Novel methodology to assess and predict segregation risk in a continuous direct compression via mini-batch blending process

) and the flow function coefficient (ffc). Based on this observation, an empirical linear relationship was established linking segregation tendency to flowability. To provide a pharmaceutically relevant measure, a secondary model was developed using chemical assay data, where segregation was quantified as the change in standard deviation of API concentration (Δstd) between the inlet and outlet of the rig. This model relates segregation behaviour to two measurable bulk properties: flow function coefficient and bulk density. The proposed approach provides a practical framework for early-stage assessment of segregation risk in cDC processes using limited material quantities. While the model is specific to the studied system, the methodology may be applicable to other powder handling processes subject to further validation.