WO2009080699A3 - Peg-interferon-beta formulations - Google Patents

Peg-interferon-beta formulations Download PDF

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Publication number
WO2009080699A3
WO2009080699A3 PCT/EP2008/067876 EP2008067876W WO2009080699A3 WO 2009080699 A3 WO2009080699 A3 WO 2009080699A3 EP 2008067876 W EP2008067876 W EP 2008067876W WO 2009080699 A3 WO2009080699 A3 WO 2009080699A3
Authority
WO
WIPO (PCT)
Prior art keywords
peg
interferon
surfactant
buffer
beta formulations
Prior art date
Legal status (The legal status 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 status listed.)
Ceased
Application number
PCT/EP2008/067876
Other languages
French (fr)
Other versions
WO2009080699A2 (en
Inventor
Alessandra Del Rio
Joel Richard
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Merck Serono SA
Original Assignee
Merck Serono SA
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
Priority to EA201070773A priority Critical patent/EA201070773A1/en
Priority to ES08863833T priority patent/ES2387236T3/en
Priority to RSP20120318 priority patent/RS52417B/en
Priority to PL08863833T priority patent/PL2234645T3/en
Priority to BRPI0821029-2A priority patent/BRPI0821029A2/en
Priority to AU2008340058A priority patent/AU2008340058A1/en
Priority to US12/738,375 priority patent/US9138403B2/en
Priority to HRP20120483AT priority patent/HRP20120483T1/en
Priority to EP08863833A priority patent/EP2234645B1/en
Priority to DK08863833T priority patent/DK2234645T3/en
Priority to SI200830666T priority patent/SI2234645T1/en
Priority to CN2008801185845A priority patent/CN101878043A/en
Application filed by Merck Serono SA filed Critical Merck Serono SA
Priority to JP2010538728A priority patent/JP5563475B2/en
Priority to AT08863833T priority patent/ATE555812T1/en
Publication of WO2009080699A2 publication Critical patent/WO2009080699A2/en
Publication of WO2009080699A3 publication Critical patent/WO2009080699A3/en
Priority to IL206441A priority patent/IL206441A0/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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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)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Peptides Or Proteins (AREA)

Abstract

The invention relates to a liquid pharmaceutical composition comprising a pegylated IFN-β (PEG- IFN-β), an excipient, a surfactant and a buffer wherein said excipient is a polyol, wherein said surfactant is a non-ionic surfactant and wherein said buffer is a sodium acetate buffer.
PCT/EP2008/067876 2007-12-20 2008-12-18 Peg-interferon-beta formulations Ceased WO2009080699A2 (en)

Priority Applications (15)

Application Number Priority Date Filing Date Title
ES08863833T ES2387236T3 (en) 2007-12-20 2008-12-18 Pegylated interferon beta formulations
RSP20120318 RS52417B (en) 2007-12-20 2008-12-18 PEG-INTERFERON-BETA FORMULATIONS
PL08863833T PL2234645T3 (en) 2007-12-20 2008-12-18 Peg-interferon-beta formulations
BRPI0821029-2A BRPI0821029A2 (en) 2007-12-20 2008-12-18 Peg-interferon-beta formulations
AU2008340058A AU2008340058A1 (en) 2007-12-20 2008-12-18 PEG-interferon-beta formulations
US12/738,375 US9138403B2 (en) 2007-12-20 2008-12-18 PEG-interferon-beta formulations
HRP20120483AT HRP20120483T1 (en) 2007-12-20 2008-12-18 Peg-interferon-beta formulations
DK08863833T DK2234645T3 (en) 2007-12-20 2008-12-18 PEG-interferon-beta formulations
EP08863833A EP2234645B1 (en) 2007-12-20 2008-12-18 Peg-interferon-beta formulations
EA201070773A EA201070773A1 (en) 2007-12-20 2008-12-18 COMPOSITIONS OF PEG-INTERFERON-BETA
CN2008801185845A CN101878043A (en) 2007-12-20 2008-12-18 PEG-interferon-beta formulation
SI200830666T SI2234645T1 (en) 2007-12-20 2008-12-18 Peg-interferon-beta formulations
JP2010538728A JP5563475B2 (en) 2007-12-20 2008-12-18 PEG interferon-beta preparation
AT08863833T ATE555812T1 (en) 2007-12-20 2008-12-18 PEG INTERFERON BETA FORMULATIONS
IL206441A IL206441A0 (en) 2007-12-20 2010-06-17 Peg-interferon-beta formulations and their preparation

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
EP07150258 2007-12-20
EP07150258.7 2007-12-20
US1025808P 2008-01-07 2008-01-07
US61/010,258 2008-01-07

Publications (2)

Publication Number Publication Date
WO2009080699A2 WO2009080699A2 (en) 2009-07-02
WO2009080699A3 true WO2009080699A3 (en) 2009-11-26

Family

ID=39760852

Family Applications (1)

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

Country Status (20)

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

Families Citing this family (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
BRPI0821029A2 (en) * 2007-12-20 2015-06-16 Merck Serono Sa Peg-interferon-beta formulations
US20120269770A1 (en) * 2010-11-22 2012-10-25 Mark Brader Stable Preserved Compositions of Interferon-Beta
SG10201707477SA (en) * 2013-03-13 2017-10-30 Eleven Biotherapeutics Inc Chimeric cytokine formulations for ocular delivery
WO2016052584A1 (en) * 2014-09-30 2016-04-07 東レ株式会社 METHOD FOR PRE-TREATING SAMPLE SOLUTION FOR USE IN DETECTION AND QUANTIFICATION OF POLYETHYLENE GLYCOL-MODIFIED INTERFERON-β, METHOD FOR DETECTING POLYETHYLENE GLYCOL-MODIFIED INTERFERON-β, AND METHOD FOR QUANTIFYING POLYETHYLENE GLYCOL-MODIFIED INTERFERON-β
PE20170922A1 (en) * 2014-11-10 2017-07-12 Glaxosmithkline Intellectual Property (No 2) Ltd LONG-ACTING COMBINATION COMPOSITIONS AND PROCEDURES FOR HEPATITIS C
WO2016163764A2 (en) * 2015-04-07 2016-10-13 에이비온 주식회사 Stabilized preparation of interferon beta variant
KR101943160B1 (en) * 2016-10-06 2019-01-30 에이비온 주식회사 Stabilized Formulations of Interferon beta Mutant
CN116023466B (en) * 2023-03-30 2023-06-27 北京生物制品研究所有限责任公司 Method for purifying PEG modified recombinant human interferon beta 1b protein

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Title
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