Claims for Patent: 9,821,075

Summary for Patent: 9,821,075

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 or pharmacokinetics of the NSAID for the treatment of conditions such as pain.
Inventor(s):	Herriot Tabuteau
Assignee:	Axsome Therapeutics Inc
Application Number:	US15/132,130
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,821,075
Patent Claims:	1. A dosage form comprising a complex of meloxicam and a sulfobutyl ether β-cyclodextrin (SBEβCD), and a bicarbonate, wherein the dosage form is an oral dosage form having a shorter Tmax of meloxicam than an otherwise identical reference dosage form that does not contain a SBEβCD or a bicarbonate, and wherein the complex is formed by mixing meloxicam and the cyclodextrin in a solution and drying the solution to form the complex. 2. The dosage form of claim 1, wherein the SBEβCD has about 6 to about 7 sulfobutyl ether groups for each molecule of β-cyclodextrin. 3. The dosage form of claim 1, wherein the bicarbonate comprises sodium bicarbonate. 4. The dosage form of claim 2, wherein the meloxicam and the SBEβCD have a molar ratio of about 0.8 to about 1.2. 5. The dosage form of claim 1, which is an oral dosage form. 6. The dosage form of claim 1, wherein about 50 mg to about 200 mg of the SBEβCD is present in the dosage form. 7. The dosage form of claim 1, wherein the bicarbonate is present in an amount of about 400 mg to about 600 mg. 8. The dosage form of claim 1, further comprising an acid inhibitor. 9. The dosage form of claim 8, wherein the acid inhibitor is a proton pump inhibitor. 10. The dosage form of claim 9, wherein the proton pump inhibitor is esomeprazole. 11. The dosage form of claim 10, wherein about 30 mg to about 50 mg of esomeprazole is present in the dosage form. 12. A method of administering meloxicam orally to a patient in need of treatment therewith, comprising orally administering the dosage form of claim 1. 13. The method of claim 12, wherein the bicarbonate is sodium bicarbonate. 14. The method of claim 13, wherein the dosage form contains about 300 mg to about 600 mg of sodium bicarbonate. 15. The method of claim 12, wherein the dosage form further comprises a proton pump inhibitor. 16. The method of claim 15, wherein the proton pump inhibitor is esomeprazole, omeprazole, lansoprazole, pantoprazole, or rabeprazole. 17. The method of claim 12, wherein the dosage form is administered to treat pain. 18. The method of claim 12, wherein the dosage form is administered to treat inflammatory pain. 19. The method of claim 12, wherein the dosage form is administered to treat osteoarthritis, rheumatoid arthritis, or juvenile rheumatoid arthritis.