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Risk assessment of neonatal excipient exposure: lessons from food safety and other areas
M A Turner1, J C Duncan2, U Shah2
1University of Liverpool, Department of Women's and Children's Health, Institute of Translational Medicine, Liverpool Women's NHS Foundation Trust, Crown Street, Liverpool L8 7SS, UK.
Insights
Medicines for newborns often contain excipients, substances added to improve drug formulation. Careful risk assessment is crucial to balance potential toxicity with ensuring neonates receive beneficial medications.
Area of Science:
- Neonatal pharmacology
- Pharmaceutical sciences
- Drug formulation
Background:
- Neonatal medications frequently contain excipients, which are inactive ingredients used to improve drug stability, efficacy, and patient acceptability.
- Most drugs administered to neonates are adapted from adult or pediatric formulations, raising questions about the safety and suitability of their excipients for this vulnerable population.
- While many excipients are considered safe for neonatal use, some may pose risks at higher concentrations, necessitating thorough risk assessment.
Purpose of the Study:
- To examine the role and safety of excipients in medications intended for newborn infants.
- To discuss the challenges in assessing the risks associated with excipient exposure in neonates.
- To explore how choices regarding excipient use impact drug availability and safety throughout a medicine's lifecycle.
Main Methods:
- Review of existing literature on pharmaceutical excipients in neonatal medicine.
- Analysis of risk assessment strategies for excipient exposure in neonates.
- Examination of decision-making processes for excipient selection in drug development and clinical practice.
Main Results:
- Excipients are integral to drug formulation but require careful consideration in neonatal populations.
- Potential toxicity of certain excipients necessitates rigorous risk-benefit analysis.
- Overly cautious approaches to excipient safety may limit access to essential medicines for newborns.
Conclusions:
- A scalable approach to analyzing overall risk is essential for managing excipient exposure in neonates.
- Balancing the benefits of drug formulation with potential excipient risks is critical for neonatal care.
- Further research and standardized guidelines are needed for safe and effective use of excipients in neonatal medications.
Abstract:
Newborn babies can require significant amounts of medication containing excipients intended to improve the drug formulation. Most medicines given to neonates have been developed for adults or older children and contain excipients thought to be safe in these age groups. Many excipients have been used widely in neonates without obvious adverse effects. Some excipients may be toxic in high amounts in which case they need careful risk assessment. Alternatively, it is conceivable that ill-founded fears about excipients mean that potentially useful medicines are not made available to newborn babies. Choices about excipient exposure can occur at several stages throughout the lifecycle of a medicine, from product development through to clinical use. Making these choices requires a scalable approach to analysing the overall risk. In this contribution we examine these issues.
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