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|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 (Excelsior, MN)|
|Assignee:||Orphan Medical, Inc. (Minnetonka, MN)|
|Filing Date:||Dec 22, 1999|
|Claims:||1. A method of rendering an aqueous medium resistant to microbial growth, comprising adding the gamma-hydroxybutyrate salt to the aqueous medium, adjusting the concentration of the gamma-hydroxybutyrate salt in the aqueous medium to a final concentration of at least about 250 mg/ml, and adjusting the pH of the medium to a final pH of about 6 to about 10, so that the medium is chemically stable and resistant to microbial growth. |
2. The method of claim 1 wherein the salt is sodium gamma-hydroxybutyrate.
3. The method of claim 1 or 2 wherein the final concentration is from about 310 to about 750 mg/ml and the final pH is about 6 to about 9.
4. The method of claim 1, 2, or 3 wherein the medium does not contain a preservative.
5. The method of claim 1, wherein the concentration of said gamma-hydroxybutyrate is from about 250 to about 750 mg/ml.
6. The method of claim 1, wherein said pH-adjusting agent is an organic acid.
7. The method of claim 6, 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, sulfonic acid and nitric acid.