Predictive Dissolution/Disintegration Stability Modeling: Case Studies


Posted on November 28, 2016 in

For two immediate release tabletted products, short-term accelerated stability studies were used to determine dissolution and disintegration failure times at a range of stress conditions, which then was propagated back to ambient storage conditions based on the moisture-modified Arrhenius equation.  The onset of dissolution failures appears to be sudden and directly correlated to changes in disintegration.  If other attributes that are monitored on stability (e.g. degradant formation) will breach their acceptance criteria before dissolution will fail, this information can be leveraged to justify a lean stability strategy in which dissolution rate testing on stability is no longer warranted. Click here to view presentation.dissodeterminationcasestudies