You have probably heard of ibuprofen, a common drug-store medication to help with headaches or sprained ankles. Ibuprofen is an anti-inflammatory drug, which is also one of the reasons it might help people suffering from cystic fibrosis (CF), a genetic disease that causes lung inflammation.
A study published in The New England Journal of Medicine in 1995, titled “Effect of high-dose ibuprofen in patients with cystic fibrosis,” demonstrated that ibuprofen taken in high doses can help to slow lung function decline in CF patients. Lungs that work better are more effective at clearing the bacteria and other particles that are the cause of chronic lung infections in patients.
High-dose ibuprofen use is not an ideal long-term treatment, however, because research has also shown such use to be harmful, leading to gastrointestinal (GI) bleeding and, when combined with certain antibiotics needed for recurring lung infections, acute kidney injury.
But Carolyn Cannon, MD, PhD, an associate professor at Texas A&M Health Science Center College of Medicine, is working on a way to get the drug only to the area that needs it – the lungs — so it doesn’t counteract other medications in a patient’s system.
The idea is that an inhaled delivery system would allow for the harnessing of ibuprofen’s benefits without the negative side effects. In addition, since this is a repurposed drug – a drug already approved for one purpose but being investigated for other medical needs – with only a different delivery system, the development and regulatory approval process should be easier than that required for new therapeutic agents.
“We feel that nanoparticle ibuprofen delivered by aerosol to the lungs would be a fantastic therapeutic,” Dr. Cannon said in a press release. “The researchers who performed the original ibuprofen study thought it was working solely by inhibiting the migration of a type of white blood cell, called the neutrophil, to the lung. It goes hand-in-hand with acute inflammation. However, although this may be one mechanism of action, at the high doses that were being given to the cystic fibrosis patients, the drug also has antimicrobial properties.”
Inhaled ibuprofen might also be taken in combination with the required prescription antibiotics. “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 added. “Together, they kill the pathogens much better than either one does alone and we could get the same great effects of the high concentrations of ibuprofen without the side effects.”
Cannon’s research team is now applying for international patent protection on this technology, and hopes to begin discussions with the U.S. Food and Drug Administration (FDA) in late 2016 or early 2017 concerning the submission of an application for Investigational New Drug (IND) status, a step in starting clinical testing in people.
“We have several nanoparticle formulations, one of which … is almost pure ibuprofen,” Dr. Cannon said. “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.”
To test this hypothesis, the research team will deliver ibuprofen nanoparticles to the lungs of animal models, and measure its concentrations in the lungs and serum at different points in time. The team will also investigate the ability of ibuprofen nanoparticles to improve pneumonia survival rates in the animals.
“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 concluded.
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