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Sinus Drug Delivery by Pulsating Aerosol: Clinical Proof of Concept Studies

Moller W, Schuschnig U, Saba GK, Kruner A, Meyer G, Junge-Hulsing B, Keller M, Haussinger K.

Respiratory Drug Delivery 2010. Volume 1, 2010: 111-120.

Abstract:

There is a high incidence of chronic rhinosinusitis among European and US populations, but effective treatment remains a challenge. Since the sinuses are virtually not ventilated there has been limited success using topical drugs. In part, this is because most nasally administered aerosol drug formulations are efficiently filtered at the nasal valve and fail to reach the osteomeatal area and sinuses. Pulsating airflows generated by the PARI VibrENT were applied to the nasal cavity and sinus ventilation was studied in nine healthy human volunteers using dynamic ^81mKr-gas gamma camera imaging. Furthermore, deposition and retention of ^99mTc-DTPA radiolabeled aerosols delivered by nasal pump sprays or by pulsating aerosols from the PARI VibrENT were assessed in each volunteer over a 24-hour period.

Pulsating airflow demonstrated efficient ^81mKr-gas ventilation of the paranasal sinuses. No ^99mTc-DTPA aerosol was deposited into the sinuses using nasal pump sprays, but up to 9.5% of the nasally administered aerosol was deposited in the sinuses using pulsating airflow. In addition clearance kinetics of the ^99mTc-DTPA was reduced after pulsating aerosol delivery compared to nasal pump sprays. Our data support the hypothesis that topical drug delivery in relevant quantities to the nose and osteomeatal areas, including paranasal sinuses, is possible using pulsating airflows. Furthermore, the frequency of drug applications may be reduced due to a delayed clearance and longer residence time.