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October 12 2006 - Ref No: PR1141

Melbourn Scientific (Cambridge, UK www.melbournscientific.com) and Malvern Instruments (Malvern, UK) are combining their expertise in an innovative research project that will increase the understanding of inhaler operation. Melbourn Scientific will use the Malvern Spraytec laser diffraction particle size analyzer to make measurements of inhaler sprays produced using The Technology Partnership’s (TTP’s) ‘electronic lung’, a system developed to simulate patient-like breathing profiles. Of critical importance in this work is the Spraytec’s ability to make rapid measurements that are independent of flow rate changes.

The market for inhalation systems is growing strongly as the benefits of this drug delivery route become increasingly well understood,” notes Paul Kippax, product manager for the Spraytec system. “In response to this Malvern has developed the Spraytec to enable researchers to carry out more realistic inhaler characterization studies. Combining the capabilities of the Spraytec and the TTP electronic lung is a powerful way of gaining new insight into the factors affecting dose uniformity.

Melbourn Scientific, is the only contract laboratory to offer the use of the TTP ‘Electronic Lung’, a system which bridges the gap betweenin vitroandin vivomeasurement of the performance of dry powder inhalers. It will be investigating how the unique features of Malvern’s Spraytec analyzer can be applied to this new technology to provide a screening tool for early stage device development.

Mark Hammond Business Development Director,Melbourn Scientific adds, “Evidence suggests that the FDA and others are investigating the implications of flow rate on drug delivery. The size distribution of particles discharged from the inhaler is an important factor in determining the amount of active substance and its penetration within the respiratory tract. The advantage of the Spraytec is that it provides a dynamic measurement over the first few milliseconds of a ‘breath’, providing significantly more information than the traditional fixed flow methods. This pilot project has the potential to produce a test method that will allow customers to determine whether a given device or formulation will produce the requiredin vivobehaviour.

Malvern Instruments is a leading supplier of systems for the characterization of particle and material properties. It offers fully automated solutions for the measurement of particle size distribution, particle shape, molecular weight, zeta potential and rheological properties.

Melbourn Scientific provides contract analytical services for the pharmaceutical industry and associated device developers.  As well as offering extensive test facilities in many areas of pharmaceutical analysis, it has significant expertise in the analysis of inhaled products and delivery devices.

Melbourn Scientific www.melbourn.co.uk

Malvern Instruments www.malvern.com