SGS SA

11/06/2024 | Press release | Distributed by Public on 11/06/2024 00:15

Drug Development Spray Testing Capabilities Enhanced in Belgium

We are pleased to announce the introduction of advanced laser diffraction technology for droplet size measurement, expanding the capabilities of our drug development spray testing laboratory in Wavre, Belgium.

Sprays are an increasingly popular method for delivering medications, ranging from sinus congestion treatments to vaccinations. With sprays, absorption is rapid, bypassing the gastrointestinal tract and avoiding enzymatic degradation. For the patient, sprays are convenient and non-invasive.

A key factor in the efficacy of spray drug delivery is the size of the spray droplet. This directly influences how the active ingredient is deposited and subsequently absorbed by the body. However, several factors can affect droplet size, including formulation viscosity, storage conditions and whether the bottle is shaken before use. Therefore, achieving the optimal match between drug formulation and delivery device when developing a new product requires precise droplet size measurements.

Our investment in cutting-edge laser diffraction technology highlights our commitment to supporting the pharmaceutical industry with the latest tools and expertise. With the Malvern Spraytec system, we can now measure droplet size in real-time, during the spray event (typically a fraction of a second). With a data acquisition rate of up to 10 kilohertz, we can capture detailed droplet profiles, providing crucial insights for the optimization of both drug formulations and delivery devices.

  • Real-time droplet analysis: Records droplet size distributions at high acquisition rates, dynamically capturing changes throughout each actuation. This is crucial for assessing device reproducibility and optimizing drug delivery efficiency
  • Wide measurement range: Measures droplet sizes from 0.1 to 2000 microns with high accuracy, making it ideal for analyzing nasal spray droplets (typically in the 20-120-micron range)
  • Laser diffraction technology: Determines droplet size by measuring diffraction patterns generated as light scatters off droplets within the spray plume. This enables comprehensive analysis of average droplet size, providing developers with the data they need to perfect formulations and delivery systems

Under US Food and Drug Administration (FDA) regulations, sprays are classified as combination products. This means both the formulation and delivery device must be tested together. By utilizing the Malvern Spraytec system and Mighty Runt actuator, we can help you meet FDA requirements through precise assessments of how device actuation, including pump velocity and force, impacts drug delivery.

We are committed to providing the highest quality testing solutions to the pharmaceutical industry. Our state-of-the-art laboratory in Wavre, Belgium, is part of a global network of analytical testing, formulation, clinical research and clinical manufacturing research facilities, with sites across America, Europe and Asia-Pacific. Whatever your requirements, our experts are ready to support you throughout the development and commercial manufacture of your drug product, ensuring the delivery of safe, effective, and compliant medicines to international markets.

For further information, please contact:

Katie De Waele
Head of Business Development - Health Science
t: (+32) 10 42 11 11