A novel device for delivery of intranasal particulate medication: a pilot study

Authors


  • Potential conflict of interest: Trimel Pharmaceuticals Corporation provided financial remuneration to the study volunteers for their time, and provided the devices and lactose to conduct the experiment. NT is an employee of Trimel and assisted with device development but was not involved in study design or data analysis. SK and BR have no financial conflict of interest with Trimel and did not receive any compensation from Trimel for their work on this study.

  • Presented as a poster at the 2013 Spring Meeting of the American Rhinological Society (ARS), on April 13, 2013, Orlando, FL.

Abstract

Background

Intranasal medication delivery for allergic rhinitis (AR) is considered a mainstay of therapy but is hampered by poor compliance. Among reasons given are unpleasant sensations associated with spray penetration into the pharynx. Our objective was to study a novel method of particle delivery to the nose that would abrogate these issues.

Methods

This was a double-blind, randomized study. Subjects who met study criteria underwent intranasal particle delivery using a novel device (Trivair Nasal Deposition System; Trimel Pharmaceuticals, Toronto, Canada) that delivered anhydrous lactose particles into the nose via a transoral air puff (thus elevating soft palate and blocking the nasopharynx). Subjects had nostrils randomized into 4 groups (particle sizes 5 μm and 50 μm × doses 12.5 mg and 25 mg). Particle deposition was assessed at 1 minute, 10 minutes, and 30 minutes on the inferior turbinate, middle turbinate, and nasopharynx, respectively, using high-definition endoscopic photography. Each image was compared using an expert blinded 2-person panel for percentage particles remaining. Nonparametric data was assessed using the Wilcoxon signed-rank test via Strata software.

Results

Twelve nostrils in total met study criteria. The results showed no difference in effectiveness of nasal particle retention between the groups based on particle size or dose. No particles entered the nasopharynx or oropharynx.

Conclusion

This study provides proof-of-principle data that the Trivair Nasal Deposition System is effective at retaining medication in the nose without pharyngeal penetration. Larger studies on this device are warranted.

Ancillary