Development and Characterization of Empagliflozin Oro Dispersible Film by Solvent Casting Method

Master of Pharmacy

e objective of this study was to develop an oro dispersible film (ODF) of the antidiabetic drug Empagliflozin, using a solvent casting method and incorporating key excipients such as polymers, plasticizers, sweeteners, and a saliva-stimulating agent. As Empagliflozin is a BCS Class III drug, its solubility was enhanced by preparing an inclusion complex with β-Cyclodextrin via physical blending. The optimized formulation (F8) demonstrated excellent mouth feel, mechanical strength, and rapid disintegration (20 seconds), with 90.5% of the drug released within 3 minutes. These films were characterized for parameters such as thickness, weight uniformity, drug content, dissolution rate, and mechanical properties, with stability studies showing promising results for shelf-life stability. The development of Empagliflozin ODFs presents a significant advancement in diabetes management, of ering an ef ective, convenient, and patient-friendly dosage form that improves medication adherence and therapeutic outcomes.

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