Issue link: https://www.e-digitaleditions.com/i/1331851
Tablets & Capsules January/February 2021 43 between the particle size distribu- tions or key parameters x10, x50, and x90. The table below the figure shows the average values of the key parameters with a standard deviation. Figure 6 shows the DSC thermo- grams of the six selected batches for each roller dryer. The figure shows endothermic peaks at 236°C for all selected batches, with no signifi- cant differences in peak onset or peak position between batches from the two roller dryers. This endo- thermic event is known to be the decomposition of anhydrous beta lactose [20]. Endothermic dehydra- tion around 140°C is absent for all batches, indicating the absence of lactose monohydrate crystal water [20]. The table below the figure shows the average values of the observed peak onset and peak posi- tion with a standard deviation. The flow and tableting proper- ties were also tested on the selected batches. The flow function coeffi- cient (FFC) was evaluated by shear cell testing with a pre-consolidation strength of 4 kilopascals, and the Figure 7 Additional flow testing for the selected batches for each roller dryer that cover the maximum variation Roller dryer Average value FFC @4kPa Hausner ratio 1 8±2 1.24±0.05 2 10±2 1.23±0.06 Roller dryer 1 Roller dryer 2 FFC=1 FFC=2 FFC=4 FFC=10 Unconfined yield strength (kPa) 4.0 3.0 2.0 1.0 0.0 Major principal stress σ1 (kPa) 0 2 4 6 8 10 1.40 1.30 1.20 1.10 1.00 Hausner ratio Roller dryer 1 Roller dryer 2 Figure 6 DSC thermograms of the six batches for each roller dryer showcasing the absence of crystal water in SuperTab 21AN Roller dryer Average value (°C) Peak onset Peak position 1 233.8±0.7 235.9±0.6 2 234.0±0.4 236.1±0.2 Roller dryer 1 Roller dryer 2 10 mW/g Temperature (°C) 25 50 75 100 125 150 175 200 225 250