Nasal cast deposition for xylo- and oxymetazoline formulations using two different nasal pumps

Abstract

Background: Allergic rhinitis, rhinosinusitis, and upper respiratory tract infections, including the common cold, are caused by inflammation of nasal cavity areas. A key symptom is nasal congestion, which can be relieved with nasal spray medications. A key goal in developing a nasal spray medication delivery device for the relief of nasal congestion is delivering a fine mist to the inflamed areas while providing user comfort and convenience. Methodology: Using a Koken nasal cast model, we studied the deposition patterns of 2 xylometazoline and 1 oxymetazoline for- mulations with 2 different nasal pumps, the currently marketed Freepod and the investigational laterally actuated device. Effects of nasal tip orientation and breathing were investigated. Additionally, the degree of xylometazoline and oxymetazoline dripping down the back of the cast was assessed. Results: The largest coverage overall was observed with the xylometazoline formulation with the laterally actuated pump and without breath simulation. The laterally actuated pump used at a 30° angle resulted in deposition to the inferior, middle, and superior turbinates of the nasal cast, with less variability than the Freepod. Drippage at the back of the cast was observed with the Freepod device but not with the laterally actuated device. Conclusions: Using a nasal cast model, the laterally actuated pump used at a 30° angle produced a full mist covering areas inflamed with the common cold, allergic rhinitis, and rhinosinusitis with no dripping at the back of the cast, an improvement compared with the Freepod pump. In vivo studies are needed to confirm nasal cast results.