# High Efficiency Inhalation Delivery of Tobramycin for Children with Cystic Fibrosis

> **NIH NIH R01** · VIRGINIA COMMONWEALTH UNIVERSITY · 2021 · $475,680

## Abstract

Treatment of Pseudomonas aeruginosa (Pa) and other lung infections in pediatric cystic fibrosis (CF)
patients currently relies on adult aerosol delivery devices, and effective dry powder inhaler platforms are not
available for patients under 6 years of age. While treatment with inhaled antibiotics is considered safe and
effective, CF patients continue to progress to chronic infections and the time burden of treatment is high,
especially with the use of nebulized solutions in children under 6 years of age.
 This project will develop a new inhalable dry powder tobramycin formulation and delivery device
combination intended for pediatric patients in the age range of 2-10 years that seeks to lower the inhaled
powder burden to a single capsule delivered with high efficiency. For effective and targeted lung delivery, an
excipient enhanced growth (EEG) approach will be implemented where combination submicrometer particles
of tobramycin and mannitol (MN) are formed by spray drying. The initially small size of the aerosol allows for
effective deep lung delivery, even in diseased lungs, and the inclusion of MN as the hygroscopic excipient
results in aerosol size increase within the lungs and targeted deposition. A simple active dry powder inhaler
(DPI) system will be developed that implements new three-dimensional (3D) rod array technology, which has
previously been shown to effectively deaggregate carrier-free powders at low flows required for pediatric
applications. The initial particle size and hygroscopic excipient content will be designed to produce controlled
aerosol size increase and deposition, thereby providing a uniform concentration of tobramycin in airway
surface liquid. To develop this new approach, three Specific Aims are proposed:
Specific Aim 1: Develop an inhaled tobramycin excipient enhanced growth (TOB-EEG) formulation that is
stable and provides high dispersion when coupled with an inline dry powder inhaler (DPI) system.
Specific Aim 2: Apply a concurrent computational fluid dynamics (CFD) and in vitro approach to develop and
optimize a high-efficiency and high-dose active DPI system for pediatric CF patients across a range of ages.
Specific Aim 3: Predict and optimize regional lung delivery concentrations of tobramycin in lung airway
surface liquid using CFD, and evaluate the effects of tobramycin and excipient concentrations on in vitro
sputum penetration and antimicrobial activity.
This newly proposed TOB-EEG inhalation therapy will allow for efficient DPI use in pediatric patients < 6 years
old for the first time. Development of a convenient DPI platform will improve patient compliance and help to
promote early eradication therapy of newly identified Pa infections. The newly developed TOB-EEG
formulation will significantly increase aerosol delivery to the small airways, provide significantly more
uniform antibiotic concentration throughout the airways, and improve penetration of the antibiotic
through the mucus to improve bacterial ...

## Key facts

- **NIH application ID:** 10200865
- **Project number:** 5R01HD087339-05
- **Recipient organization:** VIRGINIA COMMONWEALTH UNIVERSITY
- **Principal Investigator:** Michael Hindle
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $475,680
- **Award type:** 5
- **Project period:** 2017-07-21 → 2024-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10200865

## Citation

> US National Institutes of Health, RePORTER application 10200865, High Efficiency Inhalation Delivery of Tobramycin for Children with Cystic Fibrosis (5R01HD087339-05). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10200865. Licensed CC0.

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