USP tablet dissolution testing is recognized as a standard analytical test in the pharmaceutical industry. With implementation of Quality by Design (QbD), dissolution testing can now also be used to obtain a mechanistic understanding of why tablets release API with varying kinetics.
Characterizing Tablet Disintegration and Particle Dissolution
From a review poster presented at American Association of Pharmaceutical Scientists (AAPS) 2008 in Atlanta, GA
USP tablet dissolution testing is recognized as a standard analytical test used in the pharmaceutical industry. However, the information gathered during the USP test is often not sufficient to establish the root cause of dissolution inconsistency. As the role of dissolution testing moves towards screening formulation development and enabling quality by design (QbD), a more mechanistic understanding is required to determine why tablets release API with varying kinetics.
A series of industrial case studies are presented where the application of in situ particle monitoring technology, METTLER TOLEDO FBRM®, is demonstrated to track a series of tablet disintegration and dissolution profiles while measuring the particle distribution in real time at full concentration with no sampling necessary.
By understanding the mechanism for particle disintegration and dissolution, users can correlate release inconsistencies to the upstream source of variability, i.e. changes in raw materials, granulation inconsistency, segregation during transfer and storage, varying impurity profile of API or tableting irregularities.
Case studies included in the paper cover comparisons of the dissolution profiles of BCS Class I (disintegration limited) and Class II (solubility limited) compounds, as well as separate investigations into the direct effect of compression force and the effect of moisture content within the granulated product on the final tablet disintegration properties.