Microbiologically sound and stable solutions of gamma-hydroxybutyrate salt for the treatment of narcolepsy
AssigneeJazz Pharmaceuticals, Inc.
InventorsHarry Cook, Martha Hamilton, Douglas Danielson, Colette Goderstad, Dayton T. Reardan
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Abstract
Disclosed are formulations of gamma-hydroxybutyrate in an aqueous medium that are resistant to microbial growth. Also disclosed are formulations of gammahydroxybutyrate 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.
Claims26
A pharmaceutical composition, comprising a solution of between 350 and 750 mg/ml of a salt of gamma-hydroxybutyrate, wherein the composition has a pH of between 7.0 to 9.0, wherein the composition is chemically stable and resistant to microbial growth and further consists of a preservative selected from the group consisting of sodium benzoate, methylparaben, propyl gallate BP, sorbic acid, chlorobutanol, dihydroacetic acid, monothioglycerol, potassium benzoate, benzoic acid, benzalkonium chloride, benzethonium chloride, benzyl alcohol, butylparaben, cetylpyridinium chloride, ethylenediamine, ethylparaben, glycerin, hypophosphorus acid, phenylmercuric nitrate, sassafras oil, sodium propionate, thimerosal, magnesium stearate, magnesium carbonate and potassium sorbate.
A pharmaceutical composition, comprising a solution of between 400 and 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 8.5 to 7.0, wherein the composition is chemically stable and resistant to microbial growth and comprises sodium benzoate.
A pharmaceutical composition, comprising a solution of between 400 and 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 8.5 to 7.0, wherein the composition is chemically stable and resistant to microbial growth and comprises butylparaben.
A pharmaceutical composition comprising a solution of between 400 and 600 mg/ml of a sodium salt of gamma-hydroxybutyrate, wherein the composition has a pH of between 8.5 to 7.0.
Dependencies are inferred from the claim text.