RU2004127446A - Препараты в форме растворов, содержащие антитела - Google Patents
Препараты в форме растворов, содержащие антитела Download PDFInfo
- 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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- Prior art keywords
- antibody
- drug
- solution
- solution according
- sugar
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Classifications
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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
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- 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
Landscapes
- 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.
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
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
RU2004127446/15A RU2335299C2 (ru) | 2002-02-14 | 2003-02-14 | Препараты в форме растворов, содержащие антитела |
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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