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 method of treating migraine comprising: orally administering a solid dosage form to a human being suffering from a migraine, wherein the solid dosage form comprises: 1) a complex of meloxicam and a sulfobutyl ether β-cyclodextrin (SBEPβCD), and 2) a bicarbonate, wherein orally administering the solid dosage form to the human being results in a T max of meloxicam that is shorter than a T max of a reference solid dosage form that: 1) contains the same amount of meloxicam, 2) does not contain an SBEβCD, and 3) does not contain a bicarbonate, wherein the solid dosage form has been shown to have a median T max of meloxicam that is less than 1 hour in human subjects.
2. The method of claim 1 , wherein the solid dosage form contains about 10 mg to about 20 mg of meloxicam.
3. The method of claim 1 , wherein the solid dosage form contains about 15 mg of meloxicam.
4. The method of claim 1 , wherein the SBEβCD has about 6 to about 7 sulfobutyl ether groups for each molecule of β-cyclodextrin.
5. The method of claim 1 , wherein the solid dosage form contains about 50 mg to about 200 mg of the SBEβCD.
6. The method of claim 1 , wherein the solid dosage form contains about 100 mg of the SBEβCD.
7. The method of claim 1 , wherein the bicarbonate is sodium bicarbonate.
8. The method of claim 1 , wherein the solid dosage form contains about 400 mg to about 600 mg of the bicarbonate.
9. The method of claim 7 , wherein the solid dosage form contains about 500 mg of sodium bicarbonate.
10. The method of claim 1 , wherein the solid dosage form further comprises an acid inhibitor.
11. The method of claim 10 , wherein the acid inhibitor is a proton pump inhibitor.
12. The method of claim 11 , wherein the proton pump inhibitor is esomeprazole, and about 30 mg to about 50 mg of esomeprazole is present in the solid dosage form.
13. The method of claim 1 , wherein the dosage form further comprises rizatriptan.
14. The method of claim 12 , wherein the solid dosage form contains about 40 mg of esomeprazole.
15. The method of claim 11 , wherein the proton pump inhibitor is esomeprazole, omeprazole, lansoprazole, pantoprazole, or rabeprazole.
16. A method of treating migraine comprising: orally administering a solid dosage form to a human being suffering from a migraine, wherein the solid dosage form comprises: 1) a complex of meloxicam and a sulfobutyl ether β-cyclodextrin (SBEPβCD), and 2) a bicarbonate, wherein orally administering the solid dosage form to the human being results in a C max of meloxicam that is at least about 30% higher than a C max of a reference solid dosage form that: 1) contains the same amount of meloxicam, 2) does not contain an SBEβCD, and 3) does not contain a bicarbonate.
17. The method of claim 16 , wherein the solid dosage form contains about 10 mg to about 20 mg of meloxicam.
18. The method of claim 16 , wherein the solid dosage form contains about 15 mg of meloxicam.
19. The method of claim 16 , wherein the SBEβCD has about 6 to about 7 sulfobutyl ether groups for each molecule of β-cyclodextrin.
20. The method of claim 16 , wherein the solid dosage form contains about 50 mg to about 200 mg of the SBEPβCD.
21. The method of claim 16 , wherein the solid dosage form contains about 100 mg of the SBEPβCD.
22. The method of claim 16 , wherein the bicarbonate is sodium bicarbonate.
23. The method of claim 16 , wherein the solid dosage form contains about 400 mg to about 600 mg of the bicarbonate.
24. The method of claim 22 , wherein the solid dosage form contains about 500 mg of sodium bicarbonate.
25. The method of claim 16 , wherein the solid dosage form further comprises an acid inhibitor.
26. The method of claim 25 , wherein the acid inhibitor is a proton pump inhibitor.
27. The method of claim 26 , wherein the proton pump inhibitor is esomeprazole.
28. The method of claim 27 , wherein about 30 mg to about 50 mg of esomeprazole is present in the solid dosage form.
29. The method of claim 27 , wherein the solid dosage form contains about 40 mg of esomeprazole.
30. The method of claim 16 , wherein the dosage form further comprises rizatriptan.