Profiling the Process Development of Wurster Coating for Modified Release Capsule products in Approved Drug Product Applications
In this paper, we have studied Wurster Coating operation for the manufacture of modified release (MR) capsule products submitted to FDA as New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs) by using a data-driven approach. We have collected and classified information into Wurster coating associated process variables, quality attributes, and scale up strategies under Quality by Design (QbD) paradigm. We have quantified the importance and risk of the process variables and quality attributes by analyzing reported frequencies and risk factors, respectively. We have also included analysis of quality attributes listed with high risk factors, such as weight gain, particle size, assay, dissolution of coated beads, and water content/ Loss on drying (LOD) and the process variables with higher risk factors, such as product temperature, spray rate, atomization air pressure, Inlet air volume and Inlet air temperature, etc.
We believe the knowledge obtained through profiling Wurster coating operation would help the industry to further improve the quality of drug product applications regarding the development of this unit operation. Moreover, systematic profiling of various unit operations under QbD paradigm could also contribute to advancing the FDA’s new Knowledge-aided Assessment & Structured Application (KASA) platform to continuously improve FDA’s assessment quality, consistency, and efficiency.
Zhouxi Wang, Xiang Yu, Larisa Wu, Yuesheng Ye, Maotang Zhou, Lawrence X. Yu,
Profiling the Process Development of Wurster Coating for Modified Release Capsule products in Approved Drug Product Applications,
International Journal of Pharmaceutics, 2022, 122053, ISSN 0378-5173,
https://doi.org/10.1016/j.ijpharm.2022.122053.