Eyeing a new way of nasal drug delivery

Laleh Golshahi, Ph.D. is in the business of controlling chaos.

It’s the chaos that comes from using nasal or oral inhalers for treating allergies, respiratory conditions like asthma or someday even heart or other serious conditions. How one person holds a spray is different from how someone else holds it — there’s variability, or chaos. And the way the spray enters the nostril also varies from one person’s anatomy to the next.

But what if consistency could be brought to the way the devices work, while delivering to the body the amount of medicine that drug makers intend?

“We want to make sprays and inhalers in a way where people don’t have to think about how they’re holding them, and the device and medicine inside always works as planned,” says Golshahi, an associate professor in the Department of Mechanical Engineering. “Our end goal is really to look at where the drug lands in the nose, because that's where it’s supposed to have the most local action.”

And so Golshahi, founder and director of the College of Engineering’s Respiratory Aerosol Research and Educational (RARE) laboratory, is studying how different nasal drug delivery products work in different people’s noses. She and her team have developed six nose models — three adult, three pediatric — that can be used by researchers and pharmaceutical companies to determine how aerosolized droplets land inside the nasal passages of millions of people of varying ages, genders and ethnicities. 

The nasal casts work like artificial noses, to test where sprayed medicines land in the airways. Golshahi hopes that the casts will speed development of vaccines and medicines and even usher in a new era of medications that can be taken through the nostrils — a doorway to the extrathoracic airways of the head and lungs.

Like a 3-D puzzle, the models are made from smaller parts that allow researchers to open them up and study how the aerosolized medicine spreads throughout the nose. The models were created with an interdisciplinary partnership that included head and neck surgeons from the School of Medicine to secure CT scans of healthy adults and children.

When it comes to approving generic nasal drugs, the U.S. Food and Drug Administration measures “bioequivalence” — or whether the generic works as well as the name-brand version on the market. Lab tests are limited, as it’s hard to measure the size of the drug droplets or how they dissolve in the nose. Golshahi’s nasal casts are a way to measure the sprays in humans — without actually using real people.

“These are product development tools. They could be used by regulators to create new metrics for drug developers to ensure they are meeting standards,” she says. “And drug companies can save money early on, before going to costly clinical trials, to have a predictive understanding of the variations they are making to their devices and formulations.”

“We want to create simple tools that find patterns, minimize complexity and control chaos,” Golshahi says.

Ultimately, if VCU researchers can get consistent results, the casts could lead to a new class of drugs that are delivered through the nose and mouth. “My whole goal is to minimize pain in different forms — for allergies, for asthma and even for mental health issues and heart disease,” she says.