Summary
Intranasal drug delivery is a well-established route of administration currently being used for a wide range of treatments, including emergency treatments such as hypoglycaemia. This paper presents two in vitro nasal cast deposition studies investigating the impact of particle size and simulated real-life patient factors on the anatomical deposition profile of an intranasal administration of a powder formulation of epinephrine for the treatment of Type 1 allergic reactions including anaphylaxis (Nasdepi®, BBP01).
Nasdepi is a combination product consisting of the Aptar Unidose Powder Spray System and a novel epinephrine powder formulation. The powder utilises lactose as a carrier and was specifically engineered for use in the device to deliver a consistent dose and deposition distribution in the nasal cavity with a focus on minimising the potential for introduction into the lungs. Understanding the impact of powder particle size and patient variables associated with real-world administration has on deposition are critical to assessing performance and reliability. The Alberta Idealized Nasal Inlet model was used to assess powders with Dv(50) ranging from 5.25 to 17.9 µm. The Aeronose™ model was run through a matrix of conditions including: vertical and horizontal orientation, with and without airflow, and coated with 12 to 80 cP solution to mimic mild to moderate rhinorrhea. In all cases the deposition distribution remained consistent with ≤ 5% of the powder bypassing the nasopharynx.