Pharmaceutical compositions comprising meloxicam
View Patent ↗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.
1. A method of improving dissolution of meloxicam in a stomach of a human being, comprising orally administering a solid dosage form comprising both a bicarbonate and meloxicam to the human being, wherein the solid dosage form contains 400 mg to 800 mg of the bicarbonate, wherein, at a designated time, the dissolution of meloxicam for the solid dosage form is improved as compared with a reference dosage form that: 1) contains the same amount of meloxicam; 2) does not contain the bicarbonate; and 3) does not contain a carbonate, wherein the rate of dissolution of meloxicam of the solid dosage form or the reference dosage form is determined by a dissolution test, wherein the dissolution test is: adding the dosage form or the reference dosage form to 500 mL of a 0.01 N HCI aqueous solution, stirring at 75 revolutions per minute (RPM) with a USP paddle apparatus II at 37° C., and determining the amount of meloxicam dissolved in the 0.01 N HCI aqueous solution at the designated time.
2. The method of claim 1 , wherein the solid dosage form further comprises a cyclodextrin.
3. The method of claim 2 , wherein the cyclodextrin is a sulfobutyl ether β-cyclodextrin (SBEβCD).
4. The method of claim 1 , wherein the solid dosage form further comprises an acid inhibitor.
5. The method of claim 4 , wherein the acid inhibitor is esomeprazole.
6. The method of claim 1 , wherein the solid dosage form is in a tablet form.
7. The method of claim 1 , wherein the solid dosage form comprises about 1 mg to about 50 mg of meloxicam.
8. The method of claim 1 , wherein the solid dosage form comprises about 15 mg of meloxicam.
9. The method of claim 1 , wherein the bicarbonate is sodium bicarbonate or potassium bicarbonate.
10. The method of claim 9 , wherein the solid dosage form comprises about 400 mg to about 600 mg of sodium bicarbonate.
11. The method of claim 10 , wherein the solid dosage form comprises about 500mg of sodium bicarbonate.
12. The method of claim 5 , wherein about 30 mg to about 50 mg of esomeprazole is present in the solid dosage form.
13. The method of claim 1 , wherein the solid dosage form has the property that the dissolution of meloxicam is at least about 70% when the designated time is 120 minutes.
14. The method of claim 1 , wherein the solid dosage form has the property that the dissolution of meloxicam is at least about 30 times that of the reference dosage form when the designated time is 120 minutes.
15. The method of claim 1 , wherein the solid dosage form has the property that the dissolution of meloxicam is at least about 40% when the designated time is 15 minutes.
16. The method of claim 1 , wherein the solid dosage form has the property that the dissolution of meloxicam is at least about 10 times that of the reference dosage form when the designated time is 15 minutes.
17. The method of claim 2 , wherein the solid dosage form has the property that the dissolution of meloxicam is at least about 60% when the designated time is 120 minutes.
18. The method of claim 2 , wherein the dissolution of meloxicam is at least about 5 times that of the reference dosage form when the designated time is 120 minutes.
19. The method of claim 2 , wherein the dissolution of meloxicam is at least about 60% when the designated time is 15 minutes.
20. The method of claim 2 , wherein the dissolution of meloxicam is at least about 2 times that of the reference dosage form when the designated time is 15 minutes.
21. The method of claim 1 , wherein the solid dosage form is orally administered to the human being to treat pain.
22. The method of claim 21 , wherein the pain is inflammatory pain.
23. The method of claim 1 , wherein the solid dosage form is orally administered to the human being to treat osteoarthritis, rheumatoid arthritis, or juvenile rheumatoid arthritis.