Utilising the latest Malvern Spraytec system, SGS can now accurately measure droplet size in real-time during the spraying event, typically occurring within a fraction of a second.
In line with US Food and Drug Administration (FDA) regulations, sprays are classified as combination products, meaning the formulation and delivery system must be tested together.
As a result, SGS technicians at the Wavre laboratory have paired the Malvern Spraytec system with the Mighty Runt actuator to precisely assess how factors like device actuation – including pump velocity and force – and droplet size impact drug delivery.
From sinus congestion treatments to vaccines, sprays are now a popular method for delivering medication owing to their non-invasive nature and rapid absorption.
As droplet size is a key factor in spray efficacy, it is crucial to assess the drug product in real-world conditions, including storage and patient usage habits.
Understanding droplet size is essential for developing drug products that deliver optimal patient outcomes.
The Malvern Spraytec system employs advanced laser technology to measure the diffraction patterns created as light scatters off droplets in the spray plume.
With a data acquisition rate of up to 10 kilohertz, it captures detailed profiles of droplets of between 20 and 120 microns.
This high-resolution data enables SGS experts to provide in-depth insights into spray formulations and delivery devices, thereby supporting optimised drug efficiency.
SGS’s state-of-the-art laboratory in Wavre, Belgium, is part of a global network extending across America, Europe and Asia-Pacific.
Established in 1971 and based in Wavre, Brussels, the facility is GMP- and FDA-certified and has more than 50 years of experience as a contract service organisation, providing integrated solutions from preclinical activities to phase I-IV trials for research, development and quality control testing.