ABSTRACT
The wet granulation process has been impacted over the last 25 years by the development
of improved equipment, innovative research, novel polymeric binders, and even Process
Analytical Technologies (PAT) applications that accurately measure granule growth
using a Lasentec (Mettler Toledo, Inc. Columbus, Ohio, U.S.A.) focused beam
reflectance measurement (FBRM) or through the use of near-infrared spectroscopy/
chemometrics and computer modeling. Changes such as the refinement of high shear
granulators and fluid bed processors have enabled a faster throughput of batches and
more accurate process monitoring. Furthermore, development of laboratory-scale models
of these two pieces of equipment has made the production of many small batches of
costly drugs possible for research purposes. Also, some binders for wet granulation are no
longer widely used while other synthetic polymers with different functionalities have
supplanted them largely due to regulatory concerns as well as their easier preparation and
subsequent quality impact on both the granulation and final tablets.
