FORMULATION AND EVALUATION OF ORAL FAST DISSOLVING FILMS OF MONTELUKAST SODIUM

Montelukast Sodium is a leukotriene receptor antagonist (LTRA) used for the treatment of asthma and to relieve symptoms of seasonal allergies. In present research work an attempt has been made to prepare mouth dissolving films of Montelukast Sodium were prepared using different polymers like PVA, HPMC by solvent casting method. The fast dissolving oral film evaluated for folding endurance, swelling index, surface pH, in-vitro disintegration time, drug content, drug polymer compatibility (IR Study), and in-vitro drug release. The physical appearance and folding endurance properties were found to be good and electron microscopy shows that films are clear, colorless with smooth surface without any scratches. The surface pH was found to be in the range of 6.35 to 6.75 which is close to salivary pH, which indicates that films may have less potential to irritate the oral mucosa, thereby they are comfortable. The drug content of all the films was in the range of 95.54 to 98.68 suggesting that drug was uniformly dispersed throughout all films. The In-vitro disintegration time of films prepared with HPMC was in the range of 21.00 to 66.67 sec. As the concentration of SSG increases the in-vitro disintegration time of the films decreases. The formulation FA3 and FA4 were found to be promising and showed a disintegration time of 21.00 and 24.33 sec respectively. The dissolution rate increased with increase in the concentration of SSG up to 8%. Hence it can be inferred that the fast dissolving oral film of Montelukast sodium may produce the rapid action thereby improving bioavailability and enhance the absorption by avoiding the first pass effect.