Evaluation of the Performance of a Blister Unit Dose Nasal Powder Device
Gregoire Deraime1, Cristina Rey-Blanes2, Gonçalo Farias1, Gerallt Williams1, Nathalie Hauchard1, Reanne Beaird2, Eddie J French3, Irene Rossi2
1Aptar Pharma, Route des Falaises, Le Vaudreuil, 27100, France
2Nanopharm Ltd, An Aptar Pharma Company, Grange Road, Cwmbran, NP44 3WY, United Kingdom
3TEKH Consulting Ltd, Queen Street, Deal, CT13 6EY, United Kingdom
Summary
A novel single dose nasal powder (UDSp) passive device incorporating a blister dosing chamber was developed. The assessment of the performance of the device was carried out by using a model spray dried formulation, which was filled semi-automatically by drum technology using the Omnidose Drum TT. The device performance was tested applying three flow rates: 15, 30 and 45 L/min. Shot weight and emitted dose uniformity reported a very high percentage of powder mass and active ingredient emitted, 96% and 99% of the loaded powder, respectively, independently of the flow rate applied. In addition, the emitted particle size distribution results obtained showed a Dv50 of about 40 µm, suitable for nasal delivery with less than 2% of particles < 10 μm, once again with no correlation with the flow rate applied. This was also reflected on the aerodynamic particle size distribution results, which reported 95% of the active deposited in the mouthpiece, induction port and stage 1. Generally, this novel UDSp blister device proved to be capable of delivering a consistent dose and a suitable particle size for nasal delivery with no dependency on flow rate employed to actuate the device. Therefore, this relatively simple device can potentially be easily employed for different applications, such as nasal vaccination. Next step in the device characterisation will be focused in determining its performance in combination with powders with different physical characteristics, exploring different filling processes and fill weights.