Microbiologically sound and stable solutions of gamma-hydroxybutyrate salt for the treatment of narcolepsy
AssigneeOrphan Medical, Inc., A Minnesota Corporation
InventorsHarry Cook, Martha Hamilton, Douglas Danielson, Colette Goderstad, Dayton 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 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.
Claims64
A pharmaceutical composition, comprising gamma-hydroxybutyrate in an aqueous medium rendered chemically stable and resistant to microbial growth.
A pharmaceutical composition, comprising sodium gamma hydroxybutyrate (sodium oxybate) and an acid in an aqueous medium rendered chemically stable and resistant to microbial growth.
An aqueous pharmaceutical composition, comprising gamma-hydroxybutyrate and malic acid rendered chemically stable in an aqueous medium resistant to microbial growth.
A pharmaceutical composition, comprising sodium oxybate and malic acid rendered chemically stable in an aqueous medium resistant to microbial growth.
A method of preparing a chemically stable and microbial growth resistant pharmaceutical composition for the treatment of a condition responsive to gamma-hydroxybutyrate, comprising admixing gamma-hydroxybutyrate and a pH-adjusting agent in an aqueous medium.
A method of preparing a chemically stable and microbial growth resistant pharmaceutical composition for the treatment of a condition responsive to gamma-hydroxybutyrate, comprising the steps of:
- a.) admixing gamma-hydroxybutyrate and an aqueous medium;
- b.) adding a pH adjusting agent while maintaining the mixture at or below 40° C.;
- and
- c.) producing a composition with a pH between about 3 and about 10.3.
A method of treating a condition responsive to gamma-hydroxybutyrate, comprising administering to a patient suspected of having said condition a therapeutic amount of a pharmaceutical composition comprising chemically stable and microbially growth resistant gamma-hydroxybutyrate.
A set for the treatment of a condition responsive to gamma-hydroxybutyrate comprising, in a suitable container, gamma-hydroxybutyrate and a pH adjusting agent.
A mixture comprising gamma-hydroxybutyrate and a pH adjusting agent in proportions so that when admixed in an aqueous medium, a pH of about 3 to about 10.3 is obtained.
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.
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.
A set for the treatment of a condition responsive to gamma-hydroxybutyrate, comprising:
- (A) water;
- (B) malic acid as a pH adjusting agent;
- and
- (C) sodium gamma-hydroxybutyrate;
- wherein components (A), (B), and (C) are packaged separately, in a suitable storage means, and wherein (A), (B) and (C) when combined yield a solution having a concentration of 500 mg/ml of sodium gamma-hydroxybutyrate and a pH of about 7.5.
Dependencies are inferred from the claim text.