The Nottingham, UK-based firm launched the new tech - the TPK-R - last week, explaining that its inlets and outlets have been positioned to match those of its aerodynamic particle size distribution (APSD) device – the Next Generation Impactor (NGI) - which means it takes up less space than the older TPK system when the two machines are connected during DPI testing.
A Copley spokeswoman told in-Pharmatechnologist.com that: “The TPK predates the NGI and is also used with the other cascade impactor in routine use for this application – The Andersen Cascade Impactor.
“Both the ACI and NGI remain in use and are likely to do so for the foreseeable future. There is now an optimal TPK design for each. Within OINDP [Orally Inhaled and Nasal Drug Products] labs the TPK is pretty much a standard so the new introduction will be welcomed by those looking for a more streamlined set-up for their NGI work.
Critical flow rate during testing is critical
Being able to assess particle dynamics is critical to understanding the performance of dry powder inhalers and such data are used to infer where the drug may deposit in the lung.
However, for this data to be useful, such testing must in conducted in conditions that match how the product is likely to be used in the real world, which is where the TPK-R will be useful according to Copley.
“Dry powder inhalers (DPIs) must be tested at a flow rate that reflects what will happen as a patient inhales. The TPK, and now the TPK-R, make it straight forward to determine what that flow rate should be, and to apply the right flow rate during testing.”
The firm – which claims it has already sold 20 of the new TPK-R systems – will continue to supply both models of the testing technology and expects demand to be split 50/50 “in the fullness of time, as more users prefer the convenience of the arrangement as they move towards using the NGI.
“Key customers will be those using the NGI to innovate new DPI technology and increasingly generic manufacturers looking to replicate the performance of DPIs initially tested with the NGI.”