Abstract

TO FORMULATION DEVELOPMENT AND EVALUATION OF DAPAGLIFLOZIN EXTENDED RELEASE TABLET

*Omkar Shivaji Palve, Babasaheb L. Chopade and Dr. Megha T. Salve

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Abstract

Dapagliflozin is the first novel sodium- glucoseco-transporter- 2(SGLT2) asset approved by the European Medicines Agency(EMA) for the treatment of type 2 diabetes. By inhibiting SGLT2, dapagliflozin blocks reabsorption of filtered glucose in the order, adding urinary glucose excretion and reducing blood glucose situations. Its medium of action is independent of pancreatic β cell function and modulation of insulin perceptivity. The results of phase III clinical trials showed that dapagliflozin, at a cure of 5 or 10mg/ day for 24 weeks as monotherapy in preliminarily undressed cases, or as addon combination remedy with metformin, glimepiride, pioglitazone or insulin- grounded remedy, significantly reduced both HbA1c and fasting tube glucose situations compared with placebo. In addition, dapagliflozin was noninferior to glipizide, in terms of glycemic control after 52 weeks, when used as add- on remedy in cases with type 2 diabetes deficiently controlled with metformin. In utmost clinical trials, dapagliflozin reduced body weight. The combination of both goods(bettered glycemic control and weight loss) is achieved to a lesser extent in treatments that include dapaglifozin. Longer- term extension studies indicated that the efficacity of dapagliflozin on the glycemic control and weight reduction is maintained for over to 2 and 4 times. Dapagliflozin was well permitted. Genital infections and urinary tract infections were more frequent in cases who entered dapagliflozin than in placebo donors. Hypoglycemic occurrences were scarce with dapagliflozin. In conclusion, dapagliflozin is a new option for the operation of type 2 diabetes, particularly when used as add- on remedy. The present study aims to develop and estimate an extendedrelease (ER) tablet expression of Dapagliflozin, a sodium- glucoseco-transporter 2(SGLT2) asset, to maintain a sustained remedial effect and enhance patient compliance in diabetes operation. The study focuses on the selection of applicable polymers, excipients, and eval uation parameters to insure optimal medicine release, stability, and bioavailability.

Keywords: Dapagliflozin, Antidiabetic drug, Binder Gelatin, Sodium Glucose co transporter inhibitors, extended release tablet.