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RU2008112146A - Композиции и способы получения слаборастворимых в воде лекарственных средств с увеличенной стабильностью - Google Patents

Композиции и способы получения слаборастворимых в воде лекарственных средств с увеличенной стабильностью Download PDF

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RU2008112146A
RU2008112146A RU2008112146/15A RU2008112146A RU2008112146A RU 2008112146 A RU2008112146 A RU 2008112146A RU 2008112146/15 A RU2008112146/15 A RU 2008112146/15A RU 2008112146 A RU2008112146 A RU 2008112146A RU 2008112146 A RU2008112146 A RU 2008112146A
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composition
composition according
docetaxel
cancer
stabilizing agent
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Тапас ДЕ (US)
Тапас Де
Нейл П. ДИСЭЙ (US)
Нейл П. ДИСЭЙ
Эндрю ЯНГ (US)
Эндрю Янг
Захари ИМ (US)
Захари Им
Патрик М. Д. СООН-ШИОНГ (US)
Патрик М. Д. Соон-Шионг
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АБРАКСИС БАЙОСАЙЕНС, ЭлЭлСи (US)
АБРАКСИС БАЙОСАЙЕНС, ЭлЭлСи
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Abstract

1. Композиция, включающая доцетаксел и стабилизирующий агент, где стабильность композиции увеличивается по сравнению с композицией без стабилизирующего агента. ! 2. Композиция по п.1, где стабилизирующая композиция дополнительно включает биосовместимый полимер. ! 3. Композиция по п.1, где биосовместимым полимером является белок-носитель. ! 4. Композиция по п.3, где белком-носителем является альбумин. ! 5. Композиция по п.4, где отношение альбумина к доцетакселу составляет примерно 18:1 или менее. ! 6. Композиция по п.1, где композиция включает наночастицы доцетаксела, покрытые биосовместимым полимером. ! 7. Композиция по п.1, где биосовместимым полимером является белок-носитель. ! 8. Композиция по п.7, где белком-носителем является альбумин. ! 9. Композиция по п.8, где отношение альбумина к доцетакселу составляет примерно 18:1 или менее. ! 10. Композиция по п.6, где наночастицы в композиции имеют средний или усредненный размер частицы не более чем примерно 200 нм. ! 11. Композиция по п.1, где композицией является жидкая суспензия доцетаксела в концентрации по меньшей мере примерно 1 мг/мл. ! 12. Композиция по п.11, где композицией является жидкая суспензия доцетаксела в концентрации по меньшей мере примерно 15 мг/мл. ! 13. Композиция по п.1, где композицией является сухая композиция, которая может быть повторно восстановлена в жидкую суспензию с по меньшей мере примерно 1 мг/мл доцетаксела. ! 14. Композиция по п.13, где сухой композицией является лиофилизированная композиция. ! 15. Композиция по любому из пп.1-14, где стабилизирующим агентом является комплексообразующий агент. ! 16. Композиция по п.15, где стабилизирующим агентом является любой из: цитрата, эдет

Claims (36)

1. Композиция, включающая доцетаксел и стабилизирующий агент, где стабильность композиции увеличивается по сравнению с композицией без стабилизирующего агента.
2. Композиция по п.1, где стабилизирующая композиция дополнительно включает биосовместимый полимер.
3. Композиция по п.1, где биосовместимым полимером является белок-носитель.
4. Композиция по п.3, где белком-носителем является альбумин.
5. Композиция по п.4, где отношение альбумина к доцетакселу составляет примерно 18:1 или менее.
6. Композиция по п.1, где композиция включает наночастицы доцетаксела, покрытые биосовместимым полимером.
7. Композиция по п.1, где биосовместимым полимером является белок-носитель.
8. Композиция по п.7, где белком-носителем является альбумин.
9. Композиция по п.8, где отношение альбумина к доцетакселу составляет примерно 18:1 или менее.
10. Композиция по п.6, где наночастицы в композиции имеют средний или усредненный размер частицы не более чем примерно 200 нм.
11. Композиция по п.1, где композицией является жидкая суспензия доцетаксела в концентрации по меньшей мере примерно 1 мг/мл.
12. Композиция по п.11, где композицией является жидкая суспензия доцетаксела в концентрации по меньшей мере примерно 15 мг/мл.
13. Композиция по п.1, где композицией является сухая композиция, которая может быть повторно восстановлена в жидкую суспензию с по меньшей мере примерно 1 мг/мл доцетаксела.
14. Композиция по п.13, где сухой композицией является лиофилизированная композиция.
15. Композиция по любому из пп.1-14, где стабилизирующим агентом является комплексообразующий агент.
16. Композиция по п.15, где стабилизирующим агентом является любой из: цитрата, эдетата, яблочной кислоты, пентетата, трометамина, их производных и их смесей.
17. Композиция по п.16, где стабилизирующим агентом является цитрат.
18. Композиция по п.17, где композиция дополнительно включает хлорид натрия.
19. Композиция по п.18, где композиция включает примерно 200 мМ цитрата натрия и примерно 300 мМ хлорида натрия.
20. Композиция по любому из пп.1-14, где стабилизирующим агентом является пирофосфат натрия или глюконат натрия.
21. Фармацевтическая композиция, включающая доцетаксел, где доцетаксел, используемый для получения композиции, находится в безводной форме.
22. Фармацевтическая композиция по п.21, где композиция дополнительно включает биосовместимый полимер.
23. Фармацевтическая композиция по п.22, где биосовместимым полимером является альбумин.
24. Фармацевтическая композиция по п.22, где композиция включает наночастицы, включающие доцетаксел, покрытый белком-носителем.
25. Фармацевтическая композиция по п.24, где белком-носителем является альбумин.
26. Фармацевтическая композиция по п.25, где массовое отношение доцетаксела и альбумина в композиции составляет примерно 18:1 или менее.
27. Фармацевтическая композиция по п.21, где композиция дополнительно включает поверхностно-активное вещество.
28. Фармацевтическая композиция по п.27, где поверхностно-активным веществом является Tween 80.
29. Фармацевтическая композиция по п.27, где поверхностно-активное вещество является безводным.
30. Способ стабилизации слаборастворимого в воде фармацевтического агента в композиции, включающий комбинирование композиции, включающей слаборастворимый в воде фармацевтический агент, со стабилизирующим агентом, где полученная в результате композиция является стабильной в тех же условиях, при которых композиция является нестабильной до добавления стабилизирующего агента.
31. Способ по п.30, где способ далее включает идентификацию и отбор композиции, которая является нестабильной при одном или нескольких условиях.
32. Способ по п.30, где стабилизирующий агент выбран из группы, состоящей из цитрата, эдетата, яблочной кислоты, пентетата, пирофосфата натрия и глюконата натрия.
33. Способ лечения рака у индивидуума, включающий введение индивидууму эффективного количества композиции по п.1.
34. Способ по п.33, где раком является любой из: рака предстательной железы, рака толстой кишки, рака молочной железы, рака головы и шеи, рака поджелудочной железы, рака легкого и рака яичника.
35. Способ лечения рака у индивидуума, включающий введение индивидууму эффективного количества композиции по любому из пп.1-14 и 21-29.
36. Способ по п.33, где раком является любой из: рака предстательной железы, рака толстой кишки, рака молочной железы, рака головы и шеи, рака поджелудочной железы, рака легкого и рака яичника.
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