BR112012016459A2 - Composto farmacêutico parenteral de ação prolongada, composição farmacêutica e sal de glatirâmero farmaceuticamente aceitável - Google Patents

Composto farmacêutico parenteral de ação prolongada, composição farmacêutica e sal de glatirâmero farmaceuticamente aceitável

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Publication number
BR112012016459A2
BR112012016459A2 BR112012016459A BR112012016459A BR112012016459A2 BR 112012016459 A2 BR112012016459 A2 BR 112012016459A2 BR 112012016459 A BR112012016459 A BR 112012016459A BR 112012016459 A BR112012016459 A BR 112012016459A BR 112012016459 A2 BR112012016459 A2 BR 112012016459A2
Authority
BR
Brazil
Prior art keywords
long
pharmaceutically acceptable
glatiramer
acting
pharmaceutical composition
Prior art date
Application number
BR112012016459A
Other languages
English (en)
Other versions
BR112012016459B1 (pt
Inventor
Marom Ehud
Rubnov Shai
Original Assignee
Mapi Pharma Ltd
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 Mapi Pharma Ltd filed Critical Mapi Pharma Ltd
Publication of BR112012016459A2 publication Critical patent/BR112012016459A2/pt
Publication of BR112012016459B1 publication Critical patent/BR112012016459B1/pt

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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
    • A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/02—Peptides of undefined number of amino acids; Derivatives thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/04—Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
    • A61K38/10—Peptides having 12 to 20 amino acids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • 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
    • A61K9/0002—Galenical forms characterised by the drug release technique; Application systems commanded by energy
    • 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
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A61K9/0024—Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue
    • 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
    • A61K9/1641—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, poloxamers
    • A61K9/1647—Polyesters, e.g. poly(lactide-co-glycolide)
    • 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
    • A61K9/1682—Processes
    • 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
    • A61K9/5031—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, poly(lactide-co-glycolide)
    • 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
    • A61K9/5089—Processes
    • 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
    • A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
    • 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
    • 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
    • A61P25/28—Drugs 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/02—Immunomodulators
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/001—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof by chemical synthesis

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Immunology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biomedical Technology (AREA)
  • Neurosurgery (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Organic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Dermatology (AREA)
  • Neurology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Hospice & Palliative Care (AREA)
  • Psychiatry (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Epoxy Compounds (AREA)
  • Transition And Organic Metals Composition Catalysts For Addition Polymerization (AREA)
  • Epoxy Resins (AREA)

Abstract

COMPOSTO FARMACÊUTICO PARENTERAL DE AÇÃO PROLONGADA, COMPOSIÇÃO FARMACÊUTICA E SAL DE GLATIRÂMERO FARMACEUTICAMENTE ACEITÁVEL. A presente invenção provê composto farmacêuticos parentais de ação prolongada compreendendo uma quantia terapeuticamente efetiva de glatirâmero. Em particular, a presente invenção provê um composto farmacêutico de ação prolongada compreendendo uma quantia terapeuticamente efetiva de acetato de glatirâmero sob a forma depot adequada para administrar em um local aceitável medicamente em um sujeito com necessidade deste. A forma depot é adequada para implantação ou injeção subcutâneo ou intramuscular.
BR112012016459A 2010-01-04 2010-08-19 composto farmacêutico parenteral de ação prolongada, composição farmacêutica e sal de glatirâmero farmaceuticamente aceitável BR112012016459B1 (pt)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US29192810P 2010-01-04 2010-01-04
PCT/IL2010/000679 WO2011080733A1 (en) 2010-01-04 2010-08-19 Depot systems comprising glatiramer or a pharmacologically acceptable salt thereof

Publications (2)

Publication Number Publication Date
BR112012016459A2 true BR112012016459A2 (pt) 2017-10-03
BR112012016459B1 BR112012016459B1 (pt) 2020-01-14

Family

ID=44226217

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112012016459A BR112012016459B1 (pt) 2010-01-04 2010-08-19 composto farmacêutico parenteral de ação prolongada, composição farmacêutica e sal de glatirâmero farmaceuticamente aceitável

Country Status (20)

Country Link
US (1) US8796226B2 (pt)
EP (2) EP3536333B1 (pt)
JP (2) JP5916622B2 (pt)
CN (3) CN107184954A (pt)
AU (1) AU2010337822B2 (pt)
BR (1) BR112012016459B1 (pt)
CA (1) CA2784394C (pt)
CY (1) CY1120975T1 (pt)
DK (2) DK2398488T3 (pt)
ES (2) ES2699692T3 (pt)
HK (2) HK1245667A1 (pt)
HR (2) HRP20221208T1 (pt)
HU (2) HUE040390T2 (pt)
LT (2) LT2398488T (pt)
MX (2) MX2020003805A (pt)
PL (2) PL2398488T3 (pt)
PT (2) PT3536333T (pt)
SI (1) SI2398488T1 (pt)
TR (1) TR201818858T4 (pt)
WO (1) WO2011080733A1 (pt)

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Also Published As

Publication number Publication date
MX349162B (es) 2017-07-14
CN107184954A (zh) 2017-09-22
JP5916622B2 (ja) 2016-05-11
PL3536333T3 (pl) 2022-12-05
US8796226B2 (en) 2014-08-05
HK1245667A1 (zh) 2018-08-31
HUE060304T2 (hu) 2023-02-28
CN107661490A (zh) 2018-02-06
US20120015891A1 (en) 2012-01-19
PL2398488T3 (pl) 2019-03-29
AU2010337822B2 (en) 2016-03-17
CA2784394A1 (en) 2011-07-07
AU2010337822A1 (en) 2012-07-12
HK1244430A1 (zh) 2018-08-10
EP2398488A4 (en) 2014-06-11
SI2398488T1 (sl) 2019-02-28
PT2398488T (pt) 2018-12-20
CA2784394C (en) 2016-12-13
WO2011080733A1 (en) 2011-07-07
HRP20182076T1 (hr) 2019-02-08
ES2699692T3 (es) 2019-02-12
DK3536333T3 (da) 2022-10-24
HRP20221208T1 (hr) 2022-12-09
EP3536333A1 (en) 2019-09-11
BR112012016459B1 (pt) 2020-01-14
JP2013516403A (ja) 2013-05-13
CY1120975T1 (el) 2019-12-11
JP2016074696A (ja) 2016-05-12
EP2398488A1 (en) 2011-12-28
EP2398488B1 (en) 2018-11-14
CN107661490B (zh) 2021-12-31
CN102686235A (zh) 2012-09-19
LT2398488T (lt) 2019-01-25
MX2012007760A (es) 2012-08-01
EP3536333B1 (en) 2022-08-03
MX2020003805A (es) 2022-05-05
HUE040390T2 (hu) 2019-03-28
DK2398488T3 (en) 2019-01-28
PT3536333T (pt) 2022-11-11
TR201818858T4 (tr) 2019-01-21
ES2928900T3 (es) 2022-11-23
LT3536333T (lt) 2022-11-10

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