Formulation and Evaluation of Enteric Coated Delayed Release Tablets of Omeprazole for Duodenal Ulcer

Author(s)

Halba, P. D., Patel, J. B., Patel, K.N., Patel, B. A., Patel, P. A.

Author's Affiliation

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 direct compression method using different concentration of crospovidone as a super disintegrant. Formulations showing less disintegration time were first subcoated with HPMC 15 cps upto 3% weight gain, followed by enteric coating with Eudragit L 100, Eudragit L 100-55 and Cellulose acetate phthalate. Pre and post compression evaluation of core and coated tablets were carried out. In vitro drug release studies were conducted in acidic and basic media to determine the appropriate coating ratio. All batches enteric coated with 8% weight gain of three polymers showed stable coating in 0.1 N HCl for 2 hours. Formulated batch F11 with 7% weight gain of Eudragit L 100-55 showed stable coating in 0.1 N HCl and had shown complete drug release in phosphate buffer pH 6.8. The prepared enteric coated tablets exhibited good physical and chemical stability, when subjected to accelerated stability studies. Further, when compared to marketed formulation (OPT tablet 20 mg Omeprazole), the prepared enteric coated tablets showed excellent similarities with marketed product (with respect to drug content, disintegration time and drug release) thereby establishing bioequivalence with marketed product.

Keywords

Enteric coating, Eudragit L 100, Eudragit L 100-55, Cellulose acetate phthalate, Direct compression, Dissolution, Stability

Cite This Article

Halba, P. D., Patel, J. B., Patel, K. N., Patel, B. A., Patel, P. A. (2013). Formulation and Evaluation of Enteric Coated Delayed Release Tablets of Omeprazole for Duodenal Ulcer. International Journal for Pharmaceutical Research Scholars (IJPRS), 2(2), 146-161.