Solstice Advanced Materials was created through the 2025 spin-off of the former Advanced Materials business of Honeywell International Inc.

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Formulating HFO-1234ze(E) pMDIs with Ethanol: Flammability Considerations

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Solstice Advanced Materials has extensive research in compatibility with APIs, enabling HFO-1234ze(E) to serve as a near drop-in replacement for HFA-134a. This paper demonstrates that the behaviour of HFO-1234ze(E)-ethanol mixtures closely matches that of HFA-134a-ethanol mixtures.

Transition with ease to low-GWP propellant HFO-1234ze(E)

To meet sustainability targets, the pMDI industry is transitioning from high global warming potential (GWP) hydrofluoroalkane propellants such as HFA-134a and HFA-227ea to lower-GWP alternatives, including HFA-152a and hydrofluoroolefin HFO-1234ze(E). While standard flammability tests classify HFO-1234ze(E) as non-flammable, the handling of bulk manufacturing processes continues to be assessed when flammable cosolvents such as ethanol are introduced.

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References

[1] United Nations Environment Program: The Kigali Amendment to the Montreal Protocol: HFC Phase-down. OzonAction Fact sheet OZS/16/11_1, UNEP, Paris, France: 2016.
[2] AstraZeneca: AstraZeneca progresses Ambition Zero Carbon programme with Honeywell partnership to develop next-generation respiratory inhalers.
[3] Pritchard J N: The climate is changing for metered-dose inhalers and action is needed. Drug Design Dev Ther 2020; 14: 3043–3055.
[4] Giffen P. et al. The Nonclinical Assessment of Trans-1,3,3,3-tetrafluoropropene (HFO-1234ze(E)). Int J Toxicol, 43(1), 4–18.
[5] Giffen P. et al. HFO-1234ze(E): A new generation propellant for use in metered dose inhalers. Tox. Sci. 204(s1), 189.
[6] United Nations: Manual of Tests and Criteria, 8th Revised Edition, 2023, 347–354.
[7] Atkinson N. Considerations for Robust Clinical and Commercial Manufacturing of Next Generation Sustainable Metered Dose Inhalers. Respiratory Drug Delivery, 2022, 75–86.
[8] ICH Q7 Good Manufacturing Practice for Active Pharmaceutical Ingredients – EMA.
[9] 21 CFR Part 211 — Current Good Manufacturing Practice for Finished Pharmaceuticals.

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