Lin Hungyen, Dong Yue, Shen Yaochun, Axel Zeitler J
Department of Chemical Engineering and Biotechnology, University of Cambridge, Cambridge CB2 3RA, UK.
Department of Electrical Engineering and Electronics, University of Liverpool, Liverpool L69 3GJ, UK.
J Pharm Sci. 2015 Oct;104(10):3377-3385. doi: 10.1002/jps.24535. Epub 2016 Jan 8.
Spectral domain optical coherence tomography (OCT) has recently attracted a lot of interest in the pharmaceutical industry as a fast and non-destructive modality for quantification of thin film coatings that cannot easily be resolved with other techniques. Because of the relative infancy of this technique, much of the research to date has focused on developing the in-line measurement technique for assessing film coating thickness. To better assess OCT for pharmaceutical coating quantification, this paper evaluates tablets with a range of film coating thickness measured using OCT and terahertz pulsed imaging (TPI) in an off-line setting. In order to facilitate automated coating quantification for film coating thickness in the range of 30-200μm, an algorithm that uses wavelet denoising and a tailored peak finding method is proposed to analyse each of the acquired A-scan. Results obtained from running the algorithm reveal an increasing disparity between the TPI and OCT measured intra-tablet variability when film coating thickness exceeds 100μm. The finding further confirms that OCT is a suitable modality for characterising pharmaceutical dosage forms with thin film coatings, whereas TPI is well suited for thick coatings. © 2015 Wiley Periodicals, Inc. and the American Pharmacists Association J Pharm Sci 104:3377-3385, 2015.
光谱域光学相干断层扫描(OCT)最近在制药行业引起了广泛关注,它是一种快速且无损的检测方法,可用于定量分析难以用其他技术分辨的薄膜包衣。由于该技术尚处于相对初期阶段,迄今为止的许多研究都集中在开发用于评估薄膜包衣厚度的在线测量技术上。为了更好地评估OCT在药物包衣定量方面的应用,本文在离线环境下,对一系列使用OCT和太赫兹脉冲成像(TPI)测量的具有不同薄膜包衣厚度的片剂进行了评估。为了便于对30 - 200μm范围内的薄膜包衣厚度进行自动包衣定量分析,提出了一种使用小波去噪和定制峰值查找方法的算法,用于分析每个采集到的A扫描。运行该算法得到的结果显示,当薄膜包衣厚度超过100μm时,TPI和OCT测量的片内变异性之间的差异越来越大。这一发现进一步证实,OCT适用于表征带有薄膜包衣的药物剂型;而TPI则非常适合用于厚包衣。© 2015威利期刊公司和美国药剂师协会《药物科学杂志》104:3377 - 3385,2015年。