Development and Evaluation of Mouth Dissolving Tablets of Montelukast Sodium Using Co-processed Excipients

Background: The concept of formulating ODT containing montelukast sodium offers an appropriate, practical approach to accomplish fast release of the drug. Absorption of these tablets takes place directly into the systemic circulation which bipass the hepatic first-pass metabolism of montelukast sodium which ultimately results in the improvement in the bioavailability. Method: In the present study ODT tablets of montelukast sodium were prepared by using different Superdisintegrants like natural and synthetic (tulasi, hibiscus, orange peel powder, Ispaghula, banana peel powder, Crospovidone). Thirteen formulations were designed, using a two level of Superdisintegrants (minimum and maximum concentration) and employing two Superdisintegrants at a time by using the co-processed technique. Results: No significant drug and excipients interaction was observed. The prepared tablets were evaluated by weight variation, thickness, hardness, friability, drug content uniformity, disintegration time, wetting time, in-vitro dissolution studies. A formulation containing 6 mg of natural and synthetic Superdisintegrants was offered the relatively rapid release of montelukast sodium when compared with other concentrations employed in this investigation. Conclusion: Montelukast sodium formulation were prepared by Crospovidone and ispaghula combination of Superdisintegrants were releases 98.91% drug in 30 min.