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Claims for Patent: 9,114,068

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Claims for Patent: 9,114,068

Title:Treating patients with intravenous ibuprofen
Abstract: Methods of treating a patient in need thereof, comprising administering to the critically ill patient an intravenous pharmaceutical composition comprising ibuprofen in an amount effective to treat at least one condition in the patient chosen from pain, inflammation, and fever and to provide a clinically relevant effect on mean arterial pressure of the patients during the dosage interval comprising no increase or no statistically significant increase in mean arterial pressure.
Inventor(s): Pavliv; Leo (Cary, NC), Rock; Amy Dix (Thompson Station, TN)
Assignee: Cumberland Pharmaceuticals, Inc. (Nashville, TN)
Application Number:14/264,267
Patent Claims: 1. A method of treating pain in human patients in need thereof, comprising administering to the human patients an intravenous ibuprofen pharmaceutical composition in an effective dose from about 400 mg to about 800 mg about every 4 to about 6 hours to treat pain, wherein the patients suffer from high blood pressure and do not suffer from inflammation, such that the mean arterial pressure of the patients does not increase during the dosage.

2. The method of claim 1, wherein the patients are critically ill, and the dose of ibuprofen administered attains a mean Cmax of about 20.8 .mu.g/ml to about 75 .mu.g/ml.

3. The method of claim 2, wherein the administered intravenous ibuprofen pharmaceutical composition attains a mean AUC of about 36.8 .mu.gh/ml to about 117.5 .mu.gh/ml.

4. The method of claim 1, wherein the ibuprofen pharmaceutical composition is an aqueous solution of arginine and ibuprofen.

5. The method of claim 4, wherein the molar ratio of arginine to ibuprofen is selected from less than or equal to 1:1, less than or equal to 0.99:1, less than or equal to 0.98:1, less than or equal to 0.97:1, less than or equal to 0.96:1, less than or equal to 0.95:1, less than or equal to 0.94:1, less than or equal to 0.93:1, less than or equal to 0.92:1, less than or equal to 0.91:1, less than or equal to 0.90:1, less than or equal to 0.60:1.

6. The method of claim 1, comprising administering the dose of ibuprofen to the patients about every 6 hours.

7. The method of claim 2, wherein the critically ill patients are patients receiving a treatment selected from the group consisting of vasopressor support, mechanical ventilation, dialysis, multiple antibiotics, pulmonary artery catheter or arterial blood pressure catheter, and combinations of any of the foregoing.

8. The method of claim 1, wherein the dose of ibuprofen pharmaceutical composition administered is selected from the group consisting of 400 mg, 450 mg, 500 mg, 550 mg, 600 mg, 650 mg, 700 mg, and 800 mg.

9. The method of claim 1, wherein the dose of the ibuprofen pharmaceutical composition is administered over 30 minutes.

10. The method of claim 1, wherein the dose of the ibuprofen pharmaceutical composition is about 800 mg.

11. The method of claim 1, wherein the dose of the ibuprofen pharmaceutical composition is about 400 mg.

12. The method of claim 2, wherein the critically ill patients are patients being treated in an Intensive Care Unit.

13. The method of claim 2, wherein the critically ill patients are being administered packed red blood cells.

14. The method of claim 1, comprising administering the dose of the ibuprofen pharmaceutical composition to the patients about every 4 hours.
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