Orbia Advance Corporation, and its Fluor & Energy Materials (F&EM) business has received approval from the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) of Chiesi's Clenil Modulite (beclomethasone; 100 mcg and 200 mcg) inhaler formulated with Orbia F&EM’s next-generation, low-GWP propellant.
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This approval marks the first use of medical-grade HFA-152a, commercially known as Zephex 152a, in a pMDI. The carbon footprint of this propellant is reduced by approximately 90% versus that of the current propellant, HFA-134a and is not classified as a PFAS.
The transition to low-GWP propellants can make a meaningful contribution toward the National Health Service’s (NHS) goal of achieving net-zero emissions by 2040. Globally, pMDI use is increasing and accounts for approximately 70% of the prescribed doses used to treat asthma and COPD, representing more than 43 billion doses annually. The approval is an important milestone in the pharmaceutical industry’s efforts to reduce the environmental impact of respiratory therapies while maintaining continuity of care for patients by preserving device choice.
Markus Laubscher, head of Orbia F&EM’s Pharma Business Unit, said: “For more than three decades Orbia has supported the respiratory pharmaceutical industry, from the first transition in the 1990s which saw the industry move from CFCs to HFAs, to today. This MHRA approval is an important milestone as we continue on that journey. By combining Orbia’s (F&EM) technical expertise and investment in this low-GWP propellant with Chiesi’s leadership in respiratory care, we are helping enable a significant reduction in the carbon footprint of pMDIs while preserving device choice for patients.”
The shift from the world’s most widely used propellant, HFA-134a to low-GWP alternatives is heavily underpinned by widespread investment across the pharmaceutical supply chain. Orbia F&EM is expanding its production capacity to meet forecasted global demand of its Zephex low-GWP propellant through the construction of a large-scale manufacturing facility in Runcorn, U.K., scheduled for completion by the end of 2026.