Tesch, M.L.; Malakar, A.; Rizvi, S.A.; Akash, M.M.H.; Ferrer, G.; Basu, S. Enhancing Intranasal Therapeutic Penetration for Treating Respiratory Illness: A Clinical Human Factor Feasibility Study. Preprints2023, 2023121002. https://doi.org/10.20944/preprints202312.1002.v1
APA Style
Tesch, M.L., Malakar, A., Rizvi, S.A., Akash, M.M.H., Ferrer, G., & Basu, S. (2023). Enhancing Intranasal Therapeutic Penetration for Treating Respiratory Illness: A Clinical Human Factor Feasibility Study. Preprints. https://doi.org/10.20944/preprints202312.1002.v1
Chicago/Turabian Style
Tesch, M.L., Gustavo Ferrer and Saikat Basu. 2023 "Enhancing Intranasal Therapeutic Penetration for Treating Respiratory Illness: A Clinical Human Factor Feasibility Study" Preprints. https://doi.org/10.20944/preprints202312.1002.v1
Abstract
Delivery of drugs through the nasal route provides an alternative, yet highly efficacious modality for administering both large and small pharmaceutic molecules. This method proves particularly advantageous for drugs that are unstable during oral administration, as they undergo significant degradation in the gastrointestinal tract or metabolization through the first-pass effect in the liver. Nasal administration stands as a viable alternative to parenteral therapy and is also suitable for long-term medical management. The nasal mucosa, characterized by high vascularity and permeability, facilitates rapid pharmaceutical absorption, ensuring a swift onset of therapeutic action. Despite its noninvasive nature, the nasal delivery technique finds broad applicability for both local treatment and systemic therapy, as the drug directly enters systemic circulation. This article explores the feasibility of a novel spray delivery mechanism for intranasal drug deposition. The study aims to determine whether users can correctly follow the state-of-the-art application instructions for a nasal spray with an optimal nozzle placement angle (namely, 12-15°) at the nostril while maintaining sufficient safety and efficacy, and without engaging in preventable usage errors that could harm the user. Additionally, the study evaluates the effectiveness of device labeling, instructions for use, and a short video in supporting the correct application of the nasal spray at the optimal angle (12-15°) and assesses whether users can differentiate the product from others with similar appearances. We have also performed physical spray tests to experimentally evaluate drug penetration to the nasopharynx (a key target site for viral infections) for two different nozzle placements – one for current package instructions coming with over-the-counter spray products and the other for the optimal spray usage procedure to enhance targeted drug delivery. Human Factors (HF) validation studies were also conducted, instructing users to follow the application instructions of the nasal spray bottle with the nozzle placed at the optimal angle to target the nasopharynx. The experimental tests consistently confirmed improved penetration with the 12-15° nozzle placement, with visual cues proving effective when used in tandem with written instructions for guiding the study participants to adhere to the recommended usage procedures.
Keywords
intranasal spray; drug delivery; respiratory transport modeling; respiratory diseases; upper airway physiology; targeted nasal therapy; gentlemistTM technology
Subject
Medicine and Pharmacology, Pulmonary and Respiratory Medicine
Copyright:
This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
