Claims for Patent: 9,295,639

Summary for Patent: 9,295,639

Title:	Treating critically ill patients with intravenous ibuprofen
Abstract:	Methods of treating at least one condition chosen from pain, inflammation, and fever in a critically ill patient in need thereof, comprising administering to the critically ill patient an intravenous pharmaceutical composition comprising ibuprofen using a first dosage regimen, wherein the first dosage regimen produces a first pharmacokinetic profile in critically ill patients that is about equivalent to a second pharmacokinetic profile produced by administration of the intravenous pharmaceutical composition using a second dosage regimen of ibuprofen to non-critically ill patients, wherein the at least one condition of the critically ill patient is thereby treated.
Inventor(s):	Pavliv; Leo (Cary, NC), Rock; Amy Dix (Nashville, TN)
Assignee:	Cumberland Pharmaceuticals Inc. (Nashville, TN)
Application Number:	12/830,991
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,295,639
Patent Claims:	1. A method of treating pain in critically ill patients in need thereof, comprising intravenously administering to a critically ill patient an ibuprofen pharmaceutical composition in a dose of about 400 mg, to attain a mean Cmax within about 80% to about 125% of 25.7 .mu.g/ml and a mean (AUC).sub.0-4 within about 80% to about 125% of 45.9 .mu.gh/ml, the critically ill patient receiving at least one treatment selected from vasopressor support and mechanical ventilation, wherein the patients are not being treated for inflammation and the dose of ibuprofen administered intravenously to the critically ill patient provides a Cmax and AUC which is about one-half of the Cmax and AUC obtained when the same dose is intravenously administered to a non-critically ill patient. 2. The method of claim 1, further comprising selecting a dosage interval for the critically ill patient of every 4 to 6 hours. 3. The method of claim 1, further comprising intravenously administering a 400 mg dose of ibuprofen to a critically ill patient, and thereafter intravenously administering a dose of 800 mg ibuprofen to the critically ill patient in order to treat the patient's pain. 4. The method of claim 1, further comprising selecting a dosage interval for the critically ill patient of every 4 to 6 hours, intravenously administering a 400 mg dose of ibuprofen to a critically ill patient, and thereafter intravenously administering a dose of 800 mg ibuprofen to the critically ill patient in order to treat the patient's pain. 5. A method of treating pain in a critically ill patient in need thereof, comprising intravenously administering to a critically ill patient an ibuprofen pharmaceutical composition in a dose from about 400 mg to about 800 mg to attain a mean Cmax from about 80 to about 125% of about 25.7 .mu.g/ml to about 60 .mu.g/ml, wherein the critically ill patient is not being treated for inflammation and is receiving at least one of the following: vasopressor support treatment, mechanical ventilation treatment, pulmonary catheter treatment, an arterial blood pressure catheter treatment, Intensive Care Unit treatment, packed red blood cells administration, and multiple antibiotics administration, and pain is thereby treated. 6. The method of claim 5, further comprising intravenously administering the ibuprofen pharmaceutical composition every 4 to 6 hours. 7. The method of claim 5, wherein the dose of ibuprofen is about 800 mg. 8. The method of claim 7, wherein the dose of ibuprofen provides a mean Cmax within about 80% to about 125% of 60 .mu.g/ml and a mean (AUC).sub.0-t within about 80% to about 125% of 94 .mu.gh/ml. 9. The method of claim 5, wherein the dose of ibuprofen is about 400 mg. 10. The method of claim 9, wherein the dose of intravenous ibuprofen administered to the critically ill patient is 400 mg and provides a mean Cmax within about 80% to about 125% of 25.7 .mu.g/ml and a mean (AUC).sub.0-4 within about 80% to about 125% of 45.9 .mu.gh/ml. 11. The method of claim 5, wherein the critically ill patient is receiving Intensive Care Unit treatment. 12. The method of claim 5, wherein the critically ill patient is receiving vasopressor support treatment. 13. The method of claim 5, wherein the critically ill patient is receiving mechanical ventilation treatment. 14. The method of claim 5, wherein the critically ill patient is receiving pulmonary or arterial blood pressure catheter treatment. 15. The method of claim 5, wherein the critically ill patient is receiving multiple antibiotics. 16. The method of claim 5, wherein the critically ill patient is being administered packed red blood cells.