DESIGNING, OPTIMIZATION, FABRICATION AND EVALUATION MOUTH DISSOLVING FILM OF MONTELUKAST SODIUM

Abstract

Montelukast sodium is a selective, high affinity, competitive leukotriene receptor antagonist specifically the cysteinyl leukotriene (cyst-LT1) receptor. It suppresses both early and late bronchoconstrictor responses to inhaled antigens or irritants and is used in prevention and long-term symptomatic management of asthma. The objective of present research work is to formulate and evaluate mouth dissolving film of currently used therapeutic molecule (Montelukast sodium) for faster disintegration, faster drug availability and improved convenience to patients. The selected formulations (MF2 and MF4) were compared with a mouth dissolving film formulation available in market (MMDF) containing different drug, as the drug under present study (Montelukast sodium) is available as tablet dosage form only. The comparison was done for various evaluation parameters. When the appearance of optimized film MF2 and MF4 was compared with marketed MDF, it was observed that all three films were homogenous. Film MF2 was white in color; MF2 was colorless while marketed film was light orange in color. Films MF2 and MF4 were slightly opaque while marketed film was opaque. Films MF2 and MF4 were smooth from one side, but rough on the other side, while marketed film was smooth on both sides. It was observed from the results of comparison of selected formulations (MF2 and MF4) and marketed film, that the films prepared and optimized under the present study exhibited results that were comparable to that of a similar dosage form (marketed mouth dissolving film) with respect to various evaluation parameters.

 

Key words: mouth dissolving film, Montelukast sodium, Oral administration