RU2006105911A - Инъецируемые стержни из фосфата кальция для доставки остеогенных белков - Google Patents
Инъецируемые стержни из фосфата кальция для доставки остеогенных белков Download PDFInfo
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- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
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- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
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Claims (35)
1. Композиция для доставки остеогенных белков путем инъекции, содержащая остеогенный белок и кальций-фосфатный материал, отличающаяся тем, что указанная композиция имеет форму твердого стержня или отверждающейся пасты.
2. Композиция по п.1, отличающаяся тем, что остеогенный белок выбран из группы, состоящей из членов семейства «костных морфогенетических белков» (BMP).
3. Композиция по п.2, отличающаяся тем, что остеогенный белок выбран из группы, состоящей из BMP-2, BMP-4, BMP-5, BMP-6, BMP-7, BMP-10, BMP-12 и BMP-13.
4. Композиция по п.1, отличающаяся тем, что остеогенный белок присутствует в количестве от примерно 1 до примерно 90 мас.% композиции, предпочтительно в количестве примерно от 15 до примерно 40 мас.% композиции, при этом композиция имеет форму твердого стержня.
5. Композиция по п.1, отличающаяся тем, что остеогенный белок присутствует в количестве примерно от 0.01 до примерно 2 мас.% композиции, предпочтительно примерно от 0.03 до примерно 1 мас.% композиции, при этом композиция представляет собой отверждающуюся пасту.
6. Композиция по п.1, содержащая дополнительно ингибитор резорбции кости.
7. Композиция по п.6, отличающаяся тем, что ингибитор резорбции кости представляет собой бифосфонат, например бифосфонат, выбранный из группы, включающей алендронат, цимадронат, клодронат, ЕВ1053, этидронаты, ибандронат, неридронат, олпадронат, памидронат, резидронат, тилудронат, YH 529, золедронат и их фармацевтически приемлемые соли, эфиры, кислоты и их смеси.
8. Композиция по любому из пп.1-7, отличающаяся тем, что кальций-фосфатный материал содержит материал, выбранный из группы, состоящей из аморфного фосфата кальция типа апатита, слабокристаллизованного фосфата кальция типа апатита, гидроксиапатита, трикальция фосфата, фторапатита и их комбинаций.
9. Композиция по п.8, отличающаяся тем, что кальций-фосфатный материал содержит слабокристаллизованный фосфат кальция типа апатита.
10. Композиция по п.9, отличающаяся тем, что слабокристаллизованный фосфат кальция типа апатита имеет отношение кальций-к-фосфату, меньшее, чем 1:1.5, предпочтительно, примерно равное 1:1.4.
11. Композиция по любому из пп.1-4, 6, 7, 9, 10, отличающаяся тем, что кальций-фосфатный материал присутствует в количестве примерно от 10 до примерно 99 мас.%, предпочтительно, примерно от 40 до примерно 60 мас.% композиции, при этом композиция имеет форму твердого стержня.
12. Композиция по любому из пп.1-7, 9, 10, содержащая дополнительно добавку, выбранную из группы, включающей фармацевтически приемлемые соли, полисахариды, пептиды, белки, аминокислоты, синтетические полимеры, природные полимеры, поверхностно-активные вещества и их сочетания, например, такие как карбоксиметилцеллюлоза, гидроксипропилметилцеллюлоза, метилцеллюлоза, полимер молочной кислоты (полилактид), полиэтиленгликоль, поливинилпирролидон, полиоксиэтиленоксид, карбоксивиниловый полимер, поливиниловый спирт, декстрансульфат и их сочетания.
13. Композиция по п.12, отличающаяся тем, что добавка присутствует в количестве примерно от 1 до примерно 90 мас.% композиции.
14. Композиция по пп.13, отличающаяся тем, что добавка присутствует в количестве примерно от 20 до примерно 40 мас.% композиции, при этом композиция имеет форму твердого стержня.
15. Композиция по любому из пп.1-4, 6, 7, 13, 14, отличающаяся тем, что указанный стержень является цилиндрическим, причем диаметр указанного цилиндрического стержня составляет примерно от 0.1 до 3.0 мм.
16. Композиция по любому из пп.1-4, 6, 7, 9, 10, 13, 14, отличающаяся тем, что длина указанного стержня составляет примерно от 1.0 мм до 5.0 см.
17. Композиция по пп.1-3, 5, 7, 9, 10 или 13, отличающаяся тем, что кальций-фосфатный материал присутствует в количестве примерно от 30 до примерно 70 мас.% композиции, предпочтительно примерно от 45 до примерно 55 мас.% композиции, при этом композиция имеет форму отвержающейся пасты.
18. Композиция по п.13, отличающаяся тем, что добавка присутствует в количестве примерно от 20 до примерно 40 мас.% композиции, при этом композиция имеет форму отвержающейся пасты.
19. Способ приготовления композиции, содержащей остеогенный белок и кальций-фосфатный материал, для доставки остеогенных белков путем инъекции, включающий следующие этапы:
(a) смешивание сухой формы остеогенного белка с сухой формой фосфата кальция, с получением сухой смеси;
(b) восстановление сухой смеси путем добавления водного буфера с получением пасты;
(c) формование пасты с получением композиции в форме стержня; и
(d) сушку композиции в форме стержня, полученной на этапе (с), с получением композиции в форме стержня для доставки остеогенных белков путем инъекции.
20. Способ по п.19, отличающийся тем, что композиция представляет собой композицию по любому из пп.1-4 или 6-16.
21. Способ по п.19, отличающийся тем, что водный буфер выбирают из группы, состоящей из фосфатного буферного раствора, физиологического раствора, буферов на основе глицина и их комбинаций.
22. Способ по п.19, отличающийся тем, что отношение водного буфера к сухой смеси варьирует от примерно 0.5:1 до примерно 2:1.
23. Способ по п.19, отличающийся тем, что формование выполняют при помощи операции, выбранной из группы, включающей формование, экструзию, прессование, сверление и сочетания указанных операций.
24. Способ по п.19, включающий далее этап резки композиции в форме стержня до этапа (а) или после него.
25. Способ приготовления композиции, содержащей остеогенный белок и кальций-фосфатный материал, для доставки остеогенных белков путем инъекции, при этом способ включает следующие этапы:
смешивание сухой формы кальций-фосфатного материала с водным буфером, содержащим остеогенный белок, с формированием пасты.
26. Способ по п.25, отличающийся тем, что композиция представляет собой композицию по любому из пп.1-3 или 5-10, 12, 13, 17, 18.
27. Способ по п.25, отличающийся тем, что водный буфер выбирают из группы, состоящей из фосфатного буферного раствора, физиологического раствора, буферов на основе глицина и их комбинаций.
28. Способ по п.25, отличающийся тем, что отношение водного буфера к кальций-фосфатному материалу варьирует от примерно 0.5:1 до примерно 2:1.
29. Способ лечения млекопитающего с дефектом кости, включающий (а) введение в участок дефекта кости эффективного количества состава для доставки остеогенных белков путем инъекции композиции по любому из пп.1-18.
30. Способ по п.29, отличающийся тем, что дефект представляет собой поражение кости остеопорозом.
31. Способ лечения по п.29, отличающийся тем, что дополнительно включает этап (b) введения в участок дефекта кости эффективного количества ингибитора резорбции кости.
32. Способ по п.29, отличающийся тем, что этап (а) выполняют перед этапом (b), или этап (b) выполняют перед этапом (а), или этап (а) и этап (b) выполняют одновременно.
33. Применение композиции, содержащей остеогенный белок и кальций-фосфатный материал, в качестве композиции для приготовления лекарственного препарата для лечения млекопитающего с дефектом кости, включающее введение путем инъекции в участок дефекта кости эффективного количества композиции для доставки остеогенных белков, причем композицию инъецируют в виде твердого стержня или пасты.
34. Применение по п.33, в котором композицию, содержащую остеогенный белок и кальций-фосфатный материал, применяют в сочетании с введением в участок дефекта кости эффективного количества ингибитора резорбции кости.
35. Применение по п.33, в котором композицию, содержащую остеогенный белок и кальций-фосфатный материал, вводят до, после или одновременно с ингибитором резорбции кости.
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US50249303P | 2003-09-12 | 2003-09-12 | |
US60/502,493 | 2003-09-12 |
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RU2006105911A true RU2006105911A (ru) | 2007-10-20 |
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US (2) | US7771755B2 (ru) |
EP (3) | EP1772154A3 (ru) |
JP (1) | JP5392981B2 (ru) |
KR (1) | KR20060133961A (ru) |
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AR (1) | AR045935A1 (ru) |
AT (1) | ATE357244T1 (ru) |
AU (1) | AU2004272072B2 (ru) |
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CA (1) | CA2537735C (ru) |
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DE (1) | DE602004005477T2 (ru) |
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US20020114795A1 (en) | 2000-12-22 | 2002-08-22 | Thorne Kevin J. | Composition and process for bone growth and repair |
SI1675608T1 (sl) * | 2003-09-12 | 2007-08-31 | Wyeth Corp | Injektibilne trdne paličice kalcijevega fosfata za dajanje osteogenih proteinov |
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