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Scale Up der Granulation im Schnellmischer

Gerd Franke und Klaus-Jürgen Steffens

Pharmazeutische Technologie, Pharmazeutisches Institut der Rheinischen Friedrich-Wilhelms-Universität Bonn

Scale-up of Granulation in High Shear Mixers

The transition of single production steps of pharmaceutical solid dosage forms from the development scale into industrial production scale very often requires a great amount of time and financial input within the technological development process. The enlargement of batch sizes by a great figure very often leads to unexpected results. For wet granulation in modern high shear mixers a precise measurement of the torque can be the basis for an optimized and time saving scaling up. Within the now completed study it is shown, that a detailed investigation of the measured torque performances can lead to a secure forecast of the granulation quality that is to be expected, while the actual granulation process is still ongoing. The division of torque, as a model, into mixing and agglomeration part, serves a supporting figure, which can be used as a comparison between pilot and production scale.

Key words Drehmomentmessung · Granulation · Scale Up · Schnellmischer