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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)|
|Patent Claims:||1. A pharmaceutical composition, consisting essentially of an aqueous solution of 500 mg/ml sodium gamma-hydroxybutyrate, and malic acid as a pH adjusting agent, wherein the composition has a pH of about 7.5, and wherein the composition is chemically stable and resistant to microbial growth, and wherein the composition is free of preservatives.|
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