1. Making Medicines Baby Size: The Challenges in Bridging the Formulation Gap in Neonatal Medicine
- Author
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Peter Field, Fiona O’Brien, David E. Clapham, Hannah Batchelor, Anthony J Nunn, Marisa Pertile, Catherine Tuleu, Grazia Caivano, and Kamelia Krysiak
- Subjects
Chemistry, Pharmaceutical ,medication error ,dosage form ,Review ,030226 pharmacology & pharmacy ,intra nasal ,Medication error ,lcsh:Chemistry ,oral ,0302 clinical medicine ,Drug Stability ,inhaled ,Precision Medicine ,topical ,device ,lcsh:QH301-705.5 ,Spectroscopy ,excipient ,Drug Administration Routes ,Biopharmaceutics ,Age Factors ,General Medicine ,Term neonates ,Computer Science Applications ,biopharmaceutics ,Pharmaceutical Preparations ,NICU ,medicine.medical_specialty ,Medicines management ,Drug Compounding ,MEDLINE ,formulation ,administration ,Catalysis ,RS ,Inorganic Chemistry ,03 medical and health sciences ,030225 pediatrics ,medicine ,Humans ,Physical and Theoretical Chemistry ,Intensive care medicine ,product development ,Molecular Biology ,Drug compounding ,formulation development ,business.industry ,Organic Chemistry ,parenteral ,Infant, Newborn ,neonates ,lcsh:Biology (General) ,lcsh:QD1-999 ,New product development ,business - 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.
- Published
- 2019