MD20180089A2 - Doze unitare cu eliberare imediată a GHB sau a uneia dintre sărurile sale terapeutic acceptabile, administrate oral, şi utilizarea acestora pentru menţinerea abstinenţei de la alcool - Google Patents
Doze unitare cu eliberare imediată a GHB sau a uneia dintre sărurile sale terapeutic acceptabile, administrate oral, şi utilizarea acestora pentru menţinerea abstinenţei de la alcool Download PDFInfo
- Publication number
- MD20180089A2 MD20180089A2 MDA20180089A MD20180089A MD20180089A2 MD 20180089 A2 MD20180089 A2 MD 20180089A2 MD A20180089 A MDA20180089 A MD A20180089A MD 20180089 A MD20180089 A MD 20180089A MD 20180089 A2 MD20180089 A2 MD 20180089A2
- Authority
- MD
- Moldova
- Prior art keywords
- ghb
- acceptable salts
- administered orally
- immediate release
- therapeutically acceptable
- Prior art date
Links
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 title abstract 3
- 239000012729 immediate-release (IR) formulation Substances 0.000 title abstract 2
- 150000003839 salts Chemical class 0.000 title abstract 2
- 239000008187 granular material Substances 0.000 abstract 3
- VWYANPOOORUCFJ-UHFFFAOYSA-N alpha-Fernenol Chemical compound CC1(C)C(O)CCC2(C)C3=CCC4(C)C5CCC(C(C)C)C5(C)CCC4(C)C3CCC21 VWYANPOOORUCFJ-UHFFFAOYSA-N 0.000 abstract 2
- 229960003928 sodium oxybate Drugs 0.000 abstract 2
- 206010019663 Hepatic failure Diseases 0.000 abstract 1
- 239000011230 binding agent Substances 0.000 abstract 1
- 239000008280 blood Substances 0.000 abstract 1
- 210000004369 blood Anatomy 0.000 abstract 1
- 239000003795 chemical substances by application Substances 0.000 abstract 1
- 239000011248 coating agent Substances 0.000 abstract 1
- 239000003085 diluting agent Substances 0.000 abstract 1
- 239000000796 flavoring agent Substances 0.000 abstract 1
- 235000013355 food flavoring agent Nutrition 0.000 abstract 1
- 235000003599 food sweetener Nutrition 0.000 abstract 1
- 208000007903 liver failure Diseases 0.000 abstract 1
- 231100000835 liver failure Toxicity 0.000 abstract 1
- 239000000314 lubricant Substances 0.000 abstract 1
- 238000012423 maintenance Methods 0.000 abstract 1
- 239000000203 mixture Substances 0.000 abstract 1
- 239000007787 solid Substances 0.000 abstract 1
- 239000003765 sweetening agent Substances 0.000 abstract 1
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)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Chemical & Material Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Medicinal Chemistry (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Epidemiology (AREA)
- Addiction (AREA)
- Biomedical Technology (AREA)
- Organic Chemistry (AREA)
- Neurology (AREA)
- Neurosurgery (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Psychiatry (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
Prezenta invenţie se referă la doze unitare cu eliberare imediată a GHB sau a uneia dintre sărurile sale terapeutic acceptabile, administrate oral.Dozele unitare, conform invenţiei, conţin 0,37…1,75 g GHB, în particular în formă de oxibutirat de sodiu. În cazul în care forma medicamentoasă a dozei unitare este granula, ea are următoarea compoziţie (% greutate în raport cu greutatea totală a granulei): ingredient activ (oxibutirat de sodiu) - 50…60%; agent efervescent - 5…15%; diluant - 2...18%; liant - 3...10%; bază (miezul solid al granulei) - 15...25%; agent de acoperire/agent de aromatizare/îndulcitor/lubrifiant - 3...6%. Doza unitară poate fi aplicată pentru menţinerea abstinenţei de la alcool la pacienţii cu forme uşoară sau moderată de dependenţă de alcool, sau cu forme severă sau extrem de severă de dependenţă de alcool, cu sau fără insuficienţă hepatică.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| FR1600554A FR3049463B1 (fr) | 2016-04-01 | 2016-04-01 | Doses unitaires a liberation immediate de ghb ou de l'un de ses sels therapeutiquement acceptables administrees par voie orale et leur utilisation pour maintenir l'abstinence alcoolique |
| PCT/FR2017/000060 WO2017168059A1 (fr) | 2016-04-01 | 2017-03-30 | Doses unitaires à libération immédiate de ghb ou de l'un de ses sels thérapeutiquement acceptables administrées par voie orale et leur utilisation pour maintenir l'abstinence alcoolique. |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| MD20180089A2 true MD20180089A2 (ro) | 2019-02-28 |
Family
ID=56555428
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| MDA20180089A MD20180089A2 (ro) | 2016-04-01 | 2017-03-30 | Doze unitare cu eliberare imediată a GHB sau a uneia dintre sărurile sale terapeutic acceptabile, administrate oral, şi utilizarea acestora pentru menţinerea abstinenţei de la alcool |
Country Status (23)
| Country | Link |
|---|---|
| US (1) | US11690816B2 (ro) |
| EP (1) | EP3435994B1 (ro) |
| JP (1) | JP7065785B2 (ro) |
| KR (2) | KR20180126037A (ro) |
| CN (1) | CN108697676A (ro) |
| AR (1) | AR108008A1 (ro) |
| AU (1) | AU2017240266B2 (ro) |
| BR (1) | BR112018016730A2 (ro) |
| CA (1) | CA3013789A1 (ro) |
| CL (1) | CL2018002730A1 (ro) |
| EA (1) | EA037591B1 (ro) |
| FR (1) | FR3049463B1 (ro) |
| HK (1) | HK1254989A1 (ro) |
| IL (1) | IL261618B (ro) |
| MA (1) | MA43089B1 (ro) |
| MD (1) | MD20180089A2 (ro) |
| MX (1) | MX2018011240A (ro) |
| PH (1) | PH12018502090A1 (ro) |
| SG (1) | SG11201808516SA (ro) |
| TW (1) | TWI781925B (ro) |
| UA (1) | UA123677C2 (ro) |
| WO (1) | WO2017168059A1 (ro) |
| ZA (1) | ZA201805322B (ro) |
Family Cites Families (9)
| 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 (zh) * | 2004-11-10 | 2008-01-02 | 纽约市哥伦比亚大学理事会 | 治疗运动障碍的方法 |
| US8729070B2 (en) * | 2008-02-20 | 2014-05-20 | Targia Pharmaceuticals | CNS pharmaceutical compositions and methods of use |
| US8771735B2 (en) * | 2008-11-04 | 2014-07-08 | Jazz Pharmaceuticals, Inc. | Immediate release dosage forms of sodium oxybate |
| US8778398B2 (en) | 2008-11-04 | 2014-07-15 | Jazz Pharmaceuticals, Inc. | Immediate release formulations and dosage forms of gamma-hydroxybutyrate |
| AU2011232408B2 (en) * | 2010-03-24 | 2015-07-30 | 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 (fr) * | 2011-02-11 | 2016-05-20 | Debregeas Et Associes Pharma | Granules d'acide gamma-hydroxybutyrique |
| 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/fr active Active
-
2017
- 2017-03-30 MA MA43089A patent/MA43089B1/fr unknown
- 2017-03-30 HK HK18114100.8A patent/HK1254989A1/zh unknown
- 2017-03-30 MX MX2018011240A patent/MX2018011240A/es unknown
- 2017-03-30 CA CA3013789A patent/CA3013789A1/fr active Pending
- 2017-03-30 WO PCT/FR2017/000060 patent/WO2017168059A1/fr not_active Ceased
- 2017-03-30 SG SG11201808516SA patent/SG11201808516SA/en unknown
- 2017-03-30 CN CN201780013791.3A patent/CN108697676A/zh active Pending
- 2017-03-30 US US16/084,075 patent/US11690816B2/en active Active
- 2017-03-30 EA EA201892223A patent/EA037591B1/ru unknown
- 2017-03-30 KR KR1020187030557A patent/KR20180126037A/ko not_active Ceased
- 2017-03-30 TW TW106110816A patent/TWI781925B/zh active
- 2017-03-30 AR ARP170100785A patent/AR108008A1/es unknown
- 2017-03-30 MD MDA20180089A patent/MD20180089A2/ro not_active Application Discontinuation
- 2017-03-30 AU AU2017240266A patent/AU2017240266B2/en active Active
- 2017-03-30 EP EP17717474.5A patent/EP3435994B1/fr active Active
- 2017-03-30 KR KR1020237014286A patent/KR20230065361A/ko not_active Ceased
- 2017-03-30 UA UAA201809871A patent/UA123677C2/uk unknown
- 2017-03-30 JP JP2018551270A patent/JP7065785B2/ja active Active
- 2017-03-30 BR BR112018016730-4A patent/BR112018016730A2/pt not_active Application Discontinuation
-
2018
- 2018-08-10 ZA ZA2018/05322A patent/ZA201805322B/en unknown
- 2018-09-05 IL IL261618A patent/IL261618B/en unknown
- 2018-09-26 CL CL2018002730A patent/CL2018002730A1/es unknown
- 2018-09-28 PH PH12018502090A patent/PH12018502090A1/en unknown
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| FC9A | Refusal of application (patent for invention) |