Effect of shape on the physical properties of pharmaceutical tablets
Effect of shape on the physical properties of pharmaceutical tablets
复制标题
形状对片剂物理性质的影响
DOI：
10.1016/j.ijpharm.2022.121993
复制
发表时间：
2022
影响因子：
5.8
通讯作者：
Cetinkaya, Cetin
中科院分区：
文献类型：
--
作者：
Sultan, Tipu;Xu, Xiaochi;Hasan Rozin, Enamul;Sorjonen, Joona;Ketolainen, Jarkko;Wikström, Håkan;Martin de Juan, Luis;Tajarobi, Pirjo;Cetinkaya, Cetin
尽管对工艺有充分的了解，但在各种药品开发和生产阶段仍经常遇到压缩口服固体剂型的质量问题。在当前的工作中，提出了一种与协作机器人臂和先进视觉系统集成的无损接触式超声波实验装置，并用于量化压缩片剂的形状对其机械性能的影响。据观察，这些特性受到片剂几何形状的影响，并且发现对压实压力线性敏感。事实证明，所提出的方法显着提高了实验波形采集的可重复性。此外，由于测量重复性的提高，波形采集精度以及相应的压力和剪切波速度的置信度提高，我们得出结论，药物致密材料确实可以具有负泊松比，因此可以是拉胀的。所提出的技术和仪器可以在连续片剂制造中找到关键应用，并且其实时质量监控随着测量重复性得到显着提高，从而最大限度地减少产品质量变化。
Despite a well-established process understanding, quality issues for compressed oral solid dosage forms are frequently encountered during various drug product development and production stages. In the current work, a non-destructive contact ultrasonic experimental rig integrated with a collaborative robot arm and an advanced vision system is presented and employed to quantify the effect of the shape of a compressed tablet on its mechanical properties. It is observed that these properties are affected by the tablet geometric shapes and found to be linearly sensitive to the compaction pressures. It is demonstrated that the presented approach significantly improves the repeatability of the experimental waveform acquisition. In addition, with the increased confidence levels in waveform acquisition accuracy and corresponding pressure and shear wave speeds due to improved measurement repeatability, we conclude that pharmaceutical compact materials can indeed have a negative Poisson's ratio, therefore can be auxetic. The presented technique and instrument could find critical applications in continuous tablet manufacturing, and its real-time quality monitoring as measurement repeatability has been significantly improved, minimizing product quality variations.