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  • Title: Feasibility of In-line monitoring of critical coating quality attributes via OCT: Thickness, variability, film homogeneity and roughness.
    Author: Sacher S, Peter A, Khinast JG.
    Journal: Int J Pharm X; 2021 Dec; 3():100067. PubMed ID: 33385160.
    Abstract:
    The feasibility of Optical Coherence Tomography (OCT) for in-line monitoring of pharmaceutical film coating processes has recently been demonstrated. OCT enables real-time acquisition of high-resolution cross-sectional images of coating layers and computation of coating thickness. In addition, coating quality attributes can be computed based on in-line data. This study assesses the in-line applicability of OCT to various coating functionalities and formulations. Several types of commercial film-coated tablets containing the most common ingredients were investigated. To that end, the tablets were placed into a miniaturized perforated drum. An in-line OCT system was used to monitor the tablet bed. This set-up resembles the final stage of an industrial pan coating process. All investigated coatings were measured, and the coating thickness, homogeneity and roughness were computed. The rotation rate was varied in a range comparable to large-scale coating operations, and no influence on the outcome was observed. The results indicate that OCT can be used to determine end-point and establish in-process control for a wide range of coating formulations. The real-time computation of coating homogeneity and roughness can support process optimization and formulation development.
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