Evidence map›Paper›PMID 41840267›Full record

ArticlePharmaceutical research2026

Regional Nasal Drug Deposition in Pediatric vs. Adult Models: In vitro Insights into User Technique and Breathing Patterns Sensitivity.

Mohammad Hejazi, Xiomara Owen, David J Edwards, Michael Hindle, Worth Longest, Theodore Schuman, Ross Walenga, Steven Chopski, Anubhav Kaviratna, Bryan Newman and 1 more

Abstract readComparative Study
PubMed Full text at PMC Publisher
In one paragraph

Article in Pharmaceutical research, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–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

2 citing papers in PubMed.

  1. Review
  2. Article
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

11 authors.

Mohammad HejaziDepartment of Mechanical and Nuclear Engineering, Virginia Commonwealth University, Room 4326, 401 W Main St, Richmond, VA, 23220, USA.ORCID http://orcid.org/0009-0000-2818-5199
Xiomara OwenDepartment of Mechanical and Nuclear Engineering, Virginia Commonwealth University, Room 4326, 401 W Main St, Richmond, VA, 23220, USA.ORCID http://orcid.org/0009-0000-1273-2952
David J EdwardsDepartment of Statistical Sciences and Operations Research, Virginia Commonwealth University, Richmond, VA, USA.ORCID http://orcid.org/0009-0005-5754-648X
Michael HindleDepartment of Pharmaceutics, Virginia Commonwealth University, Richmond, VA, USA.ORCID http://orcid.org/0000-0002-1025-1183
Worth LongestDepartment of Mechanical and Nuclear Engineering, Virginia Commonwealth University, Room 4326, 401 W Main St, Richmond, VA, 23220, USA.ORCID http://orcid.org/0000-0003-4939-5691
Theodore SchumanDepartment of Otolaryngology - Head and Neck Surgery, VCU Health, Richmond, VA, USA.ORCID http://orcid.org/0000-0001-8325-5700
Ross WalengaDivision of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.ORCID http://orcid.org/0000-0003-3261-4245
Steven ChopskiDivision of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.ORCID http://orcid.org/0000-0001-6442-9787
Anubhav KaviratnaDivision of Therapeutic Performance I, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.ORCID http://orcid.org/0000-0003-1921-5506
Bryan NewmanDivision of Therapeutic Performance I, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.ORCID http://orcid.org/0000-0002-8259-9277
Laleh GolshahiDepartment of Mechanical and Nuclear Engineering, Virginia Commonwealth University, Room 4326, 401 W Main St, Richmond, VA, 23220, USA. lgolshahi@vcu.edu.ORCID http://orcid.org/0000-0003-3450-7160

Funding

Intramural FDA HHS FD999999U.S. Food and Drug Administration 75F40120C00172U.S. Food and Drug Administration HHSF223201810144C
6 · The paper itself

Abstract

purposeAlthough in vitro studies recommended for establishing bioequivalence of locally acting nasal suspension products provide useful information regarding product performance, currently they are not designed to fully account for variability introduced by patient-specific factors such as administration technique and breathing patterns. This limitation, combined with ethical and practical challenges in conducting pediatric clinical trials, creates a knowledge gap in understanding age-related differences in nasal drug delivery.

methodsAnatomically realistic in vitro nasal models representing an average child and adult, in terms of total drug delivery to the sites of intended action posterior to nasal valve, were used to investigate the sensitivity of regional nasal drug deposition to variations in administration parameters and breathing conditions. Three breathing conditions were evaluated: breath hold, gentle sniffing, and vigorous sniffing. Administration parameters were varied using a Box-Behnken experimental design.

resultsResults showed that for commercially available nasal sprays, breathing patterns did not significantly affect drug delivery in the adult model, but extreme conditions (no breathing vs. vigorous sniffing) caused significant differences in anterior deposition in the child model. Differences between gentle sniffing and the other conditions were not statistically significant. The sensitivity analysis revealed that in vitro drug deposition patterns differ between child and adult nasal cavities under identical user parameter variations, and variable importance differed across nasal cavity regions.

conclusionsThis study demonstrates the potential for targeted drug delivery by enabling the identification of the optimal administration parameters to achieve desired outcomes, such as enhanced drug deposition in specific nasal regions.

Indexed as

Nasal CavityRespirationAdministration, IntranasalAdultAge FactorsChildDrug Delivery SystemsHumansModels, AnatomicModels, BiologicalNasal SpraysNasal Spraysnasal sprays administration parameterspredictive modelregional in vitro drug depositionresponse surface methodologytargeted intranasal drug delivery

Identifiers

PMID41840267
PMCPMC13092986

What OpenQuestion holds

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LicenceCC BY
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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.