Copley introduces the new Patient Exhalation Simulator to help inhaler developers understand the impact of poor patient technique.

12 September 2023; Nottingham, UK: Copley Scientific has released a new tool to aid those developing DPI devices and products in understanding the impact of poor patient technique and how to optimise designs for more robust drug delivery. Poor technique is a widely recognised issue associated with the use of inhalers that can lead to inadequately controlled respiratory disease and an over-reliance on emergency remedies. Reports suggest that up to 22% of patients routinely exhale into their DPI prior to dose inhalation ; such misuse can increase powder retention in the device, thereby reducing the quantity of the drug that the patient receives. Associated outcomes may include a lack of improvement and the associated prescription of higher doses, increasing the risk of adverse reactions, side-effects, and treatment costs.

The new Patient Exhalation Simulator (PES) allows investigators to simulate this misuse condition via the controlled and realistic delivery of warm, humid air into a DPI prior to routine tests to evaluate drug delivery performance. Its introduction underlines Copley’s commitment to understanding customer requirements, innovating relevant new products, and providing a uniquely comprehensive, state-of-the-art inhaler testing portfolio.

The PES is a simple, low maintenance, intuitive solution that:

• Offers accurate temperature and humidity control across a flow rate range of 10 – 60 L/min to simulate a range of different exhalation profiles.
• Is easy to set-up, simple to operate and requires minimal maintenance.
• Works with existing Copley mouthpiece adapters for streamlined integration into existing workflows.

A dedicated qualification kit is available to verify the exhalation temperature and humidity level.
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.

Find out more about the PES here.

About Copley Scientific
Copley Scientific is widely recognised as the world’s leading manufacturer and supplier of inhaled product testing equipment and is a major provider of testing systems for other pharmaceutical dosage forms. The company also supplies equipment for detergent testing.

Copley’s pharmaceutical product range includes testing equipment for all types of orally inhaled and nasal drug products – metered-dose inhalers, dry powder inhalers, nebulisers and nasal products – with a particular focus on solutions for delivered dose uniformity and aerodynamic particle size distribution measurement. It also includes testers for tablets (dissolution, disintegration, friability and hardness) capsules, powders, suppositories, semisolids and transdermals.

Used from R&D through to QC, this extensive range of equipment is supported by a full validation and aftersales service. Copley works in partnership with specialist distributors, extending localised support across the world. This network provides expert help and training to every customer, directly enhancing the application of all Copley products. www.copleyscientific.com