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ORAL MEDICAL FORMS OF BENDAMUSTIN AND THEIR THERAPEUTIC APPLICATION
专利权人:
АСТЕЛЛАС ДОЙЧЛАНД ГМБХ
发明人:
Ульрих,Таоуфик
申请号:
EA201291249
公开号:
EA201291249A1
申请日:
2011.06.01
申请国别(地区):
EA
年份:
2014
代理人:
摘要:
The invention provides a pharmaceutical composition for oral administration comprising bendamustine or a pharmaceutically acceptable ester, salt or solvate thereof as an active ingredient and a pharmaceutically acceptable excipient and exhibiting dissolution of bendamustine at least 60% in 20 minutes, 70% in 40 minutes and 80% in 60 min, as estimated using a paddle stirrer at a speed of 50 rpm according to the European Pharmacopoeia in 500 ml of dissolution medium at pH 1.5, where a pharmaceutically acceptable excipient is is either a pharmaceutically acceptable non-ionic surfactant selected from the group consisting of polyethoxylated castor oil or a derivative thereof and a block copolymer of ethylene oxide and propylene oxide, or a pharmaceutically acceptable saccharide selected from the group consisting of one or more monosaccharides, disaccharides, oligosaccharides cyclic oligosaccharide, polysaccharide and sugar alcohol, where the mass ratio of the active ingredient and saccharide excipient (s) is in the range of 1: 1-5. The invention further relates to the aforementioned pharmaceutical composition for use in oral treatment of a medical condition selected from chronic lymphocytic leukemia, acute lymphocytic leukemia, chronic myelocytic leukemia, acute myelocytic leukemia, Hodgkin's disease, non-Hodgkin lymphoma, multiple myeloma, breast cancer, ovarian cancer, small cell lung cancer and non-small cell lung cancer. The invention further relates to the aforementioned pharmaceutical composition for the aforementioned use, whereinВ изобретении предложена фармацевтическая композиция для перорального введения, содержащая бендамустин или его фармацевтически приемлемые эфир, соль или сольват в качестве активного ингредиента и фармацевтически приемлемый эксципиент и демонстрирующая растворение бендамустина по меньшей мере 60% за 20 мин, 70% за 40 мин и 80% за 60 мин, как оценивают с помощью аппарата с лопастной мешалкой при скорости вращения 50 об/мин согласно Европейс
来源网站:
中国工程科技知识中心
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