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Claims for Patent: 8,735,452

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Claims for Patent: 8,735,452

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 (Nashville, TN)
Assignee: Cumberland Pharmaceuticals Inc. (Nashville, TN)
Application Number:12/699,595
Patent Claims: 1. A method of treating pain in human patients in need thereof, comprising administering to human patients an intravenous ibuprofen pharmaceutical composition in an effective dose from about 400 mg to about 800 mg every 4 to 6 hours, to attain a mean Cmax of about 20.8 .mu.g/ml to about 60 .mu.g/ml to treat pain, wherein the patients are patients selected from the group consisting of patients having a mean arterial pressure prior to intravenous administration of the intravenous ibuprofen, such that the mean arterial pressure of the patients does not increase during the dosage interval from a baseline level measured prior to intravenous administration of the ibuprofen, the patients are critically ill and the patients are not suffering from inflammation.

2. The method of claim 1, further comprising administering to the critically ill patients an intravenous ibuprofen pharmaceutical composition in a dose from about 400 mg to about 800 mg every 4 to 6 hours, to attain a mean AUC of about 36.8 .mu.gh/ml to about 117.5 .mu.gh/ml.

3. A method of treating human patients, comprising administering to the patients an intravenous ibuprofen pharmaceutical composition in an amount effective to treat pain in the patients and providing no statistically significant increase in mean arterial pressure to said patients wherein the human patients are critically ill and wherein the patients are not suffering from inflammation, the critically ill patients being selected from the group consisting of patients who are being administered large volumes of blood products; are undergoing dialysis; are receiving multiple antibiotics; have a pulmonary artery catheter or an arterial blood pressure catheter inserted; and combinations of any of the foregoing.

4. The method of claim 3, wherein the dose of intravenous ibuprofen administered to the critically ill patients is 400 mg and provides a mean Cmax within about 80% to about 125% of 25.7 .mu.g/ml.

5. The method of claim 3, wherein the dose of intravenous ibuprofen administered to the critically ill patients is 400 mg and provides a mean (AUC).sub.0-4 within about 80% to about 125% of 45.9 .mu.gh/ml.

6. The method of claim 3, wherein the dose of intravenous ibuprofen administered to the critically ill patients is 800 mg and provides a mean Cmax of about 80% of 60 .mu.g/ml.

7. The method of claim 6, wherein the dose of intravenous ibuprofen administered to the critically ill patients is 800 mg and provides a mean (AUC).sub.0-t, within about 80% to about 125% of 94 .mu.gh/ml.

8. The method of claim 3, wherein the dose administered to the patients is from 100 to 1600 mg.

9. The method of claim 3, wherein the dose of ibuprofen administered is selected from 100 mg, 150 mg, 200 mg, 250 mg, 300 mg, 350 mg, 400 mg, 450 mg, 500 mg, 550 mg, 600 mg, 650 mg, 700 mg, 800 mg, 1000 mg, 1200 mg, 1400 mg, 1600 mg, 2400 mg, and 3200 mg.

10. The method of claim 3, wherein the dose of ibuprofen administered is selected from 100 mg, 200 mg, 400 mg, and 800 mg.

11. The method of claim 3, further comprising administering the dose of ibuprofen to the patients in a dosing interval selected from the group consisting of about every 4 hours, about every 6 hours, and greater than every 6 hours.

12. The method of claim 3, further comprising administering the pharmaceutical composition as an aqueous solution of arginine and ibuprofen.

13. A method of treating pain in critically ill patients in need thereof having increased risk of cardiovascular events, wherein the patients are not suffering from inflammation, comprising administering to critically ill patients an intravenous pharmaceutical composition comprising ibuprofen to treat pain in the patients at a dosage of (i) 100 mg ibuprofen to attain a mean Cmax of about 8.2 .mu.g/ml.+-.6.3; or (ii) 200 mg ibuprofen to attain a mean Cmax of about 11.5 .mu.g/ml.+-.2.8; or (iii) 400 mg ibuprofen to attain a mean Cmax of about 25.7 .mu.g/ml.+-.8.3 or (iv) 800 mg ibuprofen to attain a mean Cmax of about 60 .mu.g/ml, the dose of ibuprofen providing no statistically significant increase in mean arterial pressure to said patients.

14. The method of claim 1, wherein the critically ill patients are patients receiving a treatment selected from the group consisting of vasopressor support; mechanical ventilation; are being treated in an Intensive Care Unit; are being administered large volumes of blood products; are undergoing dialysis; are receiving multiple antibiotics; have a pulmonary artery catheter or an arterial blood pressure catheter inserted; and combinations of any of the foregoing.

15. The method of claim 13, wherein the critically ill patients are patients receiving a treatment selected from the group consisting of vasopressor support; mechanical ventilation; are being treated in an Intensive Care Unit; are being administered large volumes of blood products; are undergoing dialysis; are receiving multiple antibiotics; have a pulmonary artery catheter or an arterial blood pressure catheter inserted; and combinations of any of the foregoing.

16. A method of treating pain in critically ill patients having increased risk of cardiovascular events, wherein the patients are not suffering from inflammation, comprising intravenously administering to critically ill patients a dose of an intravenous ibuprofen pharmaceutical composition in an amount effective to treat pain in the critically ill patients, the dose of intravenous ibuprofen providing no statistically significant increase in mean arterial pressure to said patients.
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