Quantitative measurements of localized density variations in cylindrical tablets using X-ray microtomography
Quantitative measurements of localized density variations in cylindrical tablets using X-ray microtomography
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DOI：
10.1016/j.ejpb.2006.02.007
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发表时间：
2006-08-01
影响因子：
4.9
通讯作者：
Tchoreloff, Pierre
中科院分区：
文献类型：
--
作者：
Busignies, Virginie;Leclerc, Bernard;Tchoreloff, Pierre
直接压实是一个复杂的过程，导致片剂内部的密度分布通常是不均匀的。因此，密度变化可能会影响压实性能。对这一现象的定量分析仍然缺乏。最近，X射线显微断层扫描已成功地用于药物开发，定性研究片剂形状和断裂线对药物片剂密度的影响。在这项研究中，我们评估的密度分布在微晶纤维素（Vivapur 12（（R）压块在不同的平均孔隙率（范围从7.7%到33.5%）使用X射线断层扫描技术。首先，研究了Beer-Lambert定律的有效性。然后，进行密度校准，并获得圆柱形片剂的密度图，并使用解释的色标校准图的过程进行可视化。正如预期的那样，观察到并量化了密度的重要异质性。特别研究了外围区域的较高密度，并就片剂中部观察到的较低密度进行了评价。结果还强调，在药物片剂的情况下，重要的是区分代表总体积片剂的机械性能和仅表征片剂表面的机械性能，如布氏硬度测量。(c)2006 Elsevier B. V.保留所有权利。
Direct compaction is a complex process that results in a density distribution inside the tablets which is often heterogeneous. Therefore, the density variations may affect the compact properties. A quantitative analysis of this phenomenon is still lacking. Recently, X-ray microtomography has been successfully used in pharmaceutical development to study qualitatively the impact of tablet shape and break-line in the density of pharmaceutical tablets. In this study, we evaluate the density profile in microcrystalline cellulose (Vivapur 12((R))) compacts obtained at different mean porosity (ranging from 7.7% to 33.5%) using X-ray tomography technique. First, the validity of the Beer-Lambert law is studied. Then, density calibration is performed and density maps of cylindrical tablets are obtained and visualized using a process with colour-scale calibration plot which is explained. As expected, important heterogeneity in density is observed and quantified. The higher densities in peripheral region were particularly investigated and appraised in regard to the lower densities observed in the middle of the tablet. The results also underlined that in the case of pharmaceutical tablets, it is important to differentiate the mechanical properties representative of the total volume tablet and the mechanical properties that only characterize the tablet surface like the Brinell hardness measurements. (c) 2006 Elsevier B.V. All rights reserved.