Reducing the environmental impact of pMDI propellants
Åsa Bergström , director of global sustainability at Recipharm , shows how pharmaceutical companies can advance sustainable propellants for pressurised metered dose inhalers
The pharmaceutical industry has an important role to play in tackling climate change by reducing its greenhouse gas ( GHG ) emissions , because it is a major contributor to them . Many companies are exploring innovative solutions in a commitment to minimising their environmental footprint .
A prime example of this is the transition to ‘ green ’ propellants in pressurised metered dose inhalers ( pMDIs ), driven by both the industry ’ s desire to contribute to the Paris Agreement and the realisation of proposed legislative changes . These changes are set to reduce emissions and pave the way for technological advances and reduced climate impact for respiratory products .
Low GWP propellants
Recent legislative trends have specific implications for pMDIs , crucial devices used for delivering medications to individuals suffering from respiratory conditions such as asthma and chronic obstructive pulmonary disease ( COPD ). These changes will require manufacturers to take steps to adapt and transition towards lower global warming potential ( GWP ) propellants . 1
In the light of these implications , it is essential to address the use of hydrofluorocarbon ( HFC ) propellants in pMDIs . These propellants contribute to global GHG emissions and have a notable environmental footprint , with a single pMDI ( 200 doses ) estimated to be equivalent to a 290 km car ride . 2
The pMDI propellant changes have the potential for a substantial positive effect on reducing GHG emissions , given the widespread reliance on pMDIs for respiratory health . Further emphasising the potential significance of these changes to patients , is the large number of people affected by respiratory conditions , with about 212 million people living with COPD and about 262 million people living with asthma globally . 3 - 4
Legislative changes
Legislative changes will prompt drug developers to seek more sustainable drug delivery solutions for their products . These significant changes in the regulatory environment demand attention from pharmaceutical companies . There are three key relevant updates .
The EU Medical Device Regulation has replaced the Medical Device Directive and the Active Implantable Medical Device Directive , which previously governed the design of medical devices , including inhalation device technology .
Under the MDR , all new and modified devices used with medicinal products , including pMDIs , must conform to the general safety and performance requirements of Annex I . In February 2023 , the MDR transition periods
were extended , causing delays in its implementation for specific classifications .
Following the signing of the UN ’ s Kigali Amendment to the Montreal Protocol in 2016 , there have been significant changes in propellant regulations in some markets . This aims to reduce global consumption of HFCs by 80 – 85 % by 2047 , due to their high GWP and long atmospheric life .
New legislation has been enacted or is under consideration in major pMDI markets , such as the EU , the UK and the US , necessitating a transition away from high GWP HFCs in all applications . Although the exact timeline remains uncertain , initiating the shift towards low-GWP propellants is crucial to ensure compliance when timelines are confirmed .
56 SPECIALITY CHEMICALS MAGAZINE ESTABLISHED 1981