ABSTRACT:
The main objective of the present study was to formulate and evaluate Irbesartan based mouth dissolving film in order to achieve rapid drug release for the geriatric and dysphagic patients to increase patient compliance. The solvent casting method was used to prepare mouth dissolving films by employing HPMC E5, HPMC E15, Pullulan, HPMC K15M as the film forming polymer, PEG 400 as plasticizer, Polysorbate 80 as surfactant, citric acid to stimulate saliva flow and peppermint flavour to enhance the taste. By performing the preformulation studies, the identity and purity of Irbesartan was confirmed, which was obtained at the λmax of 246 nm with a linear calibration curve (R² = 0.9921). The drug–excipient interactions have been confirmed through FTIR studies, on the basis that it was found nil and is established as a good compatibility among the drug and formulation ingredients. The prepared films were studied with regard to their thickness, surface pH, moisture content, moisture uptake, uniformity of drug content, folding endurance, disintegration time, and in vitro drug release. Both the physicochemical and mechanical properties were found to be satisfactory for all the formulations, with thickness between 0.07 ± 0.01 to 0.18 ± 0.01 mm, an initial surface pH between 6.6 to 6.9 and a drug content between 98.1 ± 1.2% to 99.6 ± 1.1%, and also the time taken for disintegration was in the range of 20 ± 2 to 55 ± 6 seconds. Irbesartan release from all the formulations was found to be fast and cumulative percent of drug released in 600s was in the range of 91.5-99.6% in the in vitro drug release. Formulation F4 performed best in all tests, with drug release ranging from 99.6%, disintegration time 20 ± 2 seconds, a good drug content uniformity and the best mechanical characteristics of all the formulations. The results showed that the optimized Irbesartan patient friendly mouth dissolving film prepared by solvent casting method has enormous potential to be used as an immediate release patient friendly formulation with fast release of the drug, ease of use, and high therapeutic compliance.