Pharmaceutical formulation of the tubulin inhibitor Indibulin for oral administration with improved pharmacokinetic properties, and process for the manufacture thereof

摘要

Disclosed is a pharmaceutical formulation of Indibulin comprising a granulate containing micronized Indibulin having a particle size of less than 20 microns for at least 99 vol.% of the particles, at least one hydrophilic surfactant, and one or more capsulation excipients, wherein the pharmaceutical formulation is suitable for oral administration. Also disclosed is a tablet or gelatine capsule containing the above formulation, and a method of making the formulation.