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首页> 外文期刊>Journal of Pharmaceutical and Biomedical Analysis: An International Journal on All Drug-Related Topics in Pharmaceutical, Biomedical and Clinical Analysis >Measuring the distribution of density and tabletting force in pharmaceutical tablets by chemical imaging.
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Measuring the distribution of density and tabletting force in pharmaceutical tablets by chemical imaging.

机译：通过化学成像测量药物片剂中密度和压片力的分布。

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摘要

In pharmaceutical processing, the lubricant magnesium stearate (MgS) can affect compaction efficiency based on blend time and amount of MgS used. Insufficient lubrication produces intra-tablet variations in density. Consistent tablet density profiles and uniform compaction force, as managed by proper lubrication, are important for predictable performance. The current work demonstrates the utility of near-infrared (NIR) chemical imaging in measuring density variations within compacts, and relates these variations to tabletting forces as controlled by frictional properties and quantity of MgS. Lactose monohydrate was blended with 0%, 0.25%, or 1.0% MgS for 30s or 30 min. Compacts were prepared of each blend, with compaction forces monitored by load cells. Frictional properties were measured by automated shear cell. NIR chemical images were collected for each tablet, and the density at each image pixel was calculated. Density distribution within compacts was well perceived within the NIR images. Uniformity of intra-tablet density was strongly dependent upon friction between powder and die walls: tablets with no MgS or 0.25% MgS were less uniform than tablets with 1.0% MgS. In addition, absorbance variations along tablet edges, reflective of corresponding density variation, agreed with force transmission within the tablet and final tablet ejection force. Chemical imaging techniques can be used to non-destructively assess density profiles of tablets, and confirm prediction of friction alleviation and improvement in force distribution during tabletting. The density profiles were both qualitative, showing differences in density profiles between tablets of different blends, and quantitative, providing actual density and tabletting force information within a single tablet. This work demonstrates that near-infrared chemical imaging can be an effective tool in monitoring not only the physical quality of pharmaceutical tablets, but the corresponding die forces controlling tabletting and final ejection.
机译：在制药过程中，润滑剂硬脂酸镁（MgS）会根据混合时间和所用MgS的量影响压实效率。润滑不足会导致片剂内部密度变化。由适当的润滑管理的一致的片剂密度曲线和均匀的压紧力对于可预测的性能至关重要。当前的工作证明了近红外（NIR）化学成像在测量压坯内密度变化中的实用性，并将这些变化与压片力相关，压片力受摩擦性能和MgS量控制。将一水合乳糖与0％，0.25％或1.0％的MgS混合30秒或30分钟。制备每种共混物的压块，并通过称重传感器监测压紧力。摩擦性能通过自动剪切池测量。收集每个片剂的NIR化学图像，并计算每个图像像素的密度。在NIR图像中可以很好地感知压坯内的密度分布。片剂内部密度的均匀性在很大程度上取决于粉末与模具壁之间的摩擦力：不含MgS或0.25％MgS的片剂比含有1.0％MgS的片剂的均匀性差。另外，沿片剂边缘的吸光度变化反映了相应的密度变化，与片剂内的力传递和最终的片剂排出力一致。化学成像技术可用于非破坏性地评估片剂的密度分布，并确认压片过程中摩擦减轻和力分布改善的预测。密度分布图是定性的，显示了不同混合物的片剂之间密度分布图的差异，并且是定量的，提供了单个片剂中的实际密度和压片力信息。这项工作表明，近红外化学成像不仅可以监测药物片剂的物理质量，而且可以监测控制压片和最终排出的相应模头力，是一种有效的工具。

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