Pharmaceutical
modified release dosage form comprising at least one
cyclooxygenase enzyme inhibitor or its pharmaceutically acceptable salts, esters, prodrugs, solvates, hydrates, or derivatives thereof as
active agent, with a pharmaceutically acceptable carrier for controlling the release of the
cyclooxygenase enzyme 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.