Q. Do you partner often with instrument manufacturers?
A. We do, we do. Historically, we have been involved with the chemically specific particle size analysis for maybe 8 years now, we started with ChemImage, and we had one of their Falcon instruments in our laboratory. I’m talking again with Gateway Analytical, which is the spin off from ChemImage, about doing some work with them. We’ve also been working with Malvern and had one of their Morphologi 3G-IDs in our lab, and we just sent that back to them and we bought one of our own for working with nasals.
Q. So typically, how does a project come to you?
A. Well, we’re basically able to choose what to work on. Sometimes a project comes about because I go to meetings and I talk to people or because I read something in the literature or because something comes out of a meeting I had with Rob Lionberger who is my contact now at OGD for inhalables. I spent maybe an hour or hour and a half with him and some of his scientists recently discussing some of the projects that OGD would like to do.
If they ask us to do something, when they ask us to jump, we don’t ask how high, we just do it; but then we also have some freedom to do our own work.
Q. What new projects do you anticipate for the near future?
A. One of the things we just started doing – the FDA let three contracts to develop dissolution methods for inhalables in lung fluid. That’s something we’ve been talking about for 2 or 3 years now. There was a little group that talked about it at RDD in Berlin.
One of the things I hope we are going to be looking at next year is Teva’s breath-actuated albuterol inhaler because the agency recently rejected the application for safety reasons. The Maxair Autohaler is the only one that was approved in the United States, and it was just phased out in December because it’s a CFC product, but there are several in use in Europe.
The agency had concerns with this new application because the patient has to physically close the dust cover of this inhaler for the metering chamber to be returned into the bulk suspension. If you don’t do that pretty quickly, you could have dosing variability due to settling of the suspension or other factors, and since this is a rescue inhaler, we kind of expect that a patient might shake it and open it and take a breath, but they wouldn’t necessarily close it back up again.
There is a version of this inhaler marketed in Europe; so the question is, is this device different than the one that was approved in Europe, and if it’s not, why didn’t the Europeans raise this objection?
Q. What about longer term?
A. When I see new developments, I try to encourage the people who work with me to think about, okay, if that were a product, how would we analyze it? And you know, there’s these new products like enhanced condensation inhalers where the aerosol starts really small, but as it gets into the higher humidity areas of the airway, the droplets grow, so how are we going to analyze those?
And then there’s the whole business of delivering nanoparticles to the deep lung. You have to get them there somehow other than as nanoparticles because generally speaking, if they are below 100 nm, they come right back out again. But the surface to volume ratio for nanoparticles is just so tremendous, so how would we analyze those? We need to be thinking about how we would do that.
