Excipients in the Paediatric Population: A Review

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.

Download the full article here: Excipients in the Paediatric Population – A Review

or continue reading here: Rouaz, K.; Chiclana-Rodríguez, B.; Nardi-Ricart, A.; Suñé-Pou, M.; Mercadé-Frutos, D.; Suñé-Negre, J.M.; Pérez-Lozano, P.; García-Montoya, E. Excipients in the Paediatric Population: A Review. Pharmaceutics 2021, 13, 387. https://doi.org/10.3390/pharmaceutics13030387

Toxicity Databases

ACToR —Aggregated Computational Toxicology Resource
US Environmental Protection Agency’s (EPA) National Center for Computational Toxicology (NCCT)

STEP—Safety and Toxicity of Excipients for Paediatrics
European Paediatric Formulation Initiative

TOXNET—Toxicology Data Network
Specialized Information Services (SIS) USA

Lhasa Limited


The critical study suggests that excipients are often used at higher concentrations than recommended in international paediatric guidelines, and with inappropriate labelling, increasing the potential risks associated with the various excipients discussed.
Indeed, the pharmacokinetic and pharmacodynamic profiles of the child population vary substantially, with paediatric safety profiles related to the age and development of excipients often differing from those of adults. The most toxic excipients in neonates are known to be sodium benzoate, propylene glycol, methyl para hydroxybenzoate, propyl, sodium saccharine, benzyl alcohol, benzalkonium chloride, polysorbate 80 and ethanol. However, these excipients are used in formulations according to the study conducted.
European new-borns receive several potentially harmful pharmaceutical excipients: parabens, polysorbate 80, propylene glycol, benzoates, sodium saccharine, sorbitol, ethanol and benzalkonium chloride. According to the study conducted by Nellis and collaborators, there are regional variations in the neonatal administration of these potentially harmful excipients. This suggests the possibility of reducing exposure to parabens, polysorbate 80, propylene glycol and sodium saccharine by replacing it with products without these excipients. However, a joint effort by the regulatory authorities on medicines, in particular the paediatric committees, will be necessary. Current therapeutic options for the paediatric population justify further toxicokinetic and drug safety studies so that they are tailored to the special needs of the paediatric population.
In general, there is little information regarding excipients in paediatrics. It is of the utmost importance to develop new research related to the safety and toxicity of excipients to reduce the prevalence of adverse effects in paediatric populations. Gallon formulators can formulate safer, more stable and higher quality products. Furthermore, the possible adverse effects of the active ingredients and the excipients used in the paediatric population should be reconsidered—since excipients that are safe in adults—may have potentially toxic effects in children.
Finally, the development of databases such as STEP is relevant and beneficial for the development and use of drugs in paediatrics. Additionally, the SEEN project is relevant both nationally and internationally, as it reveals the current status of excipients and takes into account the frequency and quantity (in terms of medicines given to new-borns and young children).
You might also like