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A Journey to Net Zero Using Solstice Air

Hulse R, Boldt E, Decaire B, Smith G.

Respiratory Drug Delivery 2022. Volume , 2022: 97-102.

Abstract:

Within recent years there has been a global push by industry and governments to combat climate change. Greenhouse gases are major contributors to global warming and there has been a concerted effort to reduce their use. Pressurized metered dose inhalers (pMDIs) currently utilize hydrofluoroalkane (HFA)-134a and HFA-227ea, which have global warming potentials over 1000 times greater than carbon dioxide.

Hydrofluoroolefin (HFO)-1234ze(E) is a replacement to HFA propellants and exhibits favorable environmental, physical, and toxicological properties. With a near-zero global warming potential, it is nonflammable (per ASTM E-681 and ISO 10156) and is currently being used as a near drop-in replacement for HFA-134a in other applications. Preliminary formulation studies show good compatibility with common excipients and active pharmaceutical ingredients (APIs), suggesting comparable performance to current HFA-134a formulations. Completed toxicology studies have been reviewed by the US Food and Drug Administration (FDA) and Committee for Medicinal Products for Human Use (CHMP). HFO-1234ze(E) is scheduled for Phase III clinical trials with anticipated product launch in 2025.

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