- Patent Title: Unit doses for immediate release of GHB or of one of the therapeutically acceptable salts thereof, administered orally, and the use thereof to maintain alcohol abstinence
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Application No.: US16084075Application Date: 2017-03-30
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Publication No.: US11690816B2Publication Date: 2023-07-04
- Inventor: Julien Guiraud
- Applicant: DEBREGEAS ET ASSOCIES PHARMA
- Applicant Address: FR Paris
- Assignee: DEBREGEAS ET ASSOCIES PHARMA
- Current Assignee: DEBREGEAS ET ASSOCIES PHARMA
- Current Assignee Address: FR Paris
- Agency: Oliff PLC
- Priority: FR 00554 2016.04.01
- International Application: PCT/FR2017/000060 2017.03.30
- International Announcement: WO2017/168059A 2017.10.05
- Date entered country: 2018-09-11
- Main IPC: A61K31/19
- IPC: A61K31/19 ; A61P25/32 ; A61K9/50
Abstract:
An immediate release, unit doses of GHB or one of the therapeutically acceptable salts thereof administered via oral route. Such unit doses contain between 0.37 and 1.75 g of GHB, when under the form of granules, these granules have the following composition (weight % relative to the total weight of the granule):
Active ingredient (sodium oxybate): 50 to 60%;
Effervescent agent: 5 to 15%;
Diluent: 2 to 18%;
Binder: 3 to 10%;
Substrate (Solid core of the granule): 15 to 25%;
Coating agent/flavouring agent/sweetening agent/lubricant: 3 to 6%.
Application for maintaining abstinence from alcohol of patients with mild or moderate alcohol dependence or with severe or very severe alcohol dependence, either suffering or not from liver disease.
Active ingredient (sodium oxybate): 50 to 60%;
Effervescent agent: 5 to 15%;
Diluent: 2 to 18%;
Binder: 3 to 10%;
Substrate (Solid core of the granule): 15 to 25%;
Coating agent/flavouring agent/sweetening agent/lubricant: 3 to 6%.
Application for maintaining abstinence from alcohol of patients with mild or moderate alcohol dependence or with severe or very severe alcohol dependence, either suffering or not from liver disease.
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