I-Corps: Translation Potential of a Precision Anatomical Nasal Drug Delivery Assessment Platform

Award ID: 2628574

This I-Corps project is based on the development of nasal airway models based on anatomical information to improve testing and approval of inhaled drugs. Currently, the development and regulatory assessment of nasal drug products rely on indirect, weight-of-evidence approaches that do not account for how the human nasal airway interacts with an emitted aerosol. This gap slows development, increases development costs, and creates barriers to affordable generic medicines, affecting millions of patients who depend on nasal therapies for chronic conditions, neurological disorders, and respiratory disease. This technology provides physical replicas of the human nasal airway that represent the range of anatomical variability across adult and pediatric populations, enabling direct, reproducible assessment of where a drug deposits inside the nose. By giving researchers and regulators a more accurate and cost-effective tool, this technology may streamline approval of generic and combination nasal products, reduce dependence on expensive clinical trials, and ultimately improve patient access to safe and effective therapies including those targeting the central nervous system through the nasal route. This I-Corps project utilizes experiential learning coupled with first-hand investigation of the industry ecosystem to assess the translation potential of anatomically representative nasal airway models for in vitro assessment of intranasal drug performance. The models are derived from imaging data encompassing 80 nasal cavities and are designed to capture minimum, mean, and maximum drug delivery to clinically relevant nasal regions, including the olfactory epithelium. Unlike existing in vitro methods, which treat nasal anatomy as homogeneous or rely on a single idealized geometry, these models explicitly incorporate intersubject anatomical variability across adult and pediatric populations. The results include aerosol deposition studies using multiple intranasal devices and formulations, benchmarking against existing in vitro methods, and correlation with clinical outcomes. Applications include bioequivalence assessment for complex generic nasal products, pediatric label extension without additional clinical trials, optimization of device-formulation combinations in early development, and targeted olfactory deposition for nose-to-brain drug delivery. This may be used by regulatory affairs directors, device development managers, and clinical pharmacology leads at pharmaceutical companies and contract research organizations seeking validated, anatomy-informed tools for Food and Drug Administration (FDA) submissions and development risk reduction. This technology may reduce time to market and cost of development, and improve patient outcomes. This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.

NSF Program Director: Ruth Shuman