PREPARATION AND EVALUATION OF MONTELUKAST ORAL DISPERSIBLE TABLETS BY DIRECT COMPRESSION METHOD

The purpose of this research was to develop oral dispersible tablets of montelukast sodium. Montelukast sodium is most commonly used in treatment of Asthma. Oral dispersible tablets were prepared by using a direct compression method employing superdisintegrants such as low substituted hydroxyl propyl cellulose, crospovidone, croscarmellose sodium, and sodium starch glycolate. Tablets were evaluated for weight variation, thickness, hardness, friability, drug content, in vitro disintegration time, and drug release. Other parameters such as wetting time and drug-excipient compatibility were also evaluated. The tablets' hardness was maintained in the range of 3-4 kg and friability was <1% for all formulations. All tablet formulations disintegrated rapidly in vitro within 10 to 30sec. Release of drug was faster from formulations containing 7.5% crospovidone (MF11) compared to the marketed tablets. Kinetic studies indicated that all the formulations followed first order release with diffusion mechanism. Finally, it can be reasonably expected that the obtained drug dissolution rate improvement will result in an increase of its bioavailability, with the possibility of reducing drug dosage and side effects.