Formulation and Evaluation of Fast Dissolving tablets of Montelukast sodium using Co-Processed Superdisintegrants

Montelukast Sodium is a leukotriene receptor antagonist (LTRA) used for the treatment of asthma and to relieve symptoms of seasonal allergies. In the present work, fast dissolving tablets of Montelukast Sodium were prepared using novel coprocessed superdisintegrants consisting of crospovidone along with croscarmellose sodium, and crospovidone along with sodium starch glycolate in the different ratios (1:1, 1:2 and 1:3). Effect of co-processed superdisintegrants on wetting time, disintegrating time, drug content, and in-vitro release have been studied. The prepared tablets were characterized by DSC and FTIR Studies. No chemical interaction between drug and excipients was confirmed by DSC and FTIR studies. Stability studies were carried out as per ICH guidelines for three months. The values of pre-compression parameters evaluated were within prescribed limits and indicated good free flowing property. The prepared tablets formulations were evaluated for post-compressional parameters. All the postcompressional parameter are evaluated were prescribed limits and results were within IP acceptable limits. The in-vitro disintegration time of fast dissolving tablets were found to be 12.06 to 39.14 sec. which is in the range of fulfilling the official requirements. By the addition of superdisintegrants the disintegration time increased significantly (P<0.05). The tablets shows the t50% and t90%between 0.94 min to 1.82 min and 3.61 min to 5.83 min respectively. Among all formulations CP3 showed 99.79% drug release within 4 min. Montelukast sodium tablets containing co-processed superdisintegrants exhibit quick disintegration and improved drug dissolution. It can be concluded from the present work that co-processed superdisintegrants of crosscarmellose sodium+ crospovidone are superior to crospovidone + sodium starch glycolate co-processed superdisintegrants used in Montelukast Sodium fast dissolving tablets.

Author(s): B. Shravani N. G, Raghavendra Rao

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