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Formulation, characterization and in-vitro evaluation of chewable tablet containing montelukast sodiumby dry granulation method | Abstract
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Abstract

Formulation, characterization and in-vitro evaluation of chewable tablet containing montelukast sodiumby dry granulation method

Author(s): Y. Phalguna*, M. Srinivas and J. Harikrishna

Asthma 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 the 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 a chewable tablet to avert the problem of swallowing and to provide rapid onset of action, thus improving patient compliance and it also shows an increase in bioavailability. In this study montelukast sodium chewable tablets were prepared by Dry granulation method using different concentrations of Microcrystalline cellulose, Magnesium Stearate, Croscarmellose sodium, Aspartame, Mannitol, Hydroxy Propyl cellulose, Ferric oxide, these are the excipents which are used in the formulation in different ratios.The tablets were evaluated for various parameters and the results were found to be satisfactory and within specifications. F4 was selected as optimized formulation containing modified Hydroxy propyl cellulose 5mg and Croscarmellose sodium 3mg as it showed the complete drug release in 90 minutes. 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.