Abstract

Esomeprazole Magnesium Trihydrate is a proton pump inhibitor, belongs to the group of benzimidazole, used for the treatment of gastric and duodenum ulcers. Esomeprazole undergoes degradation in acidic medium of the stomach, can be coated with enteric coating polymer that will safely deliver the drug in the small intestine. In this study an attempt was made to formulate and evaluate Esomeprazole enteric coated tablets. Different core tablets of Esomeprazole were prepared by direct compression using Starch as a disintegrant and microcrystalline cellulose as a filler. Core tablet of Formulation F3 was selected and coated with a seal coating dispersion of hydroxyl propyl methyl cellulose and subsequently with a dispersion of enteric polymer such as hydroxyl propyl methyl cellulose phthalate using a syringe, where coating dispersion was applied on to the tablets manually. Seal coating was applied to achieve 1% weight gain using hydroxy propyl methyl cellulose dispersion. Enteric coating was carried out using hydroxy propyl methyl cellulose phthalate dispersion to achieve a 10%, 20% and 30% weight gain. Enteric coated tablets with and without a seal coat, which gained a 30% weight gain after enteric coating with hydroxy propyl methyl cellulose phthalate were found to show a delayed release when tested for the dissolution. They were studied for their stability under long term and accerelerated conditions for about 3 weeks. The results indicated the necessity of a seal coat between core and enteric coat in the formulation. By using this method, tablets can be coated until an optimum weight gain is obtained to get a delayed drug release, hence reducing the over usage of materials. So, by utilizing this syringe method, a variety of enteric polymers can be coated onto seal coated esomeprazole magnesium trihydrate core tablets, which are stable and exhibit a delayed drug release.