Assessment of the Automatic Filling of Orbital™ Device Loaded with a Model High Payload Blend Manufactured by Isothermal Dry Particle Coating
Cristina Rey-Blanes & Reanne Beaird1, Norma Ulrich2, Katarzyna Epeslidis2, Niall Doherty1, Antonia Zapata del Baño1, Jonathan Tournaire3, Jonathan Mulpas3, Jasdip Koner4, Rhys Jones4, Andrea Silvestri5, Irene Rossi1
1Nanopharm Ltd, An Aptar Pharma Company, Grange Road, Cwmbran, NP44 3WY, United Kingdom
2Harro Hӧfliger Verpackungsmaschinen GmbH, Helmholtzstraße 4, Allmersbach i.T., 71573, Germany
3Aptar Pharma SAS, Route des Falaises, Le Vaudreuil, 27100, France
4Aston Particle Technologies, Aston Triangle, Birmingham, B4 7ET, United Kingdom
5Sterling, Via della Carboneria 30, Corciano (PG), 06073, Italy
Summary
Orbital™ is a unit dose dry powder inhaler capable of delivering high doses to the lungs over several inhalations. The assessment of the realistic performance of Orbital™ filled manually or automatically using the Drum Lab was carried out. Isothermal Dry Particle Coating (iDPC) was used to blend (50:50% w/w) of lactose LH200 and a model cohesive drug (Fluticasone Propionate), based on previous results obtained. Two puck configurations were employed: 0.6 and 0.9 mm with a single orifice, together with two different fill weights, 125 and 250 mg. Puck content uniformity performed on the drum filled pucks confirmed homogeneity of the filling. Generally, the in vitro realistic aerodynamic performance (DD and FPM) was higher for the drum filled samples, especially for the first inhalation act. In addition, larger puck orifice translated into a higher DD and FPM which was reflected by the higher mass deposited in the different lung generations of the in silico model (alveolar > tracheobronchial > bronchiolar), only when the 0.9 mm puck was automatically filled. Finally, the positive influence of drum filling determined a higher cumulative mass emitted after five inhalations with the highest value collected for the 0.9 mm orifice puck at both fill weights (> 65%). These results demonstrated that drum is a feasible filling technology for the Orbital™ device in combination with an iDPC formulation. The iDPC blend proved to be easily handled, regardless of its high payload and poor flow characteristics, reporting even better aerodynamic results when automatic filling was performed.