Department of Chemical Engineering and Biotechnology, University of Cambridge, Cambridge CB2 3RA, UK.
J Pharm Sci. 2013 Jul;102(7):2179-86. doi: 10.1002/jps.23560. Epub 2013 Apr 22.
We present terahertz pulsed imaging (TPI) as a novel tool to quantify the hardness and surface density distribution of pharmaceutical tablets. Good agreement between the surface refractive index (SRI) measured by TPI and the crushing force measured from diametral compression tests was found using a set of tablets that were compacted at various compression forces. We also found a strong correlation between TPI results and tablet bulk density, and how these relate to tablet hardness. Numerical simulations of tablet surface density distribution by finite element analysis exhibit excellent agreement with the TPI measured SRI maps. These results show that TPI has an advantage over traditional diametral compression and is more suitable for nondestructive hardness and density distribution monitoring and control of pharmaceutical manufacturing processes.
我们提出太赫兹脉冲成像（TPI）作为一种新的工具来定量药物片剂的硬度和表面密度分布。通过一组在不同压缩力下压缩的片剂，发现 TPI 测量的表面折射率（SRI）与从直径压缩试验测量的破碎力之间具有良好的一致性。我们还发现 TPI 结果与片剂体密度之间存在很强的相关性，以及它们与片剂硬度的关系。通过有限元分析对片剂表面密度分布的数值模拟与 TPI 测量的 SRI 图具有极好的一致性。这些结果表明，TPI 优于传统的直径压缩，更适合于非破坏性的硬度和密度分布监测以及制药过程的控制。
