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Abstract

FORMULATION AND EVALUATION OF ORAL DISINTEGRATING TABLETS OF MONTELUKAST SODIUM: EFFECT OF FUNCTIONALITY OF SUPERDISINTEGRANTS

B. Shravani, N. G. Raghavendra Rao*, Gandra Pragna, M. Srikanth Reddy

Department of Pharmaceutics, Jyothishmathi Institute of Pharmaceutical science, Thimmapur, Karimnagar- 505481, AP. India.

ABSTRACT

Montelukast Sodium is a leukotriene receptor antagonist (LTRA) used for the treatment of asthma and to relieve symptoms of seasonal allergies. Montelukast blocks the action of leukotriene on the cysteinyl leukotriene receptor in the lungs and bronchial tubes by binding to it. In present research work an attempt has been made to prepare fast dissolving tablets of Montelukast sodium were prepared by using direct compression method using superdisintegrants. IR spectral analysis study showed that there was no drug interaction with formulation additives of the tablet. The blend was examined for the pre-compressional parameters results were within prescribed limits and indicated good free flowing property. The prepared tablets formulations were evaluated for post-compressional parameters. All the post-compressional parameter are evaluated were prescribed limits and results were within IP acceptable limits. The in-vitro disintegration time of Montelukast sodium fast dissolving tablets were found to be in the range of 11 to 61 sec fulfilling the official requirements. The in-vitro disintegration time of Montelukast sodium prepared by direct compression method DC7 formulation containing CP 6 % shows around 11.52 sec. The tablets prepared by direct compression method the t50% and t90%(time for 50% and 90% of release) values decreased with increase in the level of CP. In all the prepared formulation 50 % and 90 % of drug release ranges between within ranges 0.95 min to 2.91 min and 3.60 min to 8.92 min respectively. Among all formulations DC7 showed 99.85% drug release within 4 min. The stability study conducted as per the ICH guidelines and the formulations were found to be stable. 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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