SG11201808516SA - 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. - Google Patents
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.Info
- Publication number
- SG11201808516SA SG11201808516SA SG11201808516SA SG11201808516SA SG11201808516SA SG 11201808516S A SG11201808516S A SG 11201808516SA SG 11201808516S A SG11201808516S A SG 11201808516SA SG 11201808516S A SG11201808516S A SG 11201808516SA SG 11201808516S A SG11201808516S A SG 11201808516SA
- Authority
- SG
- Singapore
- Prior art keywords
- ghb
- unit doses
- acceptable salts
- immediate release
- therapeutically acceptable
- Prior art date
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1611—Inorganic compounds
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/5073—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals having two or more different coatings optionally including drug-containing subcoatings
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1629—Organic macromolecular compounds
- A61K9/1635—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/5005—Wall or coating material
- A61K9/5021—Organic macromolecular compounds
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/5005—Wall or coating material
- A61K9/5021—Organic macromolecular compounds
- A61K9/5036—Polysaccharides, e.g. gums, alginate; Cyclodextrin
- A61K9/5042—Cellulose; Cellulose derivatives, e.g. phthalate or acetate succinate esters of hydroxypropyl methylcellulose
- A61K9/5047—Cellulose ethers containing no ester groups, e.g. hydroxypropyl methylcellulose
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/5073—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals having two or more different coatings optionally including drug-containing subcoatings
- A61K9/5078—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals having two or more different coatings optionally including drug-containing subcoatings with drug-free core
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/30—Drugs for disorders of the nervous system for treating abuse or dependence
- A61P25/32—Alcohol-abuse
Landscapes
- Health & Medical Sciences (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Chemical & Material Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Pharmacology & Pharmacy (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Medicinal Chemistry (AREA)
- Life Sciences & Earth Sciences (AREA)
- Epidemiology (AREA)
- Addiction (AREA)
- Neurosurgery (AREA)
- Psychiatry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Neurology (AREA)
- Biomedical Technology (AREA)
- Organic Chemistry (AREA)
- Nutrition Science (AREA)
- Physiology (AREA)
- Inorganic Chemistry (AREA)
- Medicinal Preparation (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
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 5 The present invention concerns 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, more particularly as 10 sodium oxybate; 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 %; 15 - 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 20 suffering or not from liver disease. [No Suitable figure]
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| FR1600554A FR3049463B1 (en) | 2016-04-01 | 2016-04-01 | UNITARY DOSES FOR IMMEDIATE RELEASE OF GHB OR ONE OF ITS THERAPEUTICALLY ACCEPTABLE SALTS ADMINISTERED ORALLY AND USE THEREOF TO MAINTAIN ALCOHOLIC ABSTINENCE |
| PCT/FR2017/000060 WO2017168059A1 (en) | 2016-04-01 | 2017-03-30 | 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. |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| SG11201808516SA true SG11201808516SA (en) | 2018-11-29 |
Family
ID=56555428
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| SG11201808516SA SG11201808516SA (en) | 2016-04-01 | 2017-03-30 | 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. |
Country Status (22)
| Country | Link |
|---|---|
| US (1) | US11690816B2 (en) |
| EP (1) | EP3435994A1 (en) |
| JP (1) | JP7065785B2 (en) |
| KR (2) | KR20180126037A (en) |
| CN (1) | CN108697676A (en) |
| AR (1) | AR108008A1 (en) |
| AU (1) | AU2017240266B2 (en) |
| BR (1) | BR112018016730A2 (en) |
| CA (1) | CA3013789A1 (en) |
| CL (1) | CL2018002730A1 (en) |
| EA (1) | EA037591B1 (en) |
| FR (1) | FR3049463B1 (en) |
| HK (1) | HK1254989A1 (en) |
| IL (1) | IL261618B (en) |
| MA (1) | MA43089B1 (en) |
| MD (1) | MD20180089A2 (en) |
| MX (1) | MX2018011240A (en) |
| PH (1) | PH12018502090A1 (en) |
| SG (1) | SG11201808516SA (en) |
| TW (1) | TWI781925B (en) |
| UA (1) | UA123677C2 (en) |
| WO (1) | WO2017168059A1 (en) |
Family Cites Families (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5990162A (en) | 1997-08-29 | 1999-11-23 | Orphan Medical, Inc. | Method for treatment of fibromyalgia and chronic fatigue syndrome |
| CN101098701A (en) | 2004-11-10 | 2008-01-02 | 纽约市哥伦比亚大学理事会 | Method for treatment of movement disorders |
| US8778398B2 (en) | 2008-11-04 | 2014-07-15 | Jazz Pharmaceuticals, Inc. | Immediate release formulations and dosage forms of gamma-hydroxybutyrate |
| US8771735B2 (en) | 2008-11-04 | 2014-07-08 | Jazz Pharmaceuticals, Inc. | Immediate release dosage forms of sodium oxybate |
| WO2011119839A1 (en) | 2010-03-24 | 2011-09-29 | Jazz Pharmaceuticals, Inc. | Controlled release dosage forms for high dose, water soluble and hygroscopic drug substances |
| CA2798178C (en) | 2010-05-04 | 2017-06-13 | Jazz Pharmaceuticals, Inc. | Immediate release formulations and dosage forms of gamma-hydroxybutyrate |
| FR2971422B1 (en) * | 2011-02-11 | 2016-05-20 | Debregeas Et Associes Pharma | GAMMA-HYDROXYBUTYRIC ACID GRANULES |
| US8591922B1 (en) | 2012-12-14 | 2013-11-26 | Jazz Pharmacuticals, Inc. | Gamma-hydroxybutyrate compositions and their use for the treatment of disorders |
-
2016
- 2016-04-01 FR FR1600554A patent/FR3049463B1/en active Active
-
2017
- 2017-03-30 AU AU2017240266A patent/AU2017240266B2/en active Active
- 2017-03-30 AR ARP170100785A patent/AR108008A1/en unknown
- 2017-03-30 CA CA3013789A patent/CA3013789A1/en active Pending
- 2017-03-30 KR KR1020187030557A patent/KR20180126037A/en not_active IP Right Cessation
- 2017-03-30 US US16/084,075 patent/US11690816B2/en active Active
- 2017-03-30 KR KR1020237014286A patent/KR20230065361A/en not_active Application Discontinuation
- 2017-03-30 EA EA201892223A patent/EA037591B1/en unknown
- 2017-03-30 MA MA43089A patent/MA43089B1/en unknown
- 2017-03-30 MX MX2018011240A patent/MX2018011240A/en unknown
- 2017-03-30 WO PCT/FR2017/000060 patent/WO2017168059A1/en active Application Filing
- 2017-03-30 MD MDA20180089A patent/MD20180089A2/en not_active Application Discontinuation
- 2017-03-30 EP EP17717474.5A patent/EP3435994A1/en active Pending
- 2017-03-30 JP JP2018551270A patent/JP7065785B2/en active Active
- 2017-03-30 UA UAA201809871A patent/UA123677C2/en unknown
- 2017-03-30 TW TW106110816A patent/TWI781925B/en active
- 2017-03-30 CN CN201780013791.3A patent/CN108697676A/en active Pending
- 2017-03-30 BR BR112018016730-4A patent/BR112018016730A2/en not_active Application Discontinuation
- 2017-03-30 SG SG11201808516SA patent/SG11201808516SA/en unknown
-
2018
- 2018-09-05 IL IL261618A patent/IL261618B/en unknown
- 2018-09-26 CL CL2018002730A patent/CL2018002730A1/en unknown
- 2018-09-28 PH PH12018502090A patent/PH12018502090A1/en unknown
- 2018-11-05 HK HK18114100.8A patent/HK1254989A1/en unknown
Also Published As
| Publication number | Publication date |
|---|---|
| HK1254989A1 (en) | 2019-08-02 |
| US20190255001A1 (en) | 2019-08-22 |
| KR20230065361A (en) | 2023-05-11 |
| JP7065785B2 (en) | 2022-05-12 |
| PH12018502090A1 (en) | 2019-07-29 |
| EA201892223A1 (en) | 2019-03-29 |
| MA43089B1 (en) | 2020-02-28 |
| KR20180126037A (en) | 2018-11-26 |
| FR3049463A1 (en) | 2017-10-06 |
| MA43089A1 (en) | 2018-11-30 |
| MX2018011240A (en) | 2018-11-22 |
| TW201740930A (en) | 2017-12-01 |
| EA037591B1 (en) | 2021-04-19 |
| MD20180089A2 (en) | 2019-02-28 |
| CA3013789A1 (en) | 2017-10-05 |
| IL261618B (en) | 2021-12-01 |
| CL2018002730A1 (en) | 2019-01-11 |
| AR108008A1 (en) | 2018-07-04 |
| UA123677C2 (en) | 2021-05-12 |
| AU2017240266B2 (en) | 2022-12-01 |
| AU2017240266A1 (en) | 2018-09-13 |
| EP3435994A1 (en) | 2019-02-06 |
| WO2017168059A1 (en) | 2017-10-05 |
| IL261618A (en) | 2018-10-31 |
| FR3049463B1 (en) | 2019-07-05 |
| BR112018016730A2 (en) | 2018-12-26 |
| US11690816B2 (en) | 2023-07-04 |
| CN108697676A (en) | 2018-10-23 |
| JP2019510057A (en) | 2019-04-11 |
| TWI781925B (en) | 2022-11-01 |
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