Need of STEP database
Nearly all medicines are formulated with excipients that have been used for many years and are generally regarded as safe (GRAS). They are defined in monographs in the various pharmacopoeias and released on certificates of analysis against monograph specifications, using monograph test methods. However, these monographs are usually intended to cover use in adults and some excipients are less well tolerated in children, especially young children whose physiological systems are still undergoing development.
Excipients may be toxic, carcinogenic, mutagenic, teratogenic, or affect reproduction. Assessing the safety of excipients is an essential element of the research and development process. Detailed assessments of these compounds must be included in applications submitted to regulatory authorities. Extensive excipient safety data is publicly available in peer-reviewed scientific journals and government reports and databases, but there is very limited paediatric data which can be used for development of paediatric medicines and is distributed over many sources. This safety data has never been incorporated into a single comprehensive and readily accessible database. At the present time, industry and regulators have no central source of safety data on which to base decisions regarding the need for additional safety studies. Therefore, there is a risk that some such studies may be conducted unnecessarily or on the other hand highlight some studies that are required/necessary to be carried out.
There is no repository of excipients information (e.g., dose information, PK) that could (i) provide a basis for screening and selecting excipients for use in paediatric product development; and (ii) expedite further product-specific safety and toxicity studies.
Objectives of STEP database
Excipients in current version of the database
[Alcohol, alpha-Cyclodextrin, Aspartame, Benzalkonium Chloride, Benzoic Acid, Benzyl Alcohol, beta-Cyclodextrin, Butylated Hydroxyanisole, Butylparaben, Carboxymethylcellulose, Carboxymethylcellulose Sodium, Crospovidone, Ethylparaben, gamma-Cyclodextrin, Glyceryl Monocaprylate [Capmul MCM C8], Hypromellose, Lactose, Mannitol, Methylparaben, Microcrystalline Cellulose, Polyethylene Glycol, Polysorbate 20, Polysorbate 40, Polysorbate 60, Polysorbate 65, Polysorbate 80, Povidone, Propylene Glycol, Propylparaben, Saccharin, Saccharin Sodium, Sodium Benzoate, Sodium Lauryl Sulfate, Sodium Metabisulphite, Sorbic acid, Sorbitol, Sucralose, Vitamin E Polyethylene Glycol Succinate, Xanthan Gum, Xylitol]
Further release in July 2016
[Boric acid, Citric acid, Colloidal Silicon Dioxide, Butylated hydroxytoluene (BHT), , L-proline, Polaxmers, Maltitol, Magnesium Stearate, Sucrose, Trehalose]
Sponsor an Excipient (click on image for more information)
Video 5: How is the results page organised
Video 6: How to filter the data on results page (to be available soon)
STEP database publications ( key publication listed below)
- Salunke S, Giacoia G, Tuleu C. The STEP (safety and toxicity of excipients for paediatrics) database. Part 1-A need assessment study. Int J Pharm. 2012 Oct 5;435(2):101-11. doi: 10.1016/j.ijpharm.2012.05.004. Epub 2012 May 11. PubMed
- Salunke S, Brandys B, Giacoia G, Tuleu C. 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.
PubMed PMID: 24070789.
- Salunke S, Tuleu C; European Paediatric Formulation Initiative (EuPFI). The STEP database through the end-users eyes–USABILITY STUDY. Int J Pharm. 2015 Aug 15;492(1-2):316-31. doi: 10.1016/j.ijpharm.2015.06.016. Epub 2015 Jun 24. PubMed PMID: 26117188.
- Poster presentation – S Salunke “Safety and Toxicity of Excipients for Paediatrics (STEP) Database—A Central Repository for Safety and Toxicity Information of Excipients), AAPS, US, Oct 2015
Your feedback is welcome
The data collection and extraction for STEP is in process. However, EuPFI invites volunteers who wish to work on the data collection, extraction and population for STEP and researches who work on the safety and toxicity of excipients to provide information on their findings for inclusion in STEP.
Please click here to submit your feedback
How to give us your feedback
Please send us your data on the form provided. We also welcome any comments on the data which are already included in the database – again, on the form provided, which should be sent back to us by e-mail.
After conducting a quick quality check, we will incorporate these changes into the master version.