Publications, Pharmaceutical

Navigating pMDI Reformulation 2.0

Inhalers are a crucial medical device for people suffering from respiratory conditions such as asthma and chronic obstructive pulmonary disease (COPD). However, the use of pressurized metered-dose inhalers (pMDIs) has been linked to a significant environmental impact due to the propellants used, which contribute to greenhouse gas emissions. This has led to increased efforts to develop low global warming potential (GWP) inhalers that minimize the environmental impact.

This article examines possible responses to the environmental impact of pMDI use, the pros and cons of different inhaler types and our expertise in reformulation activities. It also reviews the strategies and support that we can offer to accelerate and derisk the development of the next generation of pressurized metered dose inhalers.

Alternative inhaler types such as dry powder inhalers (DPIs) and soft mist inhalers (SMIs) have been developed, which have a lower environmental impact and can be equally effective for patients. However, there are some limitations to these alternative inhaler types, such as the need for strong inhalation effort with DPIs, and the complexity of use and potential for increased cost with SMIs.

Earlier reformulation activities have shown that it is possible to develop inhalers with low environmental impact propellants and thus maintain the patients’ compliance. Aptar Pharma offers strategies and support to accelerate the development of the next generation of pMDIs, including the use of Low GWP Inhaler technology and SmartTrack™,  a novel integrated solution providing an alternative bioequivalence (BE) clinical endpoint approach to pMDI development. SmartTrack™ can dramatically decrease program costs, mitigate risk and expedite development from concept to delivery, ensuring that every aspect of a drug product development’s critical path is optimized.

In conclusion, the development of low GWP propellant inhalers and the reformulation of existing inhalers is a crucial step in minimizing the environmental impact of inhaler use. While there are pros and cons to alternative inhaler types, the lessons learned from earlier reformulation activities provide a roadmap for the development of more environmentally friendly and effective inhalers. Aptar Pharma’s end-to-end services can support the development of the next generation of inhalers, including pMDIs with low environmental impact propellants and innovative approaches to alterative bioequivalence using SmartTrack.

For more information on ONdrugDelivery.

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Author(s): Chris Baron Will Ganley
24 Apr 2023

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in Inhalation Drug Delivery

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