Claims for Patent: 10,369,224

Summary for Patent: 10,369,224

Title:	Pharmaceutical compositions comprising meloxicam
Abstract:	Disclosed herein are compositions comprising an NSAID such as meloxicam in combination with a cyclodextrin and/or a carbonate or a bicarbonate. These compositions may be orally administered, for example, to improve the bioavailability, solubility, or pharmacokinetics of the NSAID for the treatment of conditions such as pain.
Inventor(s):	Herriot Tabuteau
Assignee:	Axsome Therapeutics Inc
Application Number:	US16/006,642
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,369,224
Patent Claims:	1. A method of rapidly delivering meloxicam to the blood of a human being comprising orally administering a solid dosage form to a human being in need of treatment with meloxicam, wherein the dosage form comprises meloxicam and 400 mg to 800 mg of a bicarbonate, wherein the solid dosage form provides a Tmax of meloxicam in the human being that is less than 1 hour. 2. The method of claim 1, wherein the bicarbonate is sodium bicarbonate. 3. The method of claim 1, wherein the bicarbonate is potassium bicarbonate. 4. The method of claim 1, wherein the solid dosage form comprises 500 mg of sodium bicarbonate. 5. The method of claim 1, wherein the solid dosage form further comprises an acid inhibitor. 6. The method of claim 5, wherein the acid inhibitor is esomeprazole. 7. The method of claim 6, wherein about 30 mg to about 50 mg of esomeprazole is present in the solid dosage form. 8. The method of claim 6, wherein the solid dosage form contains about 40 mg of esomeprazole. 9. The method of claim 1, wherein the solid dosage form comprises about 10 mg to about 20 mg of meloxicam. 10. The method of claim 1, wherein the solid dosage form contains about 15 mg of meloxicam. 11. The method of claim 1, wherein the solid dosage form further comprises one or more pharmaceutically acceptable excipients. 12. The method of claim 1, wherein the solid dosage form is in a form of tablet or capsule. 13. The method of claim 1, wherein the solid dosage form is administered under fasting conditions. 14. The method of claim 1, wherein the solid dosage form is administered once daily. 15. The method of claim 14, wherein the solid dosage form is administered for at least 6 days. 16. The method of claim 1, wherein the first time the solid dosage form is orally administered, the human being has a Tmax of meloxicam that is at least 3-fold shorter than the Tmax of meloxicam that would result from administering a reference dosage form that: 1) contains the same amount of meloxicam, and 2) does not contain a bicarbonate. 17. The method of claim 1, wherein the first time the solid dosage form is orally administered, the human being has a Tmax of meloxicam that is at least 2-fold shorter than the Tmax of meloxicam that would result from administering a reference dosage form that: 1) contains the same amount of meloxicam, and 2) does not contain a bicarbonate. 18. The method of claim 1, wherein the first time the solid dosage form is orally administered, the human being has a Tmax of meloxicam that is shorter than the Tmax of meloxicam that would result from intramuscular injection of the same amount of meloxicam. 19. The method of claim 1, wherein the first time the solid dosage form is orally administered, the human being has a Tmax of meloxicam that is about 0.5 hours or less. 20. The method of claim 1, wherein the solid dosage form is administered to the human being to treat pain. 21. The method of claim 20, wherein the pain comprises inflammatory pain. 22. The method of claim 20, wherein the solid dosage form provides pain relief in the human being within about 30 minutes after oral administration of the solid dosage form. 23. The method of claim 1, wherein the solid dosage form is administered to the human being to treat arthritis. 24. The method of claim 23, wherein the arthritis comprises osteoarthritis. 25. The method of claim 23, wherein the arthritis comprises rheumatoid arthritis. 26. The method of claim 23, wherein the arthritis comprises juvenile rheumatoid arthritis. 27. The method of claim 1, wherein the solid dosage form is administered to the human being to treat migraine.