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Formulation And In Vitro Evaluation Of Delayed Release Oral Dosage Forms For Omeprazole

Author(s): P.Muthuprasanna, A.Satish Babu, C.Roosewelt, V.Sreedhar, Hari Krishnan, V.Gunasekaran, K.Suriaprabha

Omeprazole is a prototype member of a new class of substituted benzimidazoles which reduces gastric acid output both during basal conditions and stimulated acid secretion, irrespective of stimulus[1]. The objective of the present study is to develop a pharmaceutically equivalent, stable cost improved and quality improved formulation of omeprazole enteric coated pellets and to present in the form of tablets and capsules which were compared with the Innovators for its release efficiency. The enteric-coated drug pellets delivers the drug almost at a predetermined rate locally for a specified period of time at a specific site by reducing adverse effect. Main aim of this work is to formulate omeprazole enteric coated dosage forms , such as omeprazole enteric coated pellets and pellets in capsules, omeprazole enteric coated pellets compressed as tablets and coated with film coating material and omeprazole pellets compressed as tablets with enteric coated material were formulated and evaluated with respect to the various quality parameters such as dissolution, assay and impurity. The formula was finalized by comparing the in vitro dissolution profile with that of the Innovator in gastric and intestinal pH media.

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