RU2012153786A - Стабильные многодозовые композиции, содержащие антитело и консервант - Google Patents
Стабильные многодозовые композиции, содержащие антитело и консервант Download PDFInfo
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- RU2012153786A RU2012153786A RU2012153786/10A RU2012153786A RU2012153786A RU 2012153786 A RU2012153786 A RU 2012153786A RU 2012153786/10 A RU2012153786/10 A RU 2012153786/10A RU 2012153786 A RU2012153786 A RU 2012153786A RU 2012153786 A RU2012153786 A RU 2012153786A
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- cresol
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- phenol
- chlorobutanol
- benzyl alcohol
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- 239000000203 mixture Substances 0.000 title claims abstract 30
- ISWSIDIOOBJBQZ-UHFFFAOYSA-N Phenol Chemical compound OC1=CC=CC=C1 ISWSIDIOOBJBQZ-UHFFFAOYSA-N 0.000 claims abstract 30
- OSASVXMJTNOKOY-UHFFFAOYSA-N chlorobutanol Chemical compound CC(C)(O)C(Cl)(Cl)Cl OSASVXMJTNOKOY-UHFFFAOYSA-N 0.000 claims abstract 24
- RLSSMJSEOOYNOY-UHFFFAOYSA-N m-cresol Chemical compound CC1=CC=CC(O)=C1 RLSSMJSEOOYNOY-UHFFFAOYSA-N 0.000 claims abstract 24
- WVDDGKGOMKODPV-UHFFFAOYSA-N Benzyl alcohol Chemical compound OCC1=CC=CC=C1 WVDDGKGOMKODPV-UHFFFAOYSA-N 0.000 claims abstract 18
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims abstract 18
- 229960004926 chlorobutanol Drugs 0.000 claims abstract 12
- LXCFILQKKLGQFO-UHFFFAOYSA-N methylparaben Chemical compound COC(=O)C1=CC=C(O)C=C1 LXCFILQKKLGQFO-UHFFFAOYSA-N 0.000 claims abstract 12
- QELSKZZBTMNZEB-UHFFFAOYSA-N propylparaben Chemical compound CCCOC(=O)C1=CC=C(O)C=C1 QELSKZZBTMNZEB-UHFFFAOYSA-N 0.000 claims abstract 12
- 239000003755 preservative agent Substances 0.000 claims abstract 10
- 230000002335 preservative effect Effects 0.000 claims abstract 8
- QCDWFXQBSFUVSP-UHFFFAOYSA-N 2-phenoxyethanol Chemical compound OCCOC1=CC=CC=C1 QCDWFXQBSFUVSP-UHFFFAOYSA-N 0.000 claims abstract 6
- CFKMVGJGLGKFKI-UHFFFAOYSA-N 4-chloro-m-cresol Chemical compound CC1=CC(O)=CC=C1Cl CFKMVGJGLGKFKI-UHFFFAOYSA-N 0.000 claims abstract 6
- DNIAPMSPPWPWGF-UHFFFAOYSA-N Propylene glycol Chemical compound CC(O)CO DNIAPMSPPWPWGF-UHFFFAOYSA-N 0.000 claims abstract 6
- 229960000686 benzalkonium chloride Drugs 0.000 claims abstract 6
- 235000019445 benzyl alcohol Nutrition 0.000 claims abstract 6
- 229960004217 benzyl alcohol Drugs 0.000 claims abstract 6
- CADWTSSKOVRVJC-UHFFFAOYSA-N benzyl(dimethyl)azanium;chloride Chemical compound [Cl-].C[NH+](C)CC1=CC=CC=C1 CADWTSSKOVRVJC-UHFFFAOYSA-N 0.000 claims abstract 6
- 229960004756 ethanol Drugs 0.000 claims abstract 6
- 235000010270 methyl p-hydroxybenzoate Nutrition 0.000 claims abstract 6
- 239000004292 methyl p-hydroxybenzoate Substances 0.000 claims abstract 6
- 229960002216 methylparaben Drugs 0.000 claims abstract 6
- 229940070805 p-chloro-m-cresol Drugs 0.000 claims abstract 6
- 229960005323 phenoxyethanol Drugs 0.000 claims abstract 6
- WVDDGKGOMKODPV-ZQBYOMGUSA-N phenyl(114C)methanol Chemical compound O[14CH2]C1=CC=CC=C1 WVDDGKGOMKODPV-ZQBYOMGUSA-N 0.000 claims abstract 6
- 235000010232 propyl p-hydroxybenzoate Nutrition 0.000 claims abstract 6
- 239000004405 propyl p-hydroxybenzoate Substances 0.000 claims abstract 6
- 229960003415 propylparaben Drugs 0.000 claims abstract 6
- RTKIYNMVFMVABJ-UHFFFAOYSA-L thimerosal Chemical compound [Na+].CC[Hg]SC1=CC=CC=C1C([O-])=O RTKIYNMVFMVABJ-UHFFFAOYSA-L 0.000 claims abstract 6
- 229960004906 thiomersal Drugs 0.000 claims abstract 6
- CZMRCDWAGMRECN-UGDNZRGBSA-N Sucrose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-UGDNZRGBSA-N 0.000 claims abstract 5
- 229930006000 Sucrose Natural products 0.000 claims abstract 5
- 239000005720 sucrose Substances 0.000 claims abstract 5
- 239000003795 chemical substances by application Substances 0.000 claims abstract 2
- 239000007788 liquid Substances 0.000 claims abstract 2
- 239000004094 surface-active agent Substances 0.000 claims abstract 2
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims 6
- 239000004475 Arginine Substances 0.000 claims 3
- ODKSFYDXXFIFQN-UHFFFAOYSA-N arginine Natural products OC(=O)C(N)CCCNC(N)=N ODKSFYDXXFIFQN-UHFFFAOYSA-N 0.000 claims 3
- HNDVDQJCIGZPNO-UHFFFAOYSA-N histidine Natural products OC(=O)C(N)CC1=CN=CN1 HNDVDQJCIGZPNO-UHFFFAOYSA-N 0.000 claims 3
- 239000000244 polyoxyethylene sorbitan monooleate Substances 0.000 claims 3
- 235000010482 polyoxyethylene sorbitan monooleate Nutrition 0.000 claims 3
- 229920000053 polysorbate 80 Polymers 0.000 claims 3
- 229940068968 polysorbate 80 Drugs 0.000 claims 3
- 239000011780 sodium chloride Substances 0.000 claims 3
- 206010053567 Coagulopathies Diseases 0.000 claims 1
- 208000015294 blood coagulation disease Diseases 0.000 claims 1
- 208000027866 inflammatory disease Diseases 0.000 claims 1
- 238000002560 therapeutic procedure Methods 0.000 claims 1
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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
-
- 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
- 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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- 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
- A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
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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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- 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
- A61K47/26—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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- 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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- A61P37/00—Drugs for immunological or allergic disorders
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
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- Proteomics, Peptides & Aminoacids (AREA)
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Abstract
1. Стабильная многодозовая жидкая композиция, содержащая антитело и один или более чем один консервант.2. Композиция по п.1, где консервант присутствует в композиции в количестве от 0,001 до 2% (вес/объем), например от 0,002 до 1% (вес/объем).3. Композиция по п.1, где один или более чем один консервант выбран среди фенола, м-крезола, бензилового спирта, хлорбутанола, этанола, феноксиэтанола, п-хлор-м-крезола, метилпарабена, пропилпарабена, бензалкония хлорида, тиомерсала или любой их комбинации, например, фенола, м-крезола, бензилового спирта и хлорбутанола.4. Композиция по п.1, которая содержит один консервант, выбранный среди фенола, м-крезола, бензилового спирта, хлорбутанола, этанола, феноксиэтанола, п-хлор-м-крезола, метилпарабена, пропилпарабена, бензалкония хлорида и тиомерсала, например фенол, м-крезол, бензиловый спирт и хлорбутанола.5. Композиция по п.1, которая содержит два или более двух консервантов, выбранных среди фенола, м-крезола, бензилового спирта, хлорбутанола, этанола, феноксиэтанола, п-хлор-м-крезола, метилпарабена, пропилпарабена, бензалкония хлорида, тиомерсала или любой их комбинации, в частности фенола и м-крезола; бензилового спирта и хлорбутанола.6. Композиция по п.1, которая буферизована до рН от 5 до 7, например до рН от 6,0 до 7,0, например 6,0 или 6,5, в частности 6,5.7. Композиция по п.1, которая дополнительно содержит агент, модифицирующий тоничность, такой как сахарозу или пропиленгликоль.8. Композиция по п.1, где антитело присутствует в композиции в концентрации 50, 55, 60, 65, 70, 75, 80, 85, 90, 95, 100, 150, 200, 250 или 300 мг/мл.9. Композиция по п.1, в которой поверхностно-активное вещество отсутствует.10. Композиция по п.1, которая включает:(A
Claims (15)
1. Стабильная многодозовая жидкая композиция, содержащая антитело и один или более чем один консервант.
2. Композиция по п.1, где консервант присутствует в композиции в количестве от 0,001 до 2% (вес/объем), например от 0,002 до 1% (вес/объем).
3. Композиция по п.1, где один или более чем один консервант выбран среди фенола, м-крезола, бензилового спирта, хлорбутанола, этанола, феноксиэтанола, п-хлор-м-крезола, метилпарабена, пропилпарабена, бензалкония хлорида, тиомерсала или любой их комбинации, например, фенола, м-крезола, бензилового спирта и хлорбутанола.
4. Композиция по п.1, которая содержит один консервант, выбранный среди фенола, м-крезола, бензилового спирта, хлорбутанола, этанола, феноксиэтанола, п-хлор-м-крезола, метилпарабена, пропилпарабена, бензалкония хлорида и тиомерсала, например фенол, м-крезол, бензиловый спирт и хлорбутанола.
5. Композиция по п.1, которая содержит два или более двух консервантов, выбранных среди фенола, м-крезола, бензилового спирта, хлорбутанола, этанола, феноксиэтанола, п-хлор-м-крезола, метилпарабена, пропилпарабена, бензалкония хлорида, тиомерсала или любой их комбинации, в частности фенола и м-крезола; бензилового спирта и хлорбутанола.
6. Композиция по п.1, которая буферизована до рН от 5 до 7, например до рН от 6,0 до 7,0, например 6,0 или 6,5, в частности 6,5.
7. Композиция по п.1, которая дополнительно содержит агент, модифицирующий тоничность, такой как сахарозу или пропиленгликоль.
8. Композиция по п.1, где антитело присутствует в композиции в концентрации 50, 55, 60, 65, 70, 75, 80, 85, 90, 95, 100, 150, 200, 250 или 300 мг/мл.
9. Композиция по п.1, в которой поверхностно-активное вещество отсутствует.
10. Композиция по п.1, которая включает:
(A) 100 мг/мл антитела;
(B) 25 мМ хлорида натрия;
(C) 33 мМ гистидинового буфера;
(D) 25 мМ аргинина;
(Е) 0,001% полисорбата 80;
(F) 1,5 мг/мл фенола и 1,8 мг/мл м-крезола;
(G) 120 мМ сахарозы;
и буферизована до рН 6,5.
11. Композиция по п.1, которая включает:
(A) 100 мг/мл антитела;
(B) 25 мМ хлорида натрия;
(C) 33 мМ гистидинового буфера;
(D) 25 мМ аргинина;
(Е) 0,01% полисорбата 80;
(F) 1,5 мг/мл фенола и 1,8 мг/мл м-крезола;
(G) 120 мМ сахарозы;
и буферизована до рН 6,5.
12. Композиция по п.1, которая включает:
(A) 100 мг/мл антитела;
(B) 25 мМ хлорида натрия;
(C) 33 мМ гистидинового буфера;
(D) 25 мМ аргинина;
(Е) 0,01% полисорбата 80;
(F) 1,5 мг/мл фенола и 1,8 мг/мл м-крезола;
(G) 120 мМ сахарозы;
и буферизована до рН 6.
13. Стабильная композиция антитела по любому из пп.1-10 для применения в терапии.
14. Стабильная композиция антитела по любому из пп.1-11 для применения в лечении воспалительного заболевания.
15. Стабильная композиция по любому из пп.1-11 для применения в лечении коагулопатии.
Applications Claiming Priority (5)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP10164298 | 2010-05-28 | ||
| EP10164298.1 | 2010-05-28 | ||
| US35152210P | 2010-06-04 | 2010-06-04 | |
| US61/351,522 | 2010-06-04 | ||
| PCT/EP2011/058648 WO2011147921A1 (en) | 2010-05-28 | 2011-05-26 | Stable multi-dose compositions comprising an antibody and a preservative |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| RU2012153786A true RU2012153786A (ru) | 2014-07-10 |
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| Application Number | Title | Priority Date | Filing Date |
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| RU2012153786/10A RU2012153786A (ru) | 2010-05-28 | 2011-05-26 | Стабильные многодозовые композиции, содержащие антитело и консервант |
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| Country | Link |
|---|---|
| US (2) | US20130136733A1 (ru) |
| EP (1) | EP2575761B1 (ru) |
| JP (3) | JP6294075B2 (ru) |
| KR (1) | KR20130086144A (ru) |
| CN (2) | CN102905692B (ru) |
| AU (1) | AU2011257219B2 (ru) |
| BR (1) | BR112012030139A2 (ru) |
| CA (1) | CA2800188A1 (ru) |
| ES (1) | ES2993022T3 (ru) |
| HR (1) | HRP20241526T1 (ru) |
| MX (1) | MX2012013586A (ru) |
| RS (1) | RS66182B1 (ru) |
| RU (1) | RU2012153786A (ru) |
| WO (1) | WO2011147921A1 (ru) |
Families Citing this family (30)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1642983A (zh) | 2002-01-25 | 2005-07-20 | G2治疗有限公司 | 抗C5aR抗体及其应用 |
| CN101970494B (zh) | 2008-02-20 | 2015-01-21 | G2炎症私人有限公司 | 人源化抗-C5aR抗体 |
| JP2011526591A (ja) | 2008-06-30 | 2011-10-13 | ノボ・ノルデイスク・エー／エス | 抗ヒトインターロイキン−２０抗体 |
| US8454956B2 (en) | 2009-08-31 | 2013-06-04 | National Cheng Kung University | Methods for treating rheumatoid arthritis and osteoporosis with anti-IL-20 antibodies |
| BR112012021576A2 (pt) | 2010-02-26 | 2016-10-25 | Novo Nordisk As | composições estáveis contendo anticorpo. |
| EA201892184A1 (ru) | 2010-03-01 | 2019-03-29 | БАЙЕР ХЕЛЬСКЕР ЛЛСи | Оптимизированные моноклональные антитела против ингибитора пути тканевого фактора |
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| CN102905692A (zh) | 2013-01-30 |
| US20180104335A1 (en) | 2018-04-19 |
| CN105055306A (zh) | 2015-11-18 |
| JP6294075B2 (ja) | 2018-03-14 |
| EP2575761C0 (en) | 2024-08-14 |
| US20130136733A1 (en) | 2013-05-30 |
| CN105055306B (zh) | 2019-10-01 |
| BR112012030139A2 (pt) | 2017-06-13 |
| AU2011257219A1 (en) | 2012-11-22 |
| HRP20241526T1 (hr) | 2025-01-03 |
| EP2575761B1 (en) | 2024-08-14 |
| RS66182B1 (sr) | 2024-12-31 |
| CN102905692B (zh) | 2015-09-16 |
| JP2016084367A (ja) | 2016-05-19 |
| JP6239657B2 (ja) | 2017-11-29 |
| KR20130086144A (ko) | 2013-07-31 |
| JP6568917B2 (ja) | 2019-08-28 |
| US10835602B2 (en) | 2020-11-17 |
| EP2575761A1 (en) | 2013-04-10 |
| CA2800188A1 (en) | 2011-12-01 |
| JP2013527189A (ja) | 2013-06-27 |
| MX2012013586A (es) | 2013-01-24 |
| JP2018030879A (ja) | 2018-03-01 |
| AU2011257219B2 (en) | 2014-12-04 |
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