Pharmaceutical compositions comprising meloxicam
Disclosed herein are compositions comprising an NSAID such as meloxicam and/or rizatriptan 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 pain such as migraine, arthritis, and other conditions. Also disclosed herein are methods of treating pain, such as migraine, comprising administering meloxicam and rizatriptan to a human being suffering from pain, such as migraine. For migraine, these methods may be particularly useful when the meloxicam and rizatriptan are administered while the human being is suffering from an acute attack of migraine pain or migraine aura. In some embodiments, the combination of meloxicam and rizatriptan may be administered in a manner that results in a T max of meloxicam of 3 hours or less.
1. A method of treating migraine, comprising orally administering a combination at least twice a month for at least six months to a human being in need thereof, wherein the combination comprises about 20 mg of meloxicam, or a molar equivalent amount of a salt form of meloxicam, and from about 10 mg to about 15 mg of rizatriptan, or a molar equivalent amount of a salt form of rizatriptan.
2. The method of claim 1 , wherein, upon orally administering the combination, the T max of meloxicam in the human being is less than 60 minutes.
3. The method of claim 1 , wherein, upon orally administering the combination, the T max of meloxicam in the human being is about 5×10 1 minutes.
4. The method of claim 1 , wherein, upon orally administering the combination, the C max of meloxicam in the human being is from about 2,500 ng/ml to about 3,000 ng/ml.
5. The method of claim 1 , wherein, upon orally administering the combination, the C max of meloxicam in the human being is about 3×10 3 ng/ml.
6. The method of claim 1 , wherein, upon orally administering the combination, the AUC 0-inf of meloxicam in the human being is from about 50,000 ng*hr/mL to about 70,000 ng*hr/mL.
7. The method of claim 1 , wherein, upon orally administering the combination, the AUC 0-inf of meloxicam in the human being is from about 50,000 ng*hr/mL to about 60,000 ng*hr/mL.
8. The method of claim 1 , wherein, upon orally administering the combination, the AUC 0-inf of meloxicam in the human being is about 5×10 4 ng*hr/mL.
9. The method of claim 1 , wherein, upon orally administering the combination, the mean elimination half-life in the human being is about 2×10 1 hours for meloxicam.
10. The method of claim 1 , wherein the combination further comprises sodium bicarbonate.
11. The method of claim 10 , wherein, upon orally administering the combination, the T max of meloxicam in the human being is less than 60 minutes.
12. The method of claim 10 , wherein, upon orally administering the combination, the T max of meloxicam in the human being is about 5×10 1 minutes.
13. The method of claim 10 , wherein, upon orally administering the combination, the C max of meloxicam in the human being is from about 2,500 ng/ml to about 3,000 ng/ml.
14. The method of claim 10 , wherein, upon orally administering the combination, the C max of meloxicam in the human being is about 3×10 3 ng/ml.
15. The method of claim 10 , wherein, upon orally administering the combination, the AUC 0-inf of meloxicam in the human being is from about 50,000 ng*hr/mL to about 70,000 ng*hr/mL.
16. The method of claim 10 , wherein, upon orally administering the combination, the AUC 0-inf of meloxicam in the human being is from about 50,000 ng*hr/mL to about 60,000 ng*hr/mL.
17. The method of claim 10 , wherein, upon orally administering the combination, the AUC 0-inf of meloxicam in the human being is about 5×10 4 ng*hr/mL.
18. The method of claim 10 , wherein, upon orally administering the combination, the mean elimination half-life in the human being is about 2×10 1 hours for meloxicam.
19. A method of treating migraine, comprising orally administering a combination at least twice a month for at least six months to a human being in need thereof, wherein the combination comprises about 20 mg of meloxicam, or a molar equivalent amount of a salt form of meloxicam, and from about 10 mg to about 15 mg of rizatriptan, or a molar equivalent amount of a salt form of rizatriptan, and wherein the human being has at least 10 migraine attacks per month before the treatment.
20. The method of claim 19 , wherein the human being has about 10 to 15 migraine attacks per month before the treatment.