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Claims for Patent: 8,883,849

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Claims for Patent: 8,883,849

Title:Treatment of sleep disturbances
Abstract: The present invention provides a new composition for treating pain-associated sleep disturbances, especially shortened sleep duration, comprising ibuprofen and diphenhydramine. The composition is further prepared as a bilayer tablet or caplet, or alternatively as a soft gelatin capsule composition, to prevent interaction between the active ingredients.
Inventor(s): Cook; Graham D. (Midlothian, VA), Koch; Todd S. (Powhatan, VA), Giamalva; David H. (Glen Allen, VA), Bianco; Justin (Vineland, NJ), Fort; James J. (Midlothian, VA), Doyle; Geraldine (Chatham, NJ), Cooper; Steven (Denville, NJ)
Assignee: Wyeth LLC (New York, NY)
Application Number:13/584,054
Patent Claims: 1. A method of treating a patient suffering from a pain-associated sleep disturbance comprising administering a liquid composition formulated inside a soft gelatin capsule to the patient, wherein the liquid composition consists of: from about 200 to about 400 mg of ibuprofen; from about 10 to about 50 mg of diphenhydramine; polyethylene glycol; potassium hydroxide; and water.

2. The method of claim 1, wherein the sleep disturbance affects sleep duration.

3. The method of claim 1, wherein the ibuprofen and diphenhydramine are dissolved in the polyethylene glycol, potassium hydroxide and water solution.

4. The method of claim 1, wherein the diphenhydramine is present as diphenhydramine HCI or diphenyhydramine citrate.

5. The method of claim 4, wherein the diphenhydramine HCI is present in a range from about 12.5 mg to about 50 mg.

6. The method of claim 5, wherein the diphenhydramine HCI is present in a range from about 25 mg to about 50 mg.

7. The method of claim 6, wherein the diphenhydramine HCI is present in an amount of about 25 mg.

8. The method of claim 4, wherein the diphenhydramine citrate is present in a range from about 19 mg to 38 mg.

9. The method of claim 8, wherein the diphenhydramine citrate is present in an amount of 38 mg.

10. The method of claim 1, wherein the ibuprofen is present in a range from about 200 mg to about 300 mg.

11. The method of claim 10, wherein the ibuprofen is present in an amount about 200 mg.

12. The method of claim 1, wherein one dose of the composition is administered.

13. The method of claim 1, wherein two doses of the composition are administered.

14. The method of claim 1, wherein one dose of the composition is administered and a second dose is optionally administered.

15. A method of treating a patient suffering from a pain-associated sleep disturbance comprising administering a liquid composition formulated inside a soft gelatin capsule to the patient, wherein the liquid composition consists of: from about 200 mg to about 400 mg ibuprofen, from about 12.5 mg to about 50 mg diphenhydramine, polyethylene glycol, potassium hydroxide, and water.

16. The method of claim 15, wherein the diphenhydramine is present as diphenhydramine HCI or diphenyhydramine citrate.

17. The method of claim 16, wherein the diphenhydramine HCI is present in an amount of about 25 mg.

18. The method of claim 16, wherein the diphenhydramine citrate is present in an amount of 38 mg.

19. The method of claim 15, wherein the ibuprofen is present in an amount about 200 mg.

20. The method of claim 15, wherein the ibuprofen and diphenhydramine are dissolved in the polyethylene glycol,potassium hydroxide and water solution.

21. The method of claim 15, wherein one dose of the composition is administered.

22. The method of claim 15, wherein two doses of the composition are administered.

23. The method of claim 15, wherein one dose of the composition is administered and a second dose is optionally administered.
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