Report

January 20

ToxHQ System For Product Formulation

Broughton Nicotine Services Director of Product Safety and Compliance, Yvonne Wilding, discusses a leading-edge software tool designed and in use at Broughton to assist with toxicological screening and risk assessments.

Yvonne discusses the importance of bringing safe products to market.

Product Safety

One of the important things about bringing successful and safe products to market, is being able to make well informed decisions at the start of any project. For example, there are many hundreds of e-liquid flavours available for manufacturers to choose from. This is of relevance to those ENDS manufacturers who produce closed pod systems and must select one or two flavours to go with their product. These flavours are often uniquely different in their chemical make-up and contain a long list of chemical ingredients. Natural flavourings can be even more complex, and it can be very difficult to identify the associated constituents.

Increasingly regulators will expect a company to know what each of the chemicals are in any flavour, what the level of ingredients are, and what the toxicological significance of any of those chemicals used in that flavouring is. Some chemicals commonly used in food flavourings are on approved lists which makes their use more acceptable. However, these lists of ‘approved’ chemicals commonly used in food flavours have only been assessed for oral effects and their safety for administration to the lungs via inhalation is largely unknown.

Toxicological Screening

As a uniquely sensitive organ system, the lungs are much more vulnerable to potential harm than the gastro-intestinal tract. Broughton Nicotine Services, in cooperation with our sister company Broughton Software, have developed a software solution called TOXHQ. The resulting system can perform e-liquid and flavouring toxicology screening for products early in development.

Risk Assessment

Companies can come to us for a range of potential flavourings and gain an early heads up on the toxicological risks associated with each flavour which they can then use in their decision-making processes. This can help them avoid any chemicals of toxicological concern when selecting their e-liquid formulation. This can ultimately smooth the pathway to regulatory approval and most importantly can help ensure only the safest products are brought forward for consumer use.

 

ToxHQ System For Product Formulation

Can we help you?

Broughton Nicotine Services have deep CRO capabilities and an experienced team of scientific and regulatory professionals to manage full service global regulatory projects. Our knowledge of global regulatory pathways offers significant insights that can be incorporated into your project plans. Our mission is to accelerate safer nicotine-delivery products to market; advancing a smoke-free future.

Book a meeting with us today to discuss your requirements.

 

About the Author

Yvonne Wilding is the Director of Product Safety and Compliance. She has over 10 years of broad regulatory toxicology experience and 20 years of pharmaceutical drug development Research & Development leadership. She has been responsible for numerous MAA and NDA submissions, for both small molecules and biologics and has experience stretching from early candidate selection through life cycle management of new medicines. Her toxicology experience was gained with GlaxoSmithKline's (GSK) large portfolio of respiratory products in a specialized inhalation toxicology department. Yvonne began her career as a regulatory toxicologist for GSK responsible for designing the strategic drug safety evaluation programs to satisfy all global markets using both in-vivo and in-vitro approaches; for operational delivery both with an in-house team and with Contract Research Organisations (CRO). This involved working closely with clinical teams and key opinion leaders to ensure patient safety at each stage of development. She has extensive experience of interacting with regulatory agencies. Following on from Toxicology, Yvonne was responsible for managing and leading drug development programs encompassing all functional disciplines to ensure delivery of successful marketing applications and to maximise the commercial opportunity for each product. Yvonne’s clinical experience encompasses clinical program strategy, study management, clinical portfolio management and pharmacovigilance. Most recently, Yvonne worked with AstraZeneca in the Precision Medicine department to develop new diagnostic tests and submit PMA applications for companion diagnostics devices evaluating genetic biomarkers of disease susceptibility in collaboration with major diagnostic companies.