Mettler Toledo has initiated a collaboration with Actera Pharmaceuticals, San Francisco, to expand the applications of Focused Beam Reflectance Measurement (FBRM) probes into pharmaceutical solid dosage form development. An FBRM in situ particle size tracking instrument is located in Actera’s product innovation labs at the California Institute for Quantitative Biosciences (QB3@953) in San Francisco. Mark Menning and Sean Dalziel are founding partners in Actera Pharmaceuticals, with pioneering expertise in pharmaceutical dosage form development.
“We find FBRM can elucidate the kinetics and mechanisms of tablet, granule, and particle deagglomeration in dosage forms, and is a more sensitive physical characterization method than compendial USP dissolution”, said Menning. “The FBRM technology, where applied appropriately, can facilitate improved optimization of drug product formulation and process parameters, bridging of in vitro to human bioavailability performance, and elucidate complex physical stability changes”, said Dalziel. Actera provides this application as a service to pharmaceutical and biotech companies.
FBRM technology measures particles and droplets in concentrated suspensions and emulsions in real-time, without sampling and preparation. Unlike other offline particle size analysis techniques, FBRM can track changes in particulate systems capturing rapid or subtle kinetic events. FBRM has been extensively applied to Active Pharmaceutical Ingredient (API) crystallization. Expanding its utility to development and optimization of tablets and capsule products is a natural fit for FBRM technology. “We are delighted to collaborate with Actera Pharmaceuticals as we advance the applications for dissolution and solid dosage formulation” said Des O’Grady, METTLER TOLEDO Particle System Characterization Market Development Manager.