What can we expect from stability testing in 2024

~ Stability trends in the pharmaceutical, nicotine, and cannabinoid sectors ~

Stability studies are a crucial element in determining the shelf life, active ingredient efficacy, and long term safety and stability of pharmaceuticals, nicotine delivery systems, and cannabinoid products. Stability testing is guided by ICH guidelines, leading some to assume that, since guidelines haven’t changed, stability testing isn’t changing either. While the ICH guidelines remain unchanged (for now), as we approach 2024, the products undergoing testing are evolving and so the approach must too. Here Malcolm Saxton, Senior Consultant for Chemistry at Broughton, explores what we can expect to see in the world of stability testing as we go into 2024.

An important place to start is to note that ICH Q1A-Q1F is in the process of refinement to become a combined Q1 guideline. Last updated in 2003, the update will align with other more current ICH regulatory guidelines and risk management principles. The update is expected to streamline the series, promote harmonized interpretation, and cover new topics such as advanced therapies. According to the proposed ICH business plan, it is predicted that the first draft of the revised guidelines will be open for public comment in Q4 of 2024. Undoubtedly, practices will begin to evolve towards the end of 2024 to align with these guidelines in anticipation of their sign-off.

Pharmaceuticals

Biologics and advanced therapies are becoming increasingly prevalent in the field of drug development. They often have complex degradation pathways that must be understood in greater detail upfront to guide stability studies. Advanced therapies are not currently addressed in the Q1A-Q1F ICH guidelines and so scientists need to apply their knowledge of the product, as well as wider industry knowledge, ahead of the new ICH Q1 guidelines.

Nicotine

Attitudes towards nicotine are changing, and so is the way products are being manufactured. Notably, nicotine product manufacturers are moving towards a quality by design (QbD) development process. This means manufacturers will set out better specifications for stability studies and have a better understanding of their products before testing starts.

Currently, there are no specific guidelines or requirements for the stability testing of nicotine products other than the scientific justification for shelf life. Towards the end of 2023, The European Committee for Standardization (CEN) is expected to bring in new legislation regarding extractables and leachables (E&L) studies for e-cigarette products. Manufacturers are starting to employ E&L studies as part of their development process, but with new standards coming into place it will increase accountability and due diligence in the sector.

Cannabinoids

As cannabinoids increase in popularity, a large number of products are being developed that need to pass through the novel food regulatory process. There is less understanding surrounding these products and, to get a product authorized via the pathway, manufacturers must provide stability data to ensure consumer safety. As the cannabinoid market continues to evolve, an uptake in stability studies for these types of products will naturally follow.

Are you looking to conduct stability studies? Whether you already have a fully designed protocol or need to develop one, Broughton has both the expertise and facilities to assist.