RU2006122638A - Фармацевтический препарат, включающий антитело против рецептора egf - Google Patents

Фармацевтический препарат, включающий антитело против рецептора egf Download PDF

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RU2006122638A
RU2006122638A RU2006122638/15A RU2006122638A RU2006122638A RU 2006122638 A RU2006122638 A RU 2006122638A RU 2006122638/15 A RU2006122638/15 A RU 2006122638/15A RU 2006122638 A RU2006122638 A RU 2006122638A RU 2006122638 A RU2006122638 A RU 2006122638A
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salt
drug according
approximately
acid
polyoxyethylene
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RU2006122638/15A
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RU2381036C2 (ru
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Ханнис-Кристиан МАЛЕР (DE)
Ханнис-Кристиан МАЛЕР
Роберт МЮЛЛЕР (DE)
Роберт МЮЛЛЕР
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Мерк Патент ГмбХ (DE)
Мерк Патент Гмбх
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    • 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
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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
    • 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
    • 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
    • A61K47/02Inorganic 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
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12Carboxylic acids; Salts or anhydrides thereof
    • 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
    • A61K9/0012Galenical 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
    • 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
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/20Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/24Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered

Claims (14)

1. Водный препарат, включающий анти-EGFR антитело, буфер, аминокислоту и сурфактант.
2. Препарат по п.1, характеризующийся тем, что антитело представляет собой цетуксимаб или EMD 72000, или один из соответствующих мышиных, гуманизированных или химерных аналогов антитела.
3. Препарат по п.2, характеризующийся тем, что антитело представляет собой цетуксимаб или EMD 72000.
4. Препарат по любому из пп.1-3, характеризующийся тем, что буфер состоит из одной или более цитратной(ых) соли(ей), ацетатной(ых) соли(ей), соли(ей) гистидина, сукцинатной(ых) соли(ей), малатной(ых) соли(ей), фосфатной(ых) соли(ей) или лактатной(ых) соли(ей) и/или их соответствующей(их) свободной(ых) кислоты(кислот) или основания(оснований) или смеси одной или более различных солей и/или их кислоты(кислот) или основания(оснований).
5. Препарат по п.4, характеризующийся тем, что буфер состоит из одной или более цитратной(ых) соли(ей) и/или соответствующей свободной кислоты, ацетатной(ых) соли(ей) и/или соответствующей свободной кислоты, или L-гистидина и/или его соли присоединения кислоты.
6. Препарат по любому из пп.1-3, характеризующийся тем, что аминокислота представляет собой L-аргинин, глицин или L-метионин.
7. Препарат по любому из пп.1-3, характеризующийся тем, что сурфактант представляет собой эстер жирной кислоты полиэтиленсорбита или сополимер полиоксиэтилена-полиоксипропилена.
8. Препарат по п.7, характеризующийся тем, что сурфактант на основе эстера жирной кислоты полиэтиленсорбита представляет собой полиоксиэтилен(20)сорбитмоноолеат или полиоксиэтилен(20)сорбитмонолаурат.
9. Препарат по п.7, характеризующийся тем, что сурфактант представляет собой Полоксамер 407.
10. Препарат по любому из пп.1-3, характеризующийся тем, что дополнительно содержит модификатор изотоничности в концентрации, необходимой для модификации изотоничности.
11. Препарат по п.10, характеризующийся тем, что модификатор изотоничности представляет собой хлорид натрия.
12. Препарат по любому из пп.1-3, характеризующийся тем, что он имеет значение рН 5-7, предпочтительно от рН 5,2 до рН 6,0.
13. Препарат по п.12, характеризующийся тем, что он имеет значение рН приблизительно 5,5.
14. Препарат по любому из пп.1-3, характеризующийся тем, что он включает приблизительно 5 мг/мл цетуксимаба или EMD 72000, приблизительно 10 ммоль/л цитратного или гистидинового буфера, приблизительно 100 ммоль/л глицина, L-аргинин или L-метионина, приблизительно 100 ммоль/л хлорида натрия и приблизительно 0,01% полиоксиэтилен(20)сорбитмоноолеата и имеет значение рН приблизительно 5,5.
RU2006122638/15A 2003-11-26 2004-10-26 Фармацевтический препарат, включающий антитело против рецептора egf RU2381036C2 (ru)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE10355251A DE10355251A1 (de) 2003-11-26 2003-11-26 Pharmazeutische Zubereitung enthaltend einen Antikörper gegen den EGF-Rezeptor
DE10355251.0 2003-11-26

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RU2006122638A true RU2006122638A (ru) 2008-01-10
RU2381036C2 RU2381036C2 (ru) 2010-02-10

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EP (1) EP1687031B1 (ru)
JP (1) JP2007512266A (ru)
KR (1) KR20060110305A (ru)
CN (1) CN1886158B (ru)
AR (1) AR047949A1 (ru)
AT (1) ATE457740T1 (ru)
AU (1) AU2004298728B2 (ru)
BR (1) BRPI0416986A (ru)
CA (1) CA2547060A1 (ru)
CO (1) CO5690620A2 (ru)
CY (1) CY1110344T1 (ru)
DE (2) DE10355251A1 (ru)
DK (1) DK1687031T3 (ru)
EC (1) ECSP066662A (ru)
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PE (1) PE20050586A1 (ru)
PL (1) PL1687031T3 (ru)
PT (1) PT1687031E (ru)
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SG (1) SG150550A1 (ru)
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CN1886158A (zh) 2006-12-27
DE502004010783D1 (de) 2010-04-01
US20050175611A1 (en) 2005-08-11
BRPI0416986A (pt) 2007-02-06
EP1687031B1 (de) 2010-02-17
AU2004298728B2 (en) 2010-09-16
JP2007512266A (ja) 2007-05-17
CA2547060A1 (en) 2005-06-30
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KR20060110305A (ko) 2006-10-24
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PE20050586A1 (es) 2005-08-15
AR047949A1 (es) 2006-03-15
CO5690620A2 (es) 2006-10-31
RU2381036C2 (ru) 2010-02-10
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SG150550A1 (en) 2009-03-30
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CY1110344T1 (el) 2015-01-14
MXPA06005901A (es) 2006-06-27
US20110177068A1 (en) 2011-07-21
MY145214A (en) 2012-01-13
AU2004298728A1 (en) 2005-06-30
HK1095534A1 (en) 2007-05-11
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NZ548129A (en) 2010-09-30
SI1687031T1 (sl) 2010-04-30
UA90460C2 (ru) 2010-05-11
PT1687031E (pt) 2010-05-21
ATE457740T1 (de) 2010-03-15
WO2005058365A1 (de) 2005-06-30
ECSP066662A (es) 2006-10-25
EP1687031A1 (de) 2006-08-09

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