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Abstract

Montelukast sodium is a potent, selective and orally acting leukotriene receptor antagonist that acts by inhibiting physiological actions of the cysteinyl leukotrienes(LTC4,LTD4and LTE4) . It is used in the prophylaxis and treatment of asthma. As precision of dosing and patient’s compliance become important prerequisite for asthma management, there is a need to develop formulations for this drug which overcomes problems such as difficulty in swallowing, inconvenience in administration while travelling and patient’s acceptability. Hence in the present study an attempt has been made to prepare fast disintegrating tablets of Montelukast sodium in the oral cavity with enhanced dissolution rate. The tablets were prepared with three superdisintegrants i.e polyplasdone XL10,Ac-Di-Sol and Primojel. The pure drug and formulation blend was examined for angle of repose, bulk density, tapped density, Compressibility index and Haussner’s ratio. The tablets were evaluated for hardness, tensile strength, drug content, friability and were found satisfactory. The disintegration time in the oral cavity was also tested and was found to be around 9sec. Based on dissolution rate the disintegrants can be rated as Polyplasdone XL10 > Ac-di-sol > Primojel. Hence polyplasdone XL10 was recommended as suitable disintegrant for the preparation of direct compression melt-in-mouth tablets of Montelukast sodium. All the dissolution parameters were calculated and compared with market tablet. An increase in the dissolution rate was observed with M8 formulation when compared to market one. It was concluded that the rapidly disintegrating tablets with proper hardness, rapid disintegration in the oral cavity with enhanced dissolution rate can be made using super disintegrants.

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	JPR Solutions

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