In Use Stability Studies

In this presentation you will find information on:

  • In-Use Stability Studies
  • In-Use Stability: Re-capped Bottles
  • Tablet Moisture Sorption
  • Typical Half-lives for Moisture Equilibration
  • RH Consequences—Example
  • Stability Consequences: Example
  • Excursions
  • ASAPprime Modeling Approach
  • Example of ASAPprime®️ Model Approach

In-Use Stability Challenges

Regulatory expectations are that the in-use shelf-life be actually determined. Products are often removed from their original packaging. We consider different scenarios such as temperature, bottle open time, headspace exchange and dosage sorption during open time, loss of heat induction seal on recapped bottles, and fewer dosages over time.

ASAPprime® Model Approach

We use ASAP on drug product to establish fitting behavior (sensitivity to temperature and RH). We also use data-logger information to calculate impact of excursions taking account. Our goal is to reach a >95% confidence level.

Did you know…?

Clinical use periods have been accepted by health authorities using just ASAPprime® modeling.

Learn more here.