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Quantifying Pharmaceutical Film Coating with Optical Coherence Tomography and Terahertz Pulsed Imaging: An Evaluation.


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Authors

Lin, Hungyen 
Dong, Yue 
Shen, Yaochun 
Zeitler, J Axel 

Abstract

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.

Description

Keywords

Processing, coating, imaging methods, physical characterization, process analytical technology (PAT), tablet, Algorithms, Chemistry, Pharmaceutical, Data Interpretation, Statistical, Drug Compounding, Reproducibility of Results, Surface Properties, Tablets, Enteric-Coated, Terahertz Imaging, Tomography, Optical Coherence, Uncertainty, Wavelet Analysis

Journal Title

J Pharm Sci

Conference Name

Journal ISSN

0022-3549
1520-6017

Volume Title

104

Publisher

Elsevier BV
Sponsorship
Engineering and Physical Sciences Research Council (EP/L019922/1)
The authors would like to acknowledge the financial support from UK EPSRC Research Grant EP/L019787/1 and EP/L019922/1.