NOVEL DRUG DELIVERY FOR SAXAGLIPTIN AND DAPAGLIFAZOLIN:A PARADIGM IN PHARMACEUTICAL RESEARCH

Abstract

The purpose of this study was to develop a gastro-retentive bilayer floating matrix tablet of saxagliptin HCL and dapagliflozin propanediol monohydrate. The tablet was successfully prepared using sodium starch glycolate for the immediate release layer and HPMC for the sustained release layer. All formulations of saxagliptin HCL and dapagliflozin propanediol monohydrate were prepared using wet granulation techniques. The main challenge was to design a bilayer floating matrix tablet with an initial loading dose, followed by a maintenance dose of up to 24 hours, while also prolonging the gastric residence time of the drug. The compatibility of saxagliptin HCL and dapagliflozin propanediol monohydrate and their physical mixture were confirmed using FTIR and DSC studies. The results from in vitro release studies showed that formulation SADBMF 1, containing 2% SSG and 30% HPMC, exhibited 99% release of saxagliptin HCL for 60 minutes and sustained release of dapagliflozin propanediol monohydrate for 24 hours. This formulation was considered optimized. It was observed that with increased concentrations of the polymers, the drug release profile was slower. The kinetics of in vitro drug release of the optimized formulation SADBMF1 were found to follow zero-order release kinetic models, and the drug release mechanism was identified as anomalous diffusion coupling with erosion.