The European Paediatric Formulation Initiative (EuPFI) has been working on the STEP (Safety & Toxicity of Excipients for Paediatrics) database for some time, compiling clinical, non-clinical and in vitro data as well as regulatory information.
The intention is to create a resource for those formulating medicines for use in children, a group that is still routinely treated with drugs that have not been developed to meet their own specific physiological needs, putting them at risk of inaccurate dosing and side effects from potentially toxic ingredients.
Prior to the requirement to include Paediatric Investigation Plans (PIPs) in Europe in 2007, around half of all drugs on the market had never been studied in children, even though many of them were being given to them off-label.
Since the introduction of PIPs the situation has improved as drug developers now have to take children into account in the marketing applications. However, there remains a lack of data to help formulators decide whether a particular excipient is safe for paediatric use based on factors such as dosage level and route of administration.
The EuPFI intends the STEP database to become a comprehensive, free-to-access database that fills the current gap in knowledge about excipient safety in children, helping pharmaceutical scientists select appropriate excipients and serving as a resource that can be cited in marketing applications.
It was first launched in 2014 and to date has been populated with information on 40 excipients, initially focusing on those suspected of toxicity issues. Now, the EuPFI wants to accelerate the process by allowing users to select new excipients for inclusion.
"Funding and sponsorship can help to deliver the information on safety and toxicity … to facilitate paediatric drug development by financing excipients that have not yet been undertaken under the STEP database project," said EuPFI chair Catherine Tuleu, who is also director of the centre for paediatric pharmacy research at UCL School of Pharmacy in the UK.
She told delegates at the IPEC Europe Excipients Forum earlier this month that the scheme allows end-users of the database to include the excipients of their choice in the database. For a fee - estimated at £1,500 to £3,000 per excipient - EuPFI will compile the information on behalf of the sponsor.
The sponsorship programme "will help us expedite the daily tasks of collecting and curating information," said Tuleu.
The EuPFI is holding a joint workshop with the International Consortium for Innovation and Quality in Pharmaceutical Development (IQ) - scheduled for 16-17 May at the University of Maryland in Baltimore, US - that will focus on the qualification of excipient safety.