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EA201070773A1 - Составы пэг-интерферона-бета - Google Patents

Составы пэг-интерферона-бета

Info

Publication number
EA201070773A1
EA201070773A1 EA201070773A EA201070773A EA201070773A1 EA 201070773 A1 EA201070773 A1 EA 201070773A1 EA 201070773 A EA201070773 A EA 201070773A EA 201070773 A EA201070773 A EA 201070773A EA 201070773 A1 EA201070773 A1 EA 201070773A1
Authority
EA
Eurasian Patent Office
Prior art keywords
peg
interferon
beta
compositions
surfactant
Prior art date
Application number
EA201070773A
Other languages
English (en)
Inventor
Алессандра Дель Рио
Жоэль РИШАР
Original Assignee
Мерк Сероно С. А.
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 Мерк Сероно С. А. filed Critical Мерк Сероно С. А.
Publication of EA201070773A1 publication Critical patent/EA201070773A1/ru

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • 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
    • A61K47/50Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/19Cytokines; Lymphokines; Interferons
    • A61K38/21Interferons [IFN]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/19Cytokines; Lymphokines; Interferons
    • A61K38/21Interferons [IFN]
    • A61K38/215IFN-beta
    • 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
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • 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
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/34Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
    • 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
    • A61K47/50Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/56Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule
    • A61K47/59Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyureas or polyurethanes
    • A61K47/60Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyureas or polyurethanes the organic macromolecular compound being a polyoxyalkylene oligomer, polymer or dendrimer, e.g. PEG, PPG, PEO or polyglycerol
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/08Solutions
    • 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
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K14/00Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/52Cytokines; Lymphokines; Interferons
    • C07K14/555Interferons [IFN]
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K14/00Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/52Cytokines; Lymphokines; Interferons
    • C07K14/555Interferons [IFN]
    • C07K14/565IFN-beta
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2300/00Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Zoology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Organic Chemistry (AREA)
  • Immunology (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Biophysics (AREA)
  • Toxicology (AREA)
  • Genetics & Genomics (AREA)
  • Dermatology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Inorganic Chemistry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)

Abstract

Изобретение относится к жидкой фармацевтической композиции, содержащей пэгилированный ИФН-β (ПЭГ-ИФН-β), вспомогательное вещество, поверхностно-активное вещество и буфер, в которой указанным вспомогательным веществом является многоатомный спирт, в которой указанным поверхностно-активным веществом является неионное поверхностно-активное вещество и в которой указанным буфером является натрий-ацетатный буфер.
EA201070773A 2007-12-20 2008-12-18 Составы пэг-интерферона-бета EA201070773A1 (ru)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP07150258 2007-12-20
US1025808P 2008-01-07 2008-01-07
PCT/EP2008/067876 WO2009080699A2 (en) 2007-12-20 2008-12-18 Peg-interferon-beta formulations

Publications (1)

Publication Number Publication Date
EA201070773A1 true EA201070773A1 (ru) 2010-12-30

Family

ID=39760852

Family Applications (1)

Application Number Title Priority Date Filing Date
EA201070773A EA201070773A1 (ru) 2007-12-20 2008-12-18 Составы пэг-интерферона-бета

Country Status (20)

Country Link
US (1) US9138403B2 (ru)
EP (1) EP2234645B1 (ru)
JP (2) JP5563475B2 (ru)
KR (1) KR20100099298A (ru)
CN (1) CN101878043A (ru)
AT (1) ATE555812T1 (ru)
AU (1) AU2008340058A1 (ru)
BR (1) BRPI0821029A2 (ru)
CY (1) CY1112820T1 (ru)
DK (1) DK2234645T3 (ru)
EA (1) EA201070773A1 (ru)
ES (1) ES2387236T3 (ru)
HR (1) HRP20120483T1 (ru)
IL (1) IL206441A0 (ru)
PL (1) PL2234645T3 (ru)
PT (1) PT2234645E (ru)
RS (1) RS52417B (ru)
SI (1) SI2234645T1 (ru)
WO (1) WO2009080699A2 (ru)
ZA (1) ZA201001908B (ru)

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EA201070773A1 (ru) * 2007-12-20 2010-12-30 Мерк Сероно С. А. Составы пэг-интерферона-бета
US20120269770A1 (en) * 2010-11-22 2012-10-25 Mark Brader Stable Preserved Compositions of Interferon-Beta
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WO2016052584A1 (ja) * 2014-09-30 2016-04-07 東レ株式会社 ポリエチレングリコール修飾インターフェロン-βの検出及び定量に使用する試料液の前処理方法、ポリエチレングリコール修飾インターフェロン-βの検出方法及び定量方法
AU2015344741A1 (en) * 2014-11-10 2017-05-25 Glaxosmithkline Intellectual Property (No.2) Limited Combination long acting compositions and methods for hepatitis C
WO2016163764A2 (ko) * 2015-04-07 2016-10-13 에이비온 주식회사 인터페론 베타 변이체의 안정화 제제
KR101943160B1 (ko) 2016-10-06 2019-01-30 에이비온 주식회사 인터페론 베타 변이체의 안정화 제제
CN116023466B (zh) * 2023-03-30 2023-06-27 北京生物制品研究所有限责任公司 纯化PEG修饰重组人干扰素β1b蛋白的方法

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Also Published As

Publication number Publication date
PL2234645T3 (pl) 2012-10-31
HRP20120483T1 (hr) 2012-07-31
JP2011506562A (ja) 2011-03-03
WO2009080699A3 (en) 2009-11-26
ATE555812T1 (de) 2012-05-15
JP2014159445A (ja) 2014-09-04
ES2387236T3 (es) 2012-09-18
SI2234645T1 (sl) 2012-07-31
CN101878043A (zh) 2010-11-03
EP2234645A2 (en) 2010-10-06
DK2234645T3 (da) 2012-07-09
PT2234645E (pt) 2012-05-21
RS52417B (en) 2013-02-28
BRPI0821029A2 (pt) 2015-06-16
JP5563475B2 (ja) 2014-07-30
AU2008340058A1 (en) 2009-07-02
KR20100099298A (ko) 2010-09-10
WO2009080699A2 (en) 2009-07-02
EP2234645B1 (en) 2012-05-02
US9138403B2 (en) 2015-09-22
ZA201001908B (en) 2011-05-25
IL206441A0 (en) 2010-12-30
CY1112820T1 (el) 2016-02-10
US20100239529A1 (en) 2010-09-23

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