PROCESS FOR THE MANUFACTURE OF (SUB)MICRON SIZED PARTICLES BY DISSOLVING IN COMPRESSED GAS AND SURFACTANTS

摘要

The present invention relates to a process for manufacturing a pulverouspreparation of a (sub)micron-sized biologically active compound comprising thesteps of: (1) dissolving a biologically active compound under elevatedpressure in a compressed gas, liquid or supercritical fluid containing asurface modifier; or in compressed dimethylether optionally containing asurface modifier; (2a) rapidly expanding the compressed solution of step (1)thereby precipitating the dissolved compound; or (2b) spraying the compressedsolution of step (1) into an antisolvant phase optionally containing a surfacemodifier under vacuum, atmospheric pressure or elevated pressure; and (3)optionally converting the antisolvant phase of step (2b) into a pulverouspreparation using conventional powder processing techniques. With the processaccording to the present invention formation of aggregations or flocculationsof particles dissolved in the supercritical solution is prevented; moreover,the addition of cosolvents is not required, thus increasing the stabilisationof the suspension on an industrial scale.