DESIGN AND SCALE‐UP OF DRY GRANULATION PROCESSES

This chapter provides an in-depth review of the relevant literature as well as a practical guide to completing the drug product design and commercialization via dry granulation. It presents an overview of the process components, material considerations and testing, and a stepwise look at the equipment, processes, and scale-up techniques. The chapter also presents the rationale for powder modification, the evolution of dry granulation as a process to modify powders, and an overview of roller compaction - the dominant technique in the pharmaceutical industry for dry granulation. Granulation offers the opportunity to alter the properties of solid particulate material. The roller-compacted materials depend on input material characteristics as well as on process parameters. The chapter then presents a visualization of the roller compaction process, the material structure at each stage, and a brief listing of relevant material properties.