Jolyon Mitchell has long been a leading voice in OINDP development and analysis through numerous publications and through service to multiple organizations, including EPAG, and contributions to pharmacopoeias including the USP and Ph. Eur. He plans to retire from his current position with Trudell Medical International in September 2013. This is the 3rd article in a 3-part series.
Q: Where do you think OINDP development will be 10 years from now?
A: I think we’ll still be working mainly on some of the familiar topics concerning the inhaled delivery of medication, in particular, placing the emphasis on the patient interface. Despite recent setbacks, I do believe that there’s a role for systemic delivery of aerosols by the inhalation route on account that therapy taken this way is both non-invasive and relatively easy-to-do. However, we have to recognize that in the past 5 to 10 years other forms of medication delivery, for instance needle-free injection and transdermal routes, have become highly competitive for this type of therapy.
There are some exciting new developments presently at early stages; for example, in my knowledge network, colleagues at the College of Pharmacy of the University of Hawaii are investigating inhaled siRNA to treat a range of previously untreatable or poorly controlled respiratory conditions. They are also investigating nanoparticle-based chemotherapeutic molecules as potential targets for topical delivery to tumors in the lungs. I think there’s potential for growth in both areas of endeavor.
More generally, whether we’ll ever see inhaled insulin back I think is problematic. In retrospect, I think a lot of bad things happened with the marketing of the Exubera product for treating diabetes, which is a sad situation, because the underlying science was good. However, the drug product and delivery device “package” was presented as a relatively unfriendly solution to the patient. Again it all comes down to the patient experience; in this case, the large chamber that retained the aerosol for inhalation, although good from the standpoint of aerosol conservation, was apparently not liked by users.
In retrospect, the human factors side of the development may have been weaker than desirable, contributing to its withdrawal from the market. Regretfully, this loss has resulted in a large gap in terms of offerings of inhalable drugs for systemic therapy.
I also believe there will be further developments that will happen on the clinical side, again focusing with more emphasis on how the patient interacts with the drug product and related delivery device. In time, maybe the regulators will insist that trials are done specifically assessing human factor interactions in quantifiable ways as part of the process to getting the license.
