ArticlePharmaceutical medicine2018
Excipients in Neonatal Medicinal Products: Never Prescribed, Commonly Administered.
Article in Pharmaceutical medicine, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers, 1 of them a synthesis that pooled it.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
22 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Opioid treatment for opioid withdrawal in newborn infants.The Cochrane database of systematic reviews · 2021Pooled it
- Optimising Formulations for Paediatric Patients with Inherited Metabolic Disorders: The Case Study of Levocarnitine.Pharmaceutical medicine · 2026Review
- Treatment considerations for the management of neonatal onset seizures.The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG · 2025Article
- Weighing up the evidence on ethanol excipient use in common neonatal medications.Pediatric research · 2025Article
- Pediatric Pharmacy Association 2025 KIDs List of Key Potentially Inappropriate Drugs in Pediatrics.The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG · 2025Article
- Personalized Neonatal Therapy: Application of Magistral Formulas in Therapeutic Orphan Populations.Pharmaceutics · 2025Review
- Potentially Harmful Excipients: State of the Art for Oral Liquid Forms Used in Neonatology and Pediatrics Units.Pharmaceutics · 2024Article
- Evaluation of the type and frequency of extemporaneous formulations dispensed in hospital and community pharmacies.Exploratory research in clinical and social pharmacy · 2023Article
- c4c: Paediatric pharmacovigilance: Methodological considerations in research and development of medicines for children - A c4c expert group white paper.British journal of clinical pharmacology · 2022Review
- The Current States, Challenges, Ongoing Efforts, and Future Perspectives of Pharmaceutical Excipients in Pediatric Patients in Each Country and Region.Children (Basel, Switzerland) · 2022Review
- Assessing the Appropriateness of Formulations on the WHO Model List of Essential Medicines for Children: Development of a Paediatric Quality Target Product Profile Tool.Pharmaceutics · 2022Article
- Mini-Tablets: A Valid Strategy to Combine Efficacy and Safety in Pediatrics.Pharmaceuticals (Basel, Switzerland) · 2022Review
- Drug Safety in Translational Paediatric Research: Practical Points to Consider for Paediatric Safety Profiling and Protocol Development: A Scoping Review.Pharmaceutics · 2021Article
- Article
- Excipients in the Paediatric Population: A Review.Pharmaceutics · 2021Review
- Comment on: "Excipients in Neonatal Medicinal Products: Never Prescribed, Commonly Administered".Pharmaceutical medicine · 2020Article
- Authors' Reply to Santos et al.: "Excipients in Neonatal Medicinal Products: Never Prescribed, Commonly Administered".Pharmaceutical medicine · 2020Article
- Scientific considerations for global drug development.Science translational medicine · 2020Review
- Benefits and Prerequisites Associated with the Adoption of Oral 3D-Printed Medicines for Pediatric Patients: A Focus Group Study among Healthcare Professionals.Pharmaceutics · 2020Article
- A Focus Group Study about Oral Drug Administration Practices at Hospital Wards-Aspects to Consider in Drug Development of Age-Appropriate Formulations for Children.Pharmaceutics · 2020Article
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3 authors.
Funding
No grant is acknowledged in the PubMed record.
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 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).
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.