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The effect of granules characters on mechanical properties of press-coated tablets: A comparative study

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The objective of this study was to examine the relationship between crucial granule characteristics (including particle size, surface roughness, and apparent porosity) and the mechanical properties of press-coated tablets. Granules of a model formulation were generated through Roll Compaction Granulation (RCG), High Shear Granulation (HSG), and Fluidized Bed Granulation (FBG) to produce granules with varying surface roughness and apparent porosity. The study found that the surface roughness and porosity of the granules had a significantly more pronounced impact on mechanical properties than the particle size of the granules. For both brittle and plastic materials, FBG granules with the roughest surface and the highest apparent porosity exhibited the most favorable compression properties. Various tests, including the elastic recovery test, interlayer adhesion forces study, break pattern test, and X-ray microcomputed tomography investigation, suggested that granules with high apparent porosity and rough surfaces played a vital role in producing stable press-coated structures. Furthermore, when using granules to prepare press-coated tablets, selecting appropriate granules for the coat layer could mitigate the adverse effects of the rigid core on mechanical strength. These insights will contribute to the selection of compatible and suitable granule characteristics, thereby enhancing mechanical properties and expanding the application of press-coated tablets.
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