Investigation of the Performance of a Novel Unidose Powder Blister Device for Nasal Delivery
Cristina Rey-Blanes1, Reanne Beaird1, Nathalie Hauchard2, Angelo Consalvo3, Thomas Daggs3, Paul Shields3, Gonçalo Farias2 & Irene Rossi1
1Nanopharm Ltd, An Aptar Pharma Company, Grange Road, Cwmbran, NP44 3WY, United Kingdom
2Aptar Pharma SAS, Route des Falaises, Le Vaudreuil, 27100, France
3Enteris BioPharma Inc, Fulton St, Boonton, New Jersey, 07005, United States
Summary
The performance of a novel unidose blister device (UDSp blister) for nasal powders was assessed. Three different powders were used: Lactose LH400, a spray dried Hypromellose/Mannitol formulation and a lyophilised/Resonant Acoustic Mixing formulation composed of N-dodecylphosphocholine /β-Cylodextrin (DPC/β-CD). All powders had a distinct particle size (PSD) and rheological properties, which determined the fill weight obtained by vacuum drum filling. The assessment of powder rheology showed the DPC/β-CD powder to be the most cohesive, possibly due to its composition and manufacturing process. This was reflected in the emitted mass, where the lyophilised formulation presented the lowest fraction emitted (<10% at 15 L/min) that increased (<50%) at 30 L/min. LH400 was impacted by fill weight, especially at 20 mg, where the blister space was not enough to allow for a correct release of the dose. The spray dried formulation presented the best results when combined with the UDSp blister device, especially for the higher fill weights, with no impact of the flow rate applied on the emitted fraction. Moreover, the emitted particle size distribution of the spray dried and LH400 showed that neither the flow rate nor the fill weight had an impact on the size of the particles delivered, which also remained comparable to the bulk PSD measured. This study highlighted the importance of formulation development, excipient selection and manufacturing process for intranasal powder delivery. Next steps will include further investigation and optimisation of the powders’ composition, for example by evaluating model drugs, and manufacturing process for coupling with a passive nasal powder device.