Segregation tests at the bench scale were conduced on a direct-compression formulation to predict and understand segregation behaviors of a direct-compression blend at a production scale. As a result of the high segregation tendencies that were found, a Design of Experiment (DOE) was run to investigate factors that could influence content uniformity at the production scale and to identify controls required to maintain uniformity. Visual assessments of the blend showed segregation tendencies. Bench-scale segregation tests at the development scale quantified the relative severity of segregation and identified fluidization as the predominant mechanism. This provided emphasis that right-first-time and quality-by-design methods are required for this formulation to ensure successful production.
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