FORMULATION AND EVALUATION OF SUSTAINED RELEASE MATRIX TABLETS OF MONTELUKAST SODIUM

Mohd Abdul Hadi, V. Lokeswara Babu, Narottam Pal, and A. Srinivasa Rao

The objective of this study was to develop sustained release tablets of Montelukast sodium by direct compression method using various polymers. The drug excipient mixtures were subjected to pre-formulation studies. The tablets were subjected to physicochemical studies, in- vitro drug release, kinetic studies and stability studies. FTIR and DSC studies shown there was no interaction between drug and polymers. The physicochemical properties of tablets were found within the limits. Montelukast sodium is a leukotriene receptor antagonist used for the maintenance treatment of asthma. The drug release from formulations was extended for a period of 12 hrs. The kinetic treatment showed that the release of drug follows first order models. The optimized formulations were subjected to stability studies and shown there were no significant changes in drug content, physicochemical parameters and release pattern. Results of the present study indicated the suitability of the above mentioned polymers in the preparation of sustained release formulation of Montelukast sodium.