Non-destructive evaluation of polymer coating structures on pharmaceutical pellets using full-field optical coherence tomography

J Pharm Sci. 2014 Jan;103(1):161-6. doi: 10.1002/jps.23764. Epub 2013 Nov 1.

Abstract

Full-field optical coherence tomography (FF-OCT) using a conventional light-emitting diode and a complementary metal-oxide semiconductor camera has been developed for characterising coatings on small pellet samples. A set of en-face images covering an area of 700 × 700 μm(2) was taken over a depth range of 166 μm. The three-dimensional structural information, such as the coating thickness and uniformity, was subsequently obtained by analysis of the recorded en-face images. Drug-loaded pharmaceutical sustained-release pellets with two coating layers and of a sub-millimetre diameter were studied to demonstrate the usefulness of the developed system. We have shown that both coatings can be clearly resolved and the thickness was determined to be 40 and 50 μm for the outer and inner coating layers, respectively. It was also found that the outer coating layer is relatively uniform, whereas the inner coating layer has many particle-like features. X-ray computed microtomography measurements carried out on the same pellet sample confirmed all these findings. The presented FF-OCT approach is inexpensive and has better spatial resolution compared with other non-destructive analysis techniques such as terahertz pulsed imaging, and is thus considered advantageous for the quantitative analysis of thin coatings on small pellet samples.

Keywords: coating; excipients; image analysis; imaging methods; light-scattering; optical coherency tomography (OCT); pellet.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Delayed-Action Preparations / chemistry
  • Drug Implants / chemistry*
  • Particle Size
  • Polymers / chemistry*
  • Surface Properties
  • Terahertz Imaging / methods
  • Tomography, Optical Coherence / methods*

Substances

  • Delayed-Action Preparations
  • Drug Implants
  • Polymers