RU2012153786A - Стабильные многодозовые композиции, содержащие антитело и консервант - Google Patents

Стабильные многодозовые композиции, содержащие антитело и консервант Download PDF

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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
composition according
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chlorobutanol
benzyl alcohol
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Хенрик ПАРШАД
Дорте Кот ЭНГЕЛУНД
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Ново Нордиск А/С
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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.
RU2012153786/10A 2010-05-28 2011-05-26 Стабильные многодозовые композиции, содержащие антитело и консервант RU2012153786A (ru)

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EP10164298 2010-05-28
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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

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EP (1) EP2575761B1 (ru)
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KR (1) KR20130086144A (ru)
CN (2) CN102905692B (ru)
AU (1) AU2011257219B2 (ru)
BR (1) BR112012030139A2 (ru)
CA (1) CA2800188A1 (ru)
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HR (1) HRP20241526T1 (ru)
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