Particles play a critical role in granulation product quality. Fluid bed layering requires a consistent coating of API onto a spherical substrate. The particle distribution is a critical process parameter to assure dosing uniformity and bioavailability.
Formulators can significantly reduce development time by monitoring the particles in real time, and avoiding lengthy delays waiting for the results of offline particle analysis. In-line FBRM® particle characterization can track particle growth during the coating process, and can be used to identify a desired endpoint that meets particle size specifications and avoids batch failures.
Agglomeration of particles, an undesirable event which can significantly alter product performance, can also be visually detected with in-line PVM® real time imaging. With immediate detection of agglomeration, the formulator can determine the conditions leading to particles sticking together and design a process that will avoid batch failure or product loss due to agglomeration.
In-line monitoring with FBRM® Process Analytical Technology (PAT) also provides dynamic batch fingerprint that helps ensure batch repeatability from the development laboratory through scale-up to pilot plant and manufacturing.