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
acceptable salts
administered orally
immediate release
therapeutically acceptable
Prior art date
Application number
MX2018011240A
Other languages
English (en)
Inventor
Guiraud Julien
Original Assignee
Debregeas Et Associes Pharma
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Debregeas Et Associes Pharma filed Critical Debregeas Et Associes Pharma
Publication of MX2018011240A publication Critical patent/MX2018011240A/es

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
    • 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)
  • 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

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.
MX2018011240A 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. MX2018011240A (es)

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 (22)

Country Link
US (1) US11690816B2 (es)
EP (1) EP3435994A1 (es)
JP (1) JP7065785B2 (es)
KR (2) KR20230065361A (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)

Family Cites Families (8)

* Cited by examiner, † Cited by third party
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
US20090137565A1 (en) 2004-11-10 2009-05-28 The Trustees Of Columbia University In The City Of New York Method for treatment of movement disorders
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

Also Published As

Publication number Publication date
JP2019510057A (ja) 2019-04-11
FR3049463A1 (fr) 2017-10-06
AU2017240266B2 (en) 2022-12-01
KR20230065361A (ko) 2023-05-11
US11690816B2 (en) 2023-07-04
IL261618A (en) 2018-10-31
US20190255001A1 (en) 2019-08-22
EA201892223A1 (ru) 2019-03-29
SG11201808516SA (en) 2018-11-29
TW201740930A (zh) 2017-12-01
KR20180126037A (ko) 2018-11-26
MA43089A1 (fr) 2018-11-30
PH12018502090A1 (en) 2019-07-29
IL261618B (en) 2021-12-01
JP7065785B2 (ja) 2022-05-12
MA43089B1 (fr) 2020-02-28
WO2017168059A1 (fr) 2017-10-05
AR108008A1 (es) 2018-07-04
CL2018002730A1 (es) 2019-01-11
EP3435994A1 (fr) 2019-02-06
TWI781925B (zh) 2022-11-01
UA123677C2 (uk) 2021-05-12
FR3049463B1 (fr) 2019-07-05
CA3013789A1 (fr) 2017-10-05
MD20180089A2 (ro) 2019-02-28
BR112018016730A2 (pt) 2018-12-26
AU2017240266A1 (en) 2018-09-13
EA037591B1 (ru) 2021-04-19
HK1254989A1 (zh) 2019-08-02
CN108697676A (zh) 2018-10-23

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