New Nebuliser Guidance Creates International Test Demand

Change in guidance for nebulisers has created a new testing regime for anyone developing new products. Melbourn Scientific, the first UK contract laboratory to offer performance testing using the Copley Breath Simulator BRS1000, has seen an increase in international demand for testing of liquid preparations designed for nebulisation.

Mark Hammond, Business Development Director comments that the interest was stimulated by very specific guidance from the European Pharmacopoeia.

"Nebulisers, in which the patient inhales a constant stream of particles, are popular as they provide a very quick way to introduce a drug into the body. The recent changes mean that formulations now need to be assessed on a breath simulating pump for total-active-delivered and active-substance-delivery rate according to the Ph. Eur., in addition to particle/droplet size and distribution."

David Potter, Team leader at Melbourn Scientific explains: "During 2006 the European Medicines Agency (EMEA) introduced regulatory guidance on nebulisers. It is now looking to test the nebuliser and formulation as a combined product for the first time.

"An associated monograph is currently under review for inclusion in the European Pharmacopeia (2.9.44 Preparations for Nebulisation: Characterisation). This is based on work performed by the European Pharmaceutical Aerosol Group (EPAG). The guidance highlights the importance of characterising nebuliser performance in terms of drug output as well as particle size distribution for the purposes of determining product performance."

"The Copley BRS1000 is specifically designed to comply with the draft monograph, and allows us to provide accurate timely data which meets the requirements of the new guidance.

Melbourn Scientific is the first UK based contract analytical services laboratory to offer method development, validation and routine testing using the BRS1000 and one of the few routinely using the NGI impactor. This complements its testing of delivered dose and particle size distribution for a range of inhalation devices including metered-dose inhalers (MDI), dry powder inhalers (DPI), nasal sprays as well as nebulisers and novel delivery systems.

However as Mark Hammond explains equipment is only part of the equation; "The BRS1000 from Copley compliments our existing capabilities, such as laser particle sizing (using the Malvern Spraytec) and impaction techniques, for nebuliser testing. Expertise and experience have a significant impact on the project success and we are working closely with Copley Scientific to improve the methodology and protocols."

Mark Hammond comments.

"Recent projects show that a significant number of companies are now following the new guidance and as an early adopter of this technique, coupled with our particle sizing experience, makes us a leader in this area."