EA025267B1 - Водная фармацевтическая композиция этанерцепта, стабилизированная глутаматом - Google Patents

Водная фармацевтическая композиция этанерцепта, стабилизированная глутаматом Download PDF

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EA025267B1
EA025267B1 EA201490815A EA201490815A EA025267B1 EA 025267 B1 EA025267 B1 EA 025267B1 EA 201490815 A EA201490815 A EA 201490815A EA 201490815 A EA201490815 A EA 201490815A EA 025267 B1 EA025267 B1 EA 025267B1
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glutamate
etanercept
composition
aqueous pharmaceutical
composition according
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EA201490815A
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EA201490815A1 (ru
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Марк Мэннинг
Брайан Мерфи
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Кохерус Байосайенсис, Инк.
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Publication of EA201490815A1 publication Critical patent/EA201490815A1/ru
Publication of EA025267B1 publication Critical patent/EA025267B1/ru

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Abstract

Изобретение относится к водной фармацевтической композиции, не содержащей аргинин, включающей этанерцепт и стабилизатор, где стабилизатор включает 100-120 мМ глутамата и где композиция имеет рН 6,0-6,6. Композиция может дополнительно содержать один или несколько компонентов, выбранных из буфера, модификатора тоничности и эксципиента. Данное изобретение обеспечивает стабильные составы этанерцепта, которые не содержат аргинина.

Description

(57) Изобретение относится к водной фармацевтической композиции, не содержащей аргинин, включающей этанерцепт и стабилизатор, где стабилизатор включает 100-120 мМ глутамата и где композиция имеет рН 6,0-6,6. Композиция может дополнительно содержать один или несколько компонентов, выбранных из буфера, модификатора тоничности и эксципиента. Данное изобретение обеспечивает стабильные составы этанерцепта, которые не содержат аргинина.
025267 Β1

Claims (6)

1. Водная фармацевтическая композиция, не содержащая аргинин, включающая этанерцепт и стабилизатор, где стабилизатор включает 100-120 мМ глутамата и где композиция имеет рН 6,0-6,6.
2. Композиция по п.1, дополнительно включающая один или несколько компонентов, выбранных из буфера, модификатора тоничности и эксципиента.
3. Композиция по п.2, где состав включает 25-75 мг/мл этанерцепта, менее 6 мас.% сахарозы, 0-300 мМ Ν;·ιΟ и 1-30 мМ фосфата натрия.
4. Композиция по п.1, включающая 50 мг/мл этанерцепта, 0-3% сахарозы, 1-30 мМ фосфатного буфера и 0-100 мМ №С1.
5. Композиция по п.1, включающая 50 мг/мл этанерцепта, менее примерно 4 мас.% сахарозы и 1030 мМ фосфата, имеющая рН 6,3-6,5.
6. Композиция по п.1, включающая 50 мг/мл этанерцепта, 100 мМ глутамата, менее примерно 2 мас.% сахарозы, примерно 100 мМ №С1, 10-30 мМ фосфата и имеющая рН 6,3-6,5.
Евразийская патентная организация, ЕАПВ
EA201490815A 2011-10-18 2012-10-18 Водная фармацевтическая композиция этанерцепта, стабилизированная глутаматом EA025267B1 (ru)

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US201161548518P 2011-10-18 2011-10-18
US201261669480P 2012-07-09 2012-07-09
PCT/US2012/060738 WO2013059405A1 (en) 2011-10-18 2012-10-18 Etanercept formulations stabilized with amino acids

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EA201490815A1 EA201490815A1 (ru) 2014-09-30
EA025267B1 true EA025267B1 (ru) 2016-12-30

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EA201490801A EA026410B1 (ru) 2011-10-18 2012-10-18 Композиции этанерцепта, стабилизированные комбинациями сахаров и полиолов
EA201490817A EA025663B1 (ru) 2011-10-18 2012-10-18 Композиции этанерцепта, стабилизированные ионами металлов
EA201490804A EA201490804A1 (ru) 2011-10-18 2012-10-18 Препараты этанерцепта, стабилизированные хлоридом натрия
EA201490803A EA027325B1 (ru) 2011-10-18 2012-10-18 Составы этанерцепта, стабилизированные ксилитом
EA201490815A EA025267B1 (ru) 2011-10-18 2012-10-18 Водная фармацевтическая композиция этанерцепта, стабилизированная глутаматом
EA201490802A EA028520B1 (ru) 2011-10-18 2012-10-18 Препараты этанерцепта, стабилизированные меглюмином

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EA201490801A EA026410B1 (ru) 2011-10-18 2012-10-18 Композиции этанерцепта, стабилизированные комбинациями сахаров и полиолов
EA201490817A EA025663B1 (ru) 2011-10-18 2012-10-18 Композиции этанерцепта, стабилизированные ионами металлов
EA201490804A EA201490804A1 (ru) 2011-10-18 2012-10-18 Препараты этанерцепта, стабилизированные хлоридом натрия
EA201490803A EA027325B1 (ru) 2011-10-18 2012-10-18 Составы этанерцепта, стабилизированные ксилитом

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