While I always find engagement with the inhalation community both interesting and inspirational, my recent trip to the latest Respiratory Drug Delivery conference RDD Europe 2011 in Berlin on 3-6 May proved a real highlight. Our workshop on nasal sprays was well-received and I attended a couple of excellent talks that provided some food for thought.
… are not a given, in fact, non-compliance, for a diverse number of reasons, is a well-recognized and costly problem in the treatment of respiratory illnesses with inhaled drug products. On Wednesday evening, after a heavy day of presenting, I reluctantly abandoned the idea of a cold beer and an early night and opted instead to attend an evening mini-symposium, ‘Dramatically Improving Adherence in Respiratory Medicine – The Next Breakthrough in Therapy’ organized by the AAPS Inhalation and Nasal Technology Focus Group, discussing this issue. Turned out to be a good decision.
The symposium focused on the devices now available to monitor compliance. These are getting smarter both in terms of data capture and information sharing. Now, everything from a device used to the measurement of clinical end-points can be monitored remotely, enabling patients and physicians to review the degree of compliance achieved, using standard web browsers or even iPhone apps. A powerful example of how smart technology can help you get the most from a complex product or operating regime.
From a patient acceptance point of view, I imagined that this ‘Big Brother’ approach might cause friction, and I was right, some patients have rebelled. Others, however, are taking the opportunity to fine-tune their use of medication and improve their health.
Efficient Data Analysis
Jolyon Mitchell’s (Trudell Medical International, Ontario, Canada ) talk on Efficient Data Analysis (EDA) was equally compelling. EDA represents an alternative approach to the standard practice of reporting mass median aerodynamic diameter (MMAD), and various stage groupings, from cascade impaction measurements, to describe critical features of the aerodynamic particle size distribution of an inhaled product. This is required regulatory data.
I’m not going to go into the technicalities of cascade impaction or EDA here – although if you’re involved in this area there is a lot of interesting work being published on the topic, particularly by EPAG and IPAC-RS – I am going to highlight a key message that I was left with.
If you are using an analytical technique for QC then it can fail in two ways: it can pass an out-of-spec product (a type 1 failure) or fail one that meets the spec (a type 2 failure). Type 1 failures are the worst, with implications for product safety and company reputation. Type 2 failures are a source of inefficiency. A good analytical technique should minimize both so this is a good basis on which to choose between methods.
To justify the use of EDA, researchers have compared their ability to minimize type 1 and 2 failures with that of the techniques in routine practice. The data suggest that it is better, indicating superiority.
A focus on purpose
What I really liked about this work was how the team had gone right back to the original purpose of the measurement. Focusing on why you want to measure is a crucial starting point if you’re considering a switch from an established technique to one that is newer, more practical/efficient, automated or all three.
I’d love to hear what you think and look forward to your comments.