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In the present work fast dissolving tablets of Montelukast sodium were prepared using novel co-processed superdisintegrants consisting of crospovidone and sodium starch glycolate in the different ratios (1:1, 1:2 & 1:3) in vice versa. Montelukast sodium is a drug of choice in treatment of asthma and allergic rhinitis. Drug compatibility with excipients was checked by FTIR studies. After examining the flow properties of the powder blends the results were found to be within prescribed limits and indicated good flowing property and it was subjected to tablet compression. All the formulations were subjected to post compression parameters like hardness and friability (≤1%), indicated that tablets had a good mechanical strength and resistance. Drug content was found to be in the range of 93.51 to 98.79 %. The wetting time is an important criteria for understanding the capacity of disintegrants to swell in presence of little amount of water were found to be in the range of 20 to 55 sec. Among all the designed formulations, formulation F9 was found to be promising and showed an in-vitro disintegration time of 25 sec, which facilitates faster disintegration in the mouth. When compared to marketed product, the formulation F9 containing co-processed superdisintegrant (1:3 mixture of sodium starch glycolate and crospovidone) emerged as the overall best formulation based on drug release characteristics with 0.5% SLS in distilled water as dissolution medium. Short-term stability studies on promising formulation F9 indicated that there were no significant changes in hardness, drug content and in-vitro drug release. From this study, it can be concluded that dissolution rate of Montelukast sodium FDTs could be enhanced by tablets containing co-processed superdisintegrant.
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Author(s): Errolla Mahesh GB Kiran Kumar Mohammed G Ahmed Kiran kumar P
Co-processed superdisintegrants, Montelukast sodium, crospovidone, sodium starch glycolate and direct compression