(653d) Early-Stage Materials Characterization for Predicting Late-Stage Tablet Breakage during Film-Coating

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. Based on a previously discussed case of tablet breakage that led to a successful predictive approach [1], we generalized this approach to seek a better understanding of the role tablet properties and impact conditions have in tablet breakage. We found that observed tablet breakage probabilities are well characterized by the theoretical breakage model of Vogel and Peukert [2]. In this work, we focus material parameters (such as mass-based material strength (F_mat) [2], mass specific threshold energy (W_m,min) [2], peak impact fracture force [3], etc...) to develop a material/time sparing approach that enables early-stage tablet assessment for large scale coating pan success in late-stage development. Identification and determination of the approach for robust 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.

[3] Alhusban, F., & Murgatroyd, E. F. (2024). Impact testing as a new approach to determine mechanical strength of pharmaceutical tablets. International Journal of Pharmaceutics, 123891.

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 are current employees of AbbVie and may own AbbVie stock. AL previously interned at AbbVie and has no conflict of interest.