Evidence map›Paper›PMID 28856931›Full record

Trial reportDrug delivery2017

Acceptability of orodispersible films for delivery of medicines to infants and preschool children.

Mine Orlu, Sejal R Ranmal, Yucheng Sheng, Catherine Tuleu, Paul Seddon

Open access · goldAbstract readClinical Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Drug delivery, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 30 papers.

0numbers the graph read from it
0cells of the map it votes in
30citing papers in PubMed
8.1field-weighted citation impact, top 3% of its field
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

30 citing papers in PubMed, 80 citations in OpenAlex.

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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

5 authors at 2 institutions in 1 country.

Mine Orlua Department of Pharmaceutics, School of Pharmacy , University College London , London , UK.ORCID http://orcid.org/0000-0002-2047-5025
Sejal R Ranmala Department of Pharmaceutics, School of Pharmacy , University College London , London , UK.
Yucheng Shenga Department of Pharmaceutics, School of Pharmacy , University College London , London , UK.
Catherine Tuleua Department of Pharmaceutics, School of Pharmacy , University College London , London , UK.ORCID http://orcid.org/0000-0001-8384-357X
Paul Seddonb Royal Alexandra Children's Hospital , Sussex , UK.
University College London · GBRoyal Alexandra Children's Hospital · GB

Funding

Department of Health PB-PG-1111-26104
6 · The paper itself

Abstract

Orodispersible films (ODFs) possess potential to facilitate oral drug delivery to children; however, documentation of their acceptability in this age group is lacking. This study is the first to explore the initial perceptions, acceptability and ease of use of ODFs for infants and preschool children, and their caregivers through observed administration of the type of dosage form. Placebo ODFs were administered to children stratified into aged 6 to 12 months, 1 year, 2 years, 3 years, 4 years and 5 years old and into those with an acute illness or long-term stable condition in hospital setting. Acceptability of the dosage form and end-user views were assessed by (a) direct observation of administration, (b) questionnaires to caregivers and nurses, and (c) age-adapted questionnaires for children aged 3 years and over. The majority of children (78%) aged 3 years and over gave the ODF a positive rating both on verbal and non-verbal scales. Despite little prior experience, 78% of caregivers expressed positive opinion about ODFs before administration. After the ODFs were taken, 79% of infant caregivers and 86% caregivers of preschool children positively rated their child's acceptance of the ODF. The intraclass correlation coefficient value was 0.92 showing good agreement between ratings of caregivers and nurses. ODFs showed a high degree of acceptability among young children and their caregivers. If drug loading permits, pharmaceutical companies should consider developing pediatric medicines in this format. The methodology described here is useful in assessing the acceptability of active ODF preparations and other dosage forms to children.

Indexed as

Drug Delivery SystemsChild, PreschoolHumansInfantPharmaceutical PreparationsPharmaceutical Preparationsinfantmedicine acceptabilityorodispersible filmPaediatric drug deliveryquestionnaire

Identifiers

PMID28856931
PMCPMC8241014
OpenAlexW2752598143

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.