Tablets & Capsules

TC0118

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Tablets & Capsules January 2018 39 Powder compactability. The tablet compaction properties of the granules produced by fluid-bed granulation were much better than those produced by high-shear granulation (Figure 12). At a given compression force and HPC MW, the tablet breaking force was between 30 and and 90 percent higher when a dissolved binder is used (fluid- bed granulation). This is likely due to the finer and more homogeneous particle size of granules produced by the fluid-bed method. Tablet disintegration. At a given MW, the disintegration time of tablets made from the high-shear granulations was much faster than that of tablets made from the fluid-bed granulations (Figure 13). This could be related to the more fragile nature of the granules made by the high-shear method (dry binder). They are more fragile because the bridges between the particles are not as strong as those made using a dissolved binder. This fragility is thought to facilitate tablet disintegration. Tablet friability. Tablet friability was acceptable for all formulations (Figure 14), with no significant dependence on MW or granulation method. Conclusions: Fluid-bed versus high- shear granulation. When comparing granulations with the same MW of HPC: Fluid-bed granulation produced smaller granules with narrower PSDs and better tablet compaction; High-shear granulation produced larger granules with broader PSDs and better flow properties; W i t h f l u i d - b e d g r a n u l a t i o n , disintegration times are shorter, and the lower the MW of the HPC, the faster the disintegration: SSL < SL < L; With high-shear granulation, the higher the MW of the HPC, the faster the disintegration: L < SL < SSL; and No significant differences in tablet friability were observed. T&C Edmont Stoyanov, PhD, is technical direc- tor and Berna Ehlig, PhD, is development director at Nisso Chemical Europe, Düssel- dorf, Germany. Wade Tanev is technical sales director at Nisso America, 88 Pine Street, 14th Floor, New York, NY 10005. E-mail: info@NissoAmerica.com. Figure 11 Flowability of granules prepared by fluid-bed granulation and high-shear granulation HPC-SSL (FBG) HPC-SSL SFP (HSG) HPC-SL (FBG) HPC-SL FP (HSG) HPC-L (FBG) HPC-L FP (FBG) 8 7 6 5 4 3 2 1 0 Flowability through 10-mm orifice (g/sec) Bulk density (g/cm 3 ) Tapped density (g/cm 3 ) Figure 12 Compaction properties of granules prepared by fluid-bed granulation and high-shear granulation 300 250 200 150 100 50 0 5 10 15 20 25 30 Compression force (kN) Breaking force (N) HPC-SSL (FBG) HPC-SL (FBG) HPC-L (FBG) HPC-SSL SFP (HSG) HPC-SL FP (HSG) HPC-L FP (HSG) Figure 13 Disintegration time of tablets prepared from fluid-bed granulation and high-shear granulation Fluid-bed granulation High-shear granulation HPC-SSL HPC-SSL SFP HPC-SL HPC-SL FP HPC-L HPC-L FP 100 N 150 N 30 25 20 15 10 2 0 Disintegration time (min) Figure 14 Friability of tablets prepared from fluid-bed granulation and high-shear granulation 0.3 0.25 0.2 0.15 0.1 0.05 0 Friability (%) Fluid-bed granulation High-shear granulation HPC-SSL HPC-SSL SFP HPC-SL HPC-SL FP HPC-L HPC-L FP 100 N 150 N

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