RU2019121790A - Быстро распадающаяся фармацевтическая композиция - Google Patents

Быстро распадающаяся фармацевтическая композиция Download PDF

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RU2019121790A
RU2019121790A RU2019121790A RU2019121790A RU2019121790A RU 2019121790 A RU2019121790 A RU 2019121790A RU 2019121790 A RU2019121790 A RU 2019121790A RU 2019121790 A RU2019121790 A RU 2019121790A RU 2019121790 A RU2019121790 A RU 2019121790A
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pharmaceutical composition
hyaluronic acid
matrix
maltodextrin
acceptable salt
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RU2751193C2 (ru
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Ганешчандра СОНАВАНЕ
Даниэль ПЛАКСИН
Вариндер АХУДЖА
Параг ЛОКХАНДЕ
Девендра Кантилал ДЖАИН
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Ферринг Б.В.
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    • A61K31/40Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
    • A61K31/403Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil condensed with carbocyclic rings, e.g. carbazole
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    • A61K31/4985Pyrazines or piperazines ortho- or peri-condensed with heterocyclic ring systems
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    • A61K31/505Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
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Claims (23)

1. Фармацевтическая композиция, включающая открытую матричную ячеистую структуру, несущую один или несколько фармацевтически активных ингредиентов, где открытая матричная ячеистая структура включает мальтодекстрин и гиалуроновую кислоту или ее фармацевтически приемлемую соль.
2. Фармацевтическая композиция, включающая матрицу, несущую один или несколько фармацевтически активных ингредиентов, при этом матрица распадается при контакте с водной средой, указанная матрица включает мальтодекстрин и гиалуроновую кислоту или ее фармацевтически приемлемую соль.
3. Фармацевтическая композиция по п. 1 или 2, где гиалуроновая кислота имеет среднюю молекулярную массу в диапазоне от 1 × 104 до 1 × 107 дальтон, предпочтительно среднюю молекулярную массу 3 × 106±0,6 × 106 дальтон.
4. Фармацевтическая композиция по любому одному из пп. 1-3, имеющая предел прочности на разрыв по меньшей мере 0,1 Н/мм2.
5. Фармацевтическая композиция по любому одному из пп. 1-4, где мальтодекстрин и гиалуроновая кислота или ее фармацевтически приемлемая соль составляет от 10 до 99,99% от общей массы матрицы или открытой матричной ячеистой структуры и материала, переносимого матрицей или открытой матричной ячеистой структурой.
6. Фармацевтическая композиция по любому одному из пп. 1-5, где, в расчете на общую массу матрицы или открытой матричной ячеистой структуры и материала, переносимого матрицей или открытой матричной ячеистой структурой, мальтодекстрин составляет от 10 до 99% и гиалуроновая кислота или ее фармацевтически приемлемая соль составляет 0,99-5%, или мальтодекстрин составляет 40-99% и гиалуроновая кислота или ее фармацевтически приемлемая соль составляет 0,99-5%, или мальтодекстрин составляет 50-98% и гиалуроновая кислота или ее фармацевтически приемлемая соль составляет 0,99-3%.
7. Фармацевтическая композиция по любому одному из пп. 1-6, где композиция распадается в водной среде в течение 30 секунд.
8. Фармацевтическая композиция по п. 7, где композиция распадается в водной среде в течение 10 секунд.
9. Фармацевтическая композиция по любому одному из пп. 1-8, которая находится в лекарственной форме для перорального приема.
10. Фармацевтическая композиция по п. 9, которая адаптирована для сублингвального введения.
11. Фармацевтическая композиция по любому одному из пп. 1-10, где активный ингредиент представляет собой десмопрессин, десмопрессина ацетат, монтелукаст, монтелукаст натрия, силденафил, силденафила цитрат, силодозин или тадалафил.
12. Фармацевтическая композиция по любому одному из пп. 1-11, получаемая путем сублимации растворителя из отвержденного жидкого препарата, включающего активный ингредиент, мальтодекстрин и гиалуроновую кислоту или ее фармацевтически приемлемую соль в растворителе.
13. Способ получения фармацевтической композиции, включающий сублимацию растворителя из отвержденного жидкого препарата, включающего один или несколько фармацевтически активных ингредиентов, мальтодекстрин и гиалуроновую кислоту или ее фармацевтически приемлемую соль в растворителе.
14. Способ по п. 13, включающий: (a) введение единичных доз указанного жидкого препарата в углубления открытой блистерной упаковки; (b) отверждение жидкого препарата; и (c) сублимацию растворителя из отвержденного препарата с получением твердых единичных лекарственных форм в указанных углублениях.
15. Способ по п. 13 или 14, где растворитель представляет собой воду.
16. Способ по любому одному из пп. 13-15, где активный ингредиент представляет собой десмопрессин, десмопрессина ацетат, монтелукаст, монтелукаст натрия, силденафил, силденафила цитрат, силодозин или тадалафил.
17. Способ получения фармацевтической композиции, включающий:
(a) получение жидкого препарата, включающего мальтодекстрин, гиалуроновую кислоту или ее фармацевтически приемлемую соль и один или несколько активных ингредиентов, в растворителе;
(b) замораживание указанного жидкого препарата;
(c) сублимацию растворителя из замороженного препарата с получением фармацевтической композиции,
где фармацевтическая композиция распадается в течение 30 секунд при контакте с водной средой.
18. Способ по п. 17, который распадается в течение 10 секунд при контакте с водной средой.
19. Способ по п. 17 или 18, где композиция представляет собой композицию по любому одному из пп. 1-11.
RU2019121790A 2017-01-11 2018-01-11 Быстро распадающаяся фармацевтическая композиция RU2751193C2 (ru)

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