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Excipients in Neonatal Medicinal Products: Never Prescribed, Commonly Administered.


ABSTRACT: To attain effective and safe pharmacotherapy, formulations in (pre)term neonates should enable extensive dose flexibility. During product development and subsequent authorization and clinical use of such formulations, there is also a need for informed decisions on excipient exposure: in addition to the need to improve the knowledge on active compounds, there is a similar need to improve the knowledge on excipients in neonates. Excipients are added to formulations as co-solvent, surfactant, preservative, colorant and/or sweetener as vehicle(s) to result in a suitable (e.g. taste, shelf life, stability) product. Progress has been made in the awareness, knowledge and access to this knowledge on the clinical pharmacology of excipients in neonates. This is thanks to different initiatives focuss

SUBMITTER: Valeur KS 

PROVIDER: S-EPMC6105181 | biostudies-literature | 2018

REPOSITORIES: biostudies-literature