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The objective of the present study is to formulate and evaluate delayed release pellets of Omeprazole comparable to the innovator product. The formulations of Omeprazole delayed release pellets of Omeprazole were developed by enteric film coating process varying the compositions of drug loading, barrier coating and enteric coating. Eudragit L 100 55 and HPMC Phthalate 55 S were used as enteric polymers. The process variables were standardized and the different batches prepared were evaluated for assay/drug content, water content, acid resistance and dissolution rate. The drug dissolution profiles of Omeprazole delayed release formulations developed were compared with that of innovators product. Based on the results formulation containing enteric coating polymer HPMC P 55 S (12%), and plasticizers diethyl phthalate, cetyl alcohol has been selected as the best formulation developed for Omeprazole delayed release pellets.
Omeprazole, Enteric Coating, Acid Resistance