NGPs are a unique product category, falling somewhere between traditional tobacco products (combustible cigarettes) and medicinal devices. For the US regulatory routes (PMTA and MRTP) as well as the European medicinal routes (MAA), it is important to understand how your product might change in performance over the course of time before being used by the consumer.
Extractables and leachables studies establish the understanding of next generation nicotine delivery products by investigating, identifying and monitoring the wide variety of compounds that may be present in any aspect of nicotine delivery from the product and which may therefore present an unintended exposure risk to your end user. The study will inform which compounds have the potential to be present in your product, which compounds are positively identified in your product routinely, and which may develop a presence in your product over its lifetime. These compounds may find themselves in the nicotine delivery of the product or be introduced to the end user by direct contact, such as oral contact. A well designed and implemented extractables and leachables study will demonstrate that all concerns have been considered and addressed and is key to a successful submission.
Understanding and confirming the extractables and leachables profile of a product is an important aspect of the scientific documentation required by regulatory authorities in the US, Europe and UK, and can also support the protection of patents and intellectual property.
Extractables analysis is focused on the medium of nicotine delivery from the NGP or the materials of the container in which the product is stored. The objective of these studies is to identify compounds that could potentially be extracted from a device or container under a range of conditions designed to interrogate the materials. Dependent upon the product profile, numerous extraction conditions may need to be employed to identify potential compounds, such as:
Extractables and Leachables assessments are most effective when tailored to an individual product. At Broughton Nicotine Services we take the time to discuss your product with you to thoroughly understand your needs, timelines and resourcing requirements to support your regulatory submission. Upfront planning is essential as decisions made early in the process can have important implications later through the process.
Our team also understand that ensuring progress in line with agreed schedules is one of the highest priorities of NGP companies. Hence, we prioritize and adapt to respond to changes and achieve your agreed milestones.
Our team of experts, with their collective years of experience in the NGP sector, including regulatory expertise, registered toxicologists, dedicated development and validation scientists, and an experienced analytical team, are focussed purely on this industry and have the level of understanding required to design your study with you to maximise the efficiency and value of the testing.
As a Contract Research Organisation (CRO), Broughton Nicotine Services utilize the most scientifically-advanced equipment and technology to undertake extractables and leachables analysis, employing a wide variety of spectrometry and chromatography instruments, including:
Studies are carried out to best practice guidelines and dedicated Project Managers are allocated to act as a main point of contact throughout each study to monitor progress in line with agreed timelines, and provide updates and interim reports as required.
Broughton Nicotine Services operate across all Next Generation Nicotine Delivery Product Categories. Our team of scientific and regulatory experts, backed by an in-house custom-built chemistry facility, understand your specific challenges and opportunities and are committed to working with you to increase the value of your business and advance a smoke free future.