Fecha registrada: May 07 2020
Stability studies often precede patient studies and registration stability studies, as advised by the International Conference on Harmonisation (ICH) guideline Q1A (R2). Such testing is mandatory to regulatory filing and approval of the drug products for the market.
As per Q1A(R2) ICH guidance on Stability testing of new drug substances and products, “stability studies should include testing of those attributes of the drug substance that are susceptible to change during storage and are likely to influence quality, safety, and/or efficacy. The testing should cover, as appropriate, the physical, chemical, biological, and microbiological attributes. Validated stability-indicating analytical procedures should be applied.” The same principle should be applied to drug products.
The guidance specifies the storage conditions for long term, intermediate and accelerated studies and the frequency with which these studies should be performed. If a significant change is observed, stability studies should be carried out more frequently.
Even if the stability characteristics of the API/drug product are fully understood, stability behavior should be continuously monitored and verified.
To gain a better understanding of stability performance and to avoid unnecessary studies, in situ X-ray powder diffraction experiments as a function of temperature and relative humidity can be implemented.
These provide a direct means of characterizing the polymorph stability of a pharmaceutical material at high temperature and the occurrence of hydration/dehydration processes. Within such an approach, the experimental conditions required for long term, immediate or accelerated stability studies (as defined per ICH Q1A(R2)) can be easily achieved. More extreme conditions can be established in order to speed up stability investigations. Such non-ambient X-ray diffraction testing can be performed at any stage of the drug development process.
In this webinar we will give an overview of the accessories that are required for in situ stability testing, discuss prerequisites for such studies and provide a few examples of successfully performed investigations.