Assessment of the Delivery Performance of a Novel Soft Mist Inhaler Using a Pre-Filled Syringe Based Container Closure System
Pragathi Gurumurthy1, Knut Sommerer2, Imco Sibum1, Nicolas A. Buchmann1 & Bernhard Müllinger1
1 Resyca BV, Colosseum 23, Enschede, 7521 PV, The Netherlands
2 Actarmo Medical GmbH, Robert-Koch-Allee 29, Gauting, 82131, Germany
Summary
Novel drug developments (e.g. biologics) are primarily delivered as water-based liquid formulations. Soft Mist Inhalers (SMIs) deliver the water based liquid formulations through a slow-moving cloud of aerosol that is generated solely by mechanical energy. Resyca’s novel soft mist inhaler with a pre-filled syringe (PFSI) delivers high doses of liquid drugs that can be aseptically filled. This inhaler has high delivery efficiency leading to a high lung deposition. The particle size distribution measured by laser diffraction gives a VMD of 4.27 µm with a high FPF of 65.20% at 30 L/min. The average emitted dose measured gravimetrically at 30 L/min over multiple devices was 30.41 ±0.24 mg. The regional respiratory deposition calculated from the obtained aerosol data shows a high lung deposition of 62.88%.