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METHOD FOR PREPARING CARRIER PARTICLES FOR DRY POWDERS FOR INHALATION
专利权人:
КЬЕЗИ ФАРМАЧЕУТИЧИ С.п.А. (IT)
发明人:
МУЗА Росселла (IT),КОККОНИ Даниела (IT),КАМАЙОУ Алайн (IT),ГАЛЕТ Лауренче (IT)
申请号:
RU2012142295/15
公开号:
RU2012142295A
申请日:
2011.03.11
申请国别(地区):
RU
年份:
2014
代理人:
摘要:
1. A method of preparing a carrier for powdered pharmaceutical compositions for inhalation, in which lactose particles having a mass diameter in the range of 30-1000 μm are dry coated with magnesium stearate in an amount of 0.1-1.3% by weight of the carrier to provide a surface coating the lactose particles with said magnesium stearate to such an extent that the coated particles have more than 60% of the surface coating, where the dry coating step is carried out in a granulator mixer with a large shear e friction characteristics at a rotation speed equal to or greater than 500 rpm, but equal to or less than 2500 rpm. 2. The method according to claim 1, wherein the high shear mixer granulator is a CYCLOMIX ™ apparatus. The method according to claim 1 or 2, where the rotation speed is from 1000 to 2000 rpm. The method according to claim 1, wherein the dry coating step is carried out over a period of 2 to 20 minutes. The method according to claim 4, where the time is from 5 to 15 minutes. The method of claim 1, wherein the coated particles have at least 80% of the surface coating. The method of claim 6, wherein the coated particles have more than 90% of the surface coating. Carrier particles for a dry powdered pharmaceutical composition that contain lactose particles having a mass diameter in the range of 30-1000 μm, coated with magnesium stearate in an amount of 0.1-1.3 percent by weight of the carrier to such an extent that the coated particles have more than 60% of the surface coating, where these carrier particles are obtained by a method in which the coating is applied by dry method in a granulator mixer with a large shear force based on friction characteristics1. Способ приготовления носителя для порошкообразных фармацевтических композиций для ингаляции, при котором на частицы лактозы, имеющие массовый диаметр в диапазоне 30-1000 мкм, наносят сухим способом покрытие стеарата магния в количестве 0,1-1,3% по массе носителя для обеспечения поверхностного покрытия ча
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