(256b) Risk Factors for Tablet Breakage in a Film Coating Process

Film coats are often applied to pharmaceutical tablets for a variety of aesthetic and/or functional purposes. Given many years of industrial experience, the tablet coating process is typically conducted successfully and without issue. In one prior case, however, the intersection of certain material properties, process conditions, and equipment geometry resulted in observation of significant numbers of broken tablets. That case was examined, and a predictive approach was developed and applied to guide an optimal development pathway for a more robust process to mitigate the tablet breakage issue [1]. In this work, we extend and generalize the previous work that had focused on one particular formulation. In this generalization, we delve into a deeper understanding regarding the role of material and formulation properties (including drug loading, solid fraction, and extent of lubrication), tablet shape, and impact conditions related to the coating process. For each condition, the observed tablet breakage probabilities are well characterized by the theoretical breakage model of Vogel and Peukert [2]. Ramifications of this observation and recommendations for robust, risk-based drug product development are discussed.

References

[1] Ketterhagen, W. R., Larson, J., Spence, K., & Baird, J. A. (2021). Predictive approach to understand and eliminate tablet breakage during film coating. AAPS PharmSciTech, 22(5), 178.

[2] Vogel, L., & Peukert, W. (2003). Breakage behaviour of different materials—construction of a mastercurve for the breakage probability. Powder Technology, 129(1-3), 101-110.

Disclosures

AbbVie contributed to the design; participated in collection, analysis, and interpretation of data; and in writing, reviewing, and approval of the final version. AbbVie sponsored and funded the study. JL and WK current employees of AbbVie and may own AbbVie stock. AL previously interned at AbbVie.