July 12, 2023
Contract research organisation Broughton has launched a new Extractables and Leachables (E&L) testing service for the reduced-risk nicotine industry.
The scientific consultancy said the service will help nicotine product developers, manufacturers and brands bring their products to market safely and efficiently.
Broughton’s new service will offer tailored E&L studies for products aimed at the Marketing Authorisation Application (MAA) in the UK or Premarket Tobacco Product Application (PMTA) in the US with a fully integrated approach that combines technical and analytical services, with in-house toxicology consultancy, and regulatory compliance support.
Regulatory bodies such as the Medicines and Healthcare products Regulatory Agency and the US Food and Drug Administration increasingly focus on the interactions between manufacturing components, nicotine delivery devices and container-closure systems, and the final product formulation. Producers must identify and assess any toxicological risks that could arise via such interactions via E&L studies.
Aimed at supporting any reduced-risk nicotine product category such as electronic nicotine delivery systems, modern oral nicotine pouches, and nicotine replacement therapy, the service is available across all stages of the product development lifecycle, from early-stage innovation and product development to commercialisation and post-market surveillance, Broughton said.
The service covers material characterisation screens for raw materials, vape and heated tobacco devices, e-liquids, modern oral nicotine pouches, novel nicotine delivery systems, and nicotine replacement treatments for potential leachables from container closure systems, packaging and manufacturing and processing equipment.
“Extractable and leachable studies are essential to the PMTA and MAA regulatory pathways for reduced-risk nicotine products to ensure their safety and demonstrate evidence of mitigating risk. Even in emerging categories, where regulations may not exist, such as nicotine pouches, they should be adopted as a best practice approach to product understanding and stewardship,” said Chris Allen, chief executive of Broughton.
“Organic compounds and elemental impurities, including metals like chromium and lead, can leach into a product from the manufacturing process, the container closure system or packaging materials, and even the delivery mechanism. These can cause health issues over time, environmental pollution, or adversely impact the active ingredient’s efficacy.”
Allen noted that a wide range of analytical techniques is employed in E&L studies to ensure the detection of all potential leachables, which are then screened to understand their potential toxicological impact on the user and environment.
“Our scientific experts and toxicologists have years of combined experience conducting E&L studies across a range of reduced-risk nicotine product and device categories. By offering a one-stop solution for E&L studies, we can ensure a fully integrated approach across study design, extractables study delivery, leachables method development, and toxicology assessment with our specialized consultants available to troubleshoot, problem-solve and develop analytical solutions to issues that may arise,” Allen added.
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