Background: The Orbital dry powder inhaler (DPI) is a novel dry powder inhaler designed to deliver high-doses of drugs to the respiratory tract in a single dosing unit via multiple inhalation maneuvers.
Methods and Results: The Orbital DPI was tested in its prototype configuration with the full payload contained in a single dosing unit (the ‘puck’) and compared to a conventional RS01 (Plastiape S.p.A.) capsule device where the payload was divided over 10 capsules used sequentially. Two formulations were evaluated: 200 mg spray-dried ciprofloxacin and 200 mg spray-dried mannitol. The systems were evaluated for their physico-chemical properties and
aerosolisation. The particulate systems had different morphology, thermal response, moisture sorption and stability; however, they had similar aerodynamic sizes making them suitable for comparison with both devices. The aerosolisation performance from the Orbital DPI and RS01 was dependent upon the formulation type; however, the
fine particle fraction (FPF) produced by the Orbital DPI was higher than the RS01. The FPF for ciprofloxacin and mannitol were 67.1±1.8 % and 47.1 ±2.2 %, respectively.
Conclusions: The Orbital DPI provides a means of delivering high doses of dry powder to the respiratory tract through multiple breath maneuvers from a single reservoir of powder. This approach allows the delivery of a wide range of high-pay load formulations (>100 mg) for the treatment of a variety of lung disorders with much reduced handling by the patient.