| Most drug substances
(active pharmaceutical ingredients or APIs) are
solid organic compounds. The formation of solids
of uniform properties is critical in API manufacture.
A different polymorph form of an API may have poorer
solubility and bioavailability. The possible devastating
consequence due to failure to manufacture the correct
API form has resulted in increasingly strict FDA
regulations about API form, shape and size distributions.
Despite the compelling case for polymorphism studies
early in drug development, the practice is still
not standard in the pharmaceutical industry. Hence,
there is an urgent need to develop a systematic
approach to ensure the consistent production of
the right API.
At the Particle Technology
and Crystallization Center (PTCC), a collaboration
of Illinois Institute of Technology, Purdue University
and Massachusetts Institute of Technology, we
focus on the API to address basic problems in
crystallization and particle technology. This
includes polymorphism, crystal shape, crystal
size, understanding what data are required on
a very small scale to ensure successful scale-up;
interaction of active pharmaceutical ingredients
with excipients, and how unit operations, such
as granulation, compaction and tableting, affect
crystal structure.
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