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Phospholipid depot
专利权人:
ДР. РЕДДИЗ ЛАБОРАТОРИЗ;ДР. РЕДДИ'З ЛАБОРАТОРИЗ; ЛТД. (IN)
发明人:
ЧЭНЬ Хайлян (US),ЧЭНЬ Эндрю Сянь (US),СУРАКАНТИ Душиант (US),ОКУМУ Франклин (US)
申请号:
RU2013112353/15
公开号:
RU2013112353A
申请日:
2010.12.17
申请国别(地区):
RU
年份:
2014
代理人:
摘要:
1. A method of obtaining a depot preparation, comprising: (1) the formation of an oil-in-water emulsion comprising a phospholipid, oil, at least one hydrophilic water-soluble pharmaceutically active substance selected from the group consisting of vancomycin, gentamicin, their pharmaceutically an acceptable salt or mixture thereof; and water; (2) homogenizing the emulsion to obtain a primary emulsion; (3) treating the primary emulsion with a microfluidizer to obtain a monophasic solution; (4) ensuring that the pH of the primary emulsion and / or mon of the foreign solution was in the range from about 3 to about 6, adjusting the pH as necessary, (5) lyophilization of the monophasic solution with the desired pH to obtain a dry paste, (6) adding a viscosity modifier to the dry paste in an amount of about 25% mass or more of the total mass of the obtained solution with a changed viscosity, (7) removing at least some viscosity modifier to obtain a depot preparation containing from about 1% of the mass. up to about 20% of the mass. viscosity modifier with respect to the total weight of the depot preparation, and (8) sterilization of the depot preparation. 2. The method according to claim 1, wherein the depot preparation is transparent. The method according to claim 1, in which the depot preparation is translucent. The method of claim 1, wherein said step of forming an oil-in-water emulsion comprises: dissolving at least one hydrophilic water-soluble pharmaceutically active substance selected from the group consisting of vancomycin, gentamicin, a pharmaceutically acceptable salt thereof, and a mixture thereof, in water , to obtain an aqueous solution; and mixing this water �1. Способ получения депо-препарата, включающий:(1) образование эмульсии масло-в-воде, включающей в себя фосфолипид, масло, по меньшей мере одно гидрофильное водорастворимое фармацевтически активное вещество, выбранное из группы, состоящей из ванкомицина, гентамицина, их фармацевтически приемлемой соли ил
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