Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Review
. 2021 Mar 13;13(3):387.
doi: 10.3390/pharmaceutics13030387.

Excipients in the Paediatric Population: A Review

Affiliations
Review

Excipients in the Paediatric Population: A Review

Khadija Rouaz et al. Pharmaceutics. .

Abstract

This theoretical study seeks to critically review the use of excipients in the paediatric population. This study is based on the rules and recommendations of European and American drug regulatory agencies. On the one hand, this review describes the most frequent excipients used in paediatric medicine formulations, identifying the compounds that scientific literature has marked as potentially harmful regarding the side effects generated after exposure. On the other hand, this review also highlights the importance of carrying out safety -checks on the excipients, which, in most cases, are linked to toxicity studies. An excipient in the compilation of paediatric population databases is expected to target safety and toxicity, as in the STEP database. Finally, a promising pharmaceutical form for child population, ODT (Orally Disintegrating Tablets), will be studied.

Keywords: STEP and ODT; excipients; paediatrics; security; toxicology.

PubMed Disclaimer

Conflict of interest statement

The authors declare no conflict of interest.

Figures

Figure 1
Figure 1
Characteristics and advantages of ODT tablets.
Figure 2
Figure 2
Disadvantages of ODT tablets.

References

    1. Cañete C.R., García M.P., García B.P., Cabañas M.J.P. Formulación magistral y excipientes en pediatría. El Farma-céutico. Hospitales. 2018;213:22–28.
    1. 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;457:310–322. doi: 10.1016/j.ijpharm.2013.09.013. - DOI - PubMed
    1. Schmitt G. Safety of Excipients in Pediatric Formulations—A Call for Toxicity Studies in Juvenile Animals? Child. 2015;2:191–197. doi: 10.3390/children2020191. - DOI - PMC - PubMed
    1. European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) Paediatric Committee (PDCO) Guideline on Pharmaceutical Development of Medicines for Paediatric Use. [(accessed on 1 June 2020)]; Available online: https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-ph....
    1. Dunne J. The European Regulation on medicines for paediatric use. Paediatr. Respir. Rev. 2007;8:177–183. doi: 10.1016/j.prrv.2007.04.004. - DOI - PubMed