Achieving consistent, user independent, nasal dose delivery using a spring driven device
Falloon1 & A. Gibbons1
1 Recipharm, Bergen Way, King’s Lynn, PE30 2JJ, U.K.
Summary
Unit dose nasal drug delivery devices are used to administer a variety of drugs to a broad range of patients, without the need for more invasive delivery methods or the assistance of a healthcare professional (HCP). Due to the large variation in user strength, dexterity and finger size, the device design should aim to minimise the impact of differing user interaction. The focus of this investigation was to assess the performance of a novel unit dose device, measuring Essential Performance Requirements (EPRs) as an indication of consistent drug delivery. The reference device (RD) was Imigran® – a marketed user driven nasal spray, containing sumatriptan – and the novel device was a Recipharm proprietary spring driven nasal spray, currently under development, filled with the same formulation to enable direct comparison. Metered Shot Weight (MSW) and Droplet Size distribution (DSD) were measured in user and laboratory studies under representative use conditions. Results showed that the spring driven devices consistently delivered a MSW within specification limits and with significantly less variation than the user driven devices during hand actuation (Mean: 98.5 mg, RSD: 1.19% vs Mean: 101.1, RSD: 8.15%). Similarly, droplet sizes remained within a narrow range for spring driven devices (RSD: 3.11-10.44%). User driven devices appeared to be affected by actuation speed of the thumb (RSD: 26.73-34.37%), unlike spring driven devices. This supports the hypothesis that a spring driven delivery system can provide a more consistent device performance.
Key Message
Essential Performance Requirement parameters (MSW and DSD) have shown an overall significant reduction in variation for novel, spring driven, unit dose nasal delivery devices filled with marketed sumatriptan formulation. An important consideration for applications where dose accuracy and dispersion are critical to therapeutic performance.