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METHOD FOR PRODUCING GADOBENATE DIMEGLUMIN COMPLEX IN SOLID FORM
专利权人:
БРАККО ИМЭДЖИНГ СПА (IT)
发明人:
АНЕЛЛИ Пьер Лучио (IT),ЛАТТУАДА Лучано (IT),ФРЕТТА Роберта (IT),ФЕРРИГАТО Аурелия (IT),МОРОЗИНИ Пьер Франческо (IT),ЧЕРАДЖОЛИ Сильвия (IT),УГГЕРИ Фульвио (IT)
申请号:
RU2012125964/04
公开号:
RU2012125964A
申请日:
2010.11.23
申请国别(地区):
RU
年份:
2013
代理人:
摘要:
1. A method of obtaining a solid form of the compound gadobenate dimeglumine formula (I): comprising spray drying a liquid composition of the specified compound. The method according to claim 1, wherein said liquid composition has a concentration of at least 0.2 M.3. The method according to claim 2, wherein said concentration is from 0.45 M to 0.55 M. The method according to any one of claims 1 to 3, in which the liquid composition is an aqueous solution. The method according to claim 4, wherein said aqueous solution is a purified aqueous solution. The method according to claim 1, wherein the inlet temperature (T inlet) of the spray dryer is from 140 ° C to 280 ° C, and the outlet temperature (T out) is from 70 ° C to 120 ° C. The method according to claim 1, including spraying the liquid composition according to claim 1 using a high-pressure nozzle or a two-fluid nozzle. The solid powder form of dimeglumine gadobenate obtained by the method according to any one of claims 1 to 7.9. The solid form of gadobenate dimeglumine according to claim 8, characterized in that it is a water-soluble powder comprising gadobenate dimeglumine, in which the particle size is from 1 μm to 200 μm. The solid form of gadobenate dimeglumine according to claim 8, characterized in that the particle size is from 20 μm to 70 μm. A pharmaceutical kit comprising a first container containing a spray dried gadobenate dimeglumine according to any one of claims 8 to 10, and a second container containing a physiologically acceptable aqueous carrier. The pharmaceutical kit of claim 11, wherein said physiologically acceptable aqueous carrier is water for injection. The method of obtaining the solid form of 4-carboxy-5,8,11-tris (carboxymethyl) -1-phenyl-2-oxa-5,8,11-triaz1. Способ получения твердой формы соединения гадобената димеглюмина формулы (I):включающий распылительную сушку жидкой композиции указанного соединения.2. Способ по п.1, в котором у указанной жидкой композиции концентрация составляет,
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