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MX2019008482A - Tratamiento medico que comprende administracion enteral de edaravona. - Google Patents

Tratamiento medico que comprende administracion enteral de edaravona.

Info

Publication number
MX2019008482A
MX2019008482A MX2019008482A MX2019008482A MX2019008482A MX 2019008482 A MX2019008482 A MX 2019008482A MX 2019008482 A MX2019008482 A MX 2019008482A MX 2019008482 A MX2019008482 A MX 2019008482A MX 2019008482 A MX2019008482 A MX 2019008482A
Authority
MX
Mexico
Prior art keywords
edaravone
composition
liquid
enteral administration
pharmaceutical composition
Prior art date
Application number
MX2019008482A
Other languages
English (en)
Other versions
MX390101B (es
Inventor
Hyke Moolenaar Sytske
Original Assignee
Treeway Tw001 B V
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 Treeway Tw001 B V filed Critical Treeway Tw001 B V
Publication of MX2019008482A publication Critical patent/MX2019008482A/es
Publication of MX390101B publication Critical patent/MX390101B/es

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1617Organic compounds, e.g. phospholipids, fats
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/41Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/4151,2-Diazoles
    • A61K31/41521,2-Diazoles having oxo groups directly attached to the heterocyclic ring, e.g. antipyrine, phenylbutazone, sulfinpyrazone
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/10Dispersions; Emulsions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/141Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
    • A61K9/145Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1611Inorganic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1617Organic compounds, e.g. phospholipids, fats
    • A61K9/1623Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1629Organic macromolecular compounds
    • A61K9/1641Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, poloxamers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2009Inorganic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2013Organic compounds, e.g. phospholipids, fats
    • A61K9/2018Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/2031Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/28Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • A61P37/02Immunomodulators
    • A61P37/06Immunosuppressants, e.g. drugs for graft rejection
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00Drugs for disorders of the cardiovascular system
    • A61P9/10Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/02Inorganic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0087Galenical forms not covered by A61K9/02 - A61K9/7023
    • A61K9/0095Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/08Solutions

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Neurosurgery (AREA)
  • Immunology (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Inorganic Chemistry (AREA)
  • Dispersion Chemistry (AREA)
  • Transplantation (AREA)
  • Psychiatry (AREA)
  • Hospice & Palliative Care (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Cardiology (AREA)
  • Vascular Medicine (AREA)
  • Urology & Nephrology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)

Abstract

La invención se refiere a una composición farmacéutica sólida dispersable en agua para su uso en el tratamiento de una enfermedad, comprendiendo dicho tratamiento la dispersión de la composición farmacéutica en un líquido acuoso para producir un líquido administrable por vía enteral que contiene al menos 0,5 gramos de composición farmacéutica y al menos 0,3 g/l de edaravona, seguido de la administración enteral de un líquido administrable por vía enteral a un paciente humano en una cantidad que proporciona una dosis de 30-300 mg de edaravona, comprendiendo dicha composición farmacéutica: • un 2-50 % en peso de 3-metil-1-fenil-2-pirazolin-5-ona (edaravona); y • un 3-50 % en peso de un agente alcalinizante soluble. Esta composición sólida que contiene edaravona se puede dispersar de forma sencilla en un líquido acuoso para preparar una solución acuosa de edaravona que se puede ingerir por parte del paciente. La composición sólida de la presente invención ofrece la ventaja de que edaravona se disuelve muy rápidamente cuando se introduce la composición en agua y de que el líquido administrable por vía enteral obtenido de este modo tiene elevada biodisponibilidad oral.
MX2019008482A 2017-01-17 2017-07-06 Tratamiento medico que comprende administracion enteral de edaravona MX390101B (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP17151741 2017-01-17
PCT/EP2017/067005 WO2018133957A1 (en) 2017-01-17 2017-07-06 Medical treatment comprising enteral administration of edaravone

Publications (2)

Publication Number Publication Date
MX2019008482A true MX2019008482A (es) 2019-11-11
MX390101B MX390101B (es) 2025-03-20

Family

ID=57850912

Family Applications (1)

Application Number Title Priority Date Filing Date
MX2019008482A MX390101B (es) 2017-01-17 2017-07-06 Tratamiento medico que comprende administracion enteral de edaravona

Country Status (12)

Country Link
US (1) US10966960B2 (es)
EP (1) EP3570819B1 (es)
JP (1) JP6898027B2 (es)
AU (1) AU2017394478B2 (es)
BR (1) BR112019014712A2 (es)
CA (1) CA3050031A1 (es)
DK (1) DK3570819T3 (es)
ES (1) ES2868955T3 (es)
MX (1) MX390101B (es)
PL (1) PL3570819T3 (es)
PT (1) PT3570819T (es)
WO (1) WO2018133957A1 (es)

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ES2868955T3 (es) 2017-01-17 2021-10-22 Treeway Tw001 B V Tratamiento médico que comprende la administración enteral de edaravona
US11826352B2 (en) 2018-11-02 2023-11-28 Mitsubishi Tanabe Pharma Corporation Edaravone suspension for oral administration
MX2021005144A (es) 2018-11-02 2021-07-15 Mitsubishi Tanabe Pharma Corp Suspension de edaravona para administracion oral.
WO2024172852A1 (en) 2023-02-16 2024-08-22 Slayback Pharma Llc Stable pharmaceutical compositions of edaravone

Family Cites Families (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1405637B1 (en) 2000-10-24 2005-09-07 Mitsubishi Pharma Corporation Remedies for amyotrophic lateral sclerosis (als)
IS7278A (is) 2001-11-26 2003-05-27 Merlyn Associates, Inc. Barkaslanga með stefnustjórnanlegum enda og stöðuhaldandi búnaði
CN1241565C (zh) * 2003-04-16 2006-02-15 浙江震元制药有限公司 依达拉奉药物组合物及制备
CN100358520C (zh) 2003-09-11 2008-01-02 彭建华 具有良好稳定性的注射用依达拉奉粉针剂及其制备方法
EP1714960B1 (en) 2004-02-09 2018-03-28 Mitsubishi Tanabe Pharma Corporation Novel therapeutic agent for amyotrophic lateral sclerosis (als) or disease attributable to als
CN101953832B (zh) 2010-08-10 2012-02-15 南京师范大学 β-环糊精包合依达拉奉的口服药物组合物及其制备方法
CN102349893A (zh) * 2011-08-19 2012-02-15 福建天泉药业股份有限公司 依达拉奉药物组合物
US20140228420A1 (en) 2011-09-05 2014-08-14 Mitsubishi Tanabe Pharma Corporation Pharmaceutical agent for treating amyotrophic lateral sclerosis or suppressing disease progress thereof
CN103251554A (zh) 2013-06-06 2013-08-21 南京亿华药业有限公司 一种稳定的依达拉奉注射液及其制备方法
CN109125261B (zh) 2016-03-16 2021-11-30 苏州澳宗生物科技有限公司 依达拉奉剂型
ES2868955T3 (es) 2017-01-17 2021-10-22 Treeway Tw001 B V Tratamiento médico que comprende la administración enteral de edaravona
AU2018209155B2 (en) 2017-01-17 2023-11-30 Treeway Tw001 B.V. Treatment comprising oral or gastric administration of edaravone
EP3648760A1 (en) 2017-07-06 2020-05-13 Treeway TW001 B.V. Use of edaravone in oral treatment of oxidative-stress mediated neurodegenerative disorders

Also Published As

Publication number Publication date
EP3570819B1 (en) 2021-03-03
BR112019014712A2 (pt) 2020-02-18
AU2017394478A1 (en) 2019-08-01
CA3050031A1 (en) 2018-07-26
PL3570819T3 (pl) 2021-10-25
ES2868955T3 (es) 2021-10-22
PT3570819T (pt) 2021-04-20
EP3570819A1 (en) 2019-11-27
JP6898027B2 (ja) 2021-07-07
WO2018133957A1 (en) 2018-07-26
JP2020506958A (ja) 2020-03-05
US20190328711A1 (en) 2019-10-31
MX390101B (es) 2025-03-20
DK3570819T3 (da) 2021-04-06
AU2017394478B2 (en) 2023-07-20
US10966960B2 (en) 2021-04-06

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