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Published on: April 6, 2017
Overcoming dose limitations using the orbital(®) multi-breath dry powder inhaler
Paul M Young1, John Crapper, Gary Philips
11 Respiratory Technology, Woolcock Institute of Medical Research and Discipline of Pharmacology, Sydney Medical School, The University of Sydney , NSW 2037, Australia .
The new Orbital device enables high-dose dry powder medication delivery to the lungs via multiple inhalations from a single unit. This innovation improves fine particle fraction delivery for various lung disorder treatments.
Area of Science:
- Pulmonary Drug Delivery
- Respiratory Medicine
- Pharmaceutical Technology
Background:
- Current dry powder inhaler (DPI) technology often requires multiple actuations or capsule loading for high-dose delivery.
- Limitations exist in delivering substantial medication payloads (>100 mg) for treating complex lung diseases.
- A need exists for passive DPIs capable of single-unit, multi-inhalation high-dose administration.
Purpose of the Study:
- To introduce and evaluate the Orbital device, a novel approach for high-dose dry powder medicament delivery to the lung.
- To assess the Orbital device's ability to deliver high drug doses in a single dosing unit via multiple inhalation maneuvers.
- To compare the Orbital device's performance against a conventional capsule-based DPI (RS01).
Main Methods:
- The Orbital device (prototype) was tested with three spray-dried formulations: ciprofloxacin, mannitol, and a ciprofloxacin-mannitol combination.
- Physicochemical properties of formulations were evaluated, alongside aerosolization performance using a multistage liquid impinger at 60 L/min.
- Device emptying rates and fine particle fraction (FPF) were compared to sequential use of 10 capsules in the RS01 device.
Main Results:
- Formulations exhibited varied physicochemical properties but similar particle sizes suitable for both devices.
- The Orbital device consistently produced a higher fine particle fraction (FPF) compared to the RS01 device across all tested formulations.
- FPFs achieved were 67.1±1.8% for ciprofloxacin, 47.1±2.2% for mannitol, and 42.0±1.8% for the combination therapy.
Conclusions:
- The Orbital device facilitates high-dose respiratory drug delivery through multiple inhalations post-single actuation.
- This novel approach enables the administration of high-payload formulations (>100 mg) for diverse lung conditions.
- The Orbital represents a unique passive device meeting the critical criteria for high-dose, multi-inhalation therapy.
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