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Improving clinical realism: Upgraded IVIVC testing systems from Copley Scientific

New products from Copley Scientific enhance its offering for improving IVIVCs for orally inhaled and nasal drug products (OINDPs).

Improved IVIVCs support more efficient product development through the use of patient-representative breathing profiles during aerodynamic particle size distribution (APSD) measurements. Copley now offers a new air compressor, compressed air manifold and an automated compressed air flow controller for automated air flow control in enhanced IVIVC test set-ups, providing users with a fully integrated solution that simplifies measurement and improves data integrity.

‘Using a breathing simulator to investigate the impact of breathing profile on product performance enhances the value of cascade impaction in product development, bringing it closer to the clinical environment, but calls for precise air flow balancing through the test system,’ said Anna Sipitanou, Business Development Manager, Copley Scientific. ‘With manual control, fluctuations in the compressed air supply directly impact APSD data quality. These new products, when used with the TPK™ 2100 Critical Flow Controller, dramatically accelerate test set-up, at the same time ensuring that test conditions are both accurate and stable. The result is better quality data, with substantially less effort.’

Measuring more clinically realistic APSD data requires the use of a breath simulator, coupled to a cascade impactor using a mixing inlet. This set-up allows a constant flow rate to enter the cascade impactor, while the variable flow rate associated with a patient-representative breathing profile passes through the inhaler under test. Flow balancing in the system is achieved using a compressed air supply, which is now automatically controlled, significantly improving robustness, reproducibility and the speed of testing.

The new air control products significantly enhance Copley’s solutions for measuring more clinically representative APSD data and are a direct response to customer feedback. Other notable, recent additions in this area include a re-designed Next Generation Impactor (NGI) Cooler, used to reduce droplet evaporation, and NGI Cooler Stand, both of which form part of an optimised solution for nebulisers. The modified twin-port NGI Cooler now accepts a mixing inlet, while the NGI Cooler Stand efficiently accommodates a breath simulator. Researchers looking to achieve better IVIVCs now have a comprehensive range of products that work seamlessly and efficiently together to deliver high quality test data, for all OINDPs.

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