Mechanisms of the spheronization process for the formulation of spherical granules

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Spherical granules (pellets) are quit useful in many pharmaceutical applications because they have special properties with respect to the drug release. Based on the well-defined particle surface area pellets are the optimal source for a functional coating using gastric-resisted or sustained release films. Moreover, pellets show an uniform drug release, which frequently reduces side effects. This project focuses on the study of the mechanisms of pellet formation in the most common manufacturing technique - spheronisation. Therefore, several spheronisation experiments will be performed in order to investigate influence of process parameters and formulation variables on the process dynamics. Furthermore the spheronisation process will split up in sub-processes (coalescence, consolidation and fracture) that must be investigated on the different length scales by Discrete Element Method, contact and fracture mechanics. Due to the coupling of the simulations for the sub-processes, which take palce on the different time and length scales, it will be possible to calculate the entire spheronisation process. In this way it should be possible to get deeper insights in the pelletization process leading to more process understanding. Based on this, the pelletization process could be applicable to other drug subtracted that cannot be used in spheronisation today.