Data from a clinical study shows Bentrio nasal spray's residence time and rheological properties superior to saline control.-Altamira Therapetics

The study results are published in Drug Development and Industrial Pharmacy (Taylor & Francis) and its full text is publicly available at: https://www.tandfonline.com/doi/full/10.1080/03639045.2023.2183724.

Study excerpts : "The data presented in this study indicate that AM 301 (Bentrio) has a prolonged nasal residence time of up to 3.5 h compared to a saline control. AM 301 is a safe and well-tolerable medical device with features suitable for intranasal administration. Its nasal residence time and distribution encourage its use to protect nasopharyngeal areas. Two nasal spray applications per nostril provide no substantial benefit over a single spray with regards to coverage of the mucosal surface or nasal retention time." "Importantly, the formulation also reached the oropharynx, remaining in place for up to 240 min compared with 60 min in the control group. This feature is particularly important, since airborne viruses and allergens come into contact with both the nasal mucosa and oropharyngeal cavity."

Study Highlights : The study was performed on eight healthy volunteers that were administered Bentrio or a classic saline nasal spray marked with a fluorescent agent (fluoresceine 0.1%) to track the distribution within the nasal cavity and the nasal residence time for up to 240 minutes. Participants were administered a single dose or, in case of Bentrio, also a repeated dose at a different spray angle. Bentrio was found to be widely distributed in the lower to middle parts of the nasal cavity (in particular inferior turbinate and septum, to a lesser extent also on the middle turbinate), which is where airborne allergen particles typically collect. The thin protective film was present for 210 minutes. There were no meaningful differences between single and repeated dose application of Bentrio, confirming that one puff is sufficient.

In contrast, saline nasal spray showed a shorter nasal residence time of 60 minutes only. Bentrio's extended presence within the nasal cavity is achieved thanks to its special thixotropic properties: the formulation is a gel designed to adhere to the nasal mucosa for an extended time, whereas a saline solution is prone to rapid run-off. Bentrio's gel formulation becomes sprayable upon shaking it briefly prior to application. Bentrio's long nasal residence time is supporting the extended protective effect of the nasal spray as it could be observed in other studies, including grass pollen and house dust mite challenge studies.