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Pimple R. G., Kolhe M. D.* and Sakhare V. G.


The aim of the present research work, to select the best possible diluent - disintegrant combination to formulate mouth dissolving tablets of montelukast sodium, which disintegrates in matter of seconds in the oral cavity, thereby reducing the time of onset of pharmacological action. Lycoat, ludiflash, sodium starch glycolate and Mannitol, were used as disintigrant. In all the formulations, Magnesium stearate and talc were used as lubricant and glidant respectively. The results of the drug – excipient compatibility studies revealed that there was no chemical interaction between the pure drug and excipients. Direct compression method was employed to formulate the tablets, because of its cost effectiveness and due to reduced number of manufacturing steps. The precompression parameters like bulk density, tapped density, Carr‟s „index and angle of repose were determined. All the formulations showed acceptable flow properties. The post compression parameters like the hardness, thickness, friability and weight variation, disintegration time, disintegration time in oral cavity and In-vitro release were carried out and the values were found to be within IP limits. The percentage drug content of all the tablets was found to be between 96.24 % and 99.46 % of Montelukast sodium, which was within the acceptable limits. Among all the formulations F6 shows 99.82% drug release. F6 contains ludiflash (15mg), it shows better % drug release compared to other formulations.

Keywords: montelukast sodium, ludiflash, Lycoat, Direct compression, sodium starch glycolate.

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