SUSTAINABILITY
For example , in June 2020 , the European Commission launched a consultation to review its current fluorinated gas ( F-gas ) legislation , which reported its recommendations in April 2022.5 A new , more aggressive F-gas phase-down schedule has been proposed ; it also removes all exemptions , including pMDIs , that previously accounted for emissions totalling around 5 % of baseline .
Finally , there is REACH regulations for per- and polyfluorinated alkyl substances . In January 2023 , national authorities from Germany , the Netherlands , Norway , Sweden and Denmark submitted a joint restriction proposal . This calls for restrictions on any substance that has a CF 2 or
CF 3 group – properties shared by HFC and HFO ( hydrofluoroolefin ) refrigerants and propellants .
While this proposal is pending , if it is enforced from 2025 , the pMDI industry would have to adapt quickly and remove pMDIs containing the restricted gases from the European market , impacting the supply of inhalation drug products . Any changes to this regulation would , in practice , override the F-gas regulation . There is a concern in the pMDI industry that this is a catchall proposal that includes non-hazardous propellants vital to an orderly F-gas phase-down .
Key challenges
The fast adoption of lower and near-zero GWP propellants safe for pharmaceutical use is essential to ensure that people with respiratory conditions , such as COPD and asthma , do not lose access to medication . The challenge of adopting low GWP propellants for pMDIs requires careful consideration of formulation , device compatibility , regulatory requirements and patient safety .
Balancing compatibility with current formulations , maintaining component performance , navigating stringent regulations , ensuring a stable supply chain and upholding patient safety are integral aspects . Comprehensive formulation development , advanced analytical testing and rigorous
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