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In Vitro Comparison of Local Nasal Vaccine Delivery and Correlation with Device Spray Performance.

Lillian Li¹, John V Wilkins², Amir R Esmaeili²

¹Vaccine CMC Development & Supply, Sanofi, Toronto, Room 121, Building 95, Sanofi, 1755 Steeles Avenue West, Toronto, ON, M2R 3T4, USA. lillian.li@Sanofi.com.

Pharmaceutical Research

|December 19, 2022

Summary

This study evaluated intranasal vaccine delivery devices for infants, finding they consistently achieved over 80% delivery efficiency to nasal airways. Spray characteristics and nozzle distance significantly impacted vaccine deposition in infant nasal models.

Keywords:

infant nasal model intranasal device regional deposition spray performance vaccine delivery efficiency

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Area of Science:

Pharmaceutical Sciences
Biomedical Engineering
Pediatric Medicine

Background:

Intranasal vaccine delivery offers a needle-free alternative for infants.
Optimizing intranasal device performance is crucial for effective pediatric vaccination.
Understanding deposition patterns in infant nasal airways is essential for vaccine efficacy.

Purpose of the Study:

To investigate the correlation between spray characteristics and local deposition efficiency of a vaccine candidate in infant nasal airways.
To evaluate the performance of various intranasal delivery devices in a pediatric context.
To establish the first in vitro investigation of vaccine delivery in infants under 24 months.

Main Methods:

Developed in vitro tests to measure spray characteristics of four intranasal devices.
Assessed regional delivery of a vaccine formulation in five infant nasal airway replicas (3-24 months).
Correlated spray performance, geometric parameters, and delivery efficiency.

Main Results:

All four devices demonstrated consistent spray characteristics and high delivery efficiency (>80%) to target areas.
Delivery efficiency was influenced by droplet size distribution and nozzle tip-to-nasal valve distance.
Established correlations between spray performance and in vitro local dose deposition.

Conclusions:

Infant nasal models complement device spray performance evaluation.
In vitro infant nasal models can aid new product development by estimating delivery efficiency.
These findings facilitate the development of effective intranasal vaccine delivery systems for infants.