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38 January 2018 Tablets & Capsules Tablet friability. All the tablets showed acceptable friability results (Figure 9). No impact of the HPC's MW was observed. Conclusions: High-shear granulation. From these results, the following conclusions can be drawn regarding high- shear granulation: The HPC's MW has a minor effect on the granules' PSDs. Slightly fewer fines were created with HPC-SSL SFP; The lower MW HPCs (SSL and SL) have better compactability at higher compression forces (>15 kN); and Tablet disintegration time is inversely correlated to the HPC's MW: The higher the MW, the faster the disintegration, which is counterintuitive and the opposite of the results observed in the fluid-bed granulation that used a dissolved binder. For high-shear granulation, disintegration time ranks thusly: L FP < SL FP < SSL SFP. Comparison: Fluid-bed versus high-shear granulation PSD of the granules. A comparison of the PSDs of granules prepared using these wet granulation methods appears in Figure 10. As the figure shows, fluid-bed granulation produced finer particles and a narrower PSD. The difference is most prominent at the lowest-MW HPC (SSL), followed by SL and L. This implies a strong MW dependence: The higher the MW, the smaller the difference between the granule PSDs obtained from both granulation techniques. The coarser granules resulting from high-shear granulation demonstrated better powder flow across all three HPC grades (Figure 11). Figure 8 Disintegration time of tablets with breaking force of 100 N and 130 N 25 20 15 10 5 0 100 130 Breaking force (N) Disintegration time (min) HPC-SSL SFP HPC-SL FP HPC-L FP Figure 9 Friability of tablets Friability (%) Breaking force (N) 100 130 0.3 0.25 0.2 0.15 0.1 0.05 0 HPC-L FP HPC-SL FP HPC-SSL SFP Figure 10 PSD of granules prepared by fluid-bed granulation and high-shear granulation 1 1001 2001 3001 4001 1 1001 2001 3001 4001 1 1001 2001 3001 4001 1.8 1.6 1.4 1.2 1 0.8 0.6 0.4 0.2 0 2 1.8 1.6 1.4 1.2 1 0.8 0.6 0.4 0.2 0 2.5 2 1.5 1 0.5 0 Distribution density (q 3 lg) Distribution density (q 3 lg) Distribution density (q 3 lg) Particle size (μm) Particle size (μm) Particle size (μm) HPC-SSL (FBG) HPC-SL (FBG) HPC-L (FBG) HPC-SSL SFP (HSG) HPC-SL FP (HSG) HPC-L FP (HSG) quickly, which has a significant effect on tablet disintegration. The other two higher-MW HPCs (SL and L) exhibit lower hydration rates and therefore slower viscosity development. Since tablet disintegration is faster than the polymer equilibration rate, the expected effect of MW is masked.