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RU2009102994A - Ингаляционная композиция, содержащая сульфоалкиловый эфир циклодекстрина и кортикостероид - Google Patents

Ингаляционная композиция, содержащая сульфоалкиловый эфир циклодекстрина и кортикостероид Download PDF

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RU2009102994A
RU2009102994A RU2009102994/15A RU2009102994A RU2009102994A RU 2009102994 A RU2009102994 A RU 2009102994A RU 2009102994/15 A RU2009102994/15 A RU 2009102994/15A RU 2009102994 A RU2009102994 A RU 2009102994A RU 2009102994 A RU2009102994 A RU 2009102994A
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corticosteroid
composition
dose
use according
suspension
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RU2009102994/15A
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Джеймс Д. ПИПКИН (US)
Джеймс Д. Пипкин
Руперт О. ЦИММЕРЕР (US)
Руперт О. ЦИММЕРЕР
Дайан О. ТОМПСОН (US)
Дайан О. ТОМПСОН
Джерольд Л МОШЕР (US)
Джерольд Л МОШЕР
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Сайдекс Фармасьютикалз, Инк. (Us)
Сайдекс Фармасьютикалз, Инк.
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Abstract

1. Применение водной жидкой композиции, содержащей водный жидкий носитель, сульфоалкиловый эфир циклодекстрина и дозу растворенного кортикостероида, для изготовления лекарственного средства, для лечения заболевания или нарушения дыхательных путей у нуждающегося в этом субъекта, где указанную композицию вводят субъекту ингаляцией, при этом данная композиция обеспечивает улучшенный фармакокинетический профиль по сравнению с композицией на основе суспензии, введенной в аналогичных условиях. ! 2. Система, включающая распылитель, оснащенный резервуаром, и водную жидкую композицию, содержащую водный жидкий носитель, усилитель растворимости и дозу кортикостероида, в которой во время распыления композиции распылитель обеспечивает процентное уменьшение скорости увеличения концентрации кортикостероида в композиции, находящейся в резервуаре, по сравнению со скоростью увеличения концентрации композиции на основе суспензии, распыляемой распылителем в аналогичных условиях. ! 3. Применение по п.1, в котором доза кортикостероида присутствует в количестве, достаточном для достижения в плазме среднего значения AUCt, равного 160-1600 пг·ч/мл, и молярное отношение SAE-CD к кортикостероиду больше 10:1. ! 4. Применение по п.1, в котором композиция содержит 25-400 мкг кортикостероида и обеспечивает достижение в плазме значения AUCt, равного 150-1600 пг·ч/мл для кортикостероида. ! 5. Применение по п.1, в котором композиция содержит по меньшей мере 25 мкг кортикостероида и обеспечивает достижение в плазме значения AUCt, нормализованного в отношении дозы кортикостероида, равного по меньшей мере 6 (пг·ч/мл)/мкг кортикостероида. ! 6. Применение по п.1, в

Claims (20)

1. Применение водной жидкой композиции, содержащей водный жидкий носитель, сульфоалкиловый эфир циклодекстрина и дозу растворенного кортикостероида, для изготовления лекарственного средства, для лечения заболевания или нарушения дыхательных путей у нуждающегося в этом субъекта, где указанную композицию вводят субъекту ингаляцией, при этом данная композиция обеспечивает улучшенный фармакокинетический профиль по сравнению с композицией на основе суспензии, введенной в аналогичных условиях.
2. Система, включающая распылитель, оснащенный резервуаром, и водную жидкую композицию, содержащую водный жидкий носитель, усилитель растворимости и дозу кортикостероида, в которой во время распыления композиции распылитель обеспечивает процентное уменьшение скорости увеличения концентрации кортикостероида в композиции, находящейся в резервуаре, по сравнению со скоростью увеличения концентрации композиции на основе суспензии, распыляемой распылителем в аналогичных условиях.
3. Применение по п.1, в котором доза кортикостероида присутствует в количестве, достаточном для достижения в плазме среднего значения AUCt, равного 160-1600 пг·ч/мл, и молярное отношение SAE-CD к кортикостероиду больше 10:1.
4. Применение по п.1, в котором композиция содержит 25-400 мкг кортикостероида и обеспечивает достижение в плазме значения AUCt, равного 150-1600 пг·ч/мл для кортикостероида.
5. Применение по п.1, в котором композиция содержит по меньшей мере 25 мкг кортикостероида и обеспечивает достижение в плазме значения AUCt, нормализованного в отношении дозы кортикостероида, равного по меньшей мере 6 (пг·ч/мл)/мкг кортикостероида.
6. Применение по п.1, в котором композиция содержит по меньшей мере 25 мкг кортикостероида и обеспечивает достижение в плазме значения AUCt, нормализованного в отношении дозы кортикостероида, равного по меньшей мере 8 (пг·ч/мл)/мкг кортикостероида.
7. Изобретение по любому из пп.1-6, в котором циклодекстрин является соединением формулы I:
Figure 00000001
где n означает 4, 5 или 6;
R1, R2, R3, R4, R5, R6, R7, R8 и R9 каждый независимо означают -О- или группу -О-(С2-С6 алкилен)-SO3 -, причем по меньшей мере один из R1-R9 независимо означает группу -О-(С2-С6 алкилен)-SO3 -, группу -О-(СН2)mSO3 -, где m равно 2-6, -ОСН2СН2СН2SO3 - или -OCH2CH2CH2CH2SO3 -; и
S1, S2, S3, S4, S5, S6, S7, S8 и S9 каждый независимо означают фармацевтически приемлемый катион.
8. Изобретение по любому из пп.1-6, в котором циклодекстрин является соединением формулы II (SAEx-α-CD), где x равно 1-18; формулы III (SAEy-β-CD), где y равно 1-21; или формулы IV (SAEz-γ-CD), где z равно 1-24, SAE означает заместитель, являющийся сульфоалкиловым эфиром, и величины х, у и z означают среднюю степень замещения в виде числа групп сульфоалкилового эфира в одной молекуле CD.
9. Применение по п.1, в котором значение Сmax, полученное для композиции, содержащей кортикостероид, по меньшей мере в 1,5 раза больше значения Сmax, полученного для композиции на основе суспензии, когда доза кортикостероида в композиции примерно в 2 раза меньше дозы в суспензии.
10. Применение по п.1, в котором композиция обеспечивает достижение значения Сmax (пг/мл), равного 1600-1800, на основе данных, ненормализованных в отношении дозы.
11. Применение по п.1, в котором на основе нормализованной номинальной дозы кортикостероида значение Сmax, полученное для композиции, содержащей кортикостероид, по меньшей мере в 1,7 раза больше значения Сmax, полученного для композиции на основе суспензии, когда доза кортикостероида в композиции и суспензии является примерно одинаковой.
12. Применение по п.1, в котором композиция обеспечивает достижение значения AUCinf (пг·ч/мл), равного 250-2500, на основе данных, ненормализованных в отношении дозы.
13. Применение по п.1, в котором на основе ненормализованной дозы кортикостероида значение AUCinf, полученное для композиции, содержащей кортикостероид, в 1,5-3,5 раза больше значения AUCinf, полученного для композиции на основе суспензии, когда доза кортикостероида в композиции и суспензии является примерно одинаковой.
14. Применение по п.1, в котором значение AUCinf, полученное для композиции, содержащей кортикостероид, по меньшей мере в 1,5 раза больше значения AUCinf, полученного для композиции на основе суспензии, когда доза кортикостероида в композиции примерно в 2 раза меньше дозы в суспензии.
15. Применение по п.1, в котором композиция обеспечивает достижение значения AUC0-8ч (пг·ч/мл), равного 2000-3000, на основе данных, ненормализованных в отношении дозы кортикостероида.
16. Изобретение по любому из пп.1-6, в котором кортикостероид является будезонидом.
17. Изобретение по любому из пп.1-6, в котором кортикостероид выбран из группы, состоящей из дипропионата беклометазона, монопропионата беклометазона, будезонида, циклезонида, дезизобутирилциклезонида, флунизолида, пропионата флутиказона, фуроата флутиказона, фуроата мометазона, энбутата икометазона, 21-пивалата тиксокортола и ацетонида триамцинолона.
18. Изобретение по любому из пп.1-6, в котором композицию вводят распылителем, выбранным из группы, состоящей из пневматического струйного распылителя, ультразвукового распылителя, электронного распылителя, распылителя с вибрирующей мембраной, распылителя с вибрирующим ситом, распылителя с вибрирующей пластиной, распылителя, включающего вибратор и водную камеру, и распылителя с несколькими соплами.
19. Способ получения композиции, содержащей кортикостероид, который включает смешивание с большим сдвигающим усилием кортикостероида, SAE-CD и водного жидкого носителя, при этом SAE-CD присутствует в количестве, достаточном для растворения кортикостероида.
20. Способ по п.19, в котором смешивание с большим сдвигающим усилием выполняют при помощи ультразвукового устройства, градуированных шприцев, смесителя/гомогенизатора, роторно-статорного смесителя или смесителя с пилообразными зубьями.
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