# High Efficiency Aerosol Delivery using the Excipient Enhanced Growth Concept: A Human Proof of Concept Study

> **NIH NIH R01** · VIRGINIA COMMONWEALTH UNIVERSITY · 2020 · $612,895

## Abstract

Administering aerosols to the lungs via the nose, while convenient, is known to be challenging due to high
aerosol depositional losses in the delivery system and extrathoracic airways. In the first phase of this project,
we demonstrated that the new excipient enhanced growth (EEG) technique could significantly improve lung
delivery efficiency of aerosols administered during non-invasive ventilation and high flow nasal cannula
(HFNC) therapy. The EEG approach implements a small particle aerosol containing a hygroscopic excipient to
reduce depositional loss in the delivery system, increase aerosol particle size in the airways, and target the site
of deposition within the lungs. Using EEG, lung delivery efficiency values were increased from ~1-10% to
~80% together with improved targeting of the small tracheobronchial airways (30-40-fold dose increase) and
reduced intersubject variability. These results were based on testing in realistic in vitro airway models and new
whole-airway computational fluid dynamics (CFD) simulations.
 The goal of this translational project is to determine the in vivo lung delivery efficiency of EEG aerosols
administered during HFNC therapy using a newly developed and optimized HFNC aerosol delivery unit. A new
standalone HFNC therapy aerosol device (delivery unit) will be developed that can simultaneously generate
and administer an EEG aerosol. Depositional loss of the medication in the new delivery unit and streamlined
nasal cannula interface combined will be <10% of the nebulized dose. Radiolabeled conventional and EEG
formulations for mesh nebulization will be developed for human subject testing. The expected lung delivery
efficiency of 1-10% with a commercial system will be increased to 80% or greater with the new EEG clinical
system. In the human subject study, SPECT-CT images of the lung deposition will be segmented using 2D and
3D approaches and compared with CFD predictions. To accomplish these project goals, the following Aims are
proposed:
Specific Aim 1. Develop a HFNC aerosol delivery unit for nose-to-lung aerosol administration and optimize
performance using concurrent in vitro tests and whole-airway CFD simulations.
Specific Aim 2. Characterize the in vitro performance of the radiolabeled aerosol generated using the EEG
method and delivery unit and the standard of care method to establish human subject dosimetry.
Specific Aim 3. Conduct human subject testing of the HFNC aerosol delivery unit and compare delivery
efficiency with current standard of care. Validate whole-airway predictions of the CFD model, and further
optimize device performance.
Impact. This project will provide a new technique (EEG) and clinical platform (HFNC delivery unit) for high
efficiency aerosol delivery, low intersubject variability, and targeted delivery within the lungs for improving the
efficacy of existing and new inhaled medications administered using the convenient nose-to-lung route.

## Key facts

- **NIH application ID:** 9856503
- **Project number:** 5R01HL107333-08
- **Recipient organization:** VIRGINIA COMMONWEALTH UNIVERSITY
- **Principal Investigator:** Michael Hindle
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $612,895
- **Award type:** 5
- **Project period:** 2011-06-01 → 2024-01-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9856503

## Citation

> US National Institutes of Health, RePORTER application 9856503, High Efficiency Aerosol Delivery using the Excipient Enhanced Growth Concept: A Human Proof of Concept Study (5R01HL107333-08). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/9856503. Licensed CC0.

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