RU2004127446A - Препараты в форме растворов, содержащие антитела - Google Patents

Препараты в форме растворов, содержащие антитела Download PDF

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Publication number
RU2004127446A
RU2004127446A RU2004127446/15A RU2004127446A RU2004127446A RU 2004127446 A RU2004127446 A RU 2004127446A RU 2004127446/15 A RU2004127446/15 A RU 2004127446/15A RU 2004127446 A RU2004127446 A RU 2004127446A RU 2004127446 A RU2004127446 A RU 2004127446A
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Russia
Prior art keywords
antibody
drug
solution
solution according
sugar
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RU2004127446/15A
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RU2335299C2 (ru
Inventor
Маса КАКУТА (JP)
Масая КАКУТА
Дзун КИКУТИ (JP)
Дзун КИКУТИ
Хидефуми МИЦУСИМА (JP)
Хидефуми МИЦУСИМА
Йосими ИМАЕДА (JP)
Йосими ИМАЕДА
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Чугаи Сейяку Кабусики Кайся (Jp)
Чугаи Сейяку Кабусики Кайся
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Application filed by Чугаи Сейяку Кабусики Кайся (Jp), Чугаи Сейяку Кабусики Кайся filed Critical Чугаи Сейяку Кабусики Кайся (Jp)
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    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/44—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material not provided for elsewhere, e.g. haptens, metals, DNA, RNA, amino acids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/34—Macromolecular 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39591—Stabilisation, fragmentation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • 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
    • 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
    • A61K9/08—Solutions
    • 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
    • A61P37/04—Immunostimulants
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/30—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants from tumour cells
    • C07K16/3061—Blood cells
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/40—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against enzymes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies

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

Claims (19)

1. Препарат в форме раствора, содержащий антитело, включающий сахар в качестве стабилизатора.
2. Препарат в форме раствора по п. 1, дополнительно включающий поверхностно-активное вещество в качестве стабилизатора.
3. Препарат в форме раствора по п. 1 или 2, где сахаром является сахарный спирт или невосстанавливающий олигосахарид.
4. Препарат в форме раствора по п. 1 или 2, где сахаром является невосстанавливающий олигосахарид.
5. Препарат в форме раствора по п. 1 или 2, где сахаром является маннит, сахароза, трегалоза или раффиноза.
6. Препарат в форме раствора по п. 1 или 2, где сахаром является сахароза, трегалоза или раффиноза.
7. Препарат в форме раствора по п. 1 или 2, где сахаром является сахароза или трегалоза.
8. Препарат в форме раствора по п. 1 или 2, где сахаром является сахароза.
9. Препарат в форме раствора по п. 2, где поверхностно-активным веществом является Полисорбат 80 или 20.
10. Препарат в форме раствора по п.1, где антителом является рекомбинантное антитело.
11. Препарат в форме раствора по п. 10, где антителом является химерное антитело, гуманизированное антитело или антитело человека.
12. Препарат в форме раствора по п. 1, где антителом является антитело класса IgG.
13. Препарат в форме раствора по п. 12, где антителом класса IgG является антитело класса IgG1.
14. Препарат в форме раствора по п. 1, где антителом является антитело против рецептора интерлейкина-6 или антитело против НМ1.24.
15. Способ ингибирования образования мультимерных молекул антитела в препарате в форме раствора, содержащем антитело, включающий добавление сахара в раствор.
16. Способ ингибирования образования мультимерных молекул антитела во время циклов замораживание/оттаивание содержащего антитело раствора, включающий добавление в раствор невосстанавливающего олигосахарида.
17. Способ ингибирования образования мультимерных молекул антител во время циклов замораживание/оттаивание содержащего антитело раствора, включающий добавление в раствор невосстанавливающего дисахарида или невосстанавливающего трисахарида.
18. Способ ингибирования образования нерастворимых частиц во время циклов замораживание/оттаивание содержащего антитело раствора, включающий добавление поверхностно-активного вещества.
19. Способ стабилизации антитела во время циклов замораживание/оттаивание содержащего антитело раствора, включающий добавление невосстанавливающего сахара и поверхностно-активного вещества.
RU2004127446/15A 2002-02-14 2003-02-14 Препараты в форме растворов, содержащие антитела RU2335299C2 (ru)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2002-36244 2002-02-14
JP2002036244 2002-02-14

Publications (2)

Publication Number Publication Date
RU2004127446A true RU2004127446A (ru) 2005-04-10
RU2335299C2 RU2335299C2 (ru) 2008-10-10

Family

ID=27678080

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Country Status (25)

Country Link
US (4) US20050118163A1 (ru)
EP (5) EP2311489A3 (ru)
JP (4) JP3792698B2 (ru)
KR (3) KR101080021B1 (ru)
CN (3) CN101066450A (ru)
AT (1) ATE485835T1 (ru)
AU (3) AU2003211990A1 (ru)
BR (1) BRPI0307702B8 (ru)
CA (1) CA2474943C (ru)
CO (1) CO5611163A2 (ru)
CY (2) CY1111073T1 (ru)
DE (1) DE60334678D1 (ru)
DK (1) DK1475101T3 (ru)
ES (2) ES2353496T3 (ru)
HR (1) HRP20040710B1 (ru)
IL (1) IL163354A (ru)
MX (1) MXPA04007924A (ru)
NO (1) NO333553B1 (ru)
NZ (1) NZ534542A (ru)
PL (1) PL213311B1 (ru)
PT (1) PT1475101E (ru)
RU (1) RU2335299C2 (ru)
SI (1) SI1475101T1 (ru)
WO (2) WO2003068260A1 (ru)
ZA (1) ZA200406230B (ru)

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