A process for the continuous production inhalable drugs, apparatus for carrying out the process and drug produced according to this method

摘要

The invention relates to a method for the continuous production of medicaments for inhalation, a device for carrying out said method and a medicament produced by said method. The aim of the invention is a method which guarantees that the medicament conforms to strict requirements on particle size, particle-size distribution, morphology, stability and flow properties. Said aim is achieved by means of a method, comprising the following method steps:- charging a medicament solution, - segmentation of the solution by means of a segmenter and a transport medium, - initiation and control of the crystallisation process in a residence section, by means of imposing a defined temperature, whereby the seed formation process is firstly initiated by means of a sudden temperature reduction in such a manner that the solution, with regard to the temperature T and concentration C of the material dissolved therein, adopts a super-saturated, metastable or labile state and the crystal growth is then influenced by means of directed cooling; and separation of the crystal from the remaining phase in a separator, after running through the residence section.