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RU2012124069A - Фармацевтическая композиция, включающая агонист glp-1, инсулин и метионин - Google Patents

Фармацевтическая композиция, включающая агонист glp-1, инсулин и метионин Download PDF

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RU2012124069A
RU2012124069A RU2012124069/15A RU2012124069A RU2012124069A RU 2012124069 A RU2012124069 A RU 2012124069A RU 2012124069/15 A RU2012124069/15 A RU 2012124069/15A RU 2012124069 A RU2012124069 A RU 2012124069A RU 2012124069 A RU2012124069 A RU 2012124069A
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Анника ХАГЕНДОРФ
Геррит ХАУК
Вернер Мюллер
Изабелль ШЕТТЛЕ
Ферена ЗИФКЕ-ХЕНЦЛЕР
Катрин ТЕРЧ
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Санофи-Авентис Дойчланд Гмбх
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Abstract

1. Жидкая композиция, включающая агонист GLP-1 или/и его фармакологически приемлемую соль, инсулин или/и его фармакологически приемлемую соль и, необязательно, по меньшей мере одно фармацевтически приемлемое вспомогательное вещество, отличающаяся тем, что данная композиция содержит метионин.2. Жидкая композиция по п.1, отличающаяся тем, что содержит фармацевтически приемлемый консервант или/и фармацевтически приемлемое средство, обеспечивающее изотоничность.3. Жидкая композиция по п.1 или 2, отличающаяся тем, что содержит м-крезол или/и глицерин.4. Жидкая композиция по п.1, отличающаяся тем, что имеет значение pH от 3,5 до 5.5. Жидкая композиция по п.1, отличающаяся тем, что содержит метионин в количестве от 0,5 мг/мл до 20 мг/мл, в частности в количестве от 1 мг/мл до 5 мг/мл.6. Жидкая композиция по п.1, отличающаяся тем, что имеет после хранения в течение 6 месяцев при температуре +25°C химическую целостность.7. Жидкая композиция по п.1, отличающаяся тем, что имеет после хранения в течение 6 месяцев при температуре +25°C физическую целостность.8. Жидкая композиция по п.1, отличающаяся тем, что агонист GLP-1 выбирают из группы, состоящей из GLP-1 и его аналогов и производных, эксендина-3 и его аналогов и производных, эксендина-4 и его аналогов и производных, и при этом агонист GLP-1 предпочтительно выбирают из группы, которая состоит из:desProэксендин-4(1-39)-Lys-NHи эксендин-4.9. Жидкая композиция по п.1, при этом инсулин выбирают из инсулина человека, его аналогов, производных и метаболитов.10. Жидкая композиция по п.1, при этом инсулин выбирают из группы, которая состоит из Gly(A21)-Arg(B31)-Arg(B32)-инсулина человека, LysPro-инсулина человека, B28Asp инсулина человека и B29Lys(ε-тетра

Claims (28)

1. Жидкая композиция, включающая агонист GLP-1 или/и его фармакологически приемлемую соль, инсулин или/и его фармакологически приемлемую соль и, необязательно, по меньшей мере одно фармацевтически приемлемое вспомогательное вещество, отличающаяся тем, что данная композиция содержит метионин.
2. Жидкая композиция по п.1, отличающаяся тем, что содержит фармацевтически приемлемый консервант или/и фармацевтически приемлемое средство, обеспечивающее изотоничность.
3. Жидкая композиция по п.1 или 2, отличающаяся тем, что содержит м-крезол или/и глицерин.
4. Жидкая композиция по п.1, отличающаяся тем, что имеет значение pH от 3,5 до 5.
5. Жидкая композиция по п.1, отличающаяся тем, что содержит метионин в количестве от 0,5 мг/мл до 20 мг/мл, в частности в количестве от 1 мг/мл до 5 мг/мл.
6. Жидкая композиция по п.1, отличающаяся тем, что имеет после хранения в течение 6 месяцев при температуре +25°C химическую целостность.
7. Жидкая композиция по п.1, отличающаяся тем, что имеет после хранения в течение 6 месяцев при температуре +25°C физическую целостность.
8. Жидкая композиция по п.1, отличающаяся тем, что агонист GLP-1 выбирают из группы, состоящей из GLP-1 и его аналогов и производных, эксендина-3 и его аналогов и производных, эксендина-4 и его аналогов и производных, и при этом агонист GLP-1 предпочтительно выбирают из группы, которая состоит из:
desPro36эксендин-4(1-39)-Lys6-NH2 и эксендин-4.
9. Жидкая композиция по п.1, при этом инсулин выбирают из инсулина человека, его аналогов, производных и метаболитов.
10. Жидкая композиция по п.1, при этом инсулин выбирают из группы, которая состоит из Gly(A21)-Arg(B31)-Arg(B32)-инсулина человека, LysВ28ProВ29-инсулина человека, B28Asp инсулина человека и B29Lys(ε-тетрадеканоил),desB30 инсулина человека.
11. Жидкая композиция по п.1, отличающаяся тем, что содержит следующие компоненты:
(a) desPro36эксендин-4(1-39)-Lys6-NH2,
(b) Gly(A21)-Arg(B31)-Arg(B32)-инсулин человека,
(c) хлорид цинка,
(d) м-крезол (необязательно),
(e) L-метионин,
(f) глицерин,
(g) соляная кислота, в количестве, достаточном для получения значения pH примерно 4,5,
(h) раствор NaOH, в количестве достаточном для получения значения pH примерно 4,5, и
(i) вода.
12. Композиция по п.1, отличающаяся тем, что представляет собой композицию для инъекций.
13. Композиция по п.1 для лечения сахарного диабета.
14. Комбинация, включающая первую фармацевтическую композицию по одному из пп.1-13, вторую фармацевтическую композицию по одному из пп.1-13 и, необязательно, по меньшей мере одну следующую фармацевтическую композицию по одному из пп.1-13, каждая из которых содержит по меньшей мере один инсулин и по меньшей мере один агонист GLP-1, и по меньшей мере один инсулин или/и по меньшей мере один агонист GLP-1 содержатся в различных массовых долях по отношению к общей массе композиции.
15. Комбинация по п.14, при этом массовые доли по меньшей мере одного инсулина и по меньшей мере одного агониста GLP-1 в первой фармацевтической композиции, во второй фармацевтической композиции и в по меньшей мере одной, необязательной, следующей фармацевтической композиции выбирают таким образом, чтобы фармацевтические композиции имели различное отношение инсулина к агонисту GLP-1 в пересчете на массовые доли.
16. Комбинация по п.14 или 15, причем первая, вторая и. необязательно, следующая или следующие композиции содержат по меньшей мере один инсулин в, по существу, идентичных массовых долях, и по меньшей мере один агонист GLP-1 в различных массовых долях.
17. Комбинация по п.14 или 15, причем первая, вторая и, необязательно, следующая или следующие композиции содержат по меньшей мере один агонист GLP-1 в, по существу, идентичных массовых долях, а по меньшей мере один инсулин в различных массовых долях.
18. Набор, содержащий комбинацию по одному из пп.14-17.
19. Применение композиции по одному из пп.1-13, комбинации по пп.14-17 или набора по п.18 для получения лекарственного средства для лечения сахарного диабета.
20. Способ получения композиции по одному из пп.1-13, комбинации по пп.14-17 или набора по п.18, включающих композиции агониста GLP-1 или/и его фармакологически приемлемой соли с инсулином или/и его фармацевтически приемлемой солью, метионином и, необязательно, по меньшей мере одним фармацевтически приемлемым вспомогательным веществом.
21. Способ лечения пациентов композицией по одному из пп.1-13, комбинацией по пп.14-17 или набором по п.18, включающий введение композиции пациентам.
22. Применение композиции по одному из предшествующих пп.1-18, отличающееся тем, что оно происходит вместе с введением метформина, инсулина и/или агониста GLP-1 и/или фармакологически приемлемой соли.
23. Применение по п.22, отличающееся тем, что речь идет о дополнительной терапии, в частности к лечению инсулином и/или агонистом GLP-1.
24. Применение композиции по одному из пп.22 и 23, отличающееся тем, что терапию применяют у пациентов, которые не в достаточной мере могут контролировать диабет II типа с помощью инсулина и/или агониста GLP-1.
25. Применение композиции по одному из пп.1-18 в качестве дополнения к диете для того, чтобы контролировать уровень сахара в крови у пациентов с диабетом II типа, если показано применение инсулина или агониста GLP-1.
26. Применение композиции по одному из пп.22 или 23, отличающееся тем, что пациенты должны иметь значение HbA1c от 7% до 10%.
27. Применение композиция по одному из пп.22, 23 для лечения диабета II типа и/или ожирения.
28. Применение композиция по п.24 для лечения диабета II типа и/или ожирения.
RU2012124069/15A 2009-11-13 2010-11-11 Фармацевтическая композиция, включающая агонист glp-1, инсулин и метионин RU2537239C2 (ru)

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DE102009052831.8 2009-11-13
DE102009052831 2009-11-13
DE102010020902 2010-05-18
DE102010020902.3 2010-05-18
PCT/EP2010/067250 WO2011058083A1 (de) 2009-11-13 2010-11-11 Pharmazeutische zusammensetzung umfassend einen glp-1-agonisten, ein insulin und methionin

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