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A new method to predict flowability using a microscale fluid bed

机译:使用微尺度流化床预测流动性的新方法

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摘要

The purpose of this research was to develop a new method to predict the flow behavior of pharmaceutical powders using a multichamber microscale fluid bed. Different amounts of poorly flowing paracetamol were added to various grades of microcrystalline celluloses and silicified microcrystalline cellulose powders. Magnesium stearate was used as a lubricant. Experimental minimum fluidization velocities (umf) were defined using 2 to 4 g (equal to 10 mL) of material (Video 1). The reference flowability of the powders was determined using a specific flow meter. Also, the weight variation of the compressed powders, using a single-punch press, was measured. When the amount of paracetamol in the excipients was increased, the experimentalumf increased and the fluidization behavior grew worse (Video 2). Principal component analysis (PCA) established that the pressure difference over the bed as a function of fluidization velocity could be used to characterize the behavior of powders. The increase in poor fluidization behavior of the powders was in accordance with the increasing amount of paracetamol and with the increasing weight variation of the tablets. Furthermore, the angle of repose and the flow rate of silicified microcrystalline cellulose powders were predicted using a partial least squares (PLS) model. The developed method to predict flowability is a promising approach for use in the preformulation and formulation stages of new drug candidates, for example.
机译:这项研究的目的是开发一种使用多室微型流化床预测药物粉末流动行为的新方法。将不同量的流动性较差的扑热息痛添加到各种等级的微晶纤维素和硅化的微晶纤维素粉末中。硬脂酸镁用作润滑剂。实验最低流化速度(umf)使用2至4 g(等于10 mL)材料(视频1)定义。使用专用流量计确定粉末的参考流动性。另外,使用单冲床测量压缩粉末的重量变化。当赋形剂中对乙酰氨基酚的量增加时,实验量增加,流化行为变差(视频2)。主成分分析(PCA)确定,床层上的压差随流化速度的变化可用于表征粉末的行为。粉末的不良流化行为的增加与对乙酰氨基酚的量增加以及片剂的重量变化增加有关。此外,使用偏最小二乘(PLS)模型预测了硅化微晶纤维素粉末的休止角和流速。例如,开发的预测流动性的方法是一种有前途的方法,可用于新药候选药物的预配制和配制阶段。

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