Poster Presenter

PAT Tools For In-Line Monitoring Of Particle Growth And Granule Properties In Wet Granulation Processes
Firas Alshihabi, Gabriele Betz and Thierry Vandamme
Switzerland

Innovative guidance by the authorities on process analytical technologies (PAT) encourages the pharmaceutical industry to develop new tools for monitoring product quality. Wet granulation (WG) is a process widely used, where approximately 80% of the drug products are based on it. WG provides better control of drug content uniformity, control of product density and finally improves compressibility and compactibility of powders. Focused Beam Reflectance Measurement FBRM® was installed inside fluidized bed granulator in order to monitor in-line particle growth. Three batches containing Avicel®101 and PVP were monitored in-line during wet granulation process. A good correlation was observed

(R2=0.93) between FBRM® and sieve analysis, the count of particles and coarse particle growth were examined by applying mathematical equations.

Power consumption (PC) measurement was performed in a high shear mixer and the profile was recorded in-line by a computer program developed in our research group. By correlating the turning point (TP) and maximum saturation point (MAX) with tensile strength of the wetted powder bed it was proven that PC is an efficient method to monitor the cohesion of powder particles and particle growth.

The in-line monitoring enables the operator to select appropriate process parameters and control the wet granulation process more efficiently.