Quantifying Pharmaceutical Film Coating with Optical Coherence Tomography and Terahertz Pulsed Imaging: An Evaluation.
Quantifying Pharmaceutical Film Coating with Optical Coherence Tomography and Terahertz Pulsed Imaging: An Evaluation.
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DOI：
10.1002/jps.24535
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发表时间：
2015-10
影响因子：
3.8
通讯作者：
Zeitler JA
中科院分区：
文献类型：
--
作者：
Lin H;Dong Y;Shen Y;Zeitler JA
光谱域光学相干断层扫描（OCT）最近在制药行业引起了很大的兴趣，作为一种快速和非破坏性的方式量化的薄膜涂层，不能很容易地解决与其他技术。由于该技术的相对幼稚，迄今为止的大部分研究都集中在开发用于评估膜涂层厚度的在线测量技术上。为了更好地评估OCT的药物涂层量化，本文评估了片剂的一系列薄膜包衣厚度测量使用OCT和太赫兹脉冲成像（TPI）在离线设置。为了实现30-200 μm范围内薄膜涂层厚度的自动化涂层定量，提出了一种使用小波去噪和定制寻峰方法的算法来分析每个采集的A扫描。运行算法获得的结果显示，当薄膜包衣厚度超过100 μm时，TPI和OCT测量的片内变异性之间的差异越来越大。该发现进一步证实，OCT是表征薄膜包衣药物剂型的合适模式，而TPI非常适合厚包衣。版权所有© 2015作者.药物科学杂志，由Wiley Periodicals，Inc.出版。和American Pharmacologist Association J Pharm Sci 104：3377-3385，2015
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 30–200 μm, 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 100 μm. 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 The Authors. Journal of Pharmaceutical Sciences published by Wiley Periodicals, Inc. and the American Pharmacists Association J Pharm Sci 104:3377–3385, 2015