A Critical Year for our Climate
The urgent threat of climate change is the age-defining issue of our generation, and we are reaching a defining moment for our industry. The inhalation industry is committed to reducing its carbon footprint and establishing processes that are more sustainable. A global commitment to establishing a greener future must happen now; the industry’s proactive approach will address the major environmental concerns of pMDI manufacture – the carbon footprint of the propellant. The adverse effects of greenhouse gases on our climate are well documented. This is not a new revelation, rather, this industry has gone through a similar issue before! The issue is adapting the way we formulate MDIs to develop more sustainable products, whilst maintaining safety and functionality.
This article explores the legislative and economic drivers of why the industry needs to adapt, and crucially why now is the time to act. It is also important to ground ourselves and remember why we develop medicines; to better the health of the public and save lives. The effective delivery of medicines still remains a priority. The challenge to produce sustainable products cannot compromise the safety, efficacy, and patient adherence to inhaled medicines. The 1987 Montreal Agreement was the catalyst for the first-wave development of sustainable pMDIs. The successful phase-out of CFCs with F-gases had a positive impact on ozone depletion and to some extent the carbon footprint.1 Through significant investment by the industry, fewer ozone-depleting alternatives were developed (HFA-134a, HFA-227 & DPIs). Manufacturers of pMDIs understand that sustainable products cannot be developed on sentiment alone – it is the commitment to invest that ultimately allows the change to alternative propellant systems! Two major pharmaceutical companies, Astra Zeneca and Chiesi Group, have recently committed to investing in alternative propellant pMDIs. Both companies have committed to launch a ‘greener’ inhaler by 2025.2,3 Other major companies have yet to publicise their commitment. Given the timelines for pharmaceutical product development and regulatory approval of new medicines, 2025 may seem challenging. The importance of acting now is evident for both environmental and economic issues. It is clear the environmental crisis cannot wait; if and when the current propellant supply is phased out, commercial production of current inhalers becomes unrealistic. As a producer of reliever medication, Pharmaserve North West has committed to future-proofing our facilities, products, and processes. The importance of safeguarding the supply of critical medicines has been highlighted through the COVID-19 crisis. It is a collective responsibility to ensure the global delivery of life-saving pMDIs. The issues and challenges posed by the investment into two prospective greener propellants have been addressed as a matter of urgency. Working closely with industry leaders to ensure our approach to the ‘greener’ inhaler does not impact the health of the public.
Proposed Solutions
HFO-1234ze and HFA-152a have been highlighted as potential replacements for HFA-134a and HFA-227ea. Isobutane was also considered and is currently used in topical aerosols; the inhalation safety concerns make this a less favourable option.1 Both propellants address the environmental concerns of pMDIs, however, each has limitations and challenges which must be overcome before commercial production.
It has been well documented that HFA-152a is actively being developed for use in pMDIs. The properties are similar to those of HFA-134a – but critically for suspension formulations, the liquid density is significantly lower. Despite this, early formulation studies have shown that the performance is surprisingly good.4x Although the data is promising, it is critical that further studies are performed to understand the propellant performance for more inhaled APIs and also solution formulations. The performance of HFO-1234ze may look more promising, given the closeness of its properties to HFA-134a. The transferability, due to these similarities, may expedite the development process.
