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Claims for Patent: 8,859,619

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Claims for Patent: 8,859,619

Title:Microbiologically sound and stable solutions of gamma-hydroxybutyrate salt for the treatment of narcolepsy
Abstract: Disclosed are formulations of gamma-hydroxybutyrate in an aqueous medium that are resistant to microbial growth. Also disclosed are formulations of gamma-hydroxybutyrate that are also resistant to the conversion into GBL. Disclosed are methods to treat sleep disorders, including narcolepsy, with these stable formulations of GHB. The present invention also provides methods to treat alcohol and opiate withdrawal, reduced levels of growth hormone, increased intracranial pressure, and physical pain in a patient.
Inventor(s): Cook; Harry (Eden Prairie, MN), Hamilton; Martha (St. Paul, MN), Danielson; Douglas (Wyoming, MI), Goderstad; Colette (St. Paul, MN), Reardan; Dayton T. (Shorewood, MN)
Assignee: Jazz Pharmaceuticals, Inc. (Palo Alto, CA)
Application Number:13/685,561
Patent Claims: 1. A pharmaceutical composition, comprising a solution of between about 350 and 750 mg/ml of a salt of gamma-hydroxybutyrate, wherein the composition has a pH of between about 7.0 to about 9.0, wherein the composition is chemically stable and resistant to microbial growth.

2. A composition in accordance with claim 1, wherein the salt is selected from the group consisting of sodium, ammonium, calcium and magnesium forms of gamma-hydroxybutyrate.

3. A composition in accordance with claim 1, wherein the salt is selected from the group consisting of sodium and calcium forms of gamma-hydroxybutyrate.

4. A composition in accordance with claim 1, wherein the composition contains a salt selected from the group consisting of lithium, potassium, sodium, calcium, ammonium, and magnesium.

5. A composition in accordance with claim 1, wherein the composition contains a salt selected from the group consisting of potassium, sodium, calcium, and magnesium.

6. The pharmaceutical composition of claim 1, wherein the composition has a pH of between about 7.3 to about 8.5.

7. The pharmaceutical composition of claim 1, wherein the composition additionally comprises a pH adjusting or buffering agent.

8. The pharmaceutical composition of claim 7, wherein the pH adjusting or buffering agent is an acid.

9. The pharmaceutical composition of claim 8, wherein the acid is an inorganic acid.

10. The pharmaceutical composition of claim 8, wherein the acid is an organic acid.

11. The pharmaceutical composition of claim 8, wherein the acid is selected from the group consisting of malic acid, citric acid, acetic acid, boric acid, lactic acid, hydrochloric acid, phosphoric acid, sulfuric acid, and nitric acid or combinations thereof.

12. The pharmaceutical composition of claim 11, wherein the acid is malic acid.

13. A pharmaceutical composition, comprising a solution of between about 400 and about 600 mg/ml of a salt of gamma-hydroxybutyrate, selected from the group consisting of potassium, sodium, calcium, and magnesium, wherein the composition has a pH of between about 8.5 to about 7.0, wherein the composition is chemically stable and resistant to microbial growth.

14. A set comprising the pharmaceutical composition of claim 1 in one or more container means.

15. The set of claim 14, wherein the one or more container means are selected from the group consisting of a drinking cup, a dosing cup, a syringe, a pipette, a vial, an ampule, a test tube, a flask, a bottle, and a pouch syringe.

16. The set of claim 15, comprising a third container means capable of retaining a first container means, a second container means, and one or more delivery vehicles capable of administering the pharmaceutical composition to a patient.

17. The set of claim 16, wherein the first container means comprises the pharmaceutical composition, and the second container means comprises a diluent.

18. The composition of claim 1, optionally further comprising a preservative.

19. The composition of claim 1, optionally further comprising propylparaben.

20. The composition of claim 13, optionally further comprising a preservative.

21. The composition of claim 13, optionally further comprising propylparaben.
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