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Accelerated Development of MDIs with Low GWP Propellants in a QbD Era: Practical, Regulatory and Scientific Considerations

Britto L, Kidd C.

Respiratory Drug Delivery 2023. Volume , 2023: 65-80.

Abstract:

Global warming and climate change are current topics of significant concern around the world. A significant contributor of global warming is the use of hydrofluorocarbons (HFCs) with high global warming potential (GWP). Currently marketed metered dose inhalers (MDIs) contain high GWP propellants, HFC134a and HFC227ea, which contribute significantly to the carbon footprint of pharmaceutical companies that manufacture MDIs. These companies have embarked on replacement with low GWP propellants, such as HFC152a and HFO1234ze(E). There is an expectation from governmental and environmental agencies around the world, as well as Pharma, that this transition should commence as early as 2025 and be fully implemented by 2030. The objectives of this paper are to present methodologies by which timelines can be compressed, while at the same time developing products that meet pharmaceutical quality requirements. These methodologies rely on the utilization of fundamental knowledge and practical experience gained from HFC MDI products developed and manufactured over the last 25 years and the use of Quality by Design (QbD) principles.

The implementation and implications on development timelines of the new Medical Device Regulation in the European Union (EU) also needs to be taken into consideration. Early engagement with a Notified Body and regulatory agencies is highly recommended.