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.

The many materials used in the manufacture of next generation nicotine delivery products present a wide variety of potentially contaminating compounds, including:

  • Monomers, oligomers and polymers from elastomers, lubricants and thermoplastics.
  • Additives such as plasticizers, processing aids, antioxidants, catalysts, inhibitors, anti-statics and cross-linking agents.
  • Adhesives, inks, dyes, lacquers, laminates
  • Rubber and synthetic rubber constituents
  • Other contaminants introduced from raw or intermediate materials, or the manufacturing process.

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.

What is Extractables and Leachables analysis?

Extractables analysis of ENDS products

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:

Example Solvents : Aqueous, various pH Organic, various polarities
Example Conditions : Temperature
Agitation

Following extraction, a variety of analytical techniques will need to be employed to assess the solvents for extracted materials. At Broughton Nicotine Services, we have the experience and capabilities to assess your products for the presence of a wide variety of potential extractables, including, but not limited to:

Leachables analysis of Next Generation Nicotine Delivery Products

Following examination of the findings from the extractables study, a subsequent leachables study is conducted focusing on how your product and/or packaging material interacts with a specific delivery medium (e.g. a specific e-liquid, the tobacco blend in heated tobacco products and the organic fibres used in Modern Oral Nicotine Pouches (MOPs).

To ensure that the leachables study is tailored and relevant to the extractables identified, our in-house registered toxicologists will perform a toxicological assessment to identify the level of concern associated with any identified extractables.

Our on-site temperature and humidity-controlled stability chambers will allow stability data to be obtained to meet the requirements for demonstration of shelf-life conditions. The objective of the leachables study is to identify and quantify compounds of concern that are confirmed to migrate from the device or container into the nicotine delivery matrix, or to the end user by direct contact, under typical use.

Our team of experts will work to develop and validate methods for analysis of targeted leachables to ensure reliable and robust data specific to your product.

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How is Extractables and Leachables analysis carried out?

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A study tailored to your ENDS product

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.

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Extractables and Leachables technology and expertise

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:

  • CETI-8 e-cigarette vaping equipment
  • Inductively-coupled plasma – mass spectrometry (ICP-MS)
  • Ion Chromatography (IC) (cationic & anionic)
  • Gas Chromatography with flame ionisation detection (GC-FID)
  • Gas Chromatography with single quadrupole mass spectrometry (GC-MS)
  • Gas Chromatography with triple quadruple mass spectrometry (GC-MS/MS)
  • Headspace gas chromatography – mass spectrometry (HS GC-MS)
  • High performance liquid chromatography (HPLC)
  • Liquid Chromatography with triple quadrupole mass spectrometry (LC-MS/MS)
  • Malvern Spraytech (particle size distribution/analysis)
  • On-site GMP certified temperature & humidity controlled environmental storage

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.

NGP specialists who understand your requirements

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.

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