IP Library Granted Patent US 8,871,810
Granted Patent B2
US 8,871,810 · App. 12/646,499 · Granted Oct 28, 2014

Treating critically ill patients with intravenous ibuprofen

Inventors: Leo Pavliv (Cary, NC); Amy Dix Rock (Nashville, TN)
Assignee: Cumberland Pharmaceuticals Inc.
A61K31/192A61K31/197
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Quick Facts
Patent No.
US 8,871,810
App. No.
12/646,499
Granted
Oct 28, 2014
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 (13)

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 μg/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 μg/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 μg.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.

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 Mar 12, 2010
From: PAVLIV, LEO; ROCK, AMY DIX
To: CUMBERLAND PHARMACEUTICALS INC.
Reel/Frame 024076/0233 →
Continuity (5)
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 20110028553A1 · Feb 3, 2011