Issue link: https://www.e-digitaleditions.com/i/1267517
16 July 2020 Tablets & Capsules Figure 4 shows the particle size distribution of the final blend for the reformulated intermediate batch. The final fines content was 18.02 percent, and the powder blend was compressed on a rotary tablet press with no issues. The scientists then scaled up the reformulated blend to a pilot batch size of 130,000 tablets. The particle size dis- tribution of the final blend of the scale-up batch is given in Figure 5. While the fines content of the final blend for this scaled-up pilot batch was greater than for the refor- mulated intermediate batch, the slight increase in fines did not cause any powder flow problems during tableting. The batch was compressed on a rotary tablet press equipped with a force feeder. The tablet press speed was 60 rpm, and the entire batch was compressed within 2 hours and 10 minutes. The scientists performed tablet thickness, hardness, and weight checks every 15 minutes during the compression run. The tablet thick- ness and hardness are shown in Table 8. As the table As the percentage of fines was nearly the same at both roll force levels, the scientists used the 10-kilonew- ton roll force to compact the batch and recirculated the fines to yield less than 15 percent fines in the final blend. The reformulated blend's physical properties are shown in Table 7. The blend had a Flodex of 10, which is slightly higher than that of the first intermediate batch processed using the TFC roll compactor but still indi- cates excellent flow. Figure 4 Particle size distribution of reformulated final blend (Gerteis Mini-Pactor) 70.00 60.00 50.00 40.00 30.00 20.00 10.00 0.00 20/841 40/420 60/250 80/177 100/149 200/74 Fines/<74 Sieve number/Particle size (microns) Percentage retained Table 7 Physical properties of reformulated blend (Gerteis Mini-Pactor) Bulk density (mg/ml) Tapped density (mg/ml) Flodex (millimeters) 0.585 0.766 10 Figure 5 Particle size distribution of reformulated final blend (130,000-tablet scale-up batch) 50 45 40 35 30 25 20 15 10 5 0 20/841 40/420 60/250 80/177 100/149 120/125 Fines/<74 Sieve number/Particle size (microns) Percentage retained