Point of view: Product development considerations for transition to LGWP propellants in MDIs: “Status Quo” versus a “Scientifically Rationalized Approach”

In the mid-1990’s, substitution of chlorofluorocarbon (CFC) propellants with hydroflouroalkane (HFA) propellants in metered dose inhalers was made to address the ozone depleting potential of CFCs. The transition was supported by full clinical development programs that were extensive, expensive and extremely time-consuming. HFAs were considered acceptable until their identification and classification as global warming gases, which has triggered efforts for a change to a new generation of low global warming potential (LGWP) propellants.

The ongoing clinical developments to support transition to LGWP propellants can either follow the “Status Quo” or be streamlined by accommodating advances in the relevant scientific disciplines and exceptional scientific contributions from the Office of Generic Drugs (OGD), US Food and Drug Administration (FDA). If incorporated in product development, these advances could help expedite the LGWP propellant transition and potentially save millions of dollars spent on clinical programs. This article examines the Status Quo in view of relevant scientific advancements and regulatory developments and proposes a “Scientifically Rationalized Approach (SRA)” to impart both efficiency and cost-effectiveness to support the MDI transition to LGWP propellants.