Pharmaceutical modified release dosage form comprising at least one cyclooxygenase enzyme inhibitor or its pharmaceutical ly acceptable salts, esters, prodrugs, solvates, hydrates, or derivatives thereofas active agent, with a pharmaceutically acceptable carrier for controlling the release of the cyclooxygenase en/yme inhibitor is provided. The dosage form preferably provides a release of not more than about 60% of the cyclooxygenase enzyme inhibitor in 1 hour and not less than about 75% of the cyclooxygenase enzyme inhibitor after 12 hours when tested in accordance with the dissolution method (I) described herein employing Distilled water with 2.0% Sodium lauryl sulphate as the dissolution medium or in accordance with the dissolution method (II) described herein employing pH 7.0 Phosphate buffer with 2.0% Sodium lauryl sulphate as the dissolution medium or in accordance with the dissolution method (III) described herein employing 0.001 N Hydrochloric acid with 1.0% Sodium lauryl sulphate as dissolution medium. Further, the pharmaceutical composition of the present invention when tested in a group of healthy humans preferably achieves a mean peak plasma concentration (Cmax) after at least about 1 hour of administration of the dosage form,. The present invention also provides process of preparing such dosage form compositions and prophylactic and/or therapeutic methods of using such dosage form.
