Chiesi next-generation inhaler

NEXThaler’s integral mechanical dose counter only displays fully delivered doses, ensuring patients have an accurate indication of the number of doses administered and empowering physicians to provide better patient care.

NEXThaler’s novel breath-actuated – rather than button-operated – mechanism ensures ultimate ease of use. This greatly reduces the potential for patient error, minimises training time and virtually eliminates the probability of wasted doses.

We designed a unique aerosol engine that ensures the maximum quantity of the drug reaches the lungs, independent of the patient’s inspiratory flow rate. This allows the device to be prescribed to the widest possible patient population.

NEXThaler accurately dispenses each dose as it’s used, eliminating the need for pre-packaged dose manufacture. The dry powder is therefore stored in a protective chamber with an integrated desiccant which absorbs residual moisture.

This allows the device to pass the stringent storage requirements required for an inhaler – resulting in a prolonged drug life of six months after opening.  

After defining detailed requirements for the device through focus groups with patients and healthcare professionals, we generated eight different concepts, turning the best two into prototypes for further focus group assessment. The final design was subjected to multiple stages of modelling, analysis and verification, including environmental and drug delivery performance testing.

We worked closely with Chiesi to successfully transfer the design to manufacture, working onsite to quickly assess any issues, recommend design changes and carry out additional testing to ensure a robust product hit the market as quickly as possible.

Chiesi challenged us to develop a successor to its Pulvinal inhaler for both approved drug substances and drug substances in development. In light of high patient failure rates for conventional inhalers, ease of use and high performance were of paramount importance.

Chiesi needed their new DPI to be exceptionally easy to use and provide high therapeutic performance in a discreet, compact and attractive package. This involved many different complex features, including breath-activated drug delivery and robust dose counting mechanisms with full-dose feedback.

We assembled a cross-functional team with a wide range of expertise including industrial design, human factors engineering, fluid dynamics, design-for-manufacture and in-house analytical testing.

We designed and built custom automated test rigs in our life sciences lab, to ensure accurate inhaler performance assessment and measure critical device functions. This enabled us to significantly reduce overall test time and cost to take the device through verification, as well as ensuring robust and repeatable results. To date more than a million doses have been tested.