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PMID: 42797303 Published · epublish English Journal Article Review

Human Factors and Device Engineering in OTC Intranasal Drug Delivery: GentleMist Technology™.

Pharmaceutics ·Vol. 18 ·No. 9 ·2026-09-08

Alas-Pineda C, Pavón-Varela DJ, Gaitán-Zambrano K, Coto-Tejeda C, Medina-Mejía J, Andrews Interiano N, Ferrer G

Abstract

Intranasal drug delivery is noninvasive, rapid-acting, and well suited to self-administration, yet the real-world performance of nasal sprays depends on the interaction among formulation, device mechanics, nasal anatomy, and user technique rather than on the active ingredient alone. This narrative review examines how aerosol science, regional targeting, and human factors jointly shape intranasal performance, using GentleMist Technology™ as a representative example of emerging device-centered development. Computational fluid dynamics (CFD) and anatomically informed in vitro models indicate that device geometry, plume characteristics, and administration angle can significantly alter where a dose is deposited, while human factors research identifies priming, positioning, and angulation as key determinants of successful over-the-counter (OTC) use. We summarize early feasibility data suggesting that angle-optimized administration may increase posterior nasopharyngeal delivery and that essential tasks are feasible for lay users, with priming emerging as a specific usability vulnerability. We also review preliminary clinical evidence on a chlorpheniramine maleate (CPM)-based intranasal formulation in allergic rhinitis and viral upper respiratory illness. Although the strongest device-specific findings remain preliminary and require independent replication, they support an emerging shift from a formulation-centered model toward an integrated device-formulation-user paradigm.

Keywords
computational fluid dynamics drug–device combination human factors engineering intranasal drug delivery nasal biopharmaceutics nasal spray over-the-counter drug products regional deposition
作者与单位
共 7 位作者,点击展开单位 / ORCID
Alas-Pineda César ORCID
Department of Research and Development, Moxie Health Group, Hallandale Beach, FL 33009, USA.
Pavón-Varela Dennis J ORCID
Department of Research and Development, Moxie Health Group, Hallandale Beach, FL 33009, USA.
Gaitán-Zambrano Kristhel ORCID
Department of Research and Development, Moxie Health Group, Hallandale Beach, FL 33009, USA.
Coto-Tejeda Carlos ORCID
Department of Research and Development, Moxie Health Group, Hallandale Beach, FL 33009, USA.
Medina-Mejía Jhacely ORCID
Department of Research and Development, Moxie Health Group, Hallandale Beach, FL 33009, USA.
Andrews Interiano Nelly ORCID
Department of Research and Development, Moxie Health Group, Hallandale Beach, FL 33009, USA.
Ferrer Gustavo ORCID
Department of Pulmonary and Critical Care Medicine, Aventura Hospital and Medical Center, Aventura, FL 33180, USA.
Article Info
Journal
Pharmaceutics
Abbr.
Pharmaceutics
ISSN
1999-4923
Published
2026-09-08
电子出版
2026-00-08
Language
English
Country/Region
Switzerland
NLM ID
101534003
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