Stability studies are a time consuming and resource intensive task during the development of new drugs. Accelerated Stability Assessment Programme (ASAP) is an approach based on the Arrhenius equation whereby degradation increases with temperature and therefore using appropriate testing vessels and statistical analysis, it is possible to project the degradation rate at low temperature from the data generated under accelerated or stressed conditions.
Whilst the regulations require that long-term studies or real-time studies are still needed, ASAP provides an additional tool that can be applied through the whole life-cycle of the drug product, from development up to post-approval changes. ASAP is a technique to allow rapid and accurate predictions on the shelf lives of both drug substances and drug products. Scientifically driven, the ASAP tool provides a new opportunity during the development lifecycle to detect anomalies in stability data/trends. Compared with conventional stability approaches ASAP helps to generate an initial understanding of the stability, to give shelf life predictions and to quantify the effect of temperature and/or humidity [1].
ASAP helps to de-risk the development decision by enhancing predictive power and increased confidence in product formulation shelf life mitigating lifecycle risk management. Used predominately as supportive data, ASAP can help to reduce stability commitments.
What is ASAP?
The process involves short term ageing (2-4 weeks) at multiple storage conditions, using a range of temperatures and humidifies (50-80°C and 10-75%RH). During testing, the temperature and humidity are constantly measured and recorded so that the conditions within actual testing vessels are used for the statistical analysis.
Analysing degradant formation and potency loss, at each of the conditions, allows a humidity corrected Arrhenius equation to be generated using the software package ASAPprime®, which in turn can be used to predict the shelf life.
Aside from predicting shelf life, the software can be used as a rapid means to assess packaging materials. Based upon the moisture vapour transmission rate (MVTR) for each available packaging type, the software can be used to determine the most appropriate packaging material for the intended climatic zone. This can reduce costs as the requisite ICH stability tests can then be designed to be confirmatory as the optimum packaging has already been determined,
Applications:
- Shelf life assignment for development purposes, allowing rapid screening of formulation processes, formulations, climate zone changes and manufacturing processes.
- Rapid comparison between generic and originator products.
- Assessment of clinical use periods for early clinical trials, and also determining the retest periods for API, starting materials and standards.
- Post- Approval of lot stability assessments.
- Decision making regarding packaging types from supportive data for registration packages.
- Implementing Quality by Design for stability to allow model changes to processes or products and post approval to justify and potential replace annual commitment programmes.
[1] Scrivens, G. Predicting the Long-Term Stability of Solid-State Pharmaceuticals.
