期刊
EUROPEAN JOURNAL OF PHARMACEUTICAL SCIENCES
卷 44, 期 1-2, 页码 142-148出版社
ELSEVIER
DOI: 10.1016/j.ejps.2011.06.017
关键词
Optical coherence tomography; Process analytical technology; Tablet coating; Non-destructive testing
资金
- K-Project for Non-Destructive Testing and Tomography
- Austrian Research Promotion Agency (FFG) [820492]
- EU [13]
- federal state Upper Austria
Optical coherence tomography (OCT) is a non-invasive analysis technique allowing fast and high-quality cross-sectional imaging of scattering media. OCT is based on the physical phenomenon of low coherence interferometry and is thus well suited to image layered structures. In this paper, high-speed spectral domain OCT was used for the characterization of pharmaceutical tablet coatings, sampled at different stages of an industrial drum spray coating process, comprising tablets with a coating thickness ranging from uncoated to a target coating thickness of about 70 mu m. In addition to the OCT investigation of layer thickness and homogeneity, tablet weight gain and tablet diameters were determined on a single-tablet level. Scanning electron microscopy (SEM) was applied for referencing the coating thickness obtained with OCT. We demonstrated that OCT allows rapid evaluation of coating properties, such as thickness and homogeneity independently from variations of the tablet core. In contrast to indirect methods, deviations observed with OCT can be related directly to the coating properties. Furthermore, for an extended morphological coating characterization, three dimensional images were reconstructed. Pending further developments, the high axial resolution and fast data acquisition rate of OCT has the potential for highly accurate, fast and low-cost coating control during and after manufacturing. (C) 2011 Elsevier B.V. All rights reserved.
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