ГРАВЕ Детлеф (DE),ГЛИЗИНГ Забине (DE),АЙЛЕРС Роберт (DE)
申请号：
RU2011108220/15
公开号：
RU2011108220A
申请日:
2009.06.30
申请国别(地区):
RU
年份:
2012
代理人:
摘要：
1. A method of manufacturing crystalline microparticles of the active substance, comprising stages in which the suspension is prepared from the primary particles of the active substance, a solution of the active substance, a precipitant for the active substance and inert formed parts, the suspension is mixed, after which the active substance is crystallized from the suspension, the active substance is isolated in product particles and then the product particles are dried, where the primary particles and the product particles are crystalline, are in the most stable crystalline modification of the active substance, have a surface crystal area of 3-10 m2 / g and the size distribution of the primary particles and product particles is d50 = 1-2 μm, d99 <；6 μm and d100 <；12 μm for each. ! 2. The method according to claim 1, characterized in that (a) a solution of the active substance in a solvent and (b) a precipitant are added to a suspension of primary particles and inert formed parts in a mixture of a solvent and a precipitant for the active substance. ! 3. The method according to claim 1 or 2, characterized in that the separation of the product particles is carried out by removing a suspension of product particles, while preferably the method is performed continuously. ! 4. The method in accordance with claim 1 or 2, characterized in that the mixing is performed by mixing the suspension. ! 5. The method in accordance with claim 1 or 2, characterized in that d10 of the product particles is <；0.7 μm and d100 of the product particles is <；8 μm. ! 6. The method according to claim 1 or 2, characterized in that the crystallinity of the primary particles and the product particles is ≥98 wt.%, Preferably ≥99 wt.% For each. ! 7. The method according1. Способ изготовления кристаллических микрочастиц действующего вещества, содержащий этапы, в которых суспензию готовят из первичных частиц действующего вещества, раствора действующего вещества, осадителя для действующего ве
