Patent EA-003363-B1 (EA)
Title: Discrete solid dosage unit of pharmaceutical composition for oral administration, comprising celecoxib and method for treating a medical condition or disorder in a subject where treatment with a cyclooxygenase-2 inhibitor is indicated
Inventor: GAO DANCHEN
IPC: A61K9/20
Filed: 1999-11-30
Abstract: 1. A discrete solid unit dosage of a pharmaceutical composition for oral administration, comprising celecoxib in a form of articles in an amount of about 10 mg to about 1000 mg in intimate mixture with one or more pharmaceutically acceptable excipients, and having relative bioavailability not less than about 50%, preferably not less than about 70%, by comparison with an orally delivered solution containing an equivalent amount of celecoxib. 2. A discrete solid unit dosage of a pharmaceutical composition for oral administration, comprising celecoxib in a form of articles in an amount of about 10 mg to about 1000 mg in intimate mixture with one or more pharmaceutically acceptable excipients, and having a distribution of celecoxib particle sizes such that D90 if the particles are less than 200 mum, preferably less than 100 mum, more preferably less than 40 mum, and most preferably less than 25 mum, in the longest dimension of said particles. 3. A discrete solid unit dosage for oral administration according to claim 2, having relative bioavailability not less than about 50%, preferably not less than about 70%, by comparison with an orally delivered solution containing an equivalent amount of celecoxib. 4. A discrete solid unit dosage for oral administration according to any one of claims 1 to 3 selected from the group comprising tablets, pills, hard or soft capsules, lozenges, sachets or pastilles. 5. A discrete solid unit dosage for oral administration according to claim 4, prepared in the form of unit dosage capsules or tablets, wherein said excipients are selected from the group consisting of pharmaceutically acceptable diluents, disintegrants, binding agents, wetting agents and lubricants. 6. A discrete solid unit dosage for oral administration according to claim 5, comprising (a) one or more pharmaceutically acceptable diluents in a total amount of about 10% to about 85% by weight of the composition; (b) one or more pharmaceutically acceptable disintegrants in a total amount of about 0.2% to about 10% by weight of the composition; and (c) one or more pharmaceutically acceptable binding agents in an amount of about 0.5% to about 10% by weight of the composition; (d) one or more pharmaceutically acceptable wetting agents in a total amount of about 0.4% to about 10% by weight of the composition; and (e) one or more pharmaceutically acceptable lubricants in a total amount of about 0.2% to about 8% by weight of the composition. 7. A discrete solid unit dosage for oral administration according to claim 6 wherein (a) said diluents comprise lactose; (b) said disintegrants comprise croscarmellose sodium; (c) said binding agents comprise polyvinylpyrrolidone; (d) said wetting agents comprise sodium lauryl sulfate; and (e) said lubricants comprise magnesium stearate. 8. A method of treating a medical condition or disorder in a subject where treatment with a cyclooxygenase-2 inhibitor is indicated, comprising orally administering to the subject a dosage unit according to any one of claims 1 to 7 once or twice a day. 9. A method according to claim 8 wherein the condition or disorder is rheumatoid arthritis, osteoarthritis or pain.