Characterization of Deposition from Nasal Spray Devices Using A Computational Fluid Dynamics Model of The Human Nasal Passages

Abstract

Many studies suggest limited effectiveness of spray devices for nasal drug delivery due primarily to high deposition and clearance at the front of the nose. Here, nasal spray behavior was studied using experimental measurements and a computational fluid dynamics model of the human nasal passages constructed from magnetic resonance imaging scans of a healthy adult male. Eighteen commercially available nasal sprays were analyzed for spray characteristics using laser diffraction, high-speed video, and high-speed spark photography. Steadystate, inspiratory airflow (15 L/min) and particle transport were simulated under measured spray conditions. Simulated deposition efficiency and spray behavior were consistent with previous experimental studies, two of which used nasal replica molds based on this nasal geometry. Deposition fractions (numbers of deposited particles divided by the number released) of 20- and 50-microm particles exceeded 90% in the anterior part of the nose for most simulated conditions. Predicted particle penetration past the nasal valve improved when (1) the smaller of two particle sizes or the lower of two spray velocities was used, (2) the simulated nozzle was positioned 1.0 rather than 0.5 or 1.5 cm into the nostril, and (3) inspiratory airflow was present rather than absent. Simulations also predicted that delaying the appearance of normal inspiratory airflow more than 1 sec after the release of particles produced results equivalent to cases in which no inspiratory airflow was present. These predictions contribute to more effective design of drug delivery devices through a better understanding of the effects of nasal airflow and spray characteristics on particle transport in the nose.

A Comparison of the Deposition Patterns of Different Nasal Spray Formulations Using a Nasal Cast

“…For example, Guo et al (2005) observed that sprays with wider plume angles had increased posterior deposition. Meanwhile, the computational simulations of Kimbell et al (2007) failed to show any effect of plume angle on deposition.…”

“…Despite the high quantitative accuracy and good spatial resolution, these imaging methods require the incorporation of radioactive tracers into the formulation and their execution in a clinical trial. An alternative approach is to use computational fluid dynamics to simulate the particle transport and deposition in an anatomically accurate, three-dimensional computer model of the human nasal passages (Kimbell et al 2007;Inthavong et al 2011). However, the requirement of high computational power and the high complexity of the model construction limit its application in practice.…”

Nasal-nanotechnology: revolution for efficient therapeutics delivery

“…A considerable amount of nasally administered dose is deposited on the anterior portion reinforced by skin, which is recognized as a poor site for topical as well as for systemic drugs (Duchateau, 1987;Kimbell et al, 2007;Hughes et al, 2008;Kundoor & Dalby, 2010). The deposition of topical steroids at these sites leads to common adverse effects in the form of irritation, bleeding and crusting.…”

Caracterização físico-química de sistemas coloidais em sprays nasais

“…Para avaliar a eficiência de deposição das gotículas do spray nasal na cavidade nasal, é importante determinar a distribuição de tamanho de gotículas durante a atomização, pois o tamanho das gotículas está relacionado ao impacto inercial destas na mucosa nasal (INTHAVONG et al, 2014), e quanto menor o tamanho da gotícula, melhor a penetração intra-nasal e maior a deposição na mucosa nasal (KIMBELL et al, 2007), porém gotículas menores que 10µm, podem não ter suficiente impacto inercial (SUMAN, 2013), e atravessar a via nasal se alocando nas vias aéreas (KUNDOOR; DALBY, 2011).…”

“…Quanto menor o ângulo, maior a penetração intra-nasal, e maior a deposição na mucosa nasal (KIMBELL et al, 2007).…”