IP Library Granted Patent US 9,649,284
Granted Patent B2
US 9,649,284 · App. 14/825,803 · Granted May 16, 2017

Treating critically ill patients with intravenous ibuprofen

Inventors: Leo Pavliv (Cary, NC); Amy Dix Rock (Nashville, TN)
Assignee: Cumberland Pharmaceuticals, Inc.
A61K31/192A61K9/0019A61K31/197A61K45/06
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Quick Facts
Patent No.
US 9,649,284
App. No.
14/825,803
Granted
May 16, 2017
Kind
B2
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.

Claims (19)

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 μg/ml to about 75 μg/ml; (ii) a mean AUC from about 36.8 μg.h/ml to about 117.5 μg.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 μg/ml to about 75 μg/ml.

4. The method of claim 2 , wherein the first dosage regimen provides a mean Cmax within about 80% to about 125% of 60 μg/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 μg/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 μg.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 μg.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 μg/ml to about 75 μg/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 μg/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 μg.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 μg/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 μg.h/ml.

Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 25, 2026
From: CUMBERLAND PHARMACEUTICALS INC.
To: APOTEX CORP.
Reel/Frame 075763/0709 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 16, 2015
From: PAVLIV, LEO; ROCK, AMY DIX
To: CUMBERLAND PHARMACEUTICALS INC.
Reel/Frame 036807/0636 →
Continuity (7)
Continuation 14507331 · Oct 6, 2014
Continuation 12646499 · Dec 23, 2009
Continuation In Part 12570912 · Sep 30, 2009
Provisional Application 61230324 · Jul 31, 2009
Provisional Application 61230342 · Jul 31, 2009
Provisional Application 61225778 · Jul 15, 2009
Related Publication 20160113894A1 · Apr 28, 2016