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Details for Patent: 8,461,203

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Details for Patent: 8,461,203

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 (Otsego, MI), Goderstad; Colette (St. Paul, MN), Reardan; Dayton T. (Shorewood, MN)
Assignee: Jazz Pharmaceuticals, Inc. (Palo Alto, CA)
Filing Date:Jul 13, 2011
Application Number:13/182,324
Claims:1. A method of rendering an aqueous medium resistant to microbial growth, said method comprising admixing a salt of gamma hydroxybutyrate with the aqueous medium, adjusting the concentration of the gamma-hydroxybutyrate salt in the aqueous medium to a final concentration of from about 310 to about 750 mg/ml, and adjusting the pH of the medium to a final pH of about 6 to about 9, so that the medium is chemically stable and resistant to microbial growth, wherein the medium would not need to contain a preservative.

2. The method of claim 1, wherein said salt is sodium gamma-hydroxybutyrate.

3. The method of claim 1, wherein said pH-adjusting agent is an organic acid.

4. The method of claim 3, wherein said acid is selected from the group consisting of malic acid, citric acid, acetic acid, boric acid, lactic acid, hyrochloric acid, phosphoric acid, sulfuric acid, and nitric acid.

5. The method of claim 1, wherein the concentration is from about 450 to about 600 mg/ml.

6. The method of claim 1, wherein the concentration is about 500 mg/ml.

7. The method of claim 1, wherein the components are admixed sequentially.

8. The method of claim 1, wherein the components are admixed simultaneously.

9. A method of rendering an aqueous medium comprising a salt of gamma-hydroxybutyrate resistant to microbial growth, said method comprising adjusting the concentration of the gamma-hydroxybutyrate salt in the aqueous medium to a final concentration of from about 310 to about 750 mg/ml, and adjusting the pH of the medium to a final pH of about 6 to about 9, so that the medium is chemically stable and resistant to microbial growth, wherein the medium does not contain a preservative.

10. A method of rendering an aqueous medium comprising a salt of gamma-hydroxybutyrate resistant to microbial growth, said method comprising contacting a salt of gamma hydroxybutyrate with the aqueous medium, adjusting the concentration of the gamma-hydroxybutyrate salt in the aqueous medium to a final concentration of from about 310 to about 750 mg/ml, and adjusting the pH of the medium to a final pH of about 6 to about 9, so that the medium is chemically stable and resistant to microbial growth, wherein the medium does not contain a preservative.

11. The method of claim 9 or 10, wherein the salt is sodium gamma-hydroxybutyrate.

12. The method of claim 9 or 10, wherein said pH-adjusting agent is an organic acid.

13. The method of claim 12, wherein said 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.

14. The method of claim 9 or 10, wherein the concentration of the gamma-hydroxybutyrate salt is from about 450 to about 600 mg/ml.

15. The method of claim 9 or 10, wherein the concentration of the gamma-hydroxybutyrate salt is about 500 mg/ml.

16. The method of claim 1, wherein the medium does not contain a preservative.
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