Abstract

FORMULATION AND EVALUATION OF IMMEDIATE RELEASE TABLETS OF MONTELUKAST SODIUM

R. Swetha Reddy, P. Naga Haritha*, E. Hima Bindu

Abstract

drug delivery has been known for decades as the most widely used route of administration among all the routes that have been explored for the systemic delivery of drugs via various pharmaceutical products of different dosage forms. Montelukast is a leukotriene receptor antagonist used for the maintenance treatment of asthma, chronic asthmatic attacks and to relieve symptoms of seasonal allergies. Its biological half life is 2.5 – 5.5 hrs thereby decreasing bioavailability up to 64%. In order to improve bioavailability, immediate release tablets were developed. In the present work the immediate release tablets of Montelukast sodium were prepared by direct compression method. Crosspovidone (5, 7.5, 10 w/w), crosscarmellose sodium (5, 7.5, 10 w/w) and sodium starch glycolate (5, 7.5, 10 w/w) were used as super disintegrants in different Concentrations. The blend of all formulations were evaluated for various precompression parameters like angle of repose, bulk density, tapped density, compressibility index and Hausner‟s ratio and were found to be satisfactory. The drug excipients compatibility studies were performed using FTIR technique. The tablets were evaluated for various parameters like weight variation, thickness, hardness and friability. All the results were within acceptable IP limits. Among all the formulations sodium starch glycolate (7.5%) was found to disintegrate within 20 sec. The in vitro performance of optimised formulation F8 showed 98.75% 0f the drug release within first 60 min.

Keywords: Montelukast sodium, sodium starch glycolate, superdisintegrants, direct compression, immediate release.