4 November 2008; Nottingham, UK: A new cascade impactor for abbreviated impactor measurements (AIM) from Copley Scientific accelerates inhalation product testing, increasing the value of cascade impaction as a tool for implementing Quality by Design (QbD). Multi-stage cascade impaction is unique in providing aerodynamic particle size information for inhaled drug products and is a standard requirement of the regulators.
The MSP Fast Screening Impactor (FSI) is a novel device based around the wellestablished Next Generation Impactor (NGI) preseparator. Coupled with a fine particle collector, and a USP/Ph.Eur. induction port, the FSI focuses solely on the fine particle fraction: the sub-5 micron portion of the dose that is considered to deposit deep in the lung. Large boluses impinge onto a liquid trap while a single precision stage generates a cut-off diameter of 5 microns. The fine particle dose is then trapped on a glass fibre filter in the fine particle collector. The FSI is high capacity, has low internal losses and low carryover. A range of inserts provides a 5 micron cut-off diameter at defined flow rates within the 30 to 100 L/min range, routinely used for testing metered dose and dry powder inhalers. An additional 10 micron insert is available specifically for nasal spray testing.
“Implementing QbD should decrease the analytical burden during process development,” said Mark Copley, Sales Manager for Copley Scientific. “Our approach has been to offer tools that streamline analysis wherever possible. Fine particle fraction, or fine particle dose, is one of the defining characteristics of an inhalation product. The FSI makes accessing this data quick and easy, and is therefore an excellent complement to conventional multi-stage cascade impactors.”
CAPTION: Copley Scientific’s MSP Fast Screening Impactor
About Copley Scientific
Copley Scientific is recognised as the world’s leading manufacturer of inhaler test equipment and is a major supplier of test equipment for pharmaceutical solid dosage forms, including tablet dissolution, disintegration, friability, hardness and powder testers. The company has offices in the UK and Switzerland and a partnership with aerosol particle science experts MSP Corporation in the US. Copley’s broad range of testing products for metered-dose inhalers, dry powder inhalers, nebulizers and nasal sprays are supplied and supported worldwide through close relationships with specialist distributors. Serving the pharmaceutical and associated industries, Copley offers an extensive range of equipment for research, production, clinical trials and quality control, as well as full validation and aftersales service, providing a single source for products that meet individual needs.
