The focus of the project consists in the development of a measuring system with evaluation method for the in-line quantification of the coating quality in discontinuous as well as continuous fluidized bed processes. This topic is the continuation of the former WIGRATEC project „Development of a continuous compact fluidized bed technology for the manufacturing of flowable and compactible granulates for pharmaceutical and food industry” in the years 2009-2012. The infrared based measuring system (Forschungszentrum für Medizintechnik und Biotechnologie fzmb, Bad Langensalza, Germany) facilitates the non-destructive recording of the concentration distribution and the layer thickness distribution of a defined area on granules or pellets within one measuring cycle. The required calibration data are generated with classical techniques. Inert pellets are coated with model substances by laboratory fluidized bed technique at Anhalt University in discontinuous mode. Particle size is measured in-line by Spatial Filter Velocimetry (SFV probe IPP, Parsum, Chemnitz, Germany) and off-line by digital image processing (Camsizer®, Retsch, Haan, Germany). The coating process is scaled-up to pilot scale at Glatt in Weimar and performed in discontinuous as well as continuous process mode. Last not least, the process will be applied to production.
The developed measuring system opens the possibility of in-line process control by in-line analysis of the coating layer thickness on solid particles like pellets. For a validated process, the necessary layer thickness is evaluated in preliminary investigations to guarantee the desired properties of the drug preparation (controlled release, protection of air, light or humidity, masking of bad taste or smell). Besides the contribution to Process Analytical Technology (PAT) the application of the measuring system leads to a decrease of production and material costs at constant product quality.
The co-operation is intensified by the inclusion of Anhalt University students of pharmaceutical engineering into the experimental investigations at Glatt company in Weimar.
The research project WIGRATEC+ is financially supported by the Federal Ministry of Education and Research of Germany (BMBF).
Author: Prof. Dr. Bertram Wolf, Hochschule Anhalt