The next few years will see substantial changes for pressurised metered-dose inhalers (pMDIs). As a result of emerging regulations such as the European Union’s F-Gas legislation and the Kigali Amendment to the Montreal Protocol on Substances that Deplete the Ozone Layer, the pharmaceutical industry is working to transition to more sustainable inhalers with reduced environmental impact.

In this article, Craig Sommerville, Senior Vice President of the Metered-Dose Inhaler (MDI) business unit at Kindeva, will discuss how companies can respond to these changes without compromising performance or patient welfare, and how they can act strategically to ensure they are prepared for future opportunities and regulatory shifts.

The “Green” Focus on pMDIs
As countries around the world look to mitigate the effects of climate change, there has been a renewed focus on the propellants used in inhalers.

In 1987, the Montreal Protocol was adopted, precipitating the phasing-out of ozone-depleting substances such as chlorofluorocarbons (CFCs) worldwide. At the time, collaboration and innovation enabled the industry to navigate a transition that has left a lasting legacy.

Nearly 30 years later, in 2016, the Kigali Amendment was signed, turning the world’s attention to the hydrofluorocarbons (HFCs) that effectively replaced them.

Companies are now looking to replace the current pMDI propellants – such as HFA-134a and HFA-227ea – with more environmentally friendly alternatives with a significantly reduced global warming potential (GWP). HFA-152a and HFO-1234ze have a GWP that is 90% and 99.9% lower than HFA-134a.

Economics also plays a part in the shift. The price of HFA-227ea has risen considerably in recent years, and HFA-134a prices are expected to follow the same trend.

Taking a Holistic Approach
With the regulatory focus currently trained on pMDIs, it may be tempting for companies to consider a switch away to other types of inhaler devices, such as dry powder inhalers (DPIs). However, this is where companies should take a step back and take a more holistic, strategic view. While it is imperative to reduce environmental impact, the industry must also consider the impact of any change as a whole, and plan for longer-term sustainability and compliance.