Understanding the affect of DPI device and lactose type on the output from a device

Dr Séamus D Murphy

Dry powder device are more complicated to design and develop then pMDI and Nasal devices. During the development process there are three components to optimise for a device to work correctly, device, API and lactose. Each component has a range of complex interaction which impact on how the final device will perform. On the device a designer / developer will consider a range of issues such as, type of material, how the dose will be delivered, how to maintain the uniformity and will the device be a single dose or multi dose, and also need to be easy to use. API and lactose performance is subject to, particle size, particle shape, type of production, mode of blending, how they fluidise and breakup to release the API, all play a role in the optimisation of the final product. The aim of the paper was to assess, change in the output from a Easyhaler® standard reservoir DPI device with 3 types of lactose, Respitose® SV003, Respitose® ML001 and Lactohale® 300. The following parameters were measured, plume angle, event duration and intensity profile of lactose from the device. The results show, for plume angle and event
duration there was no significant difference between Respitose® SV003 and Respitose® ML001. The results for Lactohale® 300 are significantly different. The intensity profile results provide some insight in to how the material flows from the device and the release profile for each combination. Lactohale® 300 profile is different, to that of Respitose® SV003 and Respitose® ML001, with a slow decay over the event. This may in part be due to the small size range (D50 <5um) and the mechanisims involved in the fluidisation and agglomerate breakup of the powder from the device.

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