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

Research output: Contribution to journalReview article

Authors

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

Colleges, School and Institutes

External organisations

  • School of Pharmacy, Royal College of Surgeons in Ireland, 111 St Stephens Green Dublin 2, Ireland. fionaobrien@rcsi.ie.
  • 14 Tailors, Bishops Stortford CM23 4FQ, UK. david.clapham@ntlworld.com.
  • School of Pharmacy, Royal College of Surgeons in Ireland, 111 St Stephens Green Dublin 2, Ireland. kameliakrysiak@rcsi.ie.
  • College of Medical and Dental Sciences, Institute of Clinical Sciences, University of Birmingham, Birmingham B15 2TT, UK. H.K.Batchelor@bham.ac.uk.
  • University College London School of Pharmacy, 29-39 Brunswick Square, London WC1N 1AX, UK. peter.field@ucl.ac.uk.
  • Chiesi Farmaceutici S.p.A. Largo Francesco Belloli 11/A-43122 Parma, Italy. g.caivano@chiesi.com.
  • Chiesi Farmaceutici S.p.A. Largo Francesco Belloli 11/A-43122 Parma, Italy. m.pertile@chiesi.com.
  • Department of Women's and Children's Health, University of Liverpool, Liverpool Women's Hospital, Liverpool L8 7SS, UK. a.j.nunn@liverpool.ac.uk.
  • University College London School of Pharmacy, 29-39 Brunswick Square, London WC1N 1AX, UK. c.tuleu@ucl.ac.uk.

Abstract

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.

Details

Original languageEnglish
Article number2688
Number of pages32
JournalInternational Journal of Molecular Sciences
Volume20
Issue number11
Publication statusPublished - 31 May 2019

Keywords

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