Making medicines baby size: the challenges in bridging the formulation gap in neonatal medicine

Fiona O'Brien, David Clapham, Kamelia Krysiak, Hannah Batchelor, Peter Field, Grazia Caivano, Marisa Pertile, Anthony Nunn, Catherine Tuleu

Research output: Contribution to journalReview articlepeer-review

13 Citations (Scopus)
452 Downloads (Pure)


The development of age-appropriate formulations should focus on dosage forms that can deliver variable yet accurate doses that are safe and acceptable to the child, are matched to his/her development and ability, and avoid medication errors. However, in the past decade, the medication needs of neonates have largely been neglected. The aim of this review is to expand on what differentiates the needs of preterm and term neonates from those of the older paediatric subsets, in terms of environment of care, ability to measure and administer the dose (from the perspective of the patient and carer, the routes of administration, the device and the product), neonatal biopharmaceutics and regulatory challenges. This review offers insight into those challenges posed by the formulation of medicinal products for neonatal patients in order to support the development of clinically relevant products.

Original languageEnglish
Article number2688
Number of pages32
JournalInternational Journal of Molecular Sciences
Issue number11
Publication statusPublished - 31 May 2019


  • NICU
  • administration
  • biopharmaceutics
  • device
  • dosage form
  • excipient
  • formulation
  • formulation development
  • inhaled
  • intra nasal
  • medication error
  • neonates
  • oral
  • parenteral
  • product development
  • topical


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