Quantifying tablet disintegration profiles in situ and in real time enables scientists to reliably understand the breakage and dispersion mechanisms that govern Active Pharmaceutical Ingredient (API) release rates. This essential process knowledge can support the prediction of in vivo drug release profiles during formulation development and can help identify the root cause of inconsistencies during release testing.
ParticleTrack with FBRM is a probe-based technology that allows changes in particle size and count to be monitored continuously as tablets or capsules disintegrate and dissolve.
The resulting mechanistic information complements traditional offline dissolution testing methods and can support the development and release of bioavailable, stable and manufacturable dosage forms.
Recently, METTLER TOLEDO collaborated with Actera Pharmaceuticals, pioneers in the use of ParticleTrack with FBRM technology, to fully develop the innovative in situ particle characterization applications for solid oral dosage formulation development.
"We find FBRM can elucidate the kinetics and mechanisms of tablet, granule, and particle disagglomeration in dosage forms, and is a more sensitive physical characterization method than compendial USP dissolution" Mark Menning, Actera Pharmaceuticals
"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" Sean Dalziel, Actera Pharmaceuticals.
To learn more about how Actera Pharmaceuticals or ParticleTrack with FBRM technology can improve your formulation development program, click the Request Info button below.
Fumaric Acid Microenvironment Tablet Formulation and Process Development for Crystalline Cenicriviroc Mesylate, a BCS IV Compound
By: Menning, Mark M., and Sean M. Dalziel.