Summary
General plume characterisation first became a regulatory requirement in 19981, with the introduction of the CMC draft guidance on pMDIs and DPI devices. The document outlined the basic data requirement for spray pattern and plume geometry measurement for pMDI devices. The requirements are designed to monitor consistency and quality of a device when actuated. In 2003 guidance for Nasal products on BABE (Bioavailability and Bioequivalence)2 provided details on data required and the distances where pattern information is obtained. In 2013, draft guidance on pMDIs3 start to implement the same requirements as those laid down in the Nasal guidance in 20032. At present there is no requirement for the measurement on plume geometry and spray pattern for DPI devices, because of the complexity of imaging the powder flow from DPI devices. The poster outlines the techniques used for the evaluation and implementation of FDA guidance on DPI devices. A vacuum pump operating at 50l/min extracts powder from the DPI device through Oxford Lasers OL test chamber. FDA guidances1,2, provides details on plume geometry and spray pattern, image collection and evaluation. The Spray patterns werecollected at 2 distances 3cm and 6cm from the exit of the device. The results show the Plume geometry
varies between 15 & 17 Degrees across 3 replicates with mean event duration of 82ms. The spray
pattern ovality results at 3cm show 12.7% variation & 6cm results show 6.1% variation. The poster
clearly shows that FDA guidance can be applied to DPI devices.