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首页> 外文期刊>European journal of pharmaceutical sciences >Roller compaction scale-up using roll width as scale factor and laser-based determined ribbon porosity as critical material attribute
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Roller compaction scale-up using roll width as scale factor and laser-based determined ribbon porosity as critical material attribute

机译:使用辊宽度作为比例因子并基于激光确定的带孔率作为关键材料属性进行辊压实放大

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摘要

Due to the complexity and difficulties associated with the mechanistic modeling of roller compaction process for scale-up, an innovative equipment approach is to keep roll diameter fixed between scales and instead vary the roll width. Assuming a fixed gap and roll force, this approach should create similar conditions for the nip regions of the two compactor scales, and thus result in a scale-reproducible ribbon porosity. In the present work a non-destructive laser-based technique was used to measure the ribbon porosity at-line with high precision and high accuracy as confirmed by an initial comparison to a well-established volume displacement oil intrusion method. The ribbon porosity was found to be scale-independent when comparing the average porosity of a group of ribbon samples (n = 12) from small-scale (Mini-Pactor (R)) to large-scale (Macro-Pactor (R)). A higher standard deviation of ribbons fragment porosities from the large-scale roller compactor was attributed to minor variations in powder densification across the roll width.
机译:由于与放大辊压实过程的机械模型有关的复杂性和困难,一种创新的设备方法是保持辊的直径在标度之间固定,而改变辊的宽度。假设间隙和轧制力固定,则该方法应为两个压实机氧化皮的辊隙区域创造相似的条件,从而导致氧化皮可再现的带状孔隙度。在目前的工作中,基于激光的非破坏性技术被用于以高精度和高精度在线测量带状孔隙度,这一点已通过与公认的体积排量注油法进行初步比较而得到证实。当比较一组带状样品(n = 12)从小规模(微型因子(R))到大规模(宏观(R))的平均孔隙率时,发现带状孔隙率与尺度无关。 。大型辊式压实机产生的带状碎片孔隙率的标准偏差较高,这是由于整个辊宽度上粉末密度的微小变化所致。

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