PURPOSE
To evaluate the scale-up of a high shear wet granulation process by maintaining impeller speed and the same number of impeller revolutions.
METHODS
The formulation utilized is shown in Figure 1. A development scale batch was prepared using a Collette Gral 300. A process was developed using an impeller speed of 185 RPM with a 5-minute spray time for binder solution and a 3-minute wet massing time. In the Gral 300 running at 185 rpm, the impeller will make 925 revolutions in 5 minutes. The batch was scaled up using a Freund GMX-1200 high shear granulator. Batch sizes were 132 kg (granulated in two sublots) and 352 kg (granulated in two sublots). An equivalent tip speed was calculated for the GMX-1200, and the impeller speed was set to 103 rpm. At this impeller speed, to make 925 revolutions takes 9 minutes. The lower RPM (equivalent tip speed) requires a longer time to complete the same number of revolutions in the GMX-1200 granulator. Figure 2 shows the parameters for each batch manufactured.
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