Royal College of Surgeons in Ireland
Making Medicines Baby Size.......................pdf (1.72 MB)

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

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journal contribution
posted on 2021-07-06, 15:46 authored by Fiona O'BrienFiona O'Brien, David Clapham, Kamelia Krysiak, Hannah Batchelor, Peter Field, Grazia Caivano, Marisa Pertile, Anthony Nunn, Catherine Tuleu
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.


Medication safety in neonates | Funder: School of Pharmacy, Royal College of Surgeons in Ireland | Grant ID: Clement Archer Scholarship



The original article is available at

Published Citation

O'Brien F, Clapham D, Krysiak K, Batchelor H, Field P, Caivano G, Pertile M, Nunn A, Tuleu C. Making medicines baby size: the challenges in bridging the formulation gap in neonatal medicine. Int J Mol Sci. 2019;20(11):2688.

Publication Date

31 May 2019

PubMed ID



  • School of Pharmacy and Biomolecular Sciences

Research Area

  • Biomaterials and Regenerative Medicine




  • Published Version (Version of Record)