Details for Patent: 9,155,718

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)
Filing Date:	Oct 01, 2014
Application Number:	14/504,159
Claims:	1. A liquid composition comprising ibuprofen and diphenhydramine in amounts effective to treat a pain-associated sleep disturbance, wherein the liquid composition consists of: about 200 to about 400 mg of ibuprofen; about 10 to about 50 mg of diphenhydramine; polyethylene glycol; potassium hydroxide; and water; wherein the liquid composition is formulated inside a soft gelatin capsule, and wherein the polyethylene glycol reduces interaction between the ibuprofen and the diphenhydramine inside the soft gelatin capsule. 2. The liquid composition of claim 1, wherein the ibuprofen and diphenhydramine are dissolved in the polyethylene glycol, potassium hydroxide and water solution. 3. The liquid composition of claim 1, wherein the diphenhydramine is present as diphenhydramine HCl or diphenyhydramine citrate. 4. The liquid composition of claim 3, wherein the diphenhydramine HCl is present in a range from about 12.5 mg to about 50 mg. 5. The liquid composition of claim 4, wherein the diphenhydramine HCl is present in a range from about 25 mg to about 50 mg. 6. The liquid composition of claim 5, wherein the diphenhydramine HCl is present in an amount of about 25 mg. 7. The liquid composition of claim 3, wherein the diphenhydramine citrate is present in a range from about 19 mg to 38 mg. 8. The liquid composition of claim 7, wherein the diphenhydramine citrate is present in an amount of 38 mg. 9. The liquid composition of claim 1, wherein the ibuprofen is present in a range from about 200 mg to about 300 mg. 10. The liquid composition of claim 1, wherein the ibuprofen is present in an amount about 200 mg. 11. A liquid composition formulated inside a soft gelatin capsule, wherein the liquid composition consists of: about 200 mg ibuprofen, about 38 mg diphenhydramine, polyethylene glycol, potassium hydroxide, and water; wherein the polyethylene glycol reduces interaction between the ibuprofen and the diphenhydramine inside the soft gelatin capsule.