Purpose

The aim of this study was to compare the bulk lactose flow behavior with a defined fraction with smaller particles obtained by sieving from the bulk lactose and to evaluate the effect of a glidant addition on both samples. These powders showed, in a previous work, similar flow indexes (ff_c) that motivated the addition of colloidal silicon dioxide in order to observe if there were any changes in their flow behaviors.

Methods

To evaluate this effect on the diluent flow behavior, the methods described in the European Pharmacopeia were used.

Results

The results obtained from conventional methods and shear cell methods (using the Powder Flow Tester) were compared, and they showed evident differences in the bulk and tapped densities values and flow classifications. The lactose monohydrate (F_Total) and lactose with particles smaller than 63 μm (F < 63) analyzed in a previous study presented similar ff_c. To these pure powders a glidant was added, in increasing proportion (0.25—1.00%). The results obtained for all powders with colloidal silicon dioxide showed an improvement in its flow behaviors in comparison with pure powders.

Conclusion

All the parameters studied showed an evident effect of the glidant used. For the same amount of glidant, the F < 63 presented worse flow profiles than F_Total because its particles have a larger surface area. The F_Total + 0.25 flow profile was more similar to the F < 63 + 0.50 flow profile than F < 63 + 0.25 flow profile. For both powders, the maximum amount of glidant that produces effect was 1.00% for F < 63 and 0.75% for F_Total, respectively. In all powders, the occurrence of caking was not observed.

中文翻译：

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剪切剂法对助流剂对稀释剂流动特性的影响

目的

这项研究的目的是比较乳糖的整体流动行为与确定的级分，并通过筛分从乳糖中获得的较小颗粒，并评估助流剂添加对两种样品的影响。在以前的工作中，这些粉末显示出相似的流动指数（ff _c），促使加入胶体二氧化硅，以观察其流动行为是否发生任何变化。

方法

为了评估这种对稀释剂流动行为的影响，使用了《欧洲药典》中描述的方法。

结果

比较了常规方法和剪切池方法（使用粉末流动测试仪）获得的结果，结果表明，堆积密度和分接密度值和流动分类存在明显差异。先前研究中分析的乳糖一水合物（F _Total）和粒径小于63μm（F <63）的乳糖具有相似的ff _c。向这些纯粉中添加助流剂的比例增加（0.25-1.00％）。与纯粉末相比，所有具有胶体二氧化硅的粉末所获得的结果均显示出其流动行为的改善。

结论

研究的所有参数均显示出所使用助流剂的明显效果。对于相同量的助流剂，F <63的流动曲线比F _Total差，因为其颗粒具有较大的表面积。F _Total  + 0.25流量曲线比F <63 + 0.25流量曲线更类似于F <63 + 0.50流量曲线。对于两种粉末，产生效果的助流剂的最大量分别在F <63时为1.00％，在F _Total时为0.75％。在所有粉末中，未观察到结块的发生。