Abstract

Optical Coherence Tomography (OCT) recently attracted attention for the quality control of pharmaceutical film-coatings. Current research focuses on single-layered tablet coatings with layer thicknesses between 50 and 100 µm and production end-point detection using commercial systems available for such applications. Modern multi-particulate dosage forms, particularly interesting for pediatric and personalized medicine, show coating layer thicknesses of 20 µm and below, pushing the limits of commercial pharmaceutical industrial OCT systems, which are namely their spatial and temporal resolutions. We present a novel ultra-high-resolution (UHR-) OCT prototype investigating merits and constraints of the technology based on imaging and semi-automatic layer thickness segmentation and quantification of exemplary multi-particulate dosage forms with different layer structures and layer thicknesses in a range from 7 to 50 µm. The UHR-OCT system allows, for the first time, imaging of morphological features and defects within thin pharmaceutical coatings, accurate film thickness measurements and the quantitative analyses of coating layer variability. Our investigation showcases that UHR- OCT can be the next logical and necessary step to advance quality control in pharmaceutical settings.

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