FORMULATION & EVALUATION OF ENTERIC COATED TABLETS OF ESOMEPRAZOLE

Abstract

The present study is an attempt to formulate and evaluate delayed release enteric coated tablets of Esomeprazole using enteric coated polymer Methacrylic acid Copolymer Type A. Tablets are prepared by using approved excipients, which were proved compatible with the active ingredient by IR studies. The method adopted for development was Wet granulation. Core tablets were evaluated for physical parameters like hardness, friability, thickness and disintegration time. Core tablets were sub-coated using Instacoat IC-Ms-2321 (HPMC + Ethyl Cellulose) with buildup of 3%w/w and enteric coating with Instacoat IN-II-062 (Methacrylic acid Copolymer Type A) with an average weight buildup of 5%, 10%, & 15% w/w. The disintegration of enteric coated tablets i.e. formulations with 5% weight buildup (F5a to F5c) in 0.1N HCL could not pass the test. However formulations with 10% & 15% weight buildup (F5d to F5i) showed no disintegration in 0.1N HCL for a period of 2hrs. Dissolution of enteric coated tablets (F5d to F5i) in 0.1N HCL, followed by phosphate buffer pH 6.8, was found satisfactory, where dissolution profile of 15% weight buildup tablets were faster compared to 10% w/w tablets. Among the formulation tested, tablets with 15% weight buildup showed minimum release in 0.1N HCl and the complete release in pH 6.8 phosphate buffers. Further, based on the tablets evaluation results, the formulation F5h was selected as the optimized formulation. The stability studies of the selected formulation showed that the product was stable throughout the study period (90 days).
Keywords: Esomeprazole, Sub-coating, Instacoat IN-II-062, Enteric coating, Instacoat IC-MS-2321, stability studies.