Researchers are working on a way to deliver high doses of a common anti-inflammatory — ibuprofen — directly into the lungs of cystic fibrosis (CF) patients as a possible therapy.
More than 20 years ago, scientists found that ibuprofen was able to slow lung function decline in CF patients when given at high doses. But other studies revealed that high doses of ibuprofen, taken routinely, could also cause gastrointestinal (GI) bleeding or acute kidney injury, particularly when combined with the antibiotics these patients take for their recurring lung infections.
Now, researchers led by Carolyn Cannon, MD, PhD, an associate professor at at Texas A&M Health Science Center College of Medicine, are investigating whether delivering the drug directly to the damaged area — the lungs — would provide benefits without risk of injury to the kidneys or GI tract.
“We feel that nanoparticle ibuprofen delivered by aerosol to the lungs would be a fantastic therapeutic,” said Dr. Cannon in a press release.
Because this is a different application and delivery method of an already approved drug, the development and regulatory approval process should be easier than that for a novel drug.
Since the inhaled ibuprofen is not delivered systemically, it might also be taken in conjunction with the antibiotics used to counter lung infection.
“We determined that not only does ibuprofen act as an antimicrobial itself, it is also synergistic with the antibiotics we already give to these patients,” Dr. Cannon said. “Together, they kill the pathogens much better than either one does alone.”
The team has developed “several nanoparticle formulations,” including one that “is almost pure ibuprofen,” she added. “We are excited about this formulation, but we still have to prove that it achieves our goal of high lung concentrations of the drug and low systemic concentrations.”
In preparation for testing the drug and its delivery method in people, teams led by Dr. Cannon and Dr. Hugh Smyth at the University of Texas in Austin, who developed the “pure” formulation, will measure ibuprofen concentrations in the lungs and serum of animal models after delivering the ibuprofen particles into their lungs.
“This type of experiment addresses the pharmacokinetics of the drug and aims to investigate our hypothesis that we can achieve high local concentrations in the lung while maintaining low systemic concentrations,” Dr. Cannon said.
Researchers now applying for international patent protection for their technology, and expect to begin discussions with the U.S. Food and Drug Administration (FDA) to receive approval for an Investigational New Drug (IND) application, and the right to start clinical trials.