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Adv Drug Deliv Rev. 2014 Jun;73:89-101. doi: 10.1016/j.addr.2013.11.003. Epub 2013 Nov 13.

Risk assessment of neonatal excipient exposure: lessons from food safety and other areas.

Author information

1
University 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. Electronic address: mark.turner@liverpool.ac.uk.
2
Research and Development, Alder Hey Children's NHS Foundation Trust, Eaton Road, Liverpool L12 2AP, UK.
3
Tartu University Clinics, Department of Anesthesiology and Intensive Care, Lunini 6, 51014 Tartu, Estonia.
4
Tartu University Clinics, Children's Hospital, Lunini 6, 51014 Tartu, Estonia.
5
University of Tartu, Department of Medical Microbiology, Ravila Str 19, 50411 Tartu, Estonia.
6
Clinical & Practice Research Group, School of Pharmacy, Queen's University Belfast, Northern Ireland, UK.
7
Department of Infection Immunity and Inflammation, University of Leicester, UK.
8
University Hospitals of Leicester, Department of Pharmacy, UK.
9
APHP-Hospital Robert Debré, Pharmacy Department, Paris, France.
10
APHP-Hospital Antoine Beclère, Pharmacy Department, Clamart, France.

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.

KEYWORDS:

Adverse effects; Excipients; Medicines; Neonates; Paediatrics; Pharmaceutical development; Risk analysis; Risk management

PMID:
24239480
DOI:
10.1016/j.addr.2013.11.003
[Indexed for MEDLINE]

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