If a pharmaceutical product is likely to degrade after 12 months, how can we get an early insight into that risk? The answer is to perform an accelerated stability study that collects data over a period of a few weeks under high-stress conditions, such as elevated temperature, pH for liquids, and moisture for solids.

Once a model has been selected, it can be extrapolated over time to assess the overall level of stability. Multiple impurities contributing to degradation are modelled individually and evaluated collectively to identify the highest risk factors.

For moisture-driven impurities, packaging can be used to control degradation rates. A packaging model can be constructed that accounts for moisture permeation and adsorption (in both product and desiccants). A composite model (kinetic plus packaging) evaluates overall stability.

This JSL application is an interesting combination of physics, chemistry, model fitting, and statistical estimation. The live demonstration covers the workflow navigation, modelling moisture vapour transmission rates, kinetic model fitting and ranking, the use of diagnostic plots and prediction profilers, and the generation of dashboards to present final results.

Special emphasis is given to the methodology of model selection and the challenges that are unique to accelerated stability studies.