Copley Scientific, the world’s leading manufacturer of inhaler test equipment, will be introducing the new Facemask Test Apparatus (FMA) to Next Generation Impactor (NGI) accessory for streamlined MDI testing, in accordance with draft USP chapter <1602>, at Drug Delivery to the Lungs 27 (DDL27).
This conference, which will take place at the Edinburgh International Conference Centre, Scotland, from 7 December to 9 December 2016, is one of the primary events for the inhalation community. Also on display on the Copley stand will be products specifically for generics testing, and for more clinically relevant inhaler testing.
The new FMA to NGI accessory makes it easier to measure the aerodynamic particle size distribution (APSD) of MDIs with spacers/VHCs that utilise facemasks, using the NGI, in a relevant and reproducible manner.
Combining face models with the NGI induction port, the accessory allows infant, child or adult facemasks to be interfaced directly with the NGI under controlled conditions. The alternative approach of removing the facemask often leads to a poor fit between the spacer/VHC orifice and the induction port, further making the test method less representative of the clinical situation.
Copley will also be showcasing other equipment that are used in the testing of inhaled products, including its Andersen Cascade Impactor (ACI) and Alberta Idealised Throat (AIT). The ACI on display has been specially modified to determine the aerodynamic particle size distribution (APSD) of generic Fluticasone Propionate/Salmeterol Xinafoate (PF/SX); an extremely effective combination treatment for asthma and COPD.
This modified impactor has been developed in response to the recent release of five new USP drug specific monographs for common generic targets.
The revolutionary Alberta Idealised Throat (AIT) - available with both adult and child geometries - is used during product development to better understand deposition of orally inhaled drug products (OIDPs) in the human throat.
The AIT uses clinical realism to improve the in vivo and in vitro relationship; something which is notoriously difficult to achieve and yet critical for understanding therapeutic effectiveness. The product was developed as a result of research into patient populations through information from CT scans, MRI scans and direct observational data. The product is quick and simple to use and has numerous performance benefits over human throat casts.
