A consensus research agenda for optimising nasal drug delivery

ABSTRACT

Nasal drug delivery has specific challenges which are distinct from oral inhalation, alongside which it is often considered. The next generation of nasal products will be required to deliver new classes of molecule, e.g. vaccines, biologics and drugs with action in the brain or sinuses, to local and systemic therapeutic targets. Innovations and new tools/knowledge are required to design products to deliver these therapeutic agents to the right target at the right time in the right patients. We report the outcomes of an expert meeting convened to consider gaps in knowledge and unmet research needs in terms of (i) formulation and devices, (ii) meaningful product characterization and modeling, (iii) opportunities to modify absorption and clearance. Important research questions were identified in the areas of device and formulation innovation, critical quality attributes for different nasal products, development of nasal casts for drug deposition studies, improved experimental models, the use of simulations and nasal delivery in special populations. We offer these questions as a stimulus to research and suggest that they might be addressed most effectively by collaborative research endeavors.

KEYWORDS:

• Biopharmaceutics
• nose-to-brain
• vaccine
• sinus
• biologics
• formulation
• device
• deposition
• nasal cast

Acknowledgments

R Scherließ, M Hellfritzsch and M Trenkel of Department of Pharmaceutics and Biopharmaceutics, Kiel University, Germany, are thanked for hosting the workshop which forms the basis for this report.

Author Contributions

This article codifies the gist of the discussions and key issues identified, based on contemporaneous notes made at the meeting; post-hoc referencing benchmarks the subject matter to the pharmaceutical literature. The final expert opinion section of the article reports a consensus on the key research questions for the development of the next generation of nasal drug products. The meeting was designed by B Forbes, R Scherließ and F Sonvico, who created the first draft of the manuscript. All authors attended and contributed to discussion at the workshop. All authors contributed to manuscript review and editing. All authors concur that this report accurately describes the consensus research agenda for optimising nasal drug delivery developed at the workshop.

Declaration of Interest

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewer Disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Additional information

Funding

This paper was not funded.