Thomas Foliard1, Sebastien Rabiller2 & Alain Regard2
1 Consultant for Nemera la Verpillière, 63 Avenue Tony Garnier, 69007 Lyon, France
2 Nemera la Verpillière, 63 Avenue Tony Garnier, 69007 Lyon, France
Summary
Non-invasive nasal treatments exploiting the Nose-to-Brain pathway are a promising way of addressing central nervous system (CNS) diseases and diseases affecting brain tissue. A significant challenge of Nose-to-Brain delivery is associated with the targeted administration of the drug formulation to the olfactory cleft. Nemera has explored the ability of a narrow and straight liquid stream to deliver drug to the olfactory cleft leading to the development of the Guided Stream Technology (GST).
In vitro deposition tests have been performed with the GST device using a nasal cast designed by Nemera representative of a healthy patient’s nasal cavity. The purpose of this study was to explore the impact of several key device administration parameters in a Design of Experiment (DoE): orientation of device relative to the cast during administration, depth of insertion in the nostril, and viscosity of the model formulation. The DoE generated qualitative and quantitative data on deposition outcomes in the nasal cast cavity in relation with the administration parameters and model formulation composition.
The results showed high levels of formulation deposition in the olfactory area (81% average from 81 depositions) with good experimental repeatability. Response surface analysis showed the influence of each administration parameter. The acceptable ranges of each parameter which consistently deliver a high percentage of deposition in the olfactory area of the nasal cast were defined.