Orbia Fluor & Energy Materials (Orbia) has published new research outlining the regulatory environment needed to transition successfully to low-GWP medical propellants for pressurised metered dose inhalers (pMDIs).
The whitepaper, developed in partnership with DLRC Group, focuses on guidance that can support switching propellant for existing medical products.
A 2021 study in the BMJ Open Respiratory Research journal found that switching to pMDIs containing low-GWP propellants can achieve an 89% reduction in total CO2 emissions from inhalers.
Next-generation medical propellant products, such as Orbia’s Zephex 152a, are proven to reduce the carbon emissions of the propellant gas by 90%.
Low-GWP products like Zephex 152a directly address the aims of the Kigali Amendment to the Montreal Protocol, which state the need to reduce hydrofluorocarbon (HFC) production and consumption by more than 80% by 2050.
Orbia and DLRC highlight the stepwise approach advocated by the EMA for demonstrating therapeutic equivalence in the research paper, concluding that the higher solvency power of third-generation propellants may require less redevelopment of device components than previous transitions.
It also highlights the need for increased collaboration between medical propellant manufacturers, such as Orbia, and pharmaceutical companies to produce robust data packages that support the transition to low-GWP alternatives.
A growing number of pharmaceutical companies, like AstraZeneca, Chiesi and GSK, are switching to low-GWP propellants to meet new regulatory requirements.
James Murray, Programme Manager at Orbia Fluor & Energy Materials, and one of the authors of the paper, said: “With new environmental regulations now coming into effect, there’s a growing low-GWP medical propellants."
"With this paper, we are pleased to be able to demonstrate our support for our customers who need to navigate this complex regulatory landscape.”
Ian Ashurst, Principal Regulatory Consultant at DLRC, said: “This is the second time that the pharmaceutical industry has been through a propellant transition with pMDIs; the first time was in the 1990s when the ozone-depleting CFC-based propellants were replaced with the current HFA propellants."
"That was a difficult and prolonged transition. Significant learnings have been taken from that experience, and the current transition is expected to be much smoother."
"Our joint whitepaper will help companies understand the background and the regulatory requirements for this current transition to ensure their developments are efficient and effective.”