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Lung Deposition and Pharmacokinetics of Nebulized Cyclosporine in Lung Transplant Patients
Open accessAbstract
Background Inhaled cyclosporine (CsA) is being investigated as a prophylaxis for lung transplant rejection. Lung deposition and systemic exposure of nebulized CsA in lung transplant patients was evaluated as part of the Phase 3 cyclosporine inhalation solution (CIS) trial (CYCLIST). Methods Ten patients received 300 mg of CIS (62.5 mg/mL CsA in propylene glycol) admixed with 148 MBq of Tc-DTPA (technetium-99m bound to diethylenetriaminepentaacetic acid) administered using a Sidestream(®) disposable jet nebulizer. Deposition was assessed using a dual-headed gamma camera. Blood samples were collected over a 24-hr time period after aerosol dosing and analyzed for CsA levels. A pharmacokinetic analysis of the resulting blood concentration versus time profiles was performed. Results The average total deposited dose was 53.7 ± 12.7 mg. Average pulmonary dose was 31.8 ± 16.3 mg, and stomach dose averaged 15.5 ± 11.1 mg. Device performance was consistent, with breathing maneuvers influencing dose variation. Predose coaching with five of 10 patients reduced stomach deposition (22.6 ± 11.2 vs. 8.3 ± 5.2 mg; p=0.03). Blood concentrations declined quickly from a maximum of 372 ± 140 ng/mL to 15.3 ± 9.7 ng/mL at 24 hr post dose. Levels of AUC(0-24) [area under the concentration vs. time curve from 0 to 24 hr] averaged 1,493 ± 746 ng hr/mL. On a three times per week dose regimen, this represents Conclusions Substantial doses of CsA can be delivered to the lungs of lung transplant patients…
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Undetectable plasma levels of LTI-03, a hydrophobic peptide, are consistent with the pharmacokinetic behavior of other inhaled hydrophobic compounds, such as inhaled cyclosporine formulations, which exhibit rapid and sustained lung absorption with minimal systemic exposure.
“Undetectable plasma levels of LTI-03, a hydrophobic peptide, are consistent with the PK behavior of other inhaled hydrophobic compounds, such as inhaled cyclosporine formulations, which exhibit rapid and sustained lung absorption with minimal systemic exposure32.”
From Inhaled LTI-03 for idiopathic pulmonary fibrosis: a randomized dose escalation study (2026) · cites this paper as [32]
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Inhaled LTI-03 for idiopathic pulmonary fibrosis: a randomized dose escalation study
Molyneaux, P. L., Hirani, N. A., Chia, C. C. K., Kulkarni, T., Zaman, T., Kaner, R. J., Coelho, A. L., Jannini-Sa, Y. A. P., Windsor, B., Kruger, S., et al. (2026) · Nature Communications · doi:10.1038/s41467-026-75291-3 · Cited by 1
Metadata
- Authors
- Corcoran, T. E., Niven, R., Verret, W., Dilly, S., & Johnson, B. A.
- Affiliations
- University of Pittsburgh (US)
- APT Therapeutics (United States) (US)
- Corresponding author
- Corcoran, T.E.
- Venue
- Journal of Aerosol Medicine and Pulmonary Drug Delivery
- Publisher
- SAGE Publications
- Published
- 2014-06
- Volume
- 27
- Issue
- 3
- Pages
- 178-184
- ISSN
- 1941-2703 (ISSN-L)
- 1941-2711
- PMC
- PMC4088352
- OpenAlex
- W1144699317
- Cited by
- 25
- References
- 1
- Citations by year
- 2026: 1 · 2024: 2 · 2023: 1 · 2022: 1 · 2021: 5 · 2020: 2 · 2019: 2 · 2018: 3 · 2017: 5 · 2016: 1 · 2015: 2
- FWCI
- 0.81
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- Journal of Aerosol Medicine and Pulmonary Drug Delivery (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Funders
- University of Pittsburgh (UL1TR000005, UL1RR024153, RR024153)
- National Institutes of Health (UL1TR000005, RR024153, UL1RR024153 and UL1TR000005)
- National Center for Research Resources (UL1RR024153)
- National Center for Advancing Translational Sciences
- Topics
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Inhalation and Respiratory Drug Delivery
- Health Sciences › Medicine › Surgery › Transplantation: Methods and Outcomes
- Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Pharmaceutical studies and practices
- Keywords
- cyclosporine, lung transplantation, lung deposition, aerosol deposition, pharmacokinetics, Tc-99m DTPA, jet nebulizer, systemic exposure, propylene glycol
- MeSH terms
- Administration, Inhalation, Adult, Aerosols, Aged, Drug Administration Schedule, Humans, Immunosuppressive Agents, Lung, Middle Aged, Nebulizers and Vaporizers, Ohio, Pennsylvania, Radionuclide Imaging, Lung Transplantation, Technetium Tc 99m Pentetate, Cyclosporine, Treatment Outcome, Drug Monitoring, Radiopharmaceuticals
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