Drug Delivery Report

By Simon Smith
Cambridge  Consultants Ltd, Science  Park, Milton Road, Cambridge  CB4 0DW, UK; Simon.Smith@ CambridgeConsultants.com

Introduction

The mantra  'making technology  work' is central to our business philosophy, and over the last four years we have been doing exactly that  for our client Chiesi Farmaceutici. Chiesi approached Cambridge  Consultants needing  a
next generation multi-dose dry powder  inhaler (DPI) to deliver their own innovative drug formulation  to the lung. Usually, when a new product  is considered, the first thing that  is thought of is the functional performance, but with Chiesi's inhaler we took a different approach. We assumed  that  the functional performance would be met, and made the interaction  between the device and the user the priority. The logic behind this was simple. If
an inhaler is easy to use, it is likely to be more effective for the patient,  as it will be used correctly. If it is more effective for the patient,  then  it is more likely to be prescribed by doctors and nurses, which in turn will make more money for our client.

Inhaler Design

To achieve ease of use and ensure that  the inhaler is used by the patient  correctly, as well as delivering the drug to relieve the patient's symptoms, four design activities were undertaken:

•  Understanding the users and their requirements by
both carrying out background research and speaking to healthcare professionals;

•  Analysing the users' needs to understand any key issues and then  identifying technologies to address each of them;

•  Creating concepts  that  addressed the key issues;

•  Showing the design concepts  to both patient  and physician focus groups across Europe, and using that feedback  to select and refine the best concept.

From the results of this work, it was concluded  that,
in order to maximise usability, the operating sequence should be as simple as possible, and that  the release
of the drug and the counting  of each dose should be breath-actuated (released automatically when the patient
breathes in) to give accurate  feedback  on the number  of doses taken.  This would give the user greater  confidence in the device and reassurance about  how many doses were remaining.  These attributes were integrated into a
design layout with enabling technologies to ensure product performance, including dose counting  to guarantee that doses are consistently and reliably given to the patient, environmental protection to protect  the powder  against moisture which would affect its performance, and drug de- aggregation which breaks the powder  up so that  it can be effectively inhaled and go deep into the lungs.

Conclusion

After four years of design, analysis, engineering, prototyping and testing,  the product  consistently achieves class-leading drug delivery performance and has successfully completed pharmacokinetic clinical studies. The NEXT™  device, currently being ramped  up for manufacture, has also finished extensive user-group research,  where both doctors and patients  reacted
positively to the DPI's features  and its discreet and robust, yet modern,  style. Due for launch by the end of 2007,  the device looks set to capture  significant market share as it harnesses  cutting-edge technology  to deliver the critical benefits required by the two most critical and important
segments - healthcare professionals and patients  alike.