Claims for Patent: 8,871,810

Summary for Patent: 8,871,810

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:	12/646,499
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,871,810
Patent Claims:	1. A method of treating pain in critically ill patients in need thereof, comprising administering to critically ill patients an intravenous ibuprofen pharmaceutical composition in a dose of about 800 mg and providing a mean Cmax of about 60 .mu.g/ml to treat pain in said patients, wherein the critically ill patients are not suffering from inflammation and are receiving at least one treatment selected from vasopressor support and mechanical ventilation. 2. The method of claim 1 wherein the pharmaceutical composition is an aqueous solution of arginine and ibuprofen. 3. The method of claim 1, 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. 4. A method of treating pain in critically ill patients in need thereof, comprising administering to critically ill patients who are in pain, not suffering from inflammation and are selected from the group consisting of patients who are being administered large volumes of blood products; are receiving multiple antibiotics; have a pulmonary artery catheter or an arterial blood pressure catheter inserted; and combinations of any of the foregoing, an intravenous ibuprofen pharmaceutical composition in a dose of 800 mg such that the dose reduces pain in the critically ill patients. 5. The method of claim 4, wherein the dose of intravenous ibuprofen administered to the critically ill patients provides a mean Cmax of about 60 .mu.g/ml. 6. The method of claim 5, wherein the dose of intravenous ibuprofen administered provides a mean (AUC)0-t within about 80% to about 125% of 94 .mu.g.h/ml. 7. The method of claim 4, further comprising selecting a dosage interval for the critically ill patients from dosing intervals of greater than 4 hours and greater than 6 hours. 8. The method of claim 4, further comprising administering the pharmaceutical composition as an aqueous solution of arginine and ibuprofen. 9. The method of claim 8, 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. 10. The method of claim 1, wherein the critically ill patients are patients who: 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. 11. The method of claim 1, further comprising selecting a dosage interval for the critically ill patients of every 4 to 6 hours. 12. The method of claim 4, further comprising selecting a dosage interval for the critically ill patients of every 4 to 6 hours. 13. The method of claim 1, further comprising selecting a dosage interval for the critically ill patients from dosing intervals of greater than 4 hours and greater than 6 hours.