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2nd May 2008

Breakthrough instrument to test inhalable drug delivery devices

• Low-cost optics with commercial LEDs and electronics, combined with fresh application of Mie scattering, present a low-cost, portable instrument

Cambridge Consultants has announced that it is developing a low-cost, portable instrument that has the potential to revolutionise the way certain drug delivery devices are tested. Through the innovative use of technology, the new device can mirror the performance and level of data provided by current laboratory laser diffraction measurement machines, for an estimated one-hundredth of the cost when integrated into a high volume device. The device measures the droplet size distribution in an airstream, a technique used in testing respiratory drug delivery devices.

Airborne drug delivery for deep-lung treatment relies on generating particles of a very specific size - too large and the drug never reaches the deep lung, too small and the drug is exhaled and is similarly ineffective. Methods for accurately measuring particle size are very much laboratory-based, for instance the Anderson Cascade method, which is laborious and can slow the development of devices, and the current generation of large laser diffraction measurement devices, which have high initial costs and require a lot of space and skill to operate.

By applying its established expertise in optical systems, electronic signal processing and advanced capabilities in the Mie scattering mathematical theory – a critical element of this form of droplet analysis - Cambridge Consultants has started developing a test unit which could be manufactured in volume for just a few hundred pounds - less than one-hundredth of the cost of a full laboratory laser diffraction installation, the only real solution to such measurements today.

It is also small enough to be highly portable, so it would be ideal at clinical drug delivery trials, where it is critical to establish how much drug reaches the patient’s deep lung so that doses can be accurately compared to the patient’s response. It would also be useful during end-of-line production testing of drug delivery devices.

Dr Robert Jones, Senior Consultant at Cambridge Consultants explains, “With this device we can achieve in a very simple configuration the multiple angles of combination, wavelength and polarisation-state that you need to get good data from the Mie scatter. The software, developed with this device, is based on Bayesian inference and as a result provides very useful data easily and quickly.”

The Cambridge Consultants device is based on low-cost LED components, considerably simplified optical configurations and the application of modern signal processing. It is designed to be robust, portable and simple enough to potentially be operated by semi-skilled clinicians, with standard IT equipment to produce highly accurate plots that indicate the number of droplets within a pre-selected range of sizes. Drugs can therefore be tested at the point of delivery, during clinical trials for example, to ensure doses are delivered as intended by the drug developer.

Dr Jones concludes, “We’re now looking for partners with whom to further develop this technology. The most immediate opportunity for it is within the pharmaceutical market, but there are other potential applications for our design in other aerosol products.”

A demonstration example of the instrument is to be presented for the first time at the Respiratory Drug Delivery Conference at Scottsdale, Arizona, USA, from May 11th to 15th, 2008.

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