An Overview of the Design Verification Testing Process for the GyroHaler® Dry Powder Inhaler

Claire Reece, Phil Swanbury

GyroHaler® is a multi-unit dose dry powder inhaler designed to deliver locally acting drugs to the lungs. The dry powder formulation is packaged in foil blister strips of up to 60 pre-metered doses and the device is suitable for the delivery of a wide range of respiratory drugs. The GyroHaler® is currently used in the AirFluSal® Forspiro® product marketed by Sandoz.

Vectura’s device design and development process consists of various stages including design proving, which is carried out during development phases, and design verification testing (DVT). The purpose of DVT is to verify that the inhaler is suitable for the intended use and meets the requirements of the User Requirements Specification and the Functional Specification.

The device functionality profile parameters of blister pierce position, airflow resistance and actuator operating torque were assessed through device life in normal operation. All parameters were within specification and showed low variability, demonstrating that GyroHaler® mechanical operation is robust in normal operation.

The emitted dose and aerodynamic particle size distribution of the emitted dose were assessed after operating the device in non-instructed piercing and inhalation orientations, with time delays and abort strokes between blister piercing and inhalation, and after applying crush forces. In-specification emitted doses were obtained for all of the misuse scenarios described, demonstrating that the GyroHaler® is capable of delivering an acceptable dose after these patient misuse scenarios.

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