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СТАБИЛЬНЫЕ СОСТАВЫ БОРТЕЗОМИБА
专利权人:
ИННОФАРМА; Инк. (US)
发明人:
СОППИМАТХ Кумареш (US),ПЕДЖАВЕР Сатиш (US),ПАТЕЛ Канайялал Р. (US),ДАСАРАДХИ Лаккараджу (US),СОДУМ Рама (US),ДЕСУ Хари (US),ПУРИ Навнеет (US)
申请号:
RU2012144316/15
公开号:
RU2012144316A
申请日:
2011.03.18
申请国别(地区):
RU
年份:
2014
代理人:
摘要:
1. A pharmaceutical composition comprising: a liquid composition comprising bortezomib, wherein the liquid composition is a system of essentially nonaqueous solvents suitable for injection having the total amount of water equal to or less than about 15%, and wherein the liquid composition is suitable for injection, where the system. solvent contains propylene glycol as a main component, wherein bortezomib is present in a concentration of at least 1 mg / ml, and wherein the solvent system is formulated so as to maintain the degradation of bortezomib at less than h m 10 wt%. during storage of the liquid formulation for at least three months at ambient conditions sredy.2. A pharmaceutical composition according to claim 1, wherein the system is substantially nonaqueous solvent comprises at least 50% by volume. propilenglikolya.3. A pharmaceutical composition according to claim 2, wherein the system is substantially nonaqueous solvent comprises at least 75% by volume. propilenglikolya.4. A pharmaceutical composition according to claim 2, wherein the system is substantially nonaqueous solvent comprises at least about 100%. propilenglikolya.5. A pharmaceutical composition according to claim 1, wherein the system is substantially nonaqueous solvent further contains a polar solvent in an amount equal to or less than 25% ob.6. A pharmaceutical composition according to claim 5, wherein the system is substantially nonaqueous solvent further contains a polar solvent in an amount equal to or less than 20% ob.7. A pharmaceutical composition according to claim 5 or 6, wherein the polar solvent is etanol.8. A pharmaceutical composition according to claim 1, wherein the system is substantially nonaqueous solvent further contains a polar solvent in the amounts1. Фармацевтическая композиция, содержащая:жидкий состав, содержащий бортезомибгде жидкий состав представляет собой систему по существу неводных растворителей, подходящую для инъекции, имеющую общее количество воды равное или мен
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