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RU2016144479A - Фармацевтические композиции для лечения заболеваний, опосредопосредованных муковисцидозным трансмембранным регулятором проводимости - Google Patents

Фармацевтические композиции для лечения заболеваний, опосредопосредованных муковисцидозным трансмембранным регулятором проводимости Download PDF

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RU2016144479A
RU2016144479A RU2016144479A RU2016144479A RU2016144479A RU 2016144479 A RU2016144479 A RU 2016144479A RU 2016144479 A RU2016144479 A RU 2016144479A RU 2016144479 A RU2016144479 A RU 2016144479A RU 2016144479 A RU2016144479 A RU 2016144479A
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pharmaceutical combination
dried dispersion
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Брайан Дин ФЕНИКС
Лоран Жан-клод БАНЬОЛЬ
Джеффри Глен БРОДЕР
Сачин Чандран
Элени ДОКОУ
Лори Энн ФЕРРИС
Драгутин КНЕЗИЧ
Кэти Линн МАККАРТИ
Алес МЕДЕК
Сара А. ВАГГЕНЕР
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Вертекс Фармасьютикалз Инкорпорейтед
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Claims (34)

1. Фармацевтическая комбинация, содержащая
первую высушенную распылением дисперсию и вторую высушенную распылением дисперсию, где первая высушенная распылением дисперсия содержит от 25 мг до 125 мг аморфного (R)-1-(2,2-дифторбензо[d][1,3]диоксол-5-ил)-N-(1-(2,3-дигидроксипропил)-6-фтор-2-(1-гидрокси-2-метилпропан-2-ил)-1H-индол-5-ил)циклопропанкарбоксамида и от 10 мас.% до 30 мас.% гидроксипропилметилцеллюлозы, и вторая высушенная распылением дисперсия содержит от 100 мг до 200 мг аморфного N-[2,4-бис(1,1-диметилэтил)-5-гидроксифенил]-1,4-дигидро-4-оксохинолин-3-карбоксамида.
2. Фармацевтическая комбинация по п. 1, где вторая высушенная распылением дисперсия также содержит сукцинат ацетата гипромеллозы.
3. Фармацевтическая комбинация по п. 1, где вторая высушенная распылением дисперсия содержит от 10 мас.% до 30 мас.% сукцината ацетата гипромеллозы.
4. Фармацевтическая комбинация по п. 1, где первая высушенная распылением дисперсия содержит 100 мг (R)-1-(2,2-дифторбензо[d][1,3]диоксол-5-ил)-N-(1-(2,3-дигидроксипропил)-6-фтор-2-(1-гидрокси-2-метилпропан-2-ил)-1H-индол-5-ил)циклопропанкарбоксамида.
5. Фармацевтическая комбинация по п. 1, где вторая высушенная распылением дисперсия содержит 150 мг N-[2,4-бис(1,1-диметилэтил)-5-гидроксифенил]-1,4-дигидро-4-оксохинолин-3-карбоксамида.
6. Фармацевтическая комбинация по п. 1, содержащая один или более эксципиентов, выбранных из наполнителя, разрыхлителя, смазывающего агента или любого их сочетания.
7. Фармацевтическая комбинация по п. 1, содержащая от 30 мас.% до 50 мас.% наполнителя.
8. Фармацевтическая комбинация по п. 7, где наполнитель представляет собой микрокристаллическую целлюлозу.
9. Фармацевтическая комбинация по п. 1, содержащая от 1 мас.% до 10 мас.% разрыхлителя.
10. Фармацевтическая комбинация по п. 9, где разрыхлитель представляет собой кроскармеллозу натрия.
11. Фармацевтическая комбинация по п. 1, содержащая около 1 мас.% смазывающего агента.
12. Фармацевтическая комбинация по п. 11, где смазывающий агент включает стеарат магния.
13. Фармацевтическая комбинация по п. 1, содержащая от 100 мг до 300 мг наполнителя.
14. Фармацевтическая комбинация по п. 1, содержащая от 12 мг до 36 мг разрыхлителя.
15. Фармацевтическая комбинация по п. 1, где таблетка содержит 5,9 мг смазывающего агента.
16. Фармацевтическая комбинация по п. 1, где
первая высушенная распылением дисперсия содержат 100 мг аморфного (R)-1-(2,2-дифторбензо[d][1,3]диоксол-5-ил)-N-(1-(2,3-дигидроксипропил)-6-фтор-2-(1-гидрокси-2-метилпропан-2-ил)-1H-индол-5-ил)циклопропанкарбоксамида и 20 мг гидроксипропилметилцеллюлозы, и
вторая высушенная распылением дисперсия содержит 150 мг аморфного N-[2,4-бис(1,1-диметилэтил)-5-гидроксифенил]-1,4-дигидро-4-оксохинолин-3-карбоксамида, 36,6 мг сукцината ацетата гипромеллозы и 0,9 мг лаурилсульфата натрия.
17. Фармацевтическая комбинация по п. 1, где
первая высушенная распылением дисперсия содержат 100 мг аморфного (R)-1-(2,2-дифторбензо[d][1,3]диоксол-5-ил)-N-(1-(2,3-дигидроксипропил)-6-фтор-2-(1-гидрокси-2-метилпропан-2-ил)-1H-индол-5-ил)циклопропанкарбоксамида и 20 мг гидроксипропилметилцеллюлозы, и
вторая высушенная распылением дисперсия содержит 150 мг аморфного N-[2,4-бис(1,1-диметилэтил)-5-гидроксифенил]-1,4-дигидро-4-оксохинолин-3-карбоксамида, 36,6 мг сукцината ацетата гипромеллозы и 0,9 мг лаурилсульфата натрия,
243,9 мг микрокристаллической целлюлозы,
29,6 мг кроскармеллозы натрия, и
5,9 мг стеарата магния.
18. Фармацевтическая комбинация по любому из пп. 1-17, где
фармацевтическая комбинация находится в дозированной форме.
19. Фармацевтическая комбинация по п. 18, где дозированная форма представляет собой таблетку.
20. Способ лечения муковисцидоза у пациента, включающий введение пациенту фармацевтической комбинации по любому из пп. 1-19.
21. Способ по п. 20, где фармацевтическую комбинацию вводят пациенту перорально.
22. Способ по любому из пп. 20-21, где пациент является гомозиготным в мутации ΔF508 гена муковисцидозного трансмембранного регулятора проводимости.
23. Способ по любому из пп. 20-21, где пациент является гетерозиготным в мутации ΔF508 гена муковисцидозного трансмембранного регулятора проводимости.
24. Способ по любому из пп. 20-21, где фармацевтическую комбинацию вводят один раз в сутки.
25. Способ по п. 24, где за введением фармацевтической комбинации следует введение 150 мг N-[2,4-бис(1,1-диметилэтил)-5-гидроксифенил]-1,4-дигидро-4-оксохинолин-3-карбоксамида один раз в сутки.
RU2016144479A 2014-04-15 2015-04-14 Фармацевтические композиции для лечения заболеваний, опосредованных муковисцидозным трансмембранным регулятором проводимости RU2744460C2 (ru)

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US201461979848P 2014-04-15 2014-04-15
US61/979,848 2014-04-15
US201462059287P 2014-10-03 2014-10-03
US62/059,287 2014-10-03
PCT/US2015/025722 WO2015160787A1 (en) 2014-04-15 2015-04-14 Pharmaceutical compositions for the treatment of cystic fibrosis transmembrane conductance regulator mediated diseases

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RU2016144479A true RU2016144479A (ru) 2018-05-16
RU2744460C2 RU2744460C2 (ru) 2021-03-09

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