This volume offers a comprehensive guide on the theory and practice of
amorphous solid dispersions (ASD) for handling challenges associated
with poorly soluble drugs. In twenty-three inclusive chapters, the book
examines thermodynamics and kinetics of the amorphous state and
amorphous solid dispersions, ASD technologies, excipients for
stabilizing amorphous solid dispersions such as polymers, and ASD
manufacturing technologies, including spray drying, hot melt extrusion,
fluid bed layering and solvent-controlled micro-precipitation technology
(MBP). Each technology is illustrated by specific case studies. In
addition, dedicated sections cover analytical tools and technologies for
characterization of amorphous solid dispersions, the prediction of
long-term stability, and the development of suitable dissolution methods
and regulatory aspects. The book also highlights future technologies on
the horizon, such as supercritical fluid processing, mesoporous silica,
KinetiSol(R), and the use of non-salt-forming organic acids and amino
acids for the stabilization of amorphous systems.
Amorphous Solid Dispersions: Theory and Practice is a valuable
reference to pharmaceutical scientists interested in developing
bioavailable and therapeutically effective formulations of poorly
soluble molecules in order to advance these technologies and develop
better medicines for the future.