Safety Overview of Zephex® 152a as a Low Global Warming Potential Medical Propellant
Mohar I, Lewandowski TA, Johnson S, Corr S, Leach CL.
Respiratory Drug Delivery 2025. Volume 1, 2025: 57-65.
Abstract:
Inhaled drugs administered by pressurized metered dose inhalers (pMDIs) play a vital role in the treatment of prevalent respiratory conditions such as asthma, rhinitis, and chronic obstructive pulmonary disease (COPD). Propellants that are safe, effective, and compatible with drug formulations are essential for drugs delivered by pMDIs. In alignment with global sustainability goals, 1,1-difluoroethane (HFA-152a; Zephex® 152a) has been developed as a low global warming potential (GWP) pMDI propellant with at least 90% less GWP than current pMDI propellants. The objective of this paper is to provide an overview of the safety of HFA-152a as a new pMDI propellant, including the current nonclinical toxicology program that supports the use of HFA-152a as a medical propellant, available clinical experiences with HFA-152a administered by pMDI, and predicted in-use flammability risk of an HFA-152a pMDI. The available data clearly demonstrate that HFA-152a is safe for use as a medical propellant.
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