Prediction of Bulk Powder Flow Performance Using Comprehensive Particle Size and Particle Shape Distributions

ABSTRACTThe purpose of this study is to establish a modeling approach that can be used to predict bulk powder flowability of pharmaceutical materials from their particle size and shape distributions. To build and validate the model, 23 commonly used pharmaceutical excipients and 38 binary blends were fully characterized for their particle size and shape distributions. The particle size and shape of each sample was characterized by multiple descriptors to fully reflect their morphological characteristics. The flow properties of these materials were analyzed using the Schulze Ring Shear Tester at a fixed humidity condition. A partial least squares (PLS) approach was used to build the mathematical model. Several different modeling approaches were attempted and the best method was identified as using a combination of formulation composition and particle size and shape distributions of single-component powder systems. The PLS model was shown to provide excellent predictions of powder flow function coefficient (FFC) of up to approximately 20. The results also revealed that both particle size and shape play an important role in determining the powder flow behavior.