RU2010109856A - Способ получения лекарственной композиции, основанный на увеличении сродства поверхностей кристаллических микрочастиц к активным агентам - Google Patents
Способ получения лекарственной композиции, основанный на увеличении сродства поверхностей кристаллических микрочастиц к активным агентам Download PDFInfo
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Abstract
1. Микрочастица, содержащая дикетопиперазин и полисорбат 80. ! 2. Микрочастица по п.1, дополнительно содержащая активный агент. ! 3. Микрочастица по п.1, в которой дикетопиперазин является кристаллическим. ! 4. Микрочастица по п.3, дополнительно содержащая активный агент, причем активный агент адсорбирован на кристаллической поверхности дикетопиперазина. !5. Микрочастица по п.4, в которой активный агент создает монослой на кристаллической поверхности. ! 6. Микрочастица по п.5, в которой монослой является сплошным. ! 7. Микрочастица по п.4, в которой адсорбция активного агента опосредуется за счет электростатических, полярных, ионных, гидрофобных, водородных связей или Ван-дер-Ваальсовых сил. ! 8. Микрочастица по п.1, в которой дикетопиперазин выбирают из 3,6-ди(4-аминобутил)-2,5-дикетопиперазин; 3,6-ди(сукцинил-4-аминобутил)-2,5-дикетопиперазин; 3,6-ди(малеил-4-аминобутил)-2,5-дикетопиперазин; 3,6-ди(цитраконил-4-аминобутил)-2-5-дикетопиперазин; 3,6-ди(глутарил-4-аминобутил)-2,5-дикетопиперазин; 3,6-ди(малонил-4-аминобутил)-2,5-дикетопиперазин; 3,6-ди(оксалил-4-аминобутил)-2,5-дикетопиперазин и 3,6-ди(фумарил-4-аминобутил)-2,5-дикетопиперазин. !9. Микрочастица по п.1, содержащая приблизительно 0,8% мас./мас. полисорбата 80. ! 10. Микрочастица по любому из пп.2 или 4, в которой активный агент выбирают из группы, состоящей из инсулина или его аналогов, гормона роста, гормона паращитовидной железы (РТН), грелина, гранулоцитарно-макрофагального колониестимулирующего фактора (GM-CSF), глюкагоноподобного пептида 1 (GLP-1), антител и их фрагментов и циклоспоринов. ! 11. Микрочастица по п.9, в которой активный агент содержит инсулин или его аналог. ! 12. Способ получения частиц дикето�
Claims (16)
1. Микрочастица, содержащая дикетопиперазин и полисорбат 80.
2. Микрочастица по п.1, дополнительно содержащая активный агент.
3. Микрочастица по п.1, в которой дикетопиперазин является кристаллическим.
4. Микрочастица по п.3, дополнительно содержащая активный агент, причем активный агент адсорбирован на кристаллической поверхности дикетопиперазина.
5. Микрочастица по п.4, в которой активный агент создает монослой на кристаллической поверхности.
6. Микрочастица по п.5, в которой монослой является сплошным.
7. Микрочастица по п.4, в которой адсорбция активного агента опосредуется за счет электростатических, полярных, ионных, гидрофобных, водородных связей или Ван-дер-Ваальсовых сил.
8. Микрочастица по п.1, в которой дикетопиперазин выбирают из 3,6-ди(4-аминобутил)-2,5-дикетопиперазин; 3,6-ди(сукцинил-4-аминобутил)-2,5-дикетопиперазин; 3,6-ди(малеил-4-аминобутил)-2,5-дикетопиперазин; 3,6-ди(цитраконил-4-аминобутил)-2-5-дикетопиперазин; 3,6-ди(глутарил-4-аминобутил)-2,5-дикетопиперазин; 3,6-ди(малонил-4-аминобутил)-2,5-дикетопиперазин; 3,6-ди(оксалил-4-аминобутил)-2,5-дикетопиперазин и 3,6-ди(фумарил-4-аминобутил)-2,5-дикетопиперазин.
9. Микрочастица по п.1, содержащая приблизительно 0,8% мас./мас. полисорбата 80.
10. Микрочастица по любому из пп.2 или 4, в которой активный агент выбирают из группы, состоящей из инсулина или его аналогов, гормона роста, гормона паращитовидной железы (РТН), грелина, гранулоцитарно-макрофагального колониестимулирующего фактора (GM-CSF), глюкагоноподобного пептида 1 (GLP-1), антител и их фрагментов и циклоспоринов.
11. Микрочастица по п.9, в которой активный агент содержит инсулин или его аналог.
12. Способ получения частиц дикетопиперазина, включающий:
a. получение раствора дикетопиперазина с ограниченной растворимостью при низком значении рН,
b. добавление полисорбата 80 к раствору и
c. осаждение частиц дикетопиперазина содержащих полисорбат 80 на стадии включающей добавление кислоты к раствору.
13. Способ по п.12, в котором дикетопиперазин выбирают из 3,6-ди(4-аминобутил)-2,5-дикетопиперазин; 3,6-ди(сукцинил-4-аминобутил)-2,5-дикетопиперазин; 3,6-ди(малеил-4-аминобутил)-2,5-дикетопиперазин; 3,6-ди(цитраконил-4-аминобутил)-2-5-дикетопиперазин; 3,6-ди(глутарил-4-аминобутил)-2,5-дикетопиперазин; 3,6-ди(малонил-4-аминобутил)-2,5-дикетопиперазин; 3,6-ди(оксалил-4-аминобутил)-2,5-дикетопиперазин и 3,6-ди(фумарил-4-аминобутил)-2,5-дикетопиперазин.
14. Способ по п.12, в котором дикетопиперазин выбирают из 3,6-ди(фумарил-4-аминобутил)-2,5-дикетопиперазина.
15. Способ по п.12, в котором осаждение включает добавление уксусной кислоты к раствору.
16. Способ нанесения покрытия на предварительно сформированную кристаллическую микрочастицу в суспензии с активным агентом, включающий стадии в следующей последовательности;
i) получение предварительно сформированной кристаллической микрочастицы в которой указанная кристаллическая микрочастица не содержит активного агента;
ii) получение суспензии содержащей указанную предварительно сформированную кристаллическую микрочастицу, указанный агент и растворитель;
iii) изменение свойств суспензии в указанной полученной суспензии для регулирования энергетического взаимодействия между указанным активным агентом и указанной предварительно сформированной кристаллической микрочастицой где указанной изменение свойств выбирают из группы состоящей из изменения рН раствора, добавления моновалентных или мультивалентных ионов, изменения полярности и добавления доноров водородных связей или акцепторов для регулирования свойств поверхности указанной предварительно сформированной кристаллической микрочастицы, причем стадия изменения не включает стадию удаления указанного растворителя из указанной суспензии, и
iv) адсорбирование указанного активного агента на поверхности указанной предварительно сформированной кристаллической микрочастицы для обеспечения нанесения покрытия указанного активного агента на указанную кристаллической микрочастицу без удаления растворителя из указанной суспензии; где указанная стадия изменения обуславливает адсорбцию указанного активного агента на поверхности указанной предварительно сформированной кристаллической микрочастицы.
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RU2008114306/15A RU2394550C2 (ru) | 2005-09-14 | 2006-09-14 | Способ получения лекарственной композиции, основанный на увеличении сродства поверхностей кристаллических микрочастиц к активным агентам |
RU2010109856/15A RU2443414C2 (ru) | 2005-09-14 | 2010-03-16 | Способ получения лекарственной композиции, основанный на увеличении сродства поверхностей кристаллических микрочастиц к активным агентам |
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RU2008114306/15A RU2394550C2 (ru) | 2005-09-14 | 2006-09-14 | Способ получения лекарственной композиции, основанный на увеличении сродства поверхностей кристаллических микрочастиц к активным агентам |
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EP (3) | EP1928423B1 (ru) |
JP (4) | JP5465878B2 (ru) |
KR (7) | KR101486829B1 (ru) |
CN (3) | CN104324362B (ru) |
AU (2) | AU2006290870B2 (ru) |
BR (2) | BRPI0615819B8 (ru) |
CA (2) | CA2621806C (ru) |
DK (3) | DK2656836T3 (ru) |
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