Risk assessment of neonatal excipient exposure: Lessons from food safety and other Areas

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....


http://www.sciencedirect.com/science/article/pii/S0169409X13002627


This review is part of the Advanced Drug Delivery Reviews theme issue on “Drug delivery and the paediatric population: where are we at?”

Funding source: ESNEE is funded through ERANET-PRIOMEDCHILD by the following national agencies: UK Medical Research Council, Grant G1100158; Estonian Science Foundation; INSERM, France.

Corresponding author at: Liverpool Women's NHS Foundation Trust, Crown Street, Liverpool L8 7SS, UK.