Excipients in the Paediatric Population: A Review

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).