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 one tablet to a human being experiencing a migraine attack, wherein the human being having migraine does not have uncontrolled hypertension, wherein the tablet 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, wherein the T max of meloxicam in the human being is less than 60 minutes, wherein the human being has acute pain, and wherein the human being does not have chronic daily headache.
2 . The method of claim 1 , wherein, upon orally administering the tablet, the T max of meloxicam in the human being is about 5×10 1 minutes.
3 . The method of claim 1 , wherein, upon orally administering the tablet, the C max of meloxicam in the human being is from about 2,500 ng/ml to about 3,000 ng/ml.
4 . The method of claim 1 , wherein, upon orally administering the tablet, the C max of meloxicam in the human being is about 3×10 3 ng/ml.
5 . The method of claim 1 , wherein, upon orally administering the tablet, 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.
6 . The method of claim 1 , wherein, upon orally administering the tablet, 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.
7 . The method of claim 1 , wherein, upon orally administering the tablet, the AUC 0-inf of meloxicam in the human being is about 5×10 4 ng*hr/mL.
8 . The method of claim 1 , wherein, upon orally administering the tablet, the mean elimination half-life is approximately 20 hours for meloxicam.
9 . A method of treating migraine, comprising orally administering one tablet to a human being experiencing a migraine attack, wherein the human being having migraine does not have uncontrolled hypertension, wherein the tablet 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, wherein the tablet further comprises sodium bicarbonate, wherein the T max of meloxicam in the human being is less than 60 minutes, wherein the human being has acute pain, and wherein the human being does not have chronic daily headache.
10 . The method of claim 9 , wherein, upon orally administering the tablet, the T max of meloxicam in the human being is about 5×10 1 minutes.
11 . The method of claim 9 , wherein, upon orally administering the tablet, the C max of meloxicam in the human being is from about 2,500 ng/ml to about 3,000 ng/ml.
12 . The method of claim 9 , wherein, upon orally administering the tablet, the C max of meloxicam in the human being is about 3×10 3 ng/ml.
13 . The method of claim 9 , wherein, upon orally administering the tablet, 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.
14 . The method of claim 9 , wherein, upon orally administering the tablet, 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.
15 . The method of claim 9 , wherein, upon orally administering the tablet, the AUC 0-inf of meloxicam in the human being is about 5×10 4 ng*hr/mL.
16 . The method of claim 9 , wherein, upon orally administering the tablet, the mean elimination half-life is approximately 20 hours for meloxicam.
17 . The method of claim 1 , wherein the human being experiences pain relief at about 2 hours after the tablet is orally administered.
18 . The method of claim 9 , wherein the human being experiences pain relief at about 2 hours after the tablet is orally administered.
19 . A method of treating migraine, comprising orally administering one tablet to a human being experiencing a migraine attack, wherein the human being having migraine does not have uncontrolled hypertension, wherein the tablet comprises 20 mg of meloxicam and 14.5 mg of rizatriptan benzoate, wherein the T max of meloxicam in the human being is less than 60 minutes, wherein the human being has acute pain, and wherein the human being does not have chronic daily headache.
20 . A method of treating migraine, comprising orally administering one tablet to a human being experiencing a migraine attack, wherein the human being having migraine does not have uncontrolled hypertension, wherein the tablet comprises 20 mg of meloxicam and 14.5 mg of rizatriptan benzoate, wherein the tablet further comprises sodium bicarbonate, wherein the T max of meloxicam in the human being is less than 60 minutes, wherein the human being has acute pain, and wherein the human being does not have chronic daily headache.
21 . The method of claim 1 , wherein the tablet further comprises a sulfobutyl ether β-cyclodextrin or a pharmaceutically acceptable salt thereof.
22 . The method of claim 9 , wherein the tablet further comprises a sulfobutyl ether β-cyclodextrin, or a pharmaceutically acceptable salt thereof.
23 . The method of claim 20 , wherein the tablet further comprises a sulfobutyl ether β-cyclodextrin, or a pharmaceutically acceptable salt thereof.