Particles play a critical role in final tablet quality. Upstream granule distributions from granulation to the tablet press directly affect dissolution and disintegration rates. The particle distribution is critical to ensure consistent content uniformity from table to tablet.
Dissolution testing with in situ particle characterization is a powerful tool for Quality by Design (QbD). Formulators use FBRM® in-line particle characterization to link tablet disintegration and dissolution mechanisms to upstream formulation process steps and to the initial API and excipient particle size. FBRM® can speed process development by providing immediate understanding as to whether the root cause of dissolution profile inconsistency is due to the formulation or raw materials.
Tracking tablet and granule disintegration and dissolution mechanisms in real time helps uncover the root cause of dissolution test inconsistencies. Mapping dissolution and disintegration throughout the design space with FBRM® PAT tools can easily identify critical process parameters.
By investigating the mechanism for particle disintegration and dissolution, FBRM® is used to correlate release inconsistencies to the upstream source of variability including changes in raw materials, granulation inconsistency, or tableting irregularities.
PAT tools promote faster and more thorough mapping of experimental design space, enable consistent scale-up and tech transfer, and allow control of the process to a desired endpoint that assures downstream critical product quality and process efficiency.