FORMULATION AND EVALUTION OF SUSTAINED RELEASE BILAYER TABLET OF GLICAZIDE, PIOGLITAZONE HCL, AND SITAGLIPTIN PHOSPHATE

Diabetes Mellitus 2 is a progressive metabolic disease that has Insulin Resistance and impaired insulin secretion. T2DM usually produces prolonged high blood glucose levels (hyperglycaemia), which makes medication to treat T2DM require combining different types of medication over time. The research described in this paper evaluates the performance of a sustained delivery system for three separate medications to treat T2DM that are combined into a bilayer tablet. One layer (IR) treats fast-rising blood sugars following a meal (postprandial), while the other layer (SR) is designed to maintain multiple therapeutic levels of sitagliptin phosphate and pioglitazone hydrochloride for an extended period of time.[3,4] The comprehensive Preformulation studies that were conducted included the following: Physicochemical characterization of the drug, solubility studies; determination of the melting point; UV spectrophotometric analysis and compatibility studies of the drug and excipients using FTIR spectroscopy. The IR layer was prepared using super disintegrants incorporated into the powder using direct compression, and the SR layer was prepared by wet granulation with hydrophilic polymers such as HPMC K4M and HPMC K100M. Bilayer tablets were evaluated for pre-compression flow properties and post-compression parameters. Additionally, all bilayer tablets were evaluated for consistency of drug content and in vitro dissolution profiles. According to the study, a bilayer tablet can show mechanical strength that is within acceptable ranges, an immediate release (IR) layer that rapidly disintegrates, and a sustained release (SR) layer that provides drug release over a 24-hour period. The kinetics of drug release was determined to be diffusion controlled. The results of this study indicate that this bilayer tablet will be an effective fixed-dose combination therapy for treating Type 2 Diabetes Mellitus (T2DM) by increasing both the therapeutic efficacy and patient adherence.