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Claims for Patent: 9,138,404

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Claims for Patent: 9,138,404

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:14/507,331
Patent Claims: 1. A method of treating pain in critically ill patients in need thereof, comprising administering to the critically ill patients an intravenous ibuprofen pharmaceutical composition comprising a dosage regimen of about 400 mg to about 800 mg about every 4 to about 6 hours which attains (i) a Cmax from about 20.8 .mu.g/ml to about 75 .mu.g/ml, (ii) a mean AUC of about 36.8 .mu.gh/ml to about 117.5 .mu.gh/ml, or (iii) both (i) and (ii); wherein the dosage regimen produces a pharmacokinetic profile in critically ill patients that is not equivalent to a pharmacokinetic profile produced by administration of an intravenous pharmaceutical composition comprising a dosage regimen of ibuprofen of about 400 mg to about 800 mg about 4 to about 6 hours to non-critically ill patients, 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, a pulmonary artery catheter treatment, an arterial blood pressure catheter treatment, an Intensive Care Unit treatment, packed red blood cells administration, and multiple antibiotics administration; and pain is thereby treated.

2. The method of claim 1, wherein the dosage regimen administered to the critically ill patients comprises an ibuprofen dose of about 800 mg.

3. The method of claim 2, wherein the dosage regimen administered to the critically ill patients provides a mean Cmax within about 80% to about 125% of 60 .mu.g/ml.

4. The method of claim 1, wherein the dosage regimen administered to the critically ill patients comprises an ibuprofen dose of about 400 mg.

5. The method of claim 2, wherein the dosage regimen administered to the critically ill patients provides a mean Cmax within about 80% to about 125% of 25.7 .mu.g/ml.

6. The method of claim 3, wherein the dose of intravenous ibuprofen administered attains a mean (AUC).sub.0-t within about 80% to about 125% of 94 .mu.gh/ml.

7. The method of claim 4, wherein the dose of intravenous ibuprofen administered attains a mean (AUC)0-t within about 80% to about 125% of 45.9 .mu.gh/ml.

8. The method of claim 1, wherein the dosage regimen administered to the critically ill patients comprises a dosing interval that is shorter than any dosing interval used in the dosage regimen administered to the non-critically ill patients.

9. The method of claim 1, wherein the dose of ibuprofen administered in the dosage regimen administered to the critically ill patients is selected from, 400 mg, 450 mg, 500 mg, 550 mg, 600 mg, 650 mg, 700 mg, and 800 mg.

10. The method of claim 9, wherein the dose of ibuprofen administered is selected from 400 mg and 800 mg.

11. A method of treating pain in critically ill patients in need thereof, comprising administering to the critically ill patients an intravenous ibuprofen pharmaceutical composition comprising a dose of about 800 mg to treat pain in said patients to attain a mean Cmax of within 80-125% of about 60 .mu.g/ml and an AUC within 80-125% of about 94 .mu.gh/ml, wherein the critically ill patients are not suffering from inflammation and are receiving at least one of the following: vasopressor support treatment, mechanical ventilation treatment, a pulmonary artery catheter treatment, an arterial blood pressure catheter treatment, an Intensive Care Unit treatment, packed red blood cells administration, and multiple antibiotics administration.

12. The method of claim 11, wherein the dose of intravenous ibuprofen administered attains a mean (AUC).sub.0-t within about 80% to about 125% of 94 .mu.gh/ml.

13. The method of claim 11, further comprising selecting a dosage interval for the critically ill patients from dosing intervals selected from about 4 hours and about 6 hours.

14. The method of claim 11, further comprising selecting a dosage interval for the critically ill patients of every 4 to 6 hours.

15. The method of claim 11, wherein the critically ill patients are patients being treated in an Intensive Care Unit.

16. The method of claim 11, wherein the critically ill patients are being administered packed red blood cells.

17. The method of claim 11, wherein the critically ill patients are receiving vasopressor support.

18. The method of claim 11, wherein the critically ill patients are receiving multiple antibiotics.

19. The method of claim 11, wherein the critically ill patients are being treated with mechanical ventilation.

20. The method of claim 11, wherein the critically ill patients are being treated with a pulmonary catheter or an arterial blood pressure catheter.
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