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СПОСОБ КОНТРОЛИРУЕМОЙ КРИСТАЛЛИЗАЦИИ АКТИВНОГО ФАРМАЦЕВТИЧЕСКОГО ИНГРЕДИЕНТА ИЗ СОСТОЯНИЯ ПЕРЕОХЛАЖДЕННОЙ ЖИДКОСТИ ЭКСТРУЗИЕЙ ГОРЯЧЕГО РАСПАДА
专利权人:
Ф. ХОФФМАНН-ЛЯ РОШ АГ (CH)
发明人:
ЧЭТТЕРДЖИ Ашиш (US),ДЕСАЙ Дипен (US),МИЛЛЕР Дейв Алан (US),СЭНДХУ Харприт К. (US),ШАХ Навнит Харговиндас (US)
申请号:
RU2013139701/15
公开号:
RU2013139701A
申请日:
2012.02.14
申请国别(地区):
RU
年份:
2015
代理人:
摘要:
1. A pharmaceutical composition prepared by extruding the hot melt, comprising a hydrophobic compound having a melting point below 250 ° C and a glass transition temperature below 45 ° C, made by a process comprising: (1) loading said compound simultaneously with the excipients in the extrusion cylinder of the extruder, ( 2) melting the compound by applying heat and shear force application due to shearing action of the extruder screws, to give non-crystalline compound, (3) mixing the molten connected I and auxiliaries in the first quarter - half of the barrel due to the shearing action of the extruder screws, (4) subsequent recrystallization of the compound of the molten mixture in the second half - three quarters of the extruder barrel through heat and shearing action, and (5) Punching of the composition through a die at the extruder outlet wherein the average particle diameter of the compound is significantly reduced compared to the starting material to ekstruzii.2. A composition according to claim 1, wherein the compound in the composition obtained by extruding a hot melt has an average particle diameter of less than 10 mikron.3. A composition according to claim 1, wherein the compound in the composition obtained by extruding a hot melt has an average particle diameter of less than 5 mikron.4. A composition according to claim 1, wherein the pharmaceutically acceptable carrier comprises at least one thermal binder veschestvo.5. A composition according to claim 1, wherein said thermal coupling agent is an amino sopolimer.6 methacrylate. A composition according to claim 1, wherein said thermal1. Фармацевтическая композиция, полученная путем экструзии горячего расплава, включающая гидрофобное соединение с точкой плавления ниже 250°С и температурой стеклования ниже 45°С, изготовленная способом, включающим: (1) загрузку указанного соединения одновременно со вспомогательными веществами в экструзионный цилиндр экструдера, (2) плавление соединения путем подведения тепла и
来源网站:
中国工程科技知识中心
来源网址:
http://www.ckcest.cn/home/

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