Evidence map›Paper›PMID 38465519›Full record

ArticleClinical and translational science2024

Clinical pharmacokinetics of atropine oral gel formulation in healthy volunteers.

Madison Parrot, Bhuvanesh Yathavan, Olga Averin, Logan Hoggard, Joseph E Rower, Michael Voight, Danielle Greene, Ariel Tarrell, Aviva Whelan, Hamidreza Ghandehari and 2 more

Erratum issuedOpen access · goldAbstract read
In one paragraph

Article in Clinical and translational science, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
1.8field-weighted citation impact, top 15% 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

4 citing papers in PubMed, 5 citations in OpenAlex.

  1. Article
  2. Article
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  4. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

12 authors at 3 institutions in 1 country.

Madison ParrotDivision of Clinical Pharmacology, Department of Pediatrics, Spencer Fox Eccles School of Medicine, University of Utah, Salt Lake City, Utah, USA.
Bhuvanesh YathavanDepartment of Molecular Pharmaceutics, Utah Center for Nanomedicine, College of Pharmacy, University of Utah, Salt Lake City, Utah, USA.
Olga AverinDepartment of Pharmacology and Toxicology and Center for Human Toxicology, University of Utah, Salt Lake City, Utah, USA.
Logan HoggardDepartment of Pharmacology and Toxicology and Center for Human Toxicology, University of Utah, Salt Lake City, Utah, USA.
Joseph E RowerDepartment of Pharmacology and Toxicology and Center for Human Toxicology, University of Utah, Salt Lake City, Utah, USA.ORCID 0000-0003-3629-7902
Michael VoightInvestigational Drug Service, Pharmacy Services, University of Utah Hospital, Salt Lake City, Utah, USA.
Danielle GreeneDivision of Clinical Pharmacology, Department of Pediatrics, Spencer Fox Eccles School of Medicine, University of Utah, Salt Lake City, Utah, USA.
Ariel TarrellDivision of Clinical Pharmacology, Department of Pediatrics, Spencer Fox Eccles School of Medicine, University of Utah, Salt Lake City, Utah, USA.
Aviva WhelanDivision of Clinical Pharmacology, Department of Pediatrics, Spencer Fox Eccles School of Medicine, University of Utah, Salt Lake City, Utah, USA.
Hamidreza GhandehariDepartment of Molecular Pharmaceutics, Utah Center for Nanomedicine, College of Pharmacy, University of Utah, Salt Lake City, Utah, USA.
Nancy MurphyDivision of Complex Care, Department of Pediatrics, University of Utah Health, Salt Lake City, Utah, USA.
Venkata YellepeddiDivision of Clinical Pharmacology, Department of Pediatrics, Spencer Fox Eccles School of Medicine, University of Utah, Salt Lake City, Utah, USA.ORCID 0000-0003-3819-9054
University of Utah · USUniversity of Utah Health Care · USUniversity of Utah Hospital · US

Funding

Utah Center for Clinical and Translational ScienceUL1TR002538 · NCATS · UNIVERSITY OF UTAH · PI HESS, RACHEL, MAJERSIK, JENNIFER JUHL · 2018 to 2022
$26.0M
CTSA UM1 Program at University of UtahUM1TR004409 · NCATS · UTAH STATE HIGHER EDUCATION SYSTEM--UNIVERSITY OF UTAH · PI RACHEL HESS, Jennifer Juhl Majersik · 2023 to 2026
$21.9M
Multidisciplinary Pulmonary and Critical Care Training ProgramT32HL105321 · NHLBI · UTAH STATE HIGHER EDUCATION SYSTEM--UNIVERSITY OF UTAH · PI Ramsey Hachem, Robert Paine · 2010 to 2026
$4.5M
NCATS NIH HHS UL1 TR002538NCATS NIH HHS UM1 TR004409NHLBI NIH HHS T32 HL105321
6 · The paper itself

Abstract

Sialorrhea or drooling is a common problem in children and adults with neurodevelopmental disorders. It can negatively impact the quality of life due to its physical and psychological manifestations. Providers commonly prescribe atropine eye drops for topical administration to the oral mucosa, as an off-label treatment to manage sialorrhea. However, the off-label use of atropine eye drops can be associated with medication and dosing errors and systemic side effects. To address these limitations of treatment, we developed a mucoadhesive topical oral gel formulation of atropine as an alternative route to off-label administration of atropine eye drops. In this clinical pharmacokinetic (PK) study, we evaluated the safety and PK of atropine gel (0.01% w/w) formulation after single-dose administration to the oral mucosa in 10 healthy volunteers. The PK data showed that after topical administration to the oral mucosa, atropine followed a two-compartment PK profile. The maximum plasma concentration and area under the curve extrapolated to infinite time were 0.14 ng/mL and 0.74 h·ng·mL

Indexed as

Quality of LifeSialorrheaAdministration, OralAdultArea Under CurveAtropine DerivativesChildHealthy VolunteersHumansOphthalmic SolutionsAtropine DerivativesOphthalmic Solutions

Identifiers

PMID38465519
PMCPMC10926053
OpenAlexW4392654558

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.