Abstract

FORMULATION AND EVALUATION OF SUGAR FREE CHEWABLE TABLETS OF MONTELUKAST SODIUM

Shaik Rizwana*, J. Bharathi and Dr. K. Umasankar

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Abstract

The present study was undertaken to formulate sugar free Montelukast sodium chewable tablets by direct compression method using various disintegrants and superdisintegrants. The substance used as disintegrants and superdisintegrants are maize starch, pregelatinized starch, sodium starch glycolate, croscarmellose sodium and crospovidone.nA total of five formulations (F-I to F-V) of sugar free Montelukast sodium chewable tablets were prepared by direct compression method. All the formulations were evaluated for both pre compression and post compression parameters as per the requirements of standards. Preformulation study of API such as organoleptic properties, solubility, compatibility study and FT- IR drug - excipients interaction study were carried out. The prepared blends were also evaluated for precompression parameters such as angle of repose, bulk density, tapped density, compressibility index and hausner’s ratio. The prepared tablets were evaluated for post compression parameters such as thickness, hardness, weight variation, friability, disintegration, wetting time, water absorption ratio, taste evaluation, assay and in vitro drug release study. Comparative dissolution study of optimized formulation (F-V) and marketed product was carried out and the drug release of optimized formulation (F-V) was rapid (97.29%) compared to the marketed product (88.01%) at the end of 30 minutes. From the results it was concluded that the formulation F-V showed rapid drug release compared to the marketed product. The stability results of optimized formulation (F-V) indicated that there were no significant changes found in physical appearance, thickness, hardness, average weight, friability, disintegration, assay and in vitro drug release even after stored at 25±2°C/60%±5%RH and 40±2°C/75%±5%RH for 3 months. The results showed that the optimized formulation F-V was stable even after stored at 25±2°C/60%±5%RH and 40±2°C/75%±5%RH for a period of three months.

Keywords: Formulation, Evaluation, Sugar Free Chewable Tablets, Montelukast Sodium.