MX2018011240A - Dosis unitarias de liberacion inmediata de ghb o una de sus sales terapeuticamente aceptables administradas por via oral, y a su aplicacion para mantener la abstinencia de alcohol. - Google Patents
Dosis unitarias de liberacion inmediata de ghb o una de sus sales terapeuticamente aceptables administradas por via oral, y a su aplicacion para mantener la abstinencia de alcohol.Info
- Publication number
- MX2018011240A MX2018011240A MX2018011240A MX2018011240A MX2018011240A MX 2018011240 A MX2018011240 A MX 2018011240A MX 2018011240 A MX2018011240 A MX 2018011240A MX 2018011240 A MX2018011240 A MX 2018011240A MX 2018011240 A MX2018011240 A MX 2018011240A
- Authority
- MX
- Mexico
- Prior art keywords
- ghb
- unit doses
- acceptable salts
- administered orally
- immediate release
- Prior art date
Links
- 239000012729 immediate-release (IR) formulation Substances 0.000 title abstract 2
- 150000003839 salts Chemical class 0.000 title abstract 2
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 title 1
- 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
- 208000007848 Alcoholism Diseases 0.000 abstract 1
- 206010019663 Hepatic failure Diseases 0.000 abstract 1
- 239000004480 active ingredient Substances 0.000 abstract 1
- 201000007930 alcohol dependence Diseases 0.000 abstract 1
- 208000029650 alcohol withdrawal Diseases 0.000 abstract 1
- 239000011230 binding agent Substances 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
- 208000007903 liver failure Diseases 0.000 abstract 1
- 231100000835 liver failure Toxicity 0.000 abstract 1
- 239000000314 lubricant Substances 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
- 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
- A61K9/48—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
- 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)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Abstract
La presente invención se refiere a unas dosis unitarias de liberación inmediata de GHB o una de sus sales terapéuticamente aceptables administradas por vía oral. Estas dosis unitarias contienen entre 0,37 y 1,75 g de GHB, más especialmente oxibato de sodio; cuando son granulados, estos granulados tienen la siguiente composición (% respecto del peso total del granulado): - Principio activo (oxibato de sodio): 50 a 60 %; - Agente efervescente: 5 a 15 %; - Diluente: 2 a 18 %; - Aglutinante: 3 a 10 %; - Soporte (núcleo sólido del granulado): 15 a 25 %; - Agente de revestimiento/ agente aromatizante / agente edulcorante / lubricante: 3 a 6 %. Aplicación para mantener la abstinencia de alcohol para pacientes con un nivel de alcoholismo bajo o moderado, o alto o muy alto, sin o con insuficiencia hepática.
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 |
|---|---|
| MX2018011240A true MX2018011240A (es) | 2018-11-22 |
Family
ID=56555428
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| MX2018011240A MX2018011240A (es) | 2016-04-01 | 2017-03-30 | Dosis unitarias de liberacion inmediata de ghb o una de sus sales terapeuticamente aceptables administradas por via oral, y a su aplicacion para mantener la abstinencia de alcohol. |
Country Status (23)
| Country | Link |
|---|---|
| US (1) | US11690816B2 (es) |
| EP (1) | EP3435994A1 (es) |
| JP (1) | JP7065785B2 (es) |
| KR (2) | KR20180126037A (es) |
| CN (1) | CN108697676A (es) |
| AR (1) | AR108008A1 (es) |
| AU (1) | AU2017240266B2 (es) |
| BR (1) | BR112018016730A2 (es) |
| CA (1) | CA3013789A1 (es) |
| CL (1) | CL2018002730A1 (es) |
| EA (1) | EA037591B1 (es) |
| FR (1) | FR3049463B1 (es) |
| HK (1) | HK1254989A1 (es) |
| IL (1) | IL261618B (es) |
| MA (1) | MA43089B1 (es) |
| MD (1) | MD20180089A2 (es) |
| MX (1) | MX2018011240A (es) |
| PH (1) | PH12018502090A1 (es) |
| SG (1) | SG11201808516SA (es) |
| TW (1) | TWI781925B (es) |
| UA (1) | UA123677C2 (es) |
| WO (1) | WO2017168059A1 (es) |
| ZA (1) | ZA201805322B (es) |
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 |
| WO2006053186A2 (en) * | 2004-11-10 | 2006-05-18 | The Trustees Of Columbia University In The City Of New York | Method for treatment of movement disorders |
| 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 |
| US20120076865A1 (en) * | 2010-03-24 | 2012-03-29 | Jazz Pharmaceuticals, Inc. | Controlled release dosage forms for high dose, water soluble and hygroscopic drug substances |
| BR112012028035B1 (pt) * | 2010-05-04 | 2021-05-25 | Jazz Pharmaceuticals, Inc. | formulação de liberação imediata |
| 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 MX MX2018011240A patent/MX2018011240A/es unknown
- 2017-03-30 EA EA201892223A patent/EA037591B1/ru unknown
- 2017-03-30 JP JP2018551270A patent/JP7065785B2/ja active Active
- 2017-03-30 CA CA3013789A patent/CA3013789A1/fr active Pending
- 2017-03-30 MD MDA20180089A patent/MD20180089A2/ro not_active Application Discontinuation
- 2017-03-30 CN CN201780013791.3A patent/CN108697676A/zh active Pending
- 2017-03-30 KR KR1020187030557A patent/KR20180126037A/ko not_active Ceased
- 2017-03-30 KR KR1020237014286A patent/KR20230065361A/ko not_active Ceased
- 2017-03-30 SG SG11201808516SA patent/SG11201808516SA/en unknown
- 2017-03-30 TW TW106110816A patent/TWI781925B/zh active
- 2017-03-30 WO PCT/FR2017/000060 patent/WO2017168059A1/fr active Application Filing
- 2017-03-30 AR ARP170100785A patent/AR108008A1/es unknown
- 2017-03-30 BR BR112018016730-4A patent/BR112018016730A2/pt not_active Application Discontinuation
- 2017-03-30 US US16/084,075 patent/US11690816B2/en active Active
- 2017-03-30 AU AU2017240266A patent/AU2017240266B2/en active Active
- 2017-03-30 EP EP17717474.5A patent/EP3435994A1/fr active Pending
- 2017-03-30 UA UAA201809871A patent/UA123677C2/uk unknown
- 2017-03-30 MA MA43089A patent/MA43089B1/fr unknown
-
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
- 2018-11-05 HK HK18114100.8A patent/HK1254989A1/zh unknown
Also Published As
| Publication number | Publication date |
|---|---|
| AU2017240266B2 (en) | 2022-12-01 |
| MD20180089A2 (ro) | 2019-02-28 |
| WO2017168059A1 (fr) | 2017-10-05 |
| JP7065785B2 (ja) | 2022-05-12 |
| FR3049463A1 (fr) | 2017-10-06 |
| IL261618A (en) | 2018-10-31 |
| AR108008A1 (es) | 2018-07-04 |
| ZA201805322B (en) | 2024-11-27 |
| AU2017240266A1 (en) | 2018-09-13 |
| MA43089A1 (fr) | 2018-11-30 |
| TW201740930A (zh) | 2017-12-01 |
| EA037591B1 (ru) | 2021-04-19 |
| KR20230065361A (ko) | 2023-05-11 |
| PH12018502090A1 (en) | 2019-07-29 |
| US20190255001A1 (en) | 2019-08-22 |
| FR3049463B1 (fr) | 2019-07-05 |
| UA123677C2 (uk) | 2021-05-12 |
| US11690816B2 (en) | 2023-07-04 |
| SG11201808516SA (en) | 2018-11-29 |
| BR112018016730A2 (pt) | 2018-12-26 |
| HK1254989A1 (zh) | 2019-08-02 |
| MA43089B1 (fr) | 2020-02-28 |
| TWI781925B (zh) | 2022-11-01 |
| IL261618B (en) | 2021-12-01 |
| EP3435994A1 (fr) | 2019-02-06 |
| CL2018002730A1 (es) | 2019-01-11 |
| EA201892223A1 (ru) | 2019-03-29 |
| CN108697676A (zh) | 2018-10-23 |
| JP2019510057A (ja) | 2019-04-11 |
| CA3013789A1 (fr) | 2017-10-05 |
| KR20180126037A (ko) | 2018-11-26 |
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