Investigating the Impact of Device Positioning on the Nasal Regional Deposition  

Gonçalo Farias, Manon Sautreuil, Charles Cazzola, Gerallt Williams & Julie Suman

Aptar Pharma, Route des Falaises, Le Vaudreuil, 27100, France

Summary

Novel therapeutic applications are currently being considered for nasal drug delivery. To optimise nasal drug products, the targeted regional deposition has become a key factor in product development. For this purpose realistic in vitro nasal cast models have been developed. Likewise, human factors are becoming increasingly important in the development of drug-device combination products with aspects such as device insertion angle/depth and their impact in regional deposition in the sites of absorption, and whether these pose concerns for efficacy and safety if performed incorrectly or not at all, requiring careful consideration.

The impact of the position of a customised unit dose nasal product in the nasal regional deposition, by varying the insertion angle and depth, was evaluated on a validated male nasal cast model (Aeronose™). During this study, a significant impact of both insertion angle and depth was witnessed. Lower angles (30 °) and higher insertion depths (15 mm) resulted in a higher deposition in the posterior region of the nasal cast (turbinates and olfactory region). Fixing the position of a nasal product allows a lower variability of the in vitro test for device/formulation screening purposes, but may also have to be considered for in vivo studies and real-life use due to safety and efficacy concerns.

Key Message

The insertion angle and depth of a nasal drug product in the nose has a significant impact on the nasal regional deposition in a validated male nasal cast model.