloride was prepared by wet granulation process with HPMCK100M Premium as polymer. The blend and tablets were characterized for pre and post compression evaluations. The results found to be within standard limit. The immediate release layer consists of croscarmellose sodium produces better disintegration this may due to higher interaction of superdisintegrants with water. In- vitro percentage drug release results shown that higher concentration of hydrophilic polymer sustained the release of drug due to increase in viscosity of polymer. The in-vitro release kinetics profiles of drug from sustained release layer expressed by Higuchi’s equation as the plots showed high linearity (R2>0.991) and it indicates the release of drug from the tablet through diffusion dominated mechanism. In conclusion, a novel inlay tablet contains anti diabetic drugs resulted better release profile to control Type 2 DM (Diabetes Mellitus).

Keywords: Inlay tablet, Diabetes Mellitus, Sitagliptin phosphate, Metformin hydrochloride HPMCK100M Premium.