Ultra-high-resolution optical coherence tomography for the investigation of thin multilayered pharmaceutical coatings

Optical Coherence Tomography (OCT) has recently gained attention as a promising technology for in-line monitoring of pharmaceutical film-coating processes for (single-layered) tablet coatings and end-point detec-tion with commercial systems. An increasing interest in the investigation of multiparticulate dosage forms with mostly multi-layered coatings below 20 & mu;m final film thickness demands advancement in OCT technology for pharmaceutical imaging. We present an ultra-high-resolution (UHR-) OCT and investigate its performance based on three different multiparticulate dosage forms with different layer structures (one single-layered, two multi-layered) with layer thicknesses in a range from 5 to 50 & mu;m. The achieved system resolution of 2.4 & mu;m (axial) and 3.4 & mu;m (lateral, both in air) enables the assessment of defects, film thickness variability and morphological features within the coating, previously unattainable using OCT. Despite the high transverse resolution, the provided depth of field was found sufficient to reach the core region of all dosage forms under test. We further demonstrate an automated segmentation and evaluation of UHR-OCT images for coating thicknesses, where human experts struggle using today's standard OCT systems.

Automated summary

Optical Coherence Tomography (OCT) has gained attention as a promising technology for monitoring pharmaceutical film-coating processes and end-point detection. We present an ultra-high-resolution (UHR-) OCT and demonstrate its performance on different multiparticulate dosage forms with different layer structures. The achieved system resolution enables the assessment of defects, film thickness variability, and morphological features within the coating.