The STEP (Safety and Toxicity of Excipients for Paediatrics) database: part 2 - the pilot version

Int J Pharm. 2013 Nov 30;457(1):310-22. doi: 10.1016/j.ijpharm.2013.09.013. Epub 2013 Sep 23.


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.

Keywords: ACToR; ADI; AFSSAPS; Acceptable Daily Intake; Adverse effects; Agence française de sécurité sanitaire des produits de santé (French Agency for the Safety of Health Products); Aggregated Computational Toxicology Resource; CAS; CCOHS; Canadian Centre for Occupational Health and Safety; Chemical Abstracts Service; Chemicals; Children; Database; EFSA; ESIS; ESNEE; EuPFI; European Food Safety Authority; European Paediatric Formulation Initiative; European Study of Neonatal Excipient Exposure; European chemical Substances Information System; Excipients; FDA; Food and Drug Administration; GRAS; Generally Regarded As Safe; IPCS; IT; IUPAC; Information Technology; International Programme on Chemical Safety; International Union of Pure And Applied Chemistry; JECFA; Joint FAO/WHO Expert Committee on Food Additives; NLM; NRC; NTP; National Library of Medicine; National Research Council; National Toxicology Program database; PK/PD; Pharmacokinetics/Pharmacodynamics; STEP; Safety and Toxicity of Excipients for Paediatrics; SmPC; Summary of Product Characteristics; Toxicity; URL; US PFI; Uniform Resource Locator; United States Paediatric Formulation Initiative; WHO; World Health Organization.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Animals
  • Child
  • Databases, Factual*
  • Excipients / toxicity*
  • Humans
  • Pediatrics
  • User-Computer Interface


  • Excipients