I recently had the pleasure of collaborating with a group of very talented scientists at EMS and International Institute of Pharmaceutical Research (IIPF). EMS and IIPF are two pharmaceutical companies based in Hortolândia, a city roughly 100 miles northwest of Sao Paulo, Brazil. We worked on an interesting project where FBRM was used to track Active Pharmaceutical Ingredient (API) particle size reduction during wet milling. Traditionally, offline laser diffraction had been used to track this process; however this approach proved to be time consuming, prone to inaccuracy and potentially hazardous.
By applying FBRM in situ to track particle breakage and attrition this group was able identify, in real-time, a target endpoint for every wet-milling batch. They were also able to correlate the offline laser diffraction data and concluded that “In-process FBRM minimized process time while ensuring a consistent product specification”. Furthermore, significant process understanding was achieved by revealing breakage kinetics for this material. This information can now be leveraged to ensure smooth scale-up and tech-transfer.
It was great working on this project with Andre Rosa, Fabiana Ribeiro and Jose Martins (IIPF) and Renato Carneiro and Ettamyr Catteli (EMS). They created an application note: Online Monitoring Particle Milling Employing a High Shear Mixer. For further information on developing correlations between FBRM and offline particle size measurement techniques, such as laser diffraction and sieving, check out the Correlating FBRM® Directly to Process Efficiency and Product Quality webinar from my colleague Eric Dycus.