Research Center Pharmaceutical Engineering GmbH, Inffeldgasse 13, 8010 Graz, Austria.
Research Center for Non-Destructive Testing GmbH, Science Park 2, 2. OG, Altenberger Strasse 69, 4040 Linz, Austria.
Eur J Pharm Sci. 2014 May 13;55:58-67. doi: 10.1016/j.ejps.2014.01.011. Epub 2014 Feb 3.
Optical coherence tomography (OCT) is a contact-free non-destructive high-resolution imaging technique based on low-coherence interferometry. This study investigates the application of spectral-domain OCT as an in-line quality control tool for monitoring pharmaceutical film-coated tablets. OCT images of several commercially-available film-coated tablets of different shapes, formulations and coating thicknesses were captured off-line using two OCT systems with centre wavelengths of 830nm and 1325nm. Based on the off-line image evaluation, another OCT system operating at a shorter wavelength was selected to study the feasibility of OCT as an in-line monitoring method. Since in spectral-domain OCT motion artefacts can occur as a result of the tablet or sensor head movement, a basic understanding of the relationship between the tablet speed and the motion effects is essential for correct quantifying and qualifying of the tablet coating. Experimental data was acquired by moving the sensor head of the OCT system across a static tablet bed. Although examining the homogeneity of the coating turned more difficult with increasing transverse speed of the tablets, the determination of the coating thickness was still highly accurate at a speed up to 0.7m/s. The presented OCT setup enables the investigation of the intra- and inter-tablet coating uniformity in-line during the coating process.
光学相干断层扫描(OCT)是一种基于低相干干涉测量的非接触式无损高分辨率成像技术。本研究探讨了光谱域 OCT 作为一种在线质量控制工具,用于监测制药薄膜包衣片剂的应用。使用中心波长为 830nm 和 1325nm 的两种 OCT 系统,离线捕获了几种具有不同形状、配方和涂层厚度的市售薄膜包衣片剂的 OCT 图像。基于离线图像评估,选择了另一种工作在较短波长的 OCT 系统来研究 OCT 作为在线监测方法的可行性。由于在光谱域 OCT 中,由于片剂或传感器头的运动,可能会出现运动伪影,因此了解片剂速度与运动效果之间的关系对于正确定量和定性片剂涂层至关重要。通过将 OCT 系统的传感器头在静态片剂床上移动来获取实验数据。尽管随着片剂横向速度的增加,涂层的均匀性检查变得更加困难,但在高达 0.7m/s 的速度下,涂层厚度的测定仍然非常准确。所提出的 OCT 装置能够在涂层过程中在线研究片剂内和片剂间涂层的均匀性。