How do you know if the medication you’re inhaling actually makes its way to your lungs? Fascinated by nebulizers and aerosol drug delivery, Dr. Warren Finlay and his PhD student Kevin Stapleton thought long and hard about this back in the mid-1990s. The models for testing inhalers at that time were modest at best – two pipes bent together at a 90° angle, not the best replica for the mouth and throat.
“What existed at that time to test mouth-throat deposition was overly simplistic,” says Dr. Warren Finlay, professor in the Mechanical Engineering Department at the University of Alberta. “What we needed was a simple, but more realistic model that could test inhalers at various flow rates, tracking what particles actually make their way into the lungs.”
The duo decided to review CT scans of the mouth and throat and spent many hours diving into anatomy texts. After a couple of years the first drawings of the model led to the development of prototypes. At first they made the mouth and throat replica out of wood, next fiberglass, then plastic and finally with metal. Dr. Finlay worked with many students doing measurements to improve the models over the ensuing years, including another PhD student, Yu Zhang, who helped develop an even simpler model.
“It took years of refining and testing the models to prove we had a satisfactory design that could be made from metal, as we needed it to undergo multiple cleansing to remove the drug residue, while still maintaining the quality of the model,” says Dr. Finlay.
When it came to the commercialization of the ‘Physical Mouth Throat Model’, Dr. Finlay connected with TEC Edmonton, the exclusive technology transfer agent for the University of Alberta. Through consultation it was decided that patenting the model was not the best strategy rather the drawings of the model - the computer-aided designs (CAD files) should be protected.
“Each discovery reported to TEC Edmonton requires an assessment - what is the intellectual property and its commercialization potential, how should we best protect the intellectual property,” says Darrell Petras, technology transfer manager and entrepreneur-in-residence with TEC Edmonton. “The strategy we proceed with is customized and in this case, copyright was the solution.”
After presenting aspects of the idealized ‘Physical Mouth Throat Model’ in publications and conferences over the years, including at Respiratory Drug Delivery, Dr. Finlay received multiple inquiries from pharmaceutical companies as it offered an opportunity for them to test their drugs in the lab, to see how their products performed. Then he got a call from Copley Scientific Limited, a supplier of pharmaceutical test instrumentation out of the United Kingdom, and a deal was signed for Copley Scientific to have the exclusive access to the drawings.
Copley Scientific is the world’s leading supplier of cascade impactors, precision instruments that are used to determine the particle size of the cloud produced and hence the efficacy and safety of pharmaceutical inhalers such as those used in the treatment of asthma and similar respiratory complaints.
“It is essential that the instrumentation used to test pharmaceuticals prior to release to the general public mimic as closely as possible what actually happens in the human body following discharge of the inhaler concerned. We are confident that the use of the more anatomically correct ‘Physical Mouth Throat Model’ developed by Dr. Finlay’s group will provide a major breakthrough in achieving this goal,” says Tony Copley, CEO of Copley Scientific. “In addition to Warren and his team, our thanks must also go to Darrell Petras for the speedy and efficient manner in which TEC Edmonton orchestrated the technology transfer which enabled us to get on with the commercialization of the model with the minimum of delay.”
The next step for Dr. Finlay’s team is to develop a pediatric application for their model. Humanitarians by nature, his team is also working with researchers on the U of A campus to develop adult applications in treatment of lung cancer and cystic fibrosis.
“I’m intrigued by the cultural divide between researchers and business,” says Dr. Finlay. “Trade secrets, profits, it’s a different world but when you develop something that has a greater impact, then it makes the differences between the two sides easier to swallow or in this case, inhale.”