Treatment of sleep disturbances
View Patent ↗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.
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.