Evidence map›Paper›PMID 28271493›Full record

Trial reportThe Journal of pharmacy and pharmacology2017

Palatability of a novel oral formulation of prednisone in healthy young adults.

Shasha Bai, Nathan Dormer, Catherine Shoults, Amanda Meyer, Carol D Pierce, Kathleen A Neville, Gregory L Kearns

Open access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in The Journal of pharmacy and pharmacology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
1.1field-weighted citation impact, top 23% 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

5 citing papers in PubMed, 14 citations in OpenAlex.

  1. Trial
  2. Article
  3. Review
  4. Article
  5. Review
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

7 authors at 2 institutions in 1 country.

Shasha BaiArkansas Children's Research Institute, Little Rock, AR, USA.ORCID http://orcid.org/0000-0003-4999-327X
Nathan DormerOrbis Biosciences, Inc., Lenexa, KS, USA.
Catherine ShoultsOrbis Biosciences, Inc., Lenexa, KS, USA.
Amanda MeyerOrbis Biosciences, Inc., Lenexa, KS, USA.
Carol D PierceArkansas Children's Research Institute, Little Rock, AR, USA.
Kathleen A NevilleArkansas Children's Research Institute, Little Rock, AR, USA.
Gregory L KearnsArkansas Children's Research Institute, Little Rock, AR, USA.
Arkansas Children's Hospital · USOrbis Biosciences (United States) · US

Funding

Arkansas Center for Clinical and Translational ResearchUL1TR000039 · NCATS · UNIV OF ARKANSAS FOR MED SCIS · PI BECK, CORNELIA MARIE, JAMES, LAURA P · 2012 to 2014
$10.0M
Engineering Microparticles for Taste-Masking and Controlled Release of PediatricR44HD074326 · NICHD · ORBIS BIOSCIENCES, INC. · PI DORMER, NATHAN H · 2014 to 2015
$1.3M
Engineering Microparticles for Taste-Masking and Controlled Release of PediatricR43HD074326 · NICHD · ORBIS BIOSCIENCES, INC. · PI BERKLAND, CORY, DORMER, NATHAN H · 2012 to 2012
$216k
NCATS NIH HHS UL1 TR000039NICHD NIH HHS R43 HD074326NICHD NIH HHS R44 HD074326
6 · The paper itself

Abstract

objectivesPrednisone is a widely used anti-inflammatory for a variety of conditions. While oral liquid formulations of prednisone enable weight-based dosing, children frequently find them to be objectionable due to bitter taste. This limitation of prednisone can adversely impact patient acceptance and may result in non-compliance. Efforts to mask flavours often result in poorly controlled, heterogeneous particle distributions and can provide ineffective taste masking. The present work utilized a novel drug delivery technology developed by Orbis Biosciences, Inc., to create an oral taste-masked formulation of prednisone.

methodsThe study examined the palatability of Orbis' microsphere prednisone formulation in healthy young adults (n = 24). Four test articles were used in the study including a reference formulation (Roxanne Laboratories), a control and the test formulation (Orbis) prepared in two different ways. Study participants were randomized in a crossover design. KEY

findingsResults indicated that the test prednisone formulation was indistinguishable from the control, and both were preferable to the reference formulation in every category of palatability assessed using a validated 9-point Hedonic Scale. The data also suggested that preparing the microsphere suspension immediately before administration results in the most ideal palatability properties.

conclusionsIn conclusion, the novel microsphere formulation technology was effective in taste-masking prednisone.

Indexed as

Administration, OralAdolescentAnti-Inflammatory AgentsCross-Over StudiesDrug CompoundingFemaleFlavoring AgentsHumansMalePrednisoneSingle-Blind MethodTasteYoung AdultAnti-Inflammatory AgentsFlavoring AgentsPrednisoneimmediate releasemicrospherepalatabilityprednisonetaste-masking

Identifiers

PMID28271493
PMCPMC5360468
OpenAlexW2591603955

What OpenQuestion holds

Textmetadata
LicenceTDM
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.