Film-coated tablets as solid oral dosage forms are a well-accepted way of administering drugs but are not without specific challenges during manufacturing. One relevant criterion of the final product is the visual integrity and therewith, the absence of cosmetic optical defects such as edge chipping. The aim of the present study was to examine the origin of those edge chipping defects, which were observed during commercial manufacturing of film-coated tablets, and to provide recommendations for process optimization to reduce the defect occurrence. The unraveling of the herein described phenomenon necessitated an interplay of in-depth material characterization, discrete element modeling (DEM) as well as an in-house developed optical measurement system for the automated quantification of tablet defects. As a result of this investigation, the automatic unloading step after the tablet coating process was identified as the most critical step for the occurrence of chipping defects and a replacement by manual unloading was proposed to reduce the defect propensity. The recommended optimization was subsequently confirmed in several manufacturing runs and a reduction of defect propensity by a factor of 5 was observed, highlighting the relevance and the impact of the performed thorough investigation.
Keywords: Automated picture analysis; Coating defects; Discrete element method; Industrial manufacturing of pharmaceutics; Material characterization.
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