Automated Actuator for Evaluation of Regional Droplet Deposition from Nasal Spray Devices in Nasal Airway Replicas

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The requested funds will support a new research program to expand our department’s internationally-recognized capabilities in the assessment of pharmaceutical aerosol delivery devices to include testing of devices designed to administer drugs directly to the nasal airways. Nasal drug delivery is widespread in the treatment of allergic rhinitis, a condition affecting approximately 1 in 5 Canadians. Local delivery of corticosteroids to the nasal airways by means of nasal spray pumps is a mainstay in the treatment of rhinitis. In addition, several classes of marketed products have been developed for systemic drug delivery through the nose. Rapid and direct absorption of drug through the nasal epithelium to the systemic circulation enables fast onset of action; fittingly, marketed products in this category include those intended to treat migraine headaches and break-through cancer pain. Finally, intranasal drug delivery has received considerable recent attention as a route of administration through which to bypass the blood-brain-barrier and directly target the brain, thus potentially offering novel treatment options for central nervous system diseases such as Alzheimer’s and Parkinson’s. For all these applications, a critical consideration is the deposition pattern of spray droplets within the nasal airways. Droplets collected in the anterior nasal passages may drip from the nostrils, whereas droplets passing through the nasal cavity to the nasopharynx and larynx miss their site of action, or worse may reach the lungs where adverse side-effects can occur. Despite decades of use, standard mechanical nasal spray pumps suffer inefficiencies in delivery. Competing new devices aim to improve nasal drug delivery through optimization of drug deposition and retention in the nasal airways. Unfortunately, rigorously developed in vitro benchtop methods do not presently exist for predicting in vivo deposition of drugs delivered intranasally. As a result, researchers and developers rely on in vivo studies employing gamma scintigraphy to assess regional and total nasal deposition of radiolabeled drug products. The cost and time requirements associated with conducting in vivo studies preclude their use in the early stages of nasal drug product development, where they would provide invaluable feedback to developers. Accordingly, a clear need exists to develop predictive in vitro test methods through which to provide rapid feedback on anticipated regional deposition patterns, thereby expediting early product development. We are developing test methods incorporating realistic and idealized nasal airway geometries to address this need. The instrumentation to be purchased with the requested funds, namely an automated actuator that permits repeatable and controllable actuation of nasal spray delivery devices, is a critical element to be incorporated into these methods.