Gregory Thoorens
FMC BioPolymer

For over a decade FMC BioPolymer has used Compaction Simulation to characterize excipient and formulation performance, and validate process modifications. The ability to factor in speed-dependent attributes, such as strain rate sensitivity, gives FMC BioPolymer a common language in providing support to customers, by provision of application relevant  test methods.  However finding a common ground is not always easy as many formulators still have their own ways of characterizing excipients, active ingredients and formulations.  There is also a tendency to consider excipients as non-critical without appreciating that pharmacopoeial equivalence does not guarantee fitness for purpose or interchangeability in a particular application.  Meaningful characterization of excipient performance and impact of variability is a key element of Quality by Design.  Pharmaceutically aligned excipient suppliers can make this process of excipient risk assessment more robust.