As the pharmaceutical industry advances toward low global warming potential (GWP) propellants like HFA152a and HFO1234ze(E), understanding material compatibility becomes critical, especially when it comes to leachables from common device components.
In a recent evaluation, a group of pulmonary experts at Kindeva assessed the extractable levels associated with various polybutylene terephthalate (PBT) suppliers in pressurized metered dose inhaler (pMDI) formulations containing ethanol and low-GWP propellants. The study was designed to simulate worst-case conditions and generate actionable insights for development teams reformulating with emerging propellant systems.
The findings reinforce the importance of careful material selection and formulation control during the transition to sustainable pMDI technologies:
- Propellant choice affects extractable levels
- Increasing ethanol concentration increases leachables
- PBT grade influences extractable output
- Oligomer presence may impact performance
Understanding the interactions between propellant, co-solvent and material grade is essential for ensuring product stability, safety and compliance as low-GWP formulations progress toward commercialization.
Curious about the full impact of propellant, ethanol and material selection on leachables? Explore the full poster presentation.
Connect with Kindeva to discover how our end-to-end expertise helps future-proof your low-GWP inhalation products by mitigating extractables risk and accelerating sustainable pMDI development.
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