Formulation, Optimization And Evaluation Of In-Situ Gelling Liquid Oral Formulation Of A Novel Antidiabetic Drug: Dapagliflozin

The 'In situ gel' system has emerged as one of the best Novel Drug Delivery Systems for sustained and controlled drug delivery due to its special characteristic feature of 'Sol to Gel' transition. Generally, Dapagliflozin is used as a Sodium-glucose co-transporter-2 (SGLT2) inhibitor which belongs to Class III of the Biopharmaceutics Classification System (BCS), i.e., High solubility and Low permeability. The half-life of the drug is found to be less than 13 hours, so in order to prevent repetitive administration of the drug and to improve patient compliance (particularly for bedridden patients), the present study focuses on the formulation and evaluation of sustained-release oral 'In situ gel'. Sodium alginate is used as a gelling polymer and calcium carbonate is used as a cross-linking agent. Other polymers such as pectin used to enhance the gelling capacity and also act as drug release retarding polymers. Methyl paraben is used as a preservative. Calcium carbonate contributes to the floating capability. A total of nine formulations are prepared by varying different concentrations of sodium alginate, pectin. These formulations are further evaluated for viscosity, gelling time, floating time, assay, and in vitro release studies in order to select the best-optimized formulation.