By J. Swarbrick(ed)
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Extra info for Handbook of Pharmaceutical Granulation Technology
High-agitation, high-deformable processes generally produce denser granules than those with low deformablity and low agitation intensity. In addition, the combined and competing effects of granule coalescence and consolidation make high-agitation processes difﬁcult to model and scale. Both coalescence and consolidation increase with increase in shear and deformability, whereas as granules densify, they become less deformable, which works to lower coalescence in the later stages of growth. Figure 29 Granule structures resulting from (A) low- and (B) high-deformability systems, typical for ﬂuid-bed and high-shear mixer granulators, respectively.
Granulation can retain a memory, with nuclei size distribution impacting ﬁnal granule size distribution. Therefore, initial wetting can be critical to uniform nuclei formation and often a narrow, uniform product. Wide nuclei distributions can lead to a wide granule size distribution. When the size of a particulate feed material is larger than drop size, wetting dynamics controls the distribution of coating material which has a strong inﬂuence on the later stages of growth. Wetting phenomena also inﬂuence redistribution of individual ingredients within a granule, drying processes, and redispersion of granules in a ﬂuid phase.
A very stiff formulation with low deformability may behave as a low deformability system in a high-shear mixer, or a very pliable formulation may act as a high-deformable system in a ﬂuid-bed granulator. 4. Granule Deformability Granule deformability—and hence Dc—is a strong function of moisture, as illustrated in Figure 31 by the marked increase in average granule size. , the ability of the material to resist stresses, and the ability of the surface to be strained without degradation or rupture of the granule, with this maximum allowable critical deformation strain denoted by (DL/L)c.