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Effect of resonant acoustic mixing on pharmaceutical powder blends and tablets

机译:共振声混合对药物粉末混合物和片剂的影响

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摘要

The blending performance in a resonant acoustic mixer (RAM) was characterized. The system showed to be highly effective in blending low concentrations of cohesive active pharmaceutical ingredients (APIs) and lubricants. A summary of these results will be described and changes in material properties were observed. Those changes, and their effects on tablet characteristics, were also studied. Changes in particle size, powder flow properties, and hydrophobicity of the blend were investigated. Tablets were then compressed, using a tablet press simulator, and characterized. The tableting compression force, tablet hardness, tablet weight, and tablet dissolution were considered. Results indicated that the powder blend material properties and tablet characteristics were significantly affected by acceleration (mixing intensity), blending time, and thus, total energy input. The RAM was shown to be an excellent choice for blending low concentrations of cohesive APIs, but care must be taken when blending hydrophobic lubricants because the high-energy input can adversely affect the final tablet properties such as hardness and dissolution. In addition, the material properties of the blends and tablets were correlated to the total energy input. These correlations demonstrated that total energy, in the RAM, determines, and can be used to predict, the performance of final blends and finished product.
机译:表征了在共振声混合器(RAM)中的混合性能。该系统显示出在混合低浓度的粘性活性药物成分(API)和润滑剂方面非常有效。将总结这些结果,并观察材料性能的变化。还研究了这些变化及其对片剂特性的影响。研究了混合物的粒度,粉末流动性和疏水性的变化。然后使用压片模拟器将片剂压片并进行表征。考虑压片压力,片剂硬度,片剂重量和片剂溶解度。结果表明,粉末混合材料的性能和片剂特性受加速度(混合强度),混合时间以及总能量输入的影响很大。 RAM是混合低浓度内聚性API的绝佳选择,但混合疏水性润滑剂时必须小心,因为高能量输入会不利地影响最终片剂的性能,例如硬度和溶解度。另外,共混物和片剂的材料性质与总能量输入相关。这些相关性表明,RAM中的总能量决定了最终混合物和成品的性能,并且可以用来预测最终混合物的性能。

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