GLEESON, Margaret,KIM, Soojin,KIENTZLER, Donald,KIANG, San
申请号：
ES04795750
公开号：
ES2632499T3
申请日:
2004.10.20
申请国别(地区):
ES
年份:
2017
代理人:
摘要：
A process for preparing sterile crystals of aripiprazole monohydrate of desired small particle size and narrow particle size distribution, comprising: (a) providing a jet stream of a solution of aripiprazole in an organic solvent, in which the solution of aripiprazole in the organic solvent contains from 0.01 to 0.1 kg / l of aripiprazole and wherein the jet stream of aripiprazole solution in the organic solvent is heated to a temperature ranging from 70 ° C to 85 ° C； (b) providing an anti-solvent water jet stream, wherein the anti-solvent jet stream is heated to a temperature ranging from 2 ° C to 40 ° C； (c) cause the jet stream of the aripiprazole solution in the organic solvent and the jet stream to impact and impact each other at a flow rate, each of which is the same or different but is within the range of 0.2 to 0.3 kg / min, where 0.02 inch internal diameter jet nozzles are used to create high turbulence at their point of impact to achieve high intensity micromixing of each current before nucleation, to produce a suspension of aripiprazole monohydrate crystals； and (d) recovering aripiprazole monohydrate crystals of the desired small particle size and narrow particle distribution, wherein 10% of the aripiprazole monohydrate crystals produced have a particle size of less than 10 micrometers, 50% of the crystals of aripiprazole monohydrate produced have a particle size of less than 35 micrometers and 95% of the aripiprazole monohydrate crystals produced have a particle size of less than 100 micrometers and wherein said aripiprazole monohydrate crystals have an average particle size within from the range of 25 micrometers to 100 micrometers.Un proceso para preparar cristales estériles de aripiprazol monohidrato de tamaño de partícula pequeño deseado y distribución estrecha de tamaño de partícula, que comprende: (a) proporcionar una corriente de chorro de una solución de aripiprazol en un disolvente orgánico, en la que la solución de aripiprazol en el disolvent
