Clinical potential of pulsating aerosol for sinus drug delivery.

There is a high incidence of nasal disorders including chronic rhinosinusitis (CRS), affecting ∼ 14% of the total population. However, a topical treatment regimen shows only modest efficacy, and drug delivery to the posterior nose, osteomeatal area, and paranasal sinuses is still a challenge. Therefore, the primary treatment option of CRS is functional endonasal sinus surgery (FESS). Most nasally administered aerosolized drugs are efficiently filtered by the nasal valve and do not reach the sinuses, the site of chronic inflammation. Sinus ventilation, nasal and paranasal aerosol deposition can be achieved by using a pulsating airflow, offering new topical treatment options for nasal disorders. Inhalation studies in nasal casts and in healthy volunteers have shown up to 8% of the nasally deposited drug within the sinuses, which could not be achieved using nasal pump sprays. In addition, compared with nasal pump sprays, retention kinetics of the radiolabel deposit in the nose was prolonged by about a factor of five. With this efficiency, topical aerosol therapies of sinus disorders can be achieved and, owing to the prolonged retention, reduced application modes are possible. This offers new treatment options of sinus-nasal disorders in comparison with or after FESS.