ABSTRACT
The purpose of this chapter is to provide a realistic discussion of both current
practices and emerging issues in process scale up for pharmaceutical oral solid
products. At the time when this chapter is being written (late Summer, 2007), the
pharmaceutical manufacturing community is actively engaged in a broad dialogue
regarding modernization of methods used for pharmaceutical product and process
design. In the preceding five years, under the banners of process analytical technology
(PAT) and quality by design (QbD, also known in other fields as “model-based design
and optimization”), the pharmaceutical industry has focused substantial efforts on
improving its understanding of key unit operations, and on developing statistical,
instrumental, and fundamental methods for characterizing and controlling sources of
variability in product performance.
