ArticleWorld journal of clinical pediatrics2013
Neonates need tailored drug formulations.
Article in World journal of clinical pediatrics, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02545712 (Safe Excipient Exposure in Neonates and Small ChildreN - a Retrospective, Descriptive Study Off the Amount of Ethanol, Propylene Glycol, Benzyl Alcohol, Parabens, Acesulfam k, Aspartame, Glycerol, Sorbitol and Polysorbate-80 Exposed to Pediatric Patients), which is not on this map. Cited by 7 papers.
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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.
Safe Excipient Exposure in Neonates and Small ChildreN - a Retrospective, Descriptive Study Off the Amount of Ethanol, Propylene Glycol, Benzyl Alcohol, Parabens, Acesulfam k, Aspartame, Glycerol, Sorbitol and Polysorbate-80 Exposed to Pediatric Patients
Who cites it
7 citing papers in PubMed, 15 citations in OpenAlex.
- Reply to Garnemark et al. The Swedish National Formulary for Children ePed. Comment on "Shaniv et al. A Callout for International Collaboration. Reply to Giger, E.V.; Tilen, R. Comment on "Shaniv et al. Neonatal Drug Formularies-A Global Scope.Children (Basel, Switzerland) · 2024Article
- An Update on Pharmaceutical Strategies for Oral Delivery of Therapeutic Peptides and Proteins in Adults and Pediatrics.Children (Basel, Switzerland) · 2020Review
- Say no to drugs: wait and watch strategy for medications used in the neonatal intensive care unit (NICU).World journal of pediatrics : WJP · 2020Review
- Safety and Biopharmaceutical Challenges of Excipients in Off-Label Pediatric Formulations.International journal of general medicine · 2020Review
- Article
- Safe and effective pharmacotherapy in infants and preschool children: importance of formulation aspects.Archives of disease in childhood · 2016Review
- Pharmacokinetics of nanotechnology-based formulations in pediatric populations.Advanced drug delivery reviewsReview
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
1 author at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Drugs are very strong tools used to improve outcome in neonates. Despite this fact and in contrast to tailored perfusion equipment, incubators or ventilators for neonates, we still commonly use drug formulations initially developed for adults. We would like to make the point that drug formulations given to neonates need to be tailored for this age group. Besides the obvious need to search for active compounds that take the pathophysiology of the newborn into account, this includes the dosage and formulation. The dosage or concentration should facilitate the administration of low amounts and be flexible since clearance is lower in neonates with additional extensive between-individual variability. Formulations need to be tailored for dosage variability in the low ranges and also to the clinical characteristics of neonates. A specific focus of interest during neonatal drug development therefore is a need to quantify and limit excipient exposure based on the available knowledge of their safety or toxicity. Until such tailored vials and formulations become available, compounding practices for drug formulations in neonates should be evaluated to guarantee the correct dosing, product stability and safety.
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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.