DEVELOPMENT OF MUCOADHESIVE FILMS FOR BUCCAL ADMINISTRATION OF MONTELUKAST

The Montelukast is a leukotrine receptor antagonist (LTRA) used for the maintenance treatment of asthma, chronic asthma attacks and to relieve symptoms of seasonal allergies. Montelukast biological half life is 2.5 to 5.5 hrs there by decreasing bioavailability upto 64%. So, in order to improve the bioavailability and efficacy, we have prepared buccal films of montelukast. In the present research work, buccal films were prepared using mucoadhesive polymers like HPMC (K4M), HPMC (50cps), HPMC (5 cps), Eudragit RL-100 and PVP K-30 by Solvent Casting technique. Buccal films were characterized for number of parameters like physical appearance and surface texture, weight uniformity, thickness, folding endurance, swelling index, surface pH, drug content uniformity, in vitro residence time, bursting strength, drug–excipients interaction study, and in vitro drug release study. All the prepared films were smooth surface and elegant texture. All the prepared films are weighing in between 26.33 to 37.66 mg. The thickness of the films was in the range of 0.246 to 0.373 mm. Folding endurance was in the range of 259 to 289. Swelling index in the range of 29.81 to 43.48 %. Surface pH was in the range of 6.00 to 6.83 pH. Drug content uniformity study showed uniform dispersion of the drug throughout the formulation in the range of 94.33 to 98.33 %. The in vitro residence time for all the films is in between 3.13 to 5.50 hrs. The bursting strength of films is in the range of 6.533 to 4.366 Kg/cm2. FT-IR studies revealed that,there was no incompatibility of the drug with the excipients used. In vitro drug release studies in the range of 67.35 to 93.62 at the end of 8th hrs.