Evidence map›Paper›PMID 31159216›Full record

ReviewInternational journal of molecular sciences2019

Making Medicines Baby Size: The Challenges in Bridging the Formulation Gap in Neonatal Medicine.

Fiona O'Brien, David Clapham, Kamelia Krysiak, Hannah Batchelor, Peter Field, Grazia Caivano, Marisa Pertile, Anthony Nunn, Catherine Tuleu

Abstract readReview
In one paragraph

Review in International journal of molecular sciences, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 28 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
28citing papers in PubMed, 2 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

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.

3 · Its place in the literature

Who cites it

28 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Systemic opioid regimens for postoperative pain in neonates.The Cochrane database of systematic reviews · 2023
    Pooled it
  2. Systemic opioid regimens for postoperative pain in neonates.The Cochrane database of systematic reviews · 2023
    Pooled it
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  13. Observational
  14. Review
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  17. Stability Study of a Compounded Sublingual Buprenorphine Solution for Neonatal Opioid Withdrawal Syndrome.The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG · 2023
    Article
  18. Article
  19. Review
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Fiona O'BrienSchool of Pharmacy, Royal College of Surgeons in Ireland, 111 St Stephens Green Dublin 2, Ireland. fionaobrien@rcsi.ie.
David Clapham14 Tailors, Bishops Stortford CM23 4FQ, UK. david.clapham@ntlworld.com.
Kamelia KrysiakSchool of Pharmacy, Royal College of Surgeons in Ireland, 111 St Stephens Green Dublin 2, Ireland. kameliakrysiak@rcsi.ie.ORCID 0000-0003-4439-0947
Hannah BatchelorCollege of Medical and Dental Sciences, Institute of Clinical Sciences, University of Birmingham, Birmingham B15 2TT, UK. H.K.Batchelor@bham.ac.uk.
Peter FieldUniversity College London School of Pharmacy, 29-39 Brunswick Square, London WC1N 1AX, UK. peter.field@ucl.ac.uk.
Grazia CaivanoChiesi Farmaceutici S.p.A. Largo Francesco Belloli 11/A-43122 Parma, Italy. g.caivano@chiesi.com.
Marisa PertileChiesi Farmaceutici S.p.A. Largo Francesco Belloli 11/A-43122 Parma, Italy. m.pertile@chiesi.com.ORCID 0000-0001-7736-6009
Anthony NunnDepartment of Women's and Children's Health, University of Liverpool, Liverpool Women's Hospital, Liverpool L8 7SS, UK. a.j.nunn@liverpool.ac.uk.
Catherine TuleuUniversity College London School of Pharmacy, 29-39 Brunswick Square, London WC1N 1AX, UK. c.tuleu@ucl.ac.uk.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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.

Indexed as

Precision MedicineAge FactorsChemistry, PharmaceuticalDrug Administration RoutesDrug CompoundingDrug StabilityHumansInfant, NewbornPharmaceutical PreparationsPharmaceutical Preparationsadministrationbiopharmaceuticsdevicedosage formexcipientformulationformulation developmentinhaledintra nasalmedication errorneonatesNICUoralparenteralproduct developmenttopical

Identifiers

PMID31159216
PMCPMC6600135

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.