Safety of Excipients in Pediatric Formulations-A Call for Toxicity Studies in Juvenile Animals?

Georg Schmitt

doi:10.3390/children2020191

Abstract

The development of drug products for pediatric use often requires age-appropriate formulations which can be more complex and may involve a broader range of excipients than adult dosage forms. Excipients established for adult use are not always appropriate for use in children because they can affect children differently than adults. Therefore, a comprehensive safety assessment of the excipients in a pediatric formulation is essential before use, referring to existing safety data from adult human and animals as well as safety data from pediatric use and juvenile toxicity studies, when available. The overall risk assessment needs to consider the safety risk from the excipients and the extent to which the risk from the disease as such will be ameliorated by the drug formulation. Non-clinical safety studies in juvenile animals are used to assess for specific toxicities or sensitivities of excipients and for establishing safe exposures in pediatric age groups. As for any active ingredient, non-clinical safety studies in juvenile animals should only be performed for excipients if important for clinical risk assessment and labelling. Pharmaceutical companies should be critical of excessive demands for juvenile animal testing, particularly of excipients when critically needed for significant therapeutic benefit.

Highlights

IntroductionThe development of drug products for pediatric use often requires age-appropriate formulations
The development of drug products for pediatric use often requires age-appropriate formulations.Excipients are essential components of drug formulations to overcome challenges such as solubilityChildren 2015, 2 and stability
Established excipients in drug formulations for adults may not be appropriate for use in children because they can affect children differently than adults

Summary

Introduction

The development of drug products for pediatric use often requires age-appropriate formulations. Pediatric formulations may be more complex and may involve a broader range of excipients than adult dosage forms. For these reasons, the choice of suitable excipients is a key element in pediatric drug development [1]. Established excipients in drug formulations for adults may not be appropriate for use in children because they can affect children differently than adults. The dosing accuracy of a drug product can be an issue for the safety of excipients in children.

When to Call Toxicity Studies in Juvenile Animals?

Conclusions