ABSTRACT
The goal for this chapter is to serve as a reference for granulation processes, with quantitative identification and measurement of the granule attributes responsible for improving drug product performance. Various granulation technologies are introduced with applicable granule characterization. By measuring and understanding the relationship between formulation properties and processing, it is aimed to manipulate critical granule attributes during processing through a control framework while monitoring critical attributes in real-time. Meeting this level of process control assures product performance. The adoption of real-time methods to measure critical granulation attributes has been accelerated by the introduction of continuous manufacturing. Through surface characterization methods, it is possible to assess the properties of powders that directly affect granule attributes. Thus, sensors provide understanding about the properties of granules within themselves, whereas surface characterization provides understanding about groups of granules among themselves. Advances on both sensors and surface characterization of powder properties are presented in this chapter, recognizing that research is ongoing and work remains to be done on these areas. Overall, this chapter provides an overview of the considerable refinement in our quantitative understanding of granulation, based on growing knowledge on materials’ functionality and advances in measurement science that have advanced process understanding.
