Making Medicines Baby Size: The Challenges in Bridging the Formulation Gap in Neonatal Medicine



O'Brien, Fiona, Clapham, David, Krysiak, Kamelia, Batchelor, Hannah, Field, Peter, Caivano, Grazia, Pertile, Marisa, Nunn, Anthony and Tuleu, Catherine
(2019) Making Medicines Baby Size: The Challenges in Bridging the Formulation Gap in Neonatal Medicine. INTERNATIONAL JOURNAL OF MOLECULAR SCIENCES, 20 (11). E2688-.

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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.

Item Type: Article
Uncontrolled Keywords: neonates, formulation, product development, formulation development, oral, parenteral, topical, inhaled, intra nasal, biopharmaceutics, administration, excipient, NICU, device, medication error, dosage form
Depositing User: Symplectic Admin
Date Deposited: 08 Aug 2019 10:38
Last Modified: 19 Jan 2023 00:35
DOI: 10.3390/ijms20112688
Open Access URL: https://doi.org/10.3390/ijms20112688
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URI: https://livrepository.liverpool.ac.uk/id/eprint/3051281