MICROBIOLOGICALLY SOUND AND STABLE SOLUTIONS OF GAMMA-HYDROXYBUTYRATE SALT FOR THE TREATMENT OF NARCOLEPSY
First Claim
Patent Images
1. A method of treating cataplexy or daytime sleepiness in a patient who has been diagnosed with narcolepsy, comprising:
- (i) diluting an aqueous solution comprising about 500 mg/mL of sodium gamma-hydroxybutyrate with an aqueous medium to provide a first dose of about 4.5 to about 10 grams sodium gamma-hydroxybutyrate;
(ii) diluting an aqueous solution comprising about 500 mg/mL of sodium gamma-hydroxybutyrate with an aqueous medium to provide a second dose of about 4.5 to about 10 grams of sodium gamma-hydroxybutyrate;
(iii) orally administering to a patient having narcolepsy the first dose within an hour prior to initial sleep onset; and
(iv) orally administering to the patient having narcolepsy the second dose within 2.5 to 4 hours following initial sleep onset.
9 Assignments
0 Petitions
Accused Products
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.
38 Citations
2 Claims
-
1. A method of treating cataplexy or daytime sleepiness in a patient who has been diagnosed with narcolepsy, comprising:
-
(i) diluting an aqueous solution comprising about 500 mg/mL of sodium gamma-hydroxybutyrate with an aqueous medium to provide a first dose of about 4.5 to about 10 grams sodium gamma-hydroxybutyrate; (ii) diluting an aqueous solution comprising about 500 mg/mL of sodium gamma-hydroxybutyrate with an aqueous medium to provide a second dose of about 4.5 to about 10 grams of sodium gamma-hydroxybutyrate; (iii) orally administering to a patient having narcolepsy the first dose within an hour prior to initial sleep onset; and (iv) orally administering to the patient having narcolepsy the second dose within 2.5 to 4 hours following initial sleep onset.
-
-
2. A method of treating cataplexy or daytime sleepiness in a patient who has been diagnosed with narcolepsy, comprising:
-
(i) diluting an aqueous solution comprising about 500 mg/mL of sodium gamma-hydroxybutyrate with an aqueous medium to provide a first dose of about 3 to about 10 grams of sodium gamma-hydroxybutyrate; (ii) diluting an aqueous solution comprising about 500 mg/mL of sodium gamma-hydroxybutyrate with an aqueous medium to provide a second dose of about 3 to about 10 grams of sodium gamma-hydroxybutyrate; (iii) orally administering to a patient having narcolepsy the first dose within an hour prior to initial sleep onset; and (iv) orally administering to the patient having narcolepsy the second dose within 2.5 to 4 hours following initial sleep onset.
-
Specification
-
- Resources
Litigation Campaign Assessment
Thank you for your request. You will receive a custom alert email when the Litigation Campaign Assessment is available.
×
-
Current AssigneeJazz Pharmaceuticals Incorporated (Jazz Pharmaceuticals Plc)
-
Original AssigneeJazz Pharmaceuticals Incorporated (Jazz Pharmaceuticals Plc)
-
InventorsCook, Harry, Hamilton, Martha, Danielson, Douglas, Goderstad, Colette, Reardan, Dayton
-
Granted Patent
-
Time in Patent OfficeDays
-
Field of Search
-
US Class Current514/557
-
CPC Class CodesA61J 1/00 Containers specially adapte...A61K 31/19 Carboxylic acids, e.g. valp...A61K 31/191 having two or more hydroxy ...A61K 47/02 Inorganic compoundsA61K 47/08 containing oxygen, e.g. eth...A61K 47/12 Carboxylic acids; Salts or ...A61K 47/14 Esters of carboxylic acids,...A61K 9/0019 Injectable compositions; In...A61K 9/0095 Drinks; Beverages; Syrups; ...A61P 11/00 Drugs for disorders of the ...A61P 21/00 Drugs for disorders of the ...A61P 25/00 Drugs for disorders of the ...A61P 25/16 Anti-Parkinson drugsA61P 25/20 Hypnotics; SedativesA61P 25/22 AnxiolyticsA61P 25/24 AntidepressantsA61P 25/30 for treating abuse or depen...A61P 25/32 Alcohol-abuseA61P 25/36 Opioid-abuseA61P 43/00 Drugs for specific purposes...View All
