Abstract

The aim of this study is to investigate the impact of various mixtures of crosslinked polystyrene (CPS) and yttrium-stabilized zirconia (YSZ) beads (CPS:YSZ=0:1–1:0 v:v) on the breakage kinetics and energy consumption during the wet stirred media milling (WSMM) of fenofibrate (FNB, BCS II drug). Twenty WSMM experiments were conducted with various mixtures at different stirrer speeds (3000, 4000 rpm) and bead loadings (0.35, 0.50) with a suspension of 10% FNB, 7.5% HPC-L, 0.05% SDS. Laser diffraction, viscometry, XRPD, and PLM imaging were used for characterization. A new modified microhydrodynamic model considering bead packing was used to interpret the roles of different beads. The results showed YSZ beads provided faster breakage, which was supported by the microhydrodynamic results. On the other hand, CPS beads required lower stirrer power. When both cycle time and specific energy consumption were considered for process optimality, YSZ–CPS bead mixtures performed better than YSZ or CPS alone and the optimal bead mixture was found to depend on the stirrer speed and the bead loading.

Highlights

  • The number of poorly water-soluble drug candidates coming out of drug discovery has increased tremendously over the past few decades

  • We have investigated the impact of combined use of two types of beads, crosslinked polystyrene (CPS) and yttrium-stabilized zirconia (YSZ), as a mixture on the breakage kinetics and energy consumption during the wet stirred media milling

  • While YSZ beads led to faster breakage and shorter cycle time than CPS beads, they required a higher stirrer power and specific energy consumption

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Summary

Introduction

The number of poorly water-soluble drug candidates coming out of drug discovery has increased tremendously over the past few decades. Besides the higher mass transfer coefficient associated with drug nanoparticles, sub-100 nm particles exhibit a saturation solubility owing to their high curvature higher than the thermodynamic solubility [3]. These advantages led to the use of nanosuspensions or nanocomposites in several marketed products that has various delivery routes such as oral, parental, pulmonary, ocular, and dermal [4,5,6]

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