RU2006122638A - Фармацевтический препарат, включающий антитело против рецептора egf - Google Patents
Фармацевтический препарат, включающий антитело против рецептора egf Download PDFInfo
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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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- 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
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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
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
- A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
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- 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
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- 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
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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
- A61K47/02—Inorganic compounds
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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
- A61K47/06—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
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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
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
- A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
- A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
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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
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/20—Organic 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
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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
- A61K47/06—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
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- 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
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
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- 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
- C07K16/2863—Immunoglobulins [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
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
- C07K2317/24—Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
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- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Immunology (AREA)
- Organic Chemistry (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Biochemistry (AREA)
- Molecular Biology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Microbiology (AREA)
- Mycology (AREA)
- Biophysics (AREA)
- Genetics & Genomics (AREA)
- Dermatology (AREA)
- Inorganic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Medicinal Preparation (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Peptides Or Proteins (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
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.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
DE10355251.0 | 2003-11-26 | ||
DE10355251A DE10355251A1 (de) | 2003-11-26 | 2003-11-26 | Pharmazeutische Zubereitung enthaltend einen Antikörper gegen den EGF-Rezeptor |
Publications (2)
Publication Number | Publication Date |
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RU2006122638A true RU2006122638A (ru) | 2008-01-10 |
RU2381036C2 RU2381036C2 (ru) | 2010-02-10 |
Family
ID=34609304
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
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RU2006122638/15A RU2381036C2 (ru) | 2003-11-26 | 2004-10-26 | Фармацевтический препарат, включающий антитело против рецептора egf |
Country Status (31)
Country | Link |
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US (2) | US20050175611A1 (ru) |
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) |
ES (1) | ES2339671T3 (ru) |
HK (1) | HK1095534A1 (ru) |
IL (1) | IL175727A0 (ru) |
MX (1) | MXPA06005901A (ru) |
MY (1) | MY145214A (ru) |
NZ (1) | NZ548129A (ru) |
PE (1) | PE20050586A1 (ru) |
PL (1) | PL1687031T3 (ru) |
PT (1) | PT1687031E (ru) |
RU (1) | RU2381036C2 (ru) |
SG (1) | SG150550A1 (ru) |
SI (1) | SI1687031T1 (ru) |
TW (1) | TWI322693B (ru) |
UA (1) | UA90460C2 (ru) |
WO (1) | WO2005058365A1 (ru) |
ZA (1) | ZA200605219B (ru) |
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KR20100031769A (ko) * | 2000-12-28 | 2010-03-24 | 알투스 파마슈티컬스 인코포레이티드 | 전항체 및 이의 단편의 결정과 이의 제조 및 사용 방법 |
DE10133394A1 (de) * | 2001-07-13 | 2003-01-30 | Merck Patent Gmbh | Flüssige Formulierung enthaltend Cetuximab |
DE10163459A1 (de) * | 2001-12-21 | 2003-07-03 | Merck Patent Gmbh | Lyophilisierte Zubereitung enthaltend Antikörper gegen EGF-Rezeptor |
WO2004060343A1 (en) * | 2002-12-31 | 2004-07-22 | Nektar Therapeutics | Antibody-containing particles and compositions |
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2003
- 2003-11-26 DE DE10355251A patent/DE10355251A1/de not_active Withdrawn
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2004
- 2004-10-26 PT PT04820387T patent/PT1687031E/pt unknown
- 2004-10-26 CA CA002547060A patent/CA2547060A1/en not_active Abandoned
- 2004-10-26 UA UAA200607106A patent/UA90460C2/ru unknown
- 2004-10-26 JP JP2006540214A patent/JP2007512266A/ja active Pending
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- 2004-10-26 KR KR1020067010225A patent/KR20060110305A/ko not_active Application Discontinuation
- 2004-10-26 EP EP04820387A patent/EP1687031B1/de not_active Revoked
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- 2004-10-26 WO PCT/EP2004/012044 patent/WO2005058365A1/de active Application Filing
- 2004-10-26 RU RU2006122638/15A patent/RU2381036C2/ru not_active IP Right Cessation
- 2004-10-26 CN CN2004800347064A patent/CN1886158B/zh not_active Expired - Fee Related
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- 2004-10-26 AT AT04820387T patent/ATE457740T1/de active
- 2004-10-26 DE DE502004010783T patent/DE502004010783D1/de active Active
- 2004-10-26 PL PL04820387T patent/PL1687031T3/pl unknown
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- 2004-11-22 MY MYPI20044833A patent/MY145214A/en unknown
- 2004-11-24 PE PE2004001152A patent/PE20050586A1/es not_active Application Discontinuation
- 2004-11-25 TW TW093136361A patent/TWI322693B/zh not_active IP Right Cessation
- 2004-11-26 AR ARP040104380A patent/AR047949A1/es not_active Application Discontinuation
- 2004-11-26 US US10/996,597 patent/US20050175611A1/en not_active Abandoned
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- 2006-06-21 EC EC2006006662A patent/ECSP066662A/es unknown
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2007
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