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Abstract

FORMULATION AND EVALUATION OF ENTERIC COATED SUSTAINED RELEASE TABLETS OF OMEPRAZOLE FOR DUODENAL ULCER

Dr.M.Sreenivasulu, Srikrishna.T*, Vasanthi.P, Prasanthi.K, Ishrath.Sk, Pavani.M

ABSTRACT

The objective of present study was to develop pharmaceutically elegant and stable enteric coated tablet formulation for highly unstable drug in acidic environment using pH dependent polymers. Omeprazole is a specific and non-competitive inhibitor of the enzyme H+ /K+ - ATPase. It is unstable in conditions of low pH and required protection from the effects of gastric acid when given orally so it is formulated in the form of enteric coated dosage forms. The core tablets were prepared by wet granulation method using different concentration of Ethylcellulose as a release retardant, followed by enteric coating with Eudragit L 100.The interaction between the excipients and Omeprazole was studied through FTIR spectroscopy. Various concentrations of polymer was used in the six proposed formulations (F1-F6) for the study of release rate retarded effect at 1%, 2%, 3%, 4%, 5% and 6% of total weight of tablet respectively. Then the tablets were evaluated in terms of their physical parameters (disintegration time, hardness, friability, weight variation), drug content and invitro released studies. All the formulations showed compliance with pharmacopeial standards. The invitro dissolution study were conducted using USP dissolution apparatus-II (paddle method) in 900ml 0.1N HCL for 2 hours and remaining 22 hours performed in 6.8 pH phosphate total period of an buffer at 100rpm for 24 hours. Based on the dissolution data comparisons with innovator product, formulation F5 was as the best formulation.

Keywords: Omeprazole, Enteric coated tablet, Ethylcellulose, Wet Granulation, in-vitro dissolution.


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