A new breath simulator from Copley Scientific will be on display for the first time at the 18th Congress of the International Society for Aerosols in Medicine (ISAM) on 18-22 June 2011 in Rotterdam.
The breath simulator allows the application of all of the breathing profiles specified in new guidance for nebuliser testing issued in the pharmacopoeia.
It is a direct response by Copley Scientific to the changing needs of the inhaled-product testing community, which is actively seeking ways to improve the in vivo relevance of in vitro test methods.
The new breath simulator simplifies compliance with the revised pharmacopoeia monograph on the testing of nebulisers (USP chapter 1601 and Ph Eur 2.9.44) that comes into force in August 2011.
In the past, nebuliser testing has been carried out using a standard 'adult' breathing profile.
The new monograph specifies the application of one of four different profiles - neonate, infant, child or adult, depending on the intended application of the product.
The new unit allows the user to specify the volume, frequency and inhalation/exhalation ratio of the applied breathing profile for detailed investigation of the impact of patient physiology on drug delivery.
Robust and well engineered, the breath simulator has intuitive software that simplifies use.
It comes complete with all the connectors and fittings necessary for use with the test apparatus concerned.
