Pharmaceutical compositions comprising meloxicam
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.
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 T max 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.