Copley Scientific has announced the launch of its new Patient Exhalation Simulator (PES) for use in dry powder inhaler development. According to Copley, the PES simulates exhalation into a DPI prior to inhalation of the dose, a type of misuse that can significantly affect delivery of the full dose and which may occur with more than 20% of patients.
The company explains, “Using the PES, developers can detect how inhaler misuse impacts critical quality attributes of the DPI and work towards improved device robustness. Designing out susceptibility to misuse is the preferred option but alternative steps might include reducing possible impacts via patient usage instructions.”
Copley notes that the PES works with the company’s mouthpiece adaptors and allows for control of the flow rate of the “exhalation” over a range of 10-60 L/min as well as control of the temperature and humidity of air delivered to the inhaler. A qualification kit is available for the PES for verification of the humidity and temperature.
The PES joins a number of other OINDP testing accessories launched by Copley in 2023, including the FRS bi-directional flow sensor; a new DUSA Shaker; and the Impactor Genie IG 200i.
Read the Copley Scientific press release.
