Formulation and Evaluation of Fast-Dissolving Oral Films of Empagliflozin

The objective of the present study was to develop the oral fast-dissolving film of empagliflozin by using solvent Solvent-casting method. Empagliflozin is a Class III drug used for the management of type 2 diabetes mellitus. Fast-dissolving oral films of empagliflozin were prepared with different excipients and were evaluated with various evaluation parameters. FTIR analysis showed that there was no chemical reaction between the drug and the excipients. HPMC is used as a polymer, PEG acts as a plasticizer and solubility enhancer, sodium starch glycolate acts as a super disintegrant, and DMSO is mainly used as a permeability enhancer. Evaluation of oral films includes such as Weight variation, Thickness, Folding endurance, % Elongation, Tensile strength, Drug content, Assay, Disintegration time, and invitro Diffusion studies were done. The results showed the most promising results. In this formulation 4 showed good disintegration at 20 minutes and 99% drug release within 30 minutes. The stability study results showed the prepared films were stable during the stability study.