“Design Space” Determination of a Paracetamol Fluid Bed Granulation Using Design of Experiments
20. January 2016
This study was performed to increase understanding of a paracetamol fluid bed granulation process and to identify the
critical process parameters in a laboratory scale granulation process. The screening of the process parameters and their influence on final granules quality attributes were investigated using a factorial design. For this purpose the process parameters were first screened and depicted by the Ishikawa diagram.
critical process parameters in a laboratory scale granulation process. The screening of the process parameters and their influence on final granules quality attributes were investigated using a factorial design. For this purpose the process parameters were first screened and depicted by the Ishikawa diagram.
The experimental runs performed, given by the design model, identified spray rate followed by inlet air flow and atomizing spray pressure as the critical process parameters. Trials with high spray rates lead to granules with excellent flow properties. Furthermore, by increasing the inlet air volume granules with tight particle size distribution were obtained.
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Andrea Hartung1,4, Erik Johansson3, Marcus Knoell2, Hedinn Valthorsson4,
Peter Langguth1
1 Department of Pharmaceutical Technology and Biopharmaceutics,
Johannes Gutenberg-University, Mainz, Germany
2 Hüttlin GmbH, Schopfheim, Germany
3 Umetrics AB, Umeå, Sweden
4 Novartis Pharma Stein AG, Stein, Switzerland
Corresponding author: Prof. Peter Langguth, Department of Pharmaceutical Technology
and Biopharmaceutics, Staudingerweg 5, 55099 Mainz, Germany,
e-mail: [email protected]
Peter Langguth1
1 Department of Pharmaceutical Technology and Biopharmaceutics,
Johannes Gutenberg-University, Mainz, Germany
2 Hüttlin GmbH, Schopfheim, Germany
3 Umetrics AB, Umeå, Sweden
4 Novartis Pharma Stein AG, Stein, Switzerland
Corresponding author: Prof. Peter Langguth, Department of Pharmaceutical Technology
and Biopharmaceutics, Staudingerweg 5, 55099 Mainz, Germany,
e-mail: [email protected]
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