Revolutionising Paediatric Medicine: The STEP Database

In most medicines, the active ingredient - the actual drug - makes up only a small fraction of the final product. The rest consists of excipients, inactive materials that play a crucial role.

22 October 2024

These excipients have useful functions, such as bulking, lubrication, or enhancing flavour. While these excipients are typically safe for adults, their use in children’s medicines requires additional scrutiny to ensure safety.

Recognising this critical need, Professor Catherine Tuleu and Dr Smita Salunke at UCL developed the Safety and Toxicity of Excipients for Paediatrics (STEP) database. This pioneering global resource compiles vital safety and toxicity data on excipients used specifically in children’s medicines, addressing a key gap in paediatric drug development.

Since its launch in 2014, the STEP database has become an indispensable tool for the pharmaceutical industry, now serving over 3,000 registered users across fourty four countries. What began as a database for ten excipients has grown to encompass seventy five, thanks to collaboration with industry leaders and organisations like the Bill & Melinda Gates Foundation.

This centralised information source exemplifies how improved accessibility to data promotes efficiency in drug development. By facilitating data reuse and providing a streamlined review of excipients' safety, STEP simplifies decision-making for paediatric formulations, ensuring that only the safest materials are used in children's medicines.

Transforming Paediatric Drug Development
The STEP database has had a profound impact on paediatric medicine development. By providing comprehensive, reliable safety data, STEP has reduced costs and accelerated the creation of life-saving treatments for children. Leading pharmaceutical companies—including Eli Lilly, Sanofi, and Pfizer—have integrated the database into their research, improving drug safety and streamlining regulatory approval processes.

Global regulatory authorities, such as the European Medicines Agency (EMA), Health Canada, and the Chinese Centre for Drug Evaluation, have recognised STEP as a trusted resource. Its reach extends beyond drug developers to excipient manufacturers, who benefit from its data in ensuring regulatory compliance and improving product safety.

Looking to the Future: STEP 2.0
Due to its growing popularity and global impact, STEP has secured funding from the USA National Institute of Health to expand further. The next phase, STEP 2.0, will leverage cutting-edge AI and machine learning models, automating processes to ensure ongoing updates and refinements. This integration of advanced technology will maintain the database's integrity, enhance data accuracy, and expand the number of excipients available for review - ensuring that it remains an essential tool in the development of safer, more effective paediatric medicines for years to come.