DEVELOPMENT AND EVALUATION OF MUCOADHESIVE BUCCAL FILMS OF LOSARTAN POTASSIUM

The present study concerned with the Development and Evaluation of mucoadhesive buccal films of Losartan potassium. Buccal films were prepared by solvent casting method using different ratios of HPMCK15M and CMC were added to PVA film forming polymer and PEG400 as a plasticizer. The optimized films were found to be transparent, flexible and soft and evaluated for Thickness, weight variation, surface pH, drug content, folding endurance, in vitro drug release with release kinetics , ex-vivo mucoadhesive time and bioadhesive strength by modifying pan balance method. The formulation F5 (containing HPMCK15M: CMC 2.4: 3.2) was selected as an optimized formulation. In vitro drug release studies showed sustained release upto12hours with F5 showing a maximum percentage drug release of 99.5% and more than 90 % release of Losartan potassium from all film formulations except F1, i.e., F2, F3, F4 and F5. The data were subjected to kinetic analysis which indicated all formulations follows Non-fickian (anomalous) diffusion except F2 formulation follows a fickian diffusion as the release mechanism. The best fit with the highest correlation R2 coefficients was shown by korsmeyer’s Peppa’s model closely followed by the zero order equation and then the Higuchi matrix model and then followed by first order equation. All the formulations follow Peppa's model whose drug release conforms to matrix model. It shows Ex Vivo Mucoadhesive Time up to 6.5 h .The results were compared statistically and found with satisfactory correlation. Thus in conclusion preparation protocol of Fs studied may be adopted for a successful development of a newer drug delivery system for treatment for hypertension.