Tablet Disintegration and Dissolution

Tablet disintegration is the process when a tablet breaks down
into smaller solid fragments. The most popular format of orally taken active
pharmaceutical ingredient (API) is in solid form, such as capsules and tablets. The kinetics of table disintegration in liquid media, as well as of its following dissolution strongly affects API's therapeutic efficacy, and is therefore critical in drug development.

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. The resulting mechanistic information complements traditional offline dissolution testing methods, and can support the development and release of bioavailable, stable and manufacturable dosage forms.

By quantifying tablet disintegration, ParticleTrack with FBRM technology provides valuable insight for formulation development. The ability to monitor tablet and granule disintegration behavior allows for an understanding of the underlying mechanisms of product performance. All of these dynamic events can be monitored in-situ with ParticleTrack. Measurement for optimization in real time – ParticleTrack is a precise and sensitive technology which tracks changes to particle dimension, particle shape, and particle count. Over a wide detection range from 0.5 µm to 2000 µm, measurements are acquired in real time, while particles are forming and can still be modified, enabling process optimization and control. With ParticleTrack, no sampling or sample preparation is required – even in highly concentrated (70 % and higher) and opaque suspensions.


"We find ParticleTrack 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 - Nucleo Life Sciences

"ParticleTrack 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 - Cleo Life Sciences

FBRM is the industry-standard measurement technique used for in-process measurement of particles. A highly precise chord length distribution (CLD), sensitive to particle size and count, is reported in real time without the need for sampling or sample preparation. No shape is assumed and the measurement can be applied at full process concentrations in opaque or translucent slurries and emulsions.