Assessment of the delivery performance of a novel soft mist inhaler using a pre-filled syringe based container closure system

Authors: Pragathi Kamale Gurumurthy, Knut Sommerer, Imco Sibum, Nicolas Buchmann, Bernhard Müllinger

Event: DDL 2023, 6 – 8 December 2023, Edinburgh, United Kingdom

Abstract: Biological drugs are primarily delivered as water-based liquid formulations and require efficient delivery platforms when being delivered via the inhalation route.

The soft mist inhaler tested within this study uses a container closure system that is compatible with biological drug products and achieves a high lung deposition of about 63%.

Particle size, emitted dose and inhalation flow rate play a crucial role in determining the delivery efficiency and the lung deposition.

Test results from aerosol characterisation of the PFSI device show a volumetric median diameter of 4.3 μm with a narrow size distribution (GSD of 1.4) and FPF of 65.2%. Results from emitted dose measurements confirm that the targeted dose of 30 mg was reached with 30.4 ± 0.24 mg over 10 dose actuations and across different devices.

The uniformity of single doses fulfils dose uniformity requirements are in the range of 75%–125% of the label claim. Regional respiratory lung deposition modelling shows a high deposition in the lung and the lung periphery of 62.9% and 31.9%, respectively.