Abstract:Purpose This paper communicates a methodology that uses experimental data and a new statistical method that uses a simulation to reconstruct the composition distribution of a powder blend containing drug agglomerates. The reconstructed distribution can be used subsequently to optimize sampling protocols, compute operating characteristic curves, and estimate process capability for blends containing agglomerates. Methods A blend containing a cohesive API and an excipient is prepared in a blender. Although the AP… Show more
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