Claims for Patent: 10,137,131

Summary for Patent: 10,137,131

Title:	Pharmaceutical compositions comprising meloxicam
Abstract:	Disclosed herein are compositions comprising a drug such as a triptan (e.g. rizatriptan) and/or an NSAID (e.g. 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 drug for the treatment of conditions such as pain.
Inventor(s):	Herriot Tabuteau
Assignee:	Axsome Therapeutics Inc
Application Number:	US15/936,176
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,137,131
Patent Claims:	1. A dosage form comprising a combination of: 1) a complex of meloxicam with a sulfobutyl ether β-cyclodextrin (SBEβCD), 2) a bicarbonate, and 3) a triptan; wherein the dosage form contains 400 mg to 600 mg of the bicarbonate, about 5 mg to about 50 mg of meloxicam, and about 50 mg to about 200 mg of SBEβCD; and wherein the dosage form is a solid oral dosage form having a shorter Tmax of meloxicam in a human being than a reference dosage form that: 1) contains the same amount of meloxicam, 2) does not contain an SBEβCD, and 3) does not contain a bicarbonate. 2. The dosage form of claim 1, wherein the triptan is a rizatriptan. 3. The dosage form of claim 2, wherein about 8 mg to about 13 mg of the rizatriptan is present in the dosage form based upon the weight of the rizatriptan in the free base form. 4. The dosage form of claim 3, wherein the rizatriptan is present in a salt form in an amount that is a molar equivalent of about 10 mg of the rizatriptan in the free base form. 5. The dosage form of claim 4, wherein the rizatriptan is present as rizatriptan benzoate. 6. The dosage form of claim 1, containing about 15 mg to about 25 mg of meloxicam. 7. The dosage form of claim 1, containing about 20 mg of meloxicam. 8. The dosage form of claim 1, wherein the SBEβCD has about 6 to about 7 sulfobutyl ether groups for each molecule of β-cyclodextrin. 9. The dosage form of claim 1, containing about 100 mg to about 175 mg of the SBEβCD. 10. The dosage form of claim 1, containing about 100 mg to about 140 mg of SBEβCD. 11. The dosage form of claim 1, wherein the bicarbonate comprises sodium bicarbonate. 12. The dosage form of claim 11, containing about 500 mg of sodium bicarbonate. 13. The dosage form of claim 1, wherein the oral dosage form has been shown to have a median Tmax of meloxicam that is less than about 3 hours in fasted human subjects. 14. The dosage form of claim 1, wherein the oral dosage form has been shown to have a median Tmax of meloxicam that is less than about 2 hours in fasted human subjects. 15. The dosage form of claim 1, wherein the oral dosage form has been shown to have a median Tmax of meloxicam that is less than about 1 hour in fasted human subjects. 16. The dosage form of claim 1, wherein the oral dosage form has been shown to have a median Cmax of meloxicam that is at least 1800 ng/mL in fasted human subjects. 17. The dosage form of claim 1, wherein the oral dosage form has been shown to have a median AUC0-6 of meloxicam that is at least 6,000 ng·hr/mL in fasted human subjects. 18. The dosage form of claim 1, wherein the oral dosage form has been shown to have a median time to half-maximal plasma concentration of meloxicam that is less than about 30 minutes in fasted human subjects. 19. A method of treating migraine, comprising administering a dosage form of claim 1 to a human being in need thereof. 20. The method of claim 19, wherein the oral dosage form has been shown to have a median Tmax of meloxicam that is less than about 1 hour in fasted human subjects. 21. The method of claim 19, wherein the oral dosage form has been shown to have a median Cmax of meloxicam that is at least 1800 ng/mL in fasted human subjects. 22. The method of claim 19, wherein the oral dosage form has been shown to have a median AUC0-6 of meloxicam that is at least 6,000 ng·hr/mL in fasted human subjects. 23. The method of claim 19, wherein the oral dosage form has been shown to have a median time to half-maximal plasma concentration of meloxicam that is less than about 30 minutes in fasted human subjects. 24. The method of claim 19, wherein the triptan is a rizatriptan. 25. The method of claim 24, wherein about 5 mg to about 20 mg of the rizatriptan is present in the dosage form based upon the weight of the rizatriptan in the free base form. 26. The method of claim 25, wherein the rizatriptan is present in a salt form in an amount that is a molar equivalent of about 10 mg of the rizatriptan in the free base form. 27. The method of claim 26, wherein the rizatriptan is present as rizatriptan benzoate. 28. The method of claim 19, wherein the dosage form contains about 10 mg to about 30 mg of meloxicam. 29. The method of claim 19, wherein the dosage form contains about 20 mg of meloxicam.