# Optimization of next generation pulmonary dry powder delivery systems

> **NIH NIH F31** · UNIVERSITY OF TEXAS AT AUSTIN · 2020 · $27,779

## Abstract

PROJECT SUMMARY
Tuberculosis (TB) remains the single largest infectious killer of adults worldwide, and development of drug-
resistant strains is a public health crisis. As an alternative to oral and IV delivery in TB treatment, direct lung
delivery via dry powder inhaler (DPI) can be used to achieve shorter treatment regimens, overcome drug
resistance, and rapidly reduce transmission rates. However, traditional, low-potency DPIs are not optimized to
meet the challenges of TB therapy (high doses, narrow therapeutic indices, and delivery of labile molecules).
Next-generation DPIs must exhibit efficient powder aerosolization, promote drug stability, and ensure
reproducible lung deposition independent of lung function. This must occur within the cost-constraints of TB,
which necessitates a systematic and streamlined development approach. It is hypothesized that high-dose,
carrier-free dry powders must exhibit certain properties for aerosolization to be achieved, and that the pairing of
these properties to the appropriate device dispersion mechanism will enable inspiratory flow-independent lung
deposition. Over the course of three years, this hypothesis will be tested through a comprehensive analysis of
critical physicochemical characteristics of micronized drug powders in relation to aerosolization, application of
these findings to a challenging monoclonal antibody model, and through a study of the behavior of respirable
drug particles in a variety of device and inhalation settings. The empirical data derived through these studies will
be used to model the relationship between particle cohesion, device dispersion, and aerosolization to further
optimize existing high dose DPIs and predict performance of novel DPIs. The training environment (University
of Texas) will fully support this study by providing the necessary resources for particle engineering, small
molecule and biologic analysis, and aerosol testing. In addition to promising scientific insights, the proposed
study will provide extensive training in powder characterization techniques, device prototyping, small molecule
and biological processing and analysis, and mathematical modeling that are necessary for progression to an
independent research career in the pharmaceutical sciences. The overall significance of this study is that it is a
translational research approach that links a mechanistic understanding of respirable particle behavior to the pre-
clinical development of targeted and cost-effective therapies for devastating pulmonary diseases like
tuberculosis. The systematic approach will greatly streamline the development of future small molecule and
biopharmaceutical inhaled therapies and reduce the risk of pre-clinical to clinical translation.

## Key facts

- **NIH application ID:** 9912639
- **Project number:** 5F31HL146178-02
- **Recipient organization:** UNIVERSITY OF TEXAS AT AUSTIN
- **Principal Investigator:** Ashlee D Brunaugh
- **Activity code:** F31 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $27,779
- **Award type:** 5
- **Project period:** 2019-02-06 → 2020-09-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9912639

## Citation

> US National Institutes of Health, RePORTER application 9912639, Optimization of next generation pulmonary dry powder delivery systems (5F31HL146178-02). Retrieved via AI Analytics 2026-08-01 from https://api.ai-analytics.org/grant/nih/9912639. Licensed CC0.

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