RU2003125848A - Способ получения биологических материалов и полученные с их применением препараты - Google Patents
Способ получения биологических материалов и полученные с их применением препараты Download PDFInfo
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Claims (32)
1. Способ получения продуктов, содержащих чувствительные к влаге вещества, включая биологические материалы, такие как белки, пептиды или живые клетки, включающий, по меньшей мере, данные стадии:
(i) предоставление покрывающей жидкости, включающей, по меньшей мере, один активный компонент, полимерный сахар и водорастворимый/смешивающийся с водой растворитель;
(ii) предоставление множества микрочастиц, содержащих, по меньшей мере, водорастворимые твердые частицы, формирующие гель;
(iii) псевдоожижение указанного множества микрочастиц в пределах рабочей камеры подходящего устройства для формирования псевдоожиженного слоя из указанных микрочастиц;
(iv) распыление указанной покрывающей жидкости на указанный псевдоожиженный слой из-под псевдоожиженного слоя для покрытия посредством этого указанных микрочастиц в условиях насыщения влажностью; и
(v) предоставление возможности покрытым микрочастицам высохнуть.
2. Способ по п.1, где одна или более дополнительных стадий покрытия дополнительно покрывают микрочастицы энтеросолюбильным покрытием, пленочным покрытием, отталкивающим влагу покрытием и/или маскирующим вкус покрытием.
3. Способ по п.1 или 2, где микрочастицы высушивают нагреванием.
4. Способ по любому из пп.1-3, где активный компонент включает один или несколько белков, пептидов или клеток.
5. Способ по любому из пп.1-4, где водорастворимым/смешивающимся с водой растворителем является глицерин, пропиленгликоль или комбинация из глицерина и пропилена.
6. Способ по любому из пп.1-5, где полимерный сахар выбирают из группы, включающей декстран, фруктозу, fruitose, глюкозу, инвертный сахар, лактит, лактозу, мальтит, мальтодекстрин, мальтозу, маннит, сорбит, сахарозу, трегалозу, изомальтозу, ксилит, полидекстрозу или их комбинации.
7. Способ по любому из пп.1-6, где водорастворимые твердые частицы, формирующие гель, включают одну или несколько водорастворимых формирующих гель твердых частиц, выбранных из группы, включающей акрилат и его производные, альбумин, альгинаты, карбомеры, каррагинан, целлюлозу и ее производные, декстран, декстрин, желатин, поливинилпирролидон и крахмал.
8. Способ по любому из пп.1-7, где способ проводят в условиях насыщения влажностью.
9. Способ по любому из пп.1-8, где способ проводят в условиях отсутствия кислорода.
10. Способ по любому из пп.1-9, где покрытым микрочастицам придают форму композиции для инъекции, сублингвальной таблетки, пероральной таблетки, сублингвальной таблетки с замедленным высвобождением, микрокапсул, пессариев, предсуществующей твердой дозы для назального спрея или капель, водных капель, глазной промывки или капель, растворов для промывания кожи или пищевой примеси.
11. Способ по любому из пп.1-9, где указанный способ является способом для стабилизации биологических материалов.
12. Способ по любому из пп.1-11, где размер микрочастиц составляет от 50 микрон до 1 мм.
13. Способ по любому из пп.1-12, где активным компонентом является гормон, цитокин или фактор роста.
14. Способ по п.13, где активный компонент выбирают из гормонов роста человека или животного или их производных, эритропоэтина, кальцитонина, интерферона, интерлейкина, инсулина или колониестимулирующего фактора.
15. Способ по любому из пп.1-12, где активный компонент является ферментом.
16. Способ по п.15, где указанный фермент включает стрептокиназу, мурамидазу, фермент поджелудочной железы, амилазу, протеазу, липазу, целлюлазу, бромелаин или папаин.
17. Способ по любому из пп.1-12, где активный компонент является глюканом.
18. Способ по п.17, где глюкан является β-1,3-глюканом.
19. Способ по любому из пп.1-12, где активный компонент является микроорганизмом.
20. Способ по п.19, где микроорганизм является одним или более из Bifidus или Lactobacilli.
21. Продукт, получаемый по способу по любому из пп.1-20.
22. Композиция, включающая сердцевину микрочастиц, покрытую слоем с активным компонентом и полимерным сахаром.
23. Композиция по п.22, покрытая энтеросолюбильным покрытием, пленочным покрытием, влагоотталкивающим покрытием, маскирующим вкус покрытием или одним или более такими покрытиями.
24. Композиция по п.22 или 23, где активный компонент включает белок, пептид или клетку.
25. Композиция по п.24, где активный компонент является гормоном, цитокином или гормоном роста или комбинацией двух или более из них.
26. Композиция по п.25, где активный компонент выбирают из группы, содержащей гормоны роста человека или животного или их производные, эритропоэтин, кальцитонин, интерферон, интерлейкин, инсулин и колониестимулирующий фактор.
27. Композиция по п.24, где активный компонент является микроорганизмом.
28. Композиция по п.27, где микроорганизм является одним или более из Bifidus или Lactobacilli.
29. Композиция по любому из пп.22-24, где активный компонент является противодиарейным агентом.
30. Композиция по любому из пп.22-24, где активный компонент является усилителем роста.
31. Композиция по любому из пп.22-30, включающая микрочастицы из акрилата или его производных, альбумина, альгинатов, карбомеров, каррагинана, целлюлозы или ее производных, декстрана, декстрина, желатина, поливинилпирролидона или крахмала.
32. Композиция по любому из пп.22-31, где указанная композиция находится в форме инъекционных композиций, сублингвальной таблетки, пероральной таблетки, сублингвальной таблетки с замедленным высвобождением, микрокапсул, пессариев, предсуществующей твердой дозы для назального спрея или капель, водных капель, глазной промывки или капель, растворов для промывания кожи и пищевой примеси.
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AUPR2729A AUPR272901A0 (en) | 2001-01-25 | 2001-01-25 | Method of preparing biological materials and preparations produced using same |
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CA (1) | CA2435888A1 (ru) |
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EP1353697A4 (en) | 2006-05-17 |
IL156707A0 (en) | 2004-01-04 |
JP2004528288A (ja) | 2004-09-16 |
CN1489476A (zh) | 2004-04-14 |
IL156707A (en) | 2007-10-31 |
EP1353697A1 (en) | 2003-10-22 |
US20030012819A1 (en) | 2003-01-16 |
CA2435888A1 (en) | 2002-08-01 |
KR20030081396A (ko) | 2003-10-17 |
AUPR272901A0 (en) | 2001-02-22 |
US20050019417A1 (en) | 2005-01-27 |
US6974594B2 (en) | 2005-12-13 |
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