Claims for Patent: 9,649,284

Summary for Patent: 9,649,284

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:	14/825,803
Patent Claims:	1. A method of treating pain in critically ill patients in need thereof, comprising administering to critically ill patients a dosage regimen of an intravenous ibuprofen pharmaceutical composition comprising from about 400 mg to about 800 mg ibuprofen about every 4 to about 6 hours which attains (i) a mean Cmax from about 20.8 .mu.g/ml to about 75 .mu.g/ml; (ii) a mean AUC from about 36.8 .mu.g.h/ml to about 117.5 .mu.g.h/ml; or (iii) both (i) and (ii); wherein the critically ill patients are not being treated for inflammation and are receiving at least one of the following: vasopressor support treatment, mechanical ventilation treatment, large volumes of blood products; multiple antibiotics; have a pulmonary artery catheter treatment, an arterial blood pressure catheter treatment, inserted; are being treated in an Intensive Care Unit; packed red blood cells administration, undergoing veno-venous hemofiltration, and multiple antibiotics administration; and pain is thereby treated. 2. The method of claim 1, wherein the dosage regimen comprises an ibuprofen dose of about 800 mg. 3. The method of claim 1, wherein the dosage regimen attains a Cmax of about 20.8 .mu.g/ml to about 75 .mu.g/ml. 4. The method of claim 2, wherein the first dosage regimen provides a mean Cmax within about 80% to about 125% of 60 .mu.g/ml. 5. The method of claim 1, wherein the dosage regimen comprises an ibuprofen dose of about 400 mg. 6. The method of claim 5, wherein the dosage regimen provides a mean Cmax within about 80% to about 125% of 25.7 .mu.g/ml. 7. The method of claim 2, 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. 8. 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 45.9 .mu.g.h/ml. 9. The method of claim 1, wherein the dose of ibuprofen administered in the dosage regimen is 800 mg. 10. The method of claim 1, wherein the critically ill patients are patients who are being treated in an Intensive Care Unit. 11. The method of claim 2, wherein the critically ill patients are patients who are being treated in an Intensive Care Unit. 12. The method of claim 4, wherein the critically ill patients are patients who are being treated in an Intensive Care Unit. 13. A method of treating pain in critically ill patients in need thereof, comprising administering to critically ill patients a dosage regimen of an intravenous ibuprofen pharmaceutical composition comprising from about 400 mg to about 800 mg ibuprofen about every 4 to about 6 hours which attains a Cmax from about 20.8 .mu.g/ml to about 75 .mu.g/ml; wherein the critically ill patients are not being treated for inflammation and are receiving a treatment selected from vasopressor support, mechanical ventilation, and both vasopressor support and mechanical ventilation, and pain is thereby treated. 14. The method of claim 13, wherein the dosage regimen comprises an ibuprofen dose of about 800 mg. 15. The method of claim 14, wherein the dosage regimen provides a mean Cmax within about 80% to about 125% of 60 .mu.g/ml. 16. The method of claim 14, 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. 17. The method of claim 13, wherein the dosage regimen comprises an ibuprofen dose of about 400 mg. 18. The method of claim 17, wherein the dosage regimen provides a mean Cmax within about 80% to about 125% of 25.7 .mu.g/ml. 19. The method of claim 17, wherein the dose of intravenous ibuprofen administered provides a mean (AUC)0-t within about 80% to about 125% of 45.9 .mu.g.h/ml.