Nasal drug delivery is an increasingly important route for therapeutic innovation, but testing requirements remain complex and subject to frequent change. This presentation reviews the evolving U.S. and European regulatory landscape, including USP and EP guidance, and highlights the “living document” nature of many nasal spray standards.
Key performance tests—Spray Pattern, Plume Geometry, pump delivery, spray actuation content, delivered dose uniformity, and droplet size distribution—will be examined in terms of their regulatory intent, timing within development programs, and their importance for ensuring product quality. Particular focus will be placed on best practices in method validation and the application of a weight-of-evidence approach to demonstrate robustness.
Special considerations such as device type, actuation force, and component testing will also be discussed, along with the broader challenges created by evolving guidance and regulatory expectations.
Key Learning Objectives
- Understanding the evolving regulatory landscape and how “living documents” affect nasal spray development
- Practical approaches to validating Spray Pattern, Plume Geometry, and droplet size measurements
- How to apply a weight-of-evidence approach to demonstrate robustness and regulatory confidence
- How automation and human-realistic actuation can improve reproducibility and reduce variability
