The STEP (Safety and Toxicity of Excipients for Paediatrics) database: Part 2 – The pilot version

Abstract

The screening and careful selection of excipients is a critical step in paediatric formulation development as certain excipients acceptable in adult formulations, may not be appropriate for paediatric use. While there is extensive toxicity data that could help in better understanding and highlighting the gaps in toxicity studies, the data are often scattered around the information sources and saddled with incompatible data types and formats. This paper is the second in a series that presents the update on the Safety and Toxicity of Excipients for Paediatrics ("STEP") database being developed by Eu-US PFIs, and describes the architecture data fields and functions of the database. The STEP database is a user designed resource that compiles the safety and toxicity data of excipients that is scattered over various sources and presents it in one freely accessible source. Currently, in the pilot database data from over 2000 references/10 excipients presenting preclinical, clinical, regulatory information and toxicological reviews, with references and source links. The STEP database allows searching "FOR" excipients and "BY" excipients. This dual nature of the STEP database, in which toxicity and safety information can be searched in both directions, makes it unique from existing sources. If the pilot is successful, the aim is to increase the number of excipients in the existing database so that a database large enough to be of practical research use will be available. It is anticipated that this source will prove to be a useful platform for data management and data exchange of excipient safety information.

Pediatric Drug Formulations: A Review of Challenges and Progress

“…Its aim is to improve systematic data collection on excipient toxicity and tolerance in children. [64][65][66] A similar initiative, ESNEE (European Study of Neonatal Exposure to Excipients), has developed a platform for the systematic assessment of excipients in neonates. 67 …”

Safety, dosing, and pharmaceutical quality for studies that evaluate medicinal products (including biological products) in neonates

“…There has recently been a concerted effort between different stakeholders to build a dataset to cluster the available knowledge-including safety information-on excipients in neonates (95). This has been organized in the Safety and Toxicity of Excipients for Pediatrics (STEP) database at http://www.eupfi.org/step-database/ for which anyone can register (96). It is possible to measure excipients in microsamples and to perform population PK studies in neonates (97,98).…”

Oral Liquids

“…If the pilot is proved to be successful, the database will be expanded to a fully released database and will eventually include many excipients [34].…”