Are your inhaler formulations ready for the new era of low-GWP propellants?
As the pharmaceutical industry shifts to more sustainable practices, one critical area under transformation is the development of pressurized Metered Dose Inhalers (pMDIs). Propellants such as HFA-152a and HFO-1234ze(E) are leading the charge toward low global warming potential (GWP), offering the promise of drastically reduced environmental impact. But with innovation comes complexity.
Why the Shift Matters
According to studies from American Throracic Studies (ATS), healthcare delivery accounts for 8-9% of total greenhouse gas emission in the US. The pharmaceutical industry is doing their part by transitioning to low-GWP alternatives that can greatly reduce inhaler-related emissions, with a usage reduction of pMDI HFC. This will be a substantial win for environmental health. But it requires manufacturers to rethink how inhalers are formulated, tested, and validated.
The Technical Challenges of Next-Gen Propellants
While HFA-152a and HFO-1234ze(E) offer ecological advantages, they present significant technical challenges for formulation and device design:
- Density, vapor pressure, and boiling point changes affect drug solubility, canister fill behaviors, and aerosolization.
- Spray plume characteristics shift with these new compounds, impacting delivery efficiency and patient experience.
These changes can disrupt critical performance attributes in Aerodynamic Particle Size Distribution (APSD) and Delivered Dose Uniformity (DDU) testing.
Precision Testing Tools for an Evolving Industry
At MSP, a Division of TSI, we understand the demands of next-generation inhaler development. Our testing solutions help ensure your pMDIs deliver therapeutic performance while meeting global regulatory standards.
Here's how we support your transition:
- Reliable APSD Measurement: Get consistent, accurate APSD results even when working with novel formulations or unfamiliar propellant behaviors.
- Flexible Breathing Simulation: Use child, adult, or custom breathing profiles to generate more clinically relevant data.
- Automated Shake and Fire Systems: Vertus® III, Vertus® III+, and DecaVertus® III systems eliminate operator variability, accelerate time-to-market, and improve lab safety.
- Multi-Fire-to-Waste Safety Features: Minimize operator exposure to flammable propellants while protecting the integrity of test samples.
- Regulatory Alignment: Systems are built to comply with USP <601> and other global standards, ensuring your test data stands up to scrutiny.
Getting It Right Matters
Switching to low-GWP propellants is a technical evolution that demands accurate, robust testing solutions. Poorly understood or inadequately validated propellants can lead to batch failures, regulatory delays, or worse, compromised patient safety.
With MSP’s inhaler testing solutions, you’re not just adapting to change. You’re staying ahead of it.
Let’s Build the Future of Inhalation Therapy
The move to greener propellants is more than an environmental choice: it's a technical evolution. Let’s make sure your next-generation pMDIs stay ahead of both.
Ready to future-proof your inhaler testing process?
Explore MSP's Inhaler Testing Automation Solutions
Or contact us directly at mspsales@tsi.com to speak with an expert.