(421a) A Novel Predictive Approach to Mitigate Tablet Film Coating Scuffing

Tablet film coating processes are often conducted to improve the aesthetics of the dosage form and improve robustness for downstream processing. In certain cases, however, the film coating process itself can be implicated in visual defects in the form of small gray or black blemishes on the surface of the tablets – so called tablet scuffing. While the causes of scuffing have been investigated by several groups, mitigation of tablet scuffing in practice can still be a burdensome and empirical process. Further, scuffing usually only becomes apparent in large scale processes, further increasing the resource consumption to resolve this issue.

In this work, a novel predictive approach is developed and applied to identify ways to alleviate tablet scuffing observed in commercial scale pan coating processes. The approach combines computational simulation of the coating process using the discrete element method (DEM) and a novel, lab-scale characterization of scuffing susceptibility. The DEM simulations capture the scuffing energy imparted to the tablets for various process conditions and coating pan geometries. Further, the DEM simulations also provide valuable insight into the genesis of scuffing, i.e., where and when scuffing occurs in the coating pan, which is in alignment with historical observations. Characterization of scuffing susceptibility in the lab allows for the development of a direct relation between the scuffing energy and the manifestation of observable scuffing. This characterization accounts for specifics of the materials involved, e.g., coating formulation and steel finish, that may affect the extent of scuffing.

This new predictive approach now enables quantitative prediction of tablet scuffing using only a sample of a few coated tablets. Various process-related mitigation approaches can be studied in silico, thereby reducing large scale development trials previously required. Further, the approach can also be applied to future development programs to proactively design coating processes with minimal tablet scuffing risk.

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. All authors are current employees of AbbVie and may own AbbVie stock.