IP Library Granted Patent US 10,369,224
Granted Patent B2
US 10,369,224 · App. 16/006,642 · Granted Aug 6, 2019

Pharmaceutical compositions comprising meloxicam

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Quick Facts
Patent No.
US 10,369,224
App. No.
16/006,642
Granted
Aug 6, 2019
Kind
B2
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.

Claims (27)

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 T max 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 T max of meloxicam that is at least 3-fold shorter than the T max 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 T max of meloxicam that is at least 2-fold shorter than the T max 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 T max of meloxicam that is shorter than the T max 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 T max 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.

Assignments (4)
RELEASE OF SECURITY INTEREST Recorded May 22, 2025
From: HERCULES CAPITAL, INC.
To: AXSOME THERAPEUTICS, INC.
Reel/Frame 071337/0004 →
SECURITY INTEREST Recorded May 9, 2025
From: AXSOME THERAPEUTICS, INC.; AXSOME MALTA LTD.
To: WILMINGTON TRUST, NATIONAL ASSOCIATION
Reel/Frame 071247/0836 →
INTELLECTUAL PROPERTY SECURITY AGREEMENT Recorded Sep 25, 2020
From: AXSOME THERAPEUTICS, INC.
To: HERCULES CAPITAL, INC., AS AGENT
Reel/Frame 053941/0491 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 10, 2018
From: TABUTEAU, HERRIOT
To: AXSOME THERAPEUTICS, INC.
Reel/Frame 046308/0757 →