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Excipients in Neonatal Medicinal Products: Never Prescribed, Commonly Administered

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...

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Autores principales: Valeur, Kristine Svinning, Holst, Helle, Allegaert, Karel
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer International Publishing 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6105181/
https://www.ncbi.nlm.nih.gov/pubmed/30174435
http://dx.doi.org/10.1007/s40290-018-0243-9
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author Valeur, Kristine Svinning
Holst, Helle
Allegaert, Karel
author_facet Valeur, Kristine Svinning
Holst, Helle
Allegaert, Karel
author_sort Valeur, Kristine Svinning
collection PubMed
description 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 focussing on epidemiological data, excipient pharmacokinetics, or building datasets to create this knowledge. We highlight the Safe Excipient Exposure in Neonates and Small Children (SEEN) and propylene glycol project to illustrate the feasibility to build knowledge, and discuss the methods applied and problems observed during these studies. The information generated in these and other studies (European Study on Neonatal Exposure to Excipients, ESNEE) should be integrated in repositories like the Safety and Toxicity of Excipients for Paediatrics (STEP) to facilitate access to all stakeholders. This merged knowledge should have impact and assist in improving the quality of risk assessment and decision making during drug development, applying a risk-benefit framework (explicit justification of excipients, plan product development early and engage all stakeholders, data sharing and modeling, challenges related to new excipients, context sensitive risk-benefit analysis).
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spelling pubmed-61051812018-08-30 Excipients in Neonatal Medicinal Products: Never Prescribed, Commonly Administered Valeur, Kristine Svinning Holst, Helle Allegaert, Karel Pharmaceut Med Leading Article 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 focussing on epidemiological data, excipient pharmacokinetics, or building datasets to create this knowledge. We highlight the Safe Excipient Exposure in Neonates and Small Children (SEEN) and propylene glycol project to illustrate the feasibility to build knowledge, and discuss the methods applied and problems observed during these studies. The information generated in these and other studies (European Study on Neonatal Exposure to Excipients, ESNEE) should be integrated in repositories like the Safety and Toxicity of Excipients for Paediatrics (STEP) to facilitate access to all stakeholders. This merged knowledge should have impact and assist in improving the quality of risk assessment and decision making during drug development, applying a risk-benefit framework (explicit justification of excipients, plan product development early and engage all stakeholders, data sharing and modeling, challenges related to new excipients, context sensitive risk-benefit analysis). Springer International Publishing 2018-08-10 2018 /pmc/articles/PMC6105181/ /pubmed/30174435 http://dx.doi.org/10.1007/s40290-018-0243-9 Text en © The Author(s) 2018 Open AccessThis article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 International License (http://creativecommons.org/licenses/by-nc/4.0/), which permits any noncommercial use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.
spellingShingle Leading Article
Valeur, Kristine Svinning
Holst, Helle
Allegaert, Karel
Excipients in Neonatal Medicinal Products: Never Prescribed, Commonly Administered
title Excipients in Neonatal Medicinal Products: Never Prescribed, Commonly Administered
title_full Excipients in Neonatal Medicinal Products: Never Prescribed, Commonly Administered
title_fullStr Excipients in Neonatal Medicinal Products: Never Prescribed, Commonly Administered
title_full_unstemmed Excipients in Neonatal Medicinal Products: Never Prescribed, Commonly Administered
title_short Excipients in Neonatal Medicinal Products: Never Prescribed, Commonly Administered
title_sort excipients in neonatal medicinal products: never prescribed, commonly administered
topic Leading Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6105181/
https://www.ncbi.nlm.nih.gov/pubmed/30174435
http://dx.doi.org/10.1007/s40290-018-0243-9
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