RU2013118453A - Катионы одновалентных металлов сухих порошков для ингаляций - Google Patents

Катионы одновалентных металлов сухих порошков для ингаляций Download PDF

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RU2013118453A
RU2013118453A RU2013118453/15A RU2013118453A RU2013118453A RU 2013118453 A RU2013118453 A RU 2013118453A RU 2013118453/15 A RU2013118453/15 A RU 2013118453/15A RU 2013118453 A RU2013118453 A RU 2013118453A RU 2013118453 A RU2013118453 A RU 2013118453A
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dry powder
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powder according
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RU2640921C2 (ru
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Майкл М. ЛИПП
Жан С. СУН
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Пулмэтрикс, Инк.
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Abstract

1. Вдыхаемый сухой порошок, содержащий вдыхаемые сухие частицы, которые включаютa) один или более катионов солей одновалентных металлов; при этом одна или несколько солей катионов одновалентных металлов присутствует в количестве по меньшей мере около 3% от веса сухой частицы иb) фармацевтически активное вещество, причем фармацевтически активное вещество является антибиотиком, LABA, LAMA, кортикостероидом или любой их комбинацией,где вдыхаемые сухие частицы имеют объемный медианный геометрический диаметр (ОМГД) около 10 мкм или менее и соотношение диспергируемости (1 бар/4 бар) менее чем 1,5, как измерено способом лазерной дифракции (РОДОС/HELOS системы), и где вдыхаемые сухие частицы имеют плотность утряски между 0,45 г/сми 1,2 г/см, при условии, что вдыхаемые сухие частицы не содержат двухвалентных катионов металлов в количестве 3% или более от веса данной сухой частицы.2. Вдыхаемый сухой порошок по п.1, отличающийся тем, что при дополнительном условии, вдыхаемые сухие частицы не содержат солей двухвалентных катионов металлов в количестве 5% или более от веса сухой частицы.3. Вдыхаемый сухой порошок по п.1, отличающийся тем, что вдыхаемые сухие частицы имеют объемный медианный геометрический диаметр (ОМГД) около 5,0 мкм или менее.4. Вдыхаемый сухой порошок по п.1, отличающийся тем, что вдыхаемые сухие порошки имеют фракцию тонкодисперсных частиц (ФТЧ) менее 5,6 микрона, по меньшей мере в 45%.5. Вдыхаемый сухой порошок по п.1, отличающийся тем, что вдыхаемый сухой порошок имеет массовый медианный аэродинамический диаметр (МСАД) около 5 микрон или менее.6. Вдыхаемый сухой порошок по п.1, отличающийся тем, что вдыхаемый сухой порошок дополнител�

Claims (20)

1. Вдыхаемый сухой порошок, содержащий вдыхаемые сухие частицы, которые включают
a) один или более катионов солей одновалентных металлов; при этом одна или несколько солей катионов одновалентных металлов присутствует в количестве по меньшей мере около 3% от веса сухой частицы и
b) фармацевтически активное вещество, причем фармацевтически активное вещество является антибиотиком, LABA, LAMA, кортикостероидом или любой их комбинацией,
где вдыхаемые сухие частицы имеют объемный медианный геометрический диаметр (ОМГД) около 10 мкм или менее и соотношение диспергируемости (1 бар/4 бар) менее чем 1,5, как измерено способом лазерной дифракции (РОДОС/HELOS системы), и где вдыхаемые сухие частицы имеют плотность утряски между 0,45 г/см3 и 1,2 г/см3, при условии, что вдыхаемые сухие частицы не содержат двухвалентных катионов металлов в количестве 3% или более от веса данной сухой частицы.
2. Вдыхаемый сухой порошок по п.1, отличающийся тем, что при дополнительном условии, вдыхаемые сухие частицы не содержат солей двухвалентных катионов металлов в количестве 5% или более от веса сухой частицы.
3. Вдыхаемый сухой порошок по п.1, отличающийся тем, что вдыхаемые сухие частицы имеют объемный медианный геометрический диаметр (ОМГД) около 5,0 мкм или менее.
4. Вдыхаемый сухой порошок по п.1, отличающийся тем, что вдыхаемые сухие порошки имеют фракцию тонкодисперсных частиц (ФТЧ) менее 5,6 микрона, по меньшей мере в 45%.
5. Вдыхаемый сухой порошок по п.1, отличающийся тем, что вдыхаемый сухой порошок имеет массовый медианный аэродинамический диаметр (МСАД) около 5 микрон или менее.
6. Вдыхаемый сухой порошок по п.1, отличающийся тем, что вдыхаемый сухой порошок дополнительно содержит по меньшей мере один фармацевтически приемлемый наполнитель.
7. Вдыхаемый сухой порошок по п.6, отличающийся тем, что по меньшей мере один наполнитель выбран из группы, состоящей из лейцина, мальтодекстрина, маннита и их комбинаций.
8. Вдыхаемый сухой порошок по п.1, отличающийся тем, что соль одновалентных катионов металлов является солью натрия.
9. Вдыхаемый сухой порошок по п.8, отличающийся тем, что соль натрия является хлоридом натрия, лактатом натрия, цитратом натрия, сульфатом натрия или их комбинацией.
10. Вдыхаемый сухой порошок по п.1, отличающийся тем, что соль одновалентных катионов металлов является солью калия.
11. Вдыхаемый сухой порошок по п.1, отличающийся тем, что плотность утряски порошка более чем 0,55 г/см3.
12. Вдыхаемый сухой порошок по п.1, где вдыхаемые сухие частицы дополнительно характеризуются массой порошка, испускаемой капсулой (СЕРМ) по меньшей мере 80% при испускании из пассивного ингалятора сухого порошка при следующих условиях: общая энергия вдоха менее чем приблизительно 2 Дж при использовании капсулы размера 3, которая заполнена по меньшей мере на 10% вдыхаемыми сухими частицами.
13. Вдыхаемый сухой порошок по п.1, где вдыхаемые сухие частицы дополнительно характеризуются средним диаметром (Dv50) менее чем 5 мкм при испускании из пассивного ингалятора сухого порошка, имеющего сопротивление около 0,036 кПа1/2/л в мин (LPM) при следующих условиях: общая энергия вдоха менее чем приблизительно 1,2 Дж при скорости потока 30 LPM, при использовании капсулы размера 3, которая содержит общую массу 20 мг, где указанная общая масса состоит из вдыхаемых сухих частиц.
14. Вдыхаемый сухой порошок, содержащий вдыхаемые сухие частицы, которые включают
a) один или более катионов солей одновалентных металлов; при этом одна или несколько солей катионов, одновалентных металлов присутствует в количестве по меньшей мере около 3% от веса сухой частицы и
b) фармацевтически активное вещество, причем фармацевтически активное вещество является макромолекулой,
где вдыхаемые сухие частицы имеют объемный медианный геометрический диаметр (ОМГД) около 10 мкм или менее и соотношение диспергируемости (1 бар/4 бар) менее чем 1,5, как измерено способом лазерной дифракции (РОДОС/HELOS системы), и где вдыхаемые сухие частицы имеют плотность утряски между 0,45 г/см3 и 1,2 г/см3, при условии, что вдыхаемые сухие частицы не содержат двухвалентных катионов металлов в количестве 3% или более от веса данной сухой частицы.
15. Вдыхаемый сухой порошок по п.14, отличающийся тем, что фармацевтически активное вещество выбрано из группы, состоящей из антител, гормонов и факторов роста.
16. Способ лечения респираторного заболевания, включающий введение в дыхательные пути пациента, нуждающегося в этом, эффективного количества вдыхаемого сухого порошка по п.1.
17. Способ лечения или профилактики обострения респираторного заболевания, включающий в себя введение в дыхательные пути пациента, нуждающегося в этом, эффективного количество вдыхаемого сухого порошка по п.1.
18. Способ лечения или профилактики инфекционного респираторного заболевания, включающий введение в дыхательные пути пациента, нуждающегося в этом, эффективного количество вдыхаемого сухого порошка по п.1.
19. Способ по п.16, где респираторное заболевание представляет собой астму, гиперреактивность дыхательных путей, сезонную аллергию, бронхоэктатическую болезнь, хронический бронхит, эмфизему, хроническую обструктивную болезнь легких, муковисцидоз.
20. Вдыхаемый сухой порошок, содержащий вдыхаемые сухие частицы, которые включают
a) один или более катионов солей одновалентных металлов; при этом одна или несколько солей катионов одновалентных металлов присутствует, в количестве по меньшей мере около 3% от веса сухой частицы и
b) фармацевтически активное вещество, причем фармацевтически активное вещество представляет собой МАВА,
где вдыхаемые сухие частицы имеют объемный медианный геометрический диаметр (ОМГД) около 10 мкм или менее и соотношение диспергируемости (1 бар/4 бар) менее чем 1,5, измеренное способом лазерной дифракции (РОДОС/HELOS системы), и где вдыхаемые сухие частицы имеют плотность утряски более чем около 0,45 г/см3, при условии, что вдыхаемые сухие частицы не содержат двухвалентных катионов металлов в количестве 3% или более от веса данной сухой частицы.
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