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AR079746A1 - Formulacion farmaceutica de anticuerpo - Google Patents

Formulacion farmaceutica de anticuerpo

Info

Publication number
AR079746A1
AR079746A1 ARP100104954A ARP100104954A AR079746A1 AR 079746 A1 AR079746 A1 AR 079746A1 AR P100104954 A ARP100104954 A AR P100104954A AR P100104954 A ARP100104954 A AR P100104954A AR 079746 A1 AR079746 A1 AR 079746A1
Authority
AR
Argentina
Prior art keywords
stabilizer
formula according
polysorbate
antibody
igg class
Prior art date
Application number
ARP100104954A
Other languages
English (en)
Inventor
Ulla Grauschopf
Hanns-Christian Mahler
Michael Adler
Original Assignee
Hoffmann La Roche
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 Hoffmann La Roche filed Critical Hoffmann La Roche
Publication of AR079746A1 publication Critical patent/AR079746A1/es

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • 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
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39591Stabilisation, fragmentation
    • 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
    • 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
    • A61K47/183Amino acids, e.g. glycine, EDTA or aspartame
    • 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
    • A61K47/20Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
    • 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
    • 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
    • A61P35/00Antineoplastic agents
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2863Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against receptors for growth factors, growth regulators

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Immunology (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Organic Chemistry (AREA)
  • Biochemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Dermatology (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)

Abstract

Reivindicacion 1: Formulacion farmacéutica, que comprende 1 a 200 mg/ml de un anticuerpo anti-EGFR de clase IgG, 1 a 100 mM de un agente tamponador, 0,001% a 1% (p/v) de un surfactante, 1 a 500 mM de por lo menos un estabilizador, a un pH comprendido en el intervalo de entre 4,0 y 7,0. Reivindicacion 2: Formulacion segun la reivindicacion 1, en la que la concentracion de anticuerpo anti-EGFR de clase IgG se encuentra comprendida en el intervalo de entre 1 y 10 mg/ml. Reivindicacion 3: Formulacion segun la reivindicacion 1 o 2, en la que el agente tamponador es un tampon histidina o un tampon acetato. Reivindicacion 6: Formulacion segun cualquiera de las reivindicaciones 1 a 5, en la que el surfactante es un polisorbato. Reivindicacion 12: Formulacion segun cualquiera de las reivindicaciones 1 a 11, que comprende: 5 a 50 mg/ml de un anticuerpo anti-EGFR de clase IgG, un agente tamponador 15 a 30 mM, seleccionado de entre L-histidina y acetato sodico, un surfactante al 0,02-0,05% (p/v), seleccionado de entre polisorbato 20 y polisorbato 80, por lo menos un estabilizador 120 a 300 mM, seleccionado de entre dihidrato de trehalosa, sacarosa, hidrocloruro de arginina y cloruro sádico, opcionalmente, metionina 5 a 25 mM como segundo estabilizador, a un pH de 5,5 +- 0,3. Reivindicacion 14: Formulacion segun cualquiera de las reivindicaciones 1 a 13, que comprende 20 a 50 mg/ml de mAb anti-EGFR de IgG1 ICR62-hu, L-histidina 20 mM, polisorbato 80 al 0,02-0,03% (p/v), un primer estabilizador 240 mM, en el que dicho primer estabilizador es un sacárido seleccionado de entre dihidrato de trehalosa y sacarosa, metionina 10 mM como segundo estabilizador, a un PH de 5,5 +- 0,3. Reivindicacion 16: Formulacion segun cualquiera de las reivindicaciones 1 a 15, en la que el anticuerpo EGFR de clase IgG es mAb anti-EGFR de IgG1 ICR62-hu.
ARP100104954A 2009-12-29 2010-12-27 Formulacion farmaceutica de anticuerpo AR079746A1 (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
EP09180840 2009-12-29

Publications (1)

Publication Number Publication Date
AR079746A1 true AR079746A1 (es) 2012-02-15

Family

ID=43618150

Family Applications (1)

Application Number Title Priority Date Filing Date
ARP100104954A AR079746A1 (es) 2009-12-29 2010-12-27 Formulacion farmaceutica de anticuerpo

Country Status (16)

Country Link
US (1) US20110158987A1 (es)
EP (1) EP2519262A2 (es)
JP (1) JP2013515754A (es)
KR (1) KR20120110175A (es)
CN (1) CN102686241A (es)
AR (1) AR079746A1 (es)
AU (1) AU2010338305A1 (es)
BR (1) BR112012013148A2 (es)
CA (1) CA2783715A1 (es)
IL (1) IL219592A0 (es)
MX (1) MX2012007676A (es)
RU (1) RU2012131099A (es)
SG (1) SG182304A1 (es)
TW (1) TW201200152A (es)
WO (1) WO2011080209A2 (es)
ZA (1) ZA201204266B (es)

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Also Published As

Publication number Publication date
JP2013515754A (ja) 2013-05-09
MX2012007676A (es) 2012-08-03
SG182304A1 (en) 2012-08-30
ZA201204266B (en) 2014-11-26
US20110158987A1 (en) 2011-06-30
WO2011080209A3 (en) 2012-03-15
EP2519262A2 (en) 2012-11-07
CA2783715A1 (en) 2011-07-07
TW201200152A (en) 2012-01-01
KR20120110175A (ko) 2012-10-09
CN102686241A (zh) 2012-09-19
RU2012131099A (ru) 2014-02-10
IL219592A0 (en) 2012-06-28
BR112012013148A2 (pt) 2017-03-21
WO2011080209A2 (en) 2011-07-07
AU2010338305A1 (en) 2012-05-24

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