Assessment of Orbital DPI Device’s Fluticasone Propionate Performance

This study evaluated the Orbital’s performance with four DPI formulations. The first was produced by a traditional Turbula® blending approach, and the remaining three were produced through a single step by isothermal Dry Particle Coating (iDPC). iDPC is a fluidization principle-based formulation technology. All formulations contained fluticasone propionate (FP), a challenging active pharmaceutical ingredient due to its tendency to agglomerate in lactose carrier-based systems.

The study revealed that iDPC-based formulations in conjunction with the Orbital device improved dose delivery compared to the Turbula blend. Despite showing a more homogeneous surface energy, NP formulation had less FP deposited into the ET region than iDPC-based formulations, suggesting that surface energy heterogeneity may enhance lung deposition. Notably, iDPC formulations showed significantly higher delivered and fine particle mass (FPM) doses compared to the Turbula mixer.

Further, the study showed that while the Orbital can be actuated several times for a full dose, the most significant portion of the dose was delivered in the first two breaths. This indicates that fewer breaths may be necessary to deliver a full dose, improving patient experience. Moreover, iDPC demonstrated better delivery efficiency, with the highest performing formulation, APT3, showing improved delivery without the need for magnesium stearate, which was needed in the optimized NP formulation.

In conclusion, the combination of iDPC and the Orbital device has shown promising improvements in drug delivery to the lungs, and offers potential advancements in the treatment of various lung diseases. Modifying the iDPC process parameters can lead to enhanced performance without altering the formulation, highlighting the promise of this innovative approach in respiratory medicine.