Toxic additives in medication for preterm infants

Arch Dis Child Fetal Neonatal Ed. 2009 Jul;94(4):F236-40. doi: 10.1136/adc.2008.146035. Epub 2009 Jan 21.


Background: Little is known about exposure of preterm infants to excipients during routine clinical care.

Objective: To document excipient exposure in vulnerable preterm babies in a single centre, taking into account chronic lung disease (CLD) as a marker of illness severity.

Design: Excipient exposure after treatment with eight oral liquid medications was determined by retrospectively analysing the drug charts of infants admitted to a neonatal unit.

Setting: The Leicester Neonatal Service.

Participants: 38 infants born between June 2005 and July 2006 who were less than 30 weeks' gestation and 1500 g in weight at birth and managed in Leicester to discharge.

Results: The 38 infants represented 53% of the eligible target group; 7/38 infants had CLD. During their in-patient stay, infants were exposed to over 20 excipients including ethanol and propylene glycol, chemicals associated with neurotoxicity. Infants with CLD were exposed to higher concentrations of these toxins. Infants were also exposed to high concentrations of sorbitol, with some infants being exposed to concentrations in excess of recommended guidelines for maximum exposure in adults.

Conclusions: Preterm infants are commonly exposed to excipients, some of which are potentially toxic. Strategies aimed at reducing excipient load in preterm infants are urgently required.

MeSH terms

  • Administration, Oral
  • Chronic Disease
  • Dexamethasone / administration & dosage
  • Drug Administration Schedule
  • Excipients / administration & dosage
  • Excipients / toxicity*
  • Female
  • Gestational Age
  • Glucocorticoids / administration & dosage
  • Humans
  • Infant, Newborn
  • Infant, Premature
  • Infant, Premature, Diseases / drug therapy*
  • Lung Diseases / drug therapy
  • Male
  • Retrospective Studies
  • Sorbitol / administration & dosage


  • Excipients
  • Glucocorticoids
  • Sorbitol
  • Dexamethasone