There’s much experimental work relating to AIM that’s in there. Also a theoretical basis has been developed that supports the experimental evidence for the value of EDA. I therefore think that the findings in relation to both concepts will provide a very good basis for all stakeholders to move forward with these concepts. Although primarily our focus is with users within the pharmaceutical industry, we’re also aiming the book at regulators and people involved in the setting of standards/pharmacopeial methods in relation to inhalers.
One of the important things we as co-editors have done is that we are not receiving any royalties. Instead, they are going to go to the Education for Health “Better Breathing Bangladesh” program. They have big problems associated with environmental pollution from cooking in Bangladesh, which frequently result in asthma. That country is incredibly poor, and we therefore thought that that would be a good way of putting the profits from the book out there where needy people are going to benefit.
Q: Will you continue to work with EPAG?
A: Yes, that’s another cross-industry professional group with which I hope to continue involvement. However, I cannot remain a plenary member because that role is tied to a company membership. Nevertheless, I’m hoping to retain my position as chair of their Impactor Sub-Team because that group has been very fruitful in terms of progress in understanding the cascade impactor in its role for the laboratory-based assessment of inhaler performance.
We have something like 25 members of that sub-team, and in the past few years they’ve had a series of research papers come out on research relating to the cascade impactor method. There’s lots more to do there, especially focusing on flow time profiles with DPIs.
In particular, we are trying to develop an understanding of what’s going on when the cascade impactor gets powered up from cold, as happens with DPI testing. I believe that the results of some scientifically significant work is going to come from this sub-team in the next few years, and I would hope to be able to see that through to completion.
A: What about your work with USP?
Q: We’re in the middle of a mini-revolution that was started by a decision at the USP in or about 2010 to develop a dosage-form taxonomy. As a result, this change in focus has given the General Chapters committee, through the Aerosols sub-committee, an opportunity to revise the existing content of chapter 601. This work resulted in the introduction of a new chapter, chapter 5 which is where all the dose content uniformity part of 601 has gone.
Chapter 601 is really now becoming more like its equivalent, monograph 2.9.18 of the European Pharmacopeia (Ph.Eur.), focusing on the cascade impactor method for the aerodynamic particle size distribution assessment of aerosols from orally inhaled products. What these developments are enabling us to do is focus on providing more informative information rather than just providing instruction of the form: “this is the way to do it.”
