Health risk assessments relating to the excipient components of the…

Client

Kind Consumer Ltd is a UK-based healthcare research and development company focused on inhalation technologies. Kind Consumer received a Marketing Authorisation for its lead product, Voke®, in September 2014. With thanks to Kind Consumer for allowing us to share this piece of project work in a public domain.

Background

A novel nicotine replacement device was designed to deliver a pressurised nicotine formulation via a breath operated valve in a cigarette sized medical device. Bibra was asked to carry out health risk assessments relating to the excipient components of the product’s formulation. In addition, Bibra was commissioned to assess any potential consumer health risks associated with the inhalation of potential leachables from the product.

Project goals

To provide the client with robust risk assessments (focusing on the inhalation route of exposure) regarding the chemical ingredients of the Voke® 0.45mg Inhaler contents, as well as any leachables, to support a Marketing Authorisation Application dossier for the UK Medicines and Healthcare Products Regulatory Agency (MHRA).

Approach and outcome

The client provided compositional details for the nicotine formulation, including all excipients and their concentrations. Kind Consumer also supplied various analytical reports investigating the extractable and leachable profiles of the product’s components. Bibra estimated exposures to excipients and leachables, and carried out health risk assessments on the individual chemicals, using worst-case assumptions to address uncertainties. Bibra also assessed the impact of the nicotine itself, as well as the risk associated with second hand inhalation by non-users.

Bibra was able to conclude that the estimated exposures to the nicotine formulation and the leachables from the device were highly unlikely to pose any significant risks to consumer health. Subsequently the client successfully obtained a licence for the general sale of the product from the MHRA.