Abstract Purpose Lubrication is critical in pharmaceutical manufacturing of solid dosage forms. The purpose of this paper is to systematically compare and correlate the lubrication effect of two devices, a controlled shear system and a Resonant Acoustic Mixer, on the flow properties of pharmaceutical blends. Method A model formulation was selected. Full factorial designs were conducted to examine the effect of the total strain (or total energy) and the shear rate (or power) on the powder blend flow properties. Analysis of variance (ANOVA) and effect size test using omega-squared statistics were performed. Results Lubrication significantly improved the blend flowability. Mixing without magnesium stearate, or insufficient strain, resulted in more cohesive blends. The statistical analysis suggests that the shear rate had a minimal effect on the blend flow properties. The experimental results also suggest that although the two devices had comparable lubrication effects on the overall blend flowability, the changes of the interparticle forces in the lubricated blends were not identical. Conclusion This study demonstrated a scientific approach to compare different lubrication processes in an objective and reproducible manner. The findings are useful for process design, development, and transfer between different equipment types and process scales.

中文翻译：

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受控剪切系统和共振声混合：对药物混合物的润滑和流动特性的影响

摘要 目的 润滑对于固体剂型的制药生产至关重要。本文的目的是系统地比较和关联两种设备（受控剪切系统和共振声混合器）对药物混合物流动特性的润滑效果。方法 选择模型公式。进行全因子设计以检查总应变（或总能量）和剪切速率（或功率）对粉末混合物流动特性的影响。进行方差分析 (ANOVA) 和使用 omega 平方统计量的效果大小检验。结果 润滑显着改善了混合物的流动性。在没有硬脂酸镁的情况下混合，或应变不足，会产生更具凝聚力的共混物。统计分析表明剪切速率对混合流动特性的影响最小。实验结果还表明，尽管两种装置对整体混合物流动性的润滑效果相当，但润滑混合物中颗粒间力的变化并不相同。结论 本研究展示了一种以客观和可重复的方式比较不同润滑过程的科学方法。这些发现对于不同设备类型和工艺规模之间的工艺设计、开发和转移非常有用。结论 本研究展示了一种以客观和可重复的方式比较不同润滑过程的科学方法。这些发现对于不同设备类型和工艺规模之间的工艺设计、开发和转移非常有用。结论 本研究展示了一种以客观和可重复的方式比较不同润滑过程的科学方法。这些发现对于不同设备类型和工艺规模之间的工艺设计、开发和转移非常有用。