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, solubility, or pharmacokinetics of the NSAID for the treatment of conditions such as pain.
1. A method of improving the pharmacokinetics of meloxicam comprising orally administering a solid dosage form comprising meloxicam and 400 mg to 800 mg of a bicarbonate to a human being suffering from a condition known to be treatable by meloxicam, wherein the meloxicam dissolves more rapidly from the solid dosage form as compared with a reference solid dosage form that: a) contains the same amount of meloxicam, and b) does not contain a bicarbonate, wherein the T max of meloxicam in the human being 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 tablet form or a capsule form.
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 5-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 1.5-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 administering the solid dosage form results in increased bioavailability of meloxicam as compared to the oral bioavailability 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, wherein the first time the solid dosage form is orally administered, the human being has an AUC 0-24 of meloxicam that is at least about 10 μg·hr/mL.
19. The method of claim 1 , wherein administering the solid dosage form results in an AUC 0-6 of meloxicam that is at least about 6 μg·hr/mL in the human being.
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 1 , wherein the solid dosage form is administered to the human being to treat inflammatory pain.
22. The method of claim 1 , wherein the solid dosage form is administered to the human being to treat osteoarthritis.
23. The method of claim 1 , wherein the solid dosage form is administered to the human being to treat rheumatoid arthritis.
24. The method of claim 1 , wherein the solid dosage form is administered to the human being to treat juvenile rheumatoid arthritis.
25. The method of claim 1 , wherein the solid dosage form is administered to the human being to treat migraine.