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RU2008112144A - Композиции, включающие слаборастворимые в воде фармацевтические вещества и противомикробные вещества - Google Patents

Композиции, включающие слаборастворимые в воде фармацевтические вещества и противомикробные вещества Download PDF

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RU2008112144A
RU2008112144A RU2008112144/15A RU2008112144A RU2008112144A RU 2008112144 A RU2008112144 A RU 2008112144A RU 2008112144/15 A RU2008112144/15 A RU 2008112144/15A RU 2008112144 A RU2008112144 A RU 2008112144A RU 2008112144 A RU2008112144 A RU 2008112144A
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composition according
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albumin
soluble pharmaceutical
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Нейл П. ДИСЭЙ (US)
Нейл П. ДИСЭЙ
Радж СЕЛВАРАДЖ (US)
Радж Селварадж
Эндрю ЯНГ (US)
Эндрю Янг
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, содержащая слабо растворимое в воде фармацевтическое вещество, белок-носитель и противомикробное вещество, отличное от дефероксамина, где значимый рост микробов в композиции подавлен. ! 2. Композиция по п.1, где белком-носителем является альбумин. ! 3. Композиция по п.2, где весовое отношение альбумина к слабо растворимому в воде фармацевтическому веществу в композиции составляет приблизительно 18:1 или менее. ! 4. Композиция по п.1, где композиция содержит наночастицы слаборастворимых в воде фармацевтических веществ с белком-носителем. ! 5. Композиция по п.4, где белком-носителем является альбумин. ! 6. Композиция по п.5, где весовое отношение альбумина к слабо растворимому в воде фармацевтическому веществу в композиции составляет приблизительно 18:1 или менее. ! 7. Композиция по п.4, где наночастицы в композиции имеют средний диаметр не более чем приблизительно 200 нм. ! 8. Композиция по п.7, где композиция стерилизована фильтрованием. ! 9. Композиция по п.1, где композиция является водной суспензией слабо растворимого в воде фармацевтического вещества в концентрации от приблизительно 0,1 до 20 мг/мл. ! 10. Композиция по п.1, где композиция является лиофилизированной композицией, которую можно восстановить в водную суспензию слабо растворимого в воде фармацевтического вещества в концентрации от приблизительно 0,1 до 20 мг/мл. ! 11. Композиция по п.1, где композиция пригодна для парентерального введения. ! 12. Композиция по п.1, где композиция в основном не содержит Cremophor®. ! 13. Композиция по любому из пп.1-12, где количество противомикробного вещества в композиции не вызывает токсического эффекта, когда композицию вводят индивидуум

Claims (34)

1. Композиция, содержащая слабо растворимое в воде фармацевтическое вещество, белок-носитель и противомикробное вещество, отличное от дефероксамина, где значимый рост микробов в композиции подавлен.
2. Композиция по п.1, где белком-носителем является альбумин.
3. Композиция по п.2, где весовое отношение альбумина к слабо растворимому в воде фармацевтическому веществу в композиции составляет приблизительно 18:1 или менее.
4. Композиция по п.1, где композиция содержит наночастицы слаборастворимых в воде фармацевтических веществ с белком-носителем.
5. Композиция по п.4, где белком-носителем является альбумин.
6. Композиция по п.5, где весовое отношение альбумина к слабо растворимому в воде фармацевтическому веществу в композиции составляет приблизительно 18:1 или менее.
7. Композиция по п.4, где наночастицы в композиции имеют средний диаметр не более чем приблизительно 200 нм.
8. Композиция по п.7, где композиция стерилизована фильтрованием.
9. Композиция по п.1, где композиция является водной суспензией слабо растворимого в воде фармацевтического вещества в концентрации от приблизительно 0,1 до 20 мг/мл.
10. Композиция по п.1, где композиция является лиофилизированной композицией, которую можно восстановить в водную суспензию слабо растворимого в воде фармацевтического вещества в концентрации от приблизительно 0,1 до 20 мг/мл.
11. Композиция по п.1, где композиция пригодна для парентерального введения.
12. Композиция по п.1, где композиция в основном не содержит Cremophor®.
13. Композиция по любому из пп.1-12, где количество противомикробного вещества в композиции не вызывает токсического эффекта, когда композицию вводят индивидууму.
14. Композиция по любому из пп.1-12, где противомикробным веществом является комплексообразующее вещество.
15. Композиция по п.14, где комплексообразующее вещество выбрано из группы, состоящей из эдетата, цитрата, пентетата, трометамина, их производных и их смесей.
16. Композиция по п.15, где комплексообразующее вещество содержит цитрат и эдетат.
17. Композиция по п.16, где комплексообразующее вещество содержит 200 мМ цитрата и ЭДТА.
18. Композиция по любому из пп.1-12, где противомикробным веществом является некомплексообразующее вещество.
19. Композиция по п.18, где некомплексообразующее вещество выбрано из группы, состоящей из сульфитов, бензойной кислоты, бензилового спирта, хлорбутанола, парабена, их производных и их смесей.
20. Композиция по любому из пп.1-12, где слабо растворимое фармакологическое вещество выбрано из группы, состоящей из паклитаксела, доцетаксела, ортатаксела или других таксанов, гельданамицина, 17-аллиламиногельданамицина, димера тиоколхицина, рапамицина, циклоспорина, эпотилона, радицикола и комбретастина.
21. Композиция по п.20, где слаборастворимым фармакологическим веществом является таксан или его производное.
22. Композиция по п.21, где слабо растворимым фармакологическим веществом является паклитаксел.
23. Композиция по п.17, где слабо растворимым фармакологическим веществом является паклитаксел.
24. Способ лечения рака у индивидуума, включающий введение субъекту эффективного количества композиции по пп.1-12, где слабо растворимым фармакологическим веществом является антинеопластическое вещество.
25. Способ по п.24, где количество противомикробного вещества в композиции не вызывает токсического эффекта, когда композицию вводят индивидууму.
26. Способ консервирования композиции, содержащей слабо растворимое в воде фармацевтическое вещество и белок-носитель, от значимого микробного роста, включающий добавление к композиции противомикробного вещества, отличного от дефероксамина, в количестве, которое эффективно подавляет микробный рост в композиции.
27. Сухая композиция, содержащая слабо растворимое фармацевтическое вещество, белок-носитель и сахар, где композицию можно восстановить в стабильную водную суспензию слабо растворимого фармацевтического вещества и где время восстановления композиции меньше чем для композиции без сахара, где концентрация сахара в восстановленной суспензии выше чем приблизительно 50 мг/мл.
28. Композиция по п.27, дополнительно содержащая противомикробное вещество, где подавлен значимый рост микробов в композиции.
29. Композиция по п.27, где сахаром является сукроза или маннит.
30. Композиция по п.27, где слабо растворимым в воде фармацевтическим веществом является паклитаксел.
31. Композиция по п.27, где белком-носителем является альбумин.
32. Композиция, содержащая паклитаксел, альбумин и сахар, где весовое отношение альбумина к паклитакселу составляет приблизительно 9:1 или менее, и где концентрация сахара в композиции или восстановленной из композиции суспензии выше чем приблизительно 50 мг/мл.
33. Композиция по п.32, где композиция содержит наночастицы, содержащие альбумин и паклитаксел.
34. Композиция по п.32 или 33, где сахаром является сукроза или маннит.
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