Preparation and evaluation of montelukast sodium chewable tablets using modified karaya gum

Montelukast sodium is an anti asthmatic drug. It mainly prevents leukotriene mediated effect associated with asthma and allergic arthritis. It also relieves symptoms of seasonal allergies. Asthma and seasonal allergies are more prevalent in children and swallowing an intact tablet is a major problem in this population. In addition, patients with asthma need fast and immediate action of tablet and avoidance of water is also desirable. Hence the main objective of this study is to improve the palatability by formulating montelukast sodium as chewable tablet to avert the problem of swallowing and to provide rapid onset of action, thus improving patient compliance and it also shows increase in bioavailability. In this study montelukast sodium chewable tablets were prepared by wet granulation method using different concentrations of xanthan gum, karaya gum, modified karaya gum as diluent and sodium starch glycolate (SSG) as disintegrant. The tablets were evaluated for various parameters and the results were found to be satisfactory and within specifications. F12 was selected as optimized formulation containing modified karaya gum 30% and SSG 4%, as it showed complete drug release in 90 minutes. Comparison studies were performed for optimized and marketed formulations and difference (f1) and similarity factors (f2) values were found to be 3.82 and 75.12 respectively. The optimized formulation was subjected to stability studies for three months as per ICH guidelines and showed good physical stability with insignificant changes in physical appearance and quality control tests.

Author(s): K Shruthi, Ch Archana, C Kishore, K Latha and D Thahera

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