PHARMACEUTICAL FORMULATION OF THE TUBULIN INHIBITOR INDIBULIN FOR ORAL ADMINISTRATION WITH IMPROVED PHARMACOKINETIC PROPERTIES, AND PROCESS FOR THE MANUFACTURE THEREOF

摘要

The present invention relates to a pharmaceutical formulation for oral administration of the poorly soluble and therefore hardly bioavailable tubulin inhibitor Indibulin and a process for its manufacture. In particular, there is provided a pharmaceutical formulation of lndibulin for oral administration comprising a granulate containing micronized lndibulin having a particle size of less than 20 µm for at least 99 vol.-% of the particles, at least one hydrophilic surfactant, and one or more capsulation excipients.