Microbiologically sound and stable solutions of gamma-hydroxybutyrate salt for the treatment of narcolepsy

• US 7,851,506 B2
• Filed: 07/13/2007
• Issued: 12/14/2010
• Est. Priority Date: 12/23/1998
• Status: Expired due to Fees

• Current Assignee: Jazz Pharmaceuticals Incorporated (Jazz Pharmaceuticals Plc)
• Original Assignee: Jazz Pharmaceuticals Incorporated (Jazz Pharmaceuticals Plc)
• Inventors: Reardan, Dayton, Hamilton, Martha, Goderstad, Colette, Danielson, Douglas, Cook, Harry
• Primary Examiner(s): Henley, III; Raymond J
• Application Number:
  US11/777,877
• Publication Number:
  US 20070270491A1
• Time in Patent Office: 1,250 Days
• Field of Search: 514/557
• US Class Current: 514/557
• CPC Class Codes: A61J 1/00 Containers specially adapted for medical or pharmaceutical purposes capsules or the like for oral use A61J3/07; specially adapted for surgical or diagnostic appliances or instruments A61B50/30; containers for radioactive substances G21F5/00
• CPC Class Codes: A61K 31/19 Carboxylic acids, e.g. valproic acid salicylic acid A61K31/60
• CPC Class Codes: A61K 31/191 having two or more hydroxy groups, e.g. gluconic acid
• CPC Class Codes: A61K 47/02 Inorganic compounds
• CPC Class Codes: A61K 47/08 containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
• CPC Class Codes: A61K 47/12 Carboxylic acids; Salts or anhydrides thereof
• CPC Class Codes: A61K 47/14 Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
• CPC Class Codes: A61K 9/0019 Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner non-active ingredients are additionally classified in A61K47/00
• CPC Class Codes: A61K 9/0095 Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches A61K9/0007 takes precedence; eatable gels or foams A61K9/0056; oral mucosa adhesive forms A61K9/006
• CPC Class Codes: A61P 11/00 Drugs for disorders of the respiratory system
• CPC Class Codes: A61P 21/00 Drugs for disorders of the muscular or neuromuscular system
• CPC Class Codes: A61P 25/00 Drugs for disorders of the nervous system
• CPC Class Codes: A61P 25/16 Anti-Parkinson drugs
• CPC Class Codes: A61P 25/20 Hypnotics; Sedatives
• CPC Class Codes: A61P 25/22 Anxiolytics
• CPC Class Codes: A61P 25/24 Antidepressants
• CPC Class Codes: A61P 25/30 for treating abuse or dependence
• CPC Class Codes: A61P 25/32 Alcohol-abuse
• CPC Class Codes: A61P 25/36 Opioid-abuse
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
• CPC Class Codes: A61P 5/00 : Drugs for disorders of the endocrine system
• CPC Class Codes: A61P 5/06 : of the anterior pituitary hormones, e.g. TSH, ACTH, FSH, LH, PRL, GH

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.

Claims

1. A method of treating a condition responsive to sodium gamma-hydroxybutyrate, comprising orally administering to a patient afflicted with the condition an aqueous composition comprising a first dose of about 4.5 to about 10 grams of sodium gamma-hydroxybutyrate within an hour prior to initial sleep onset and an aqueous composition comprising a second dose of about 4.5 to about 10 grams within 2 to 5 hours following initial sleep onset, wherein the aqueous composition of the first dose and the aqueous composition of the second dose each comprises a respective concentration of sodium gamma-hydroxybutyrate of greater than about 500 mg/mL, wherein the condition is selected from the group consisting of apnea, sleep time disturbances, narcolepsy, cataplexy, sleep paralysis, hypnagogic hallucination, sleep arousal, insomnia, and nocturnal myoclonus.

2. The method of claim 1, wherein the condition is narcolepsy.

3. The method of claim 1, wherein the condition is a catalepsy.