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Ramon Cabiscol Martinoli
Uniaxially compacted tablets are one of the most preferred drug dosage forms. A deeper understanding of the structure-property relationships can put some light on the final performance of the entire tableting operation. Chipping and abrasion in finishing operations, such as drum coating, are undesirable phenomena that might convey to dust formation and the rejection of an entire batch. The extent of each individual failure mechanism is dependent on formulation parameters (elasto-plastic mechanical properties of tablet components and compaction parameters) as well as geometry, stress field, and inertia within subsequent process steps. To provide a comprehensive analysis of the role of single particle properties and manufacturing conditions on the mechanical stability of a tablet, and to establish a predictive numerical tool of the overall process performance by the Discrete Element Method (DEM), a four phases study is hereby presented. First, for a selected number of pharmaceutical excipients, a direct determination of particle properties (e.g. size distribution, true density, module of elasticity or surface energy) is performed. This provides a clear characterisation of the shape, morphology and densification mechanisms on the particle scale and permits the calibration of DEM input parameters.