The Future of Breathing: Greener Inhalers on the Horizon

CRYSTAL LAKE, IL – May 07, 2026 – In a significant step toward a more sustainable future for respiratory care, Aptar Pharma has announced continued progress on a multi-year research contract with the U.S. Food and Drug Administration (FDA). The collaboration aims to address a critical environmental and public health challenge: transitioning the world’s most common inhalers to a new generation of climate-friendly propellants without compromising patient safety or drug efficacy.

The project, initiated in September 2023, focuses on metered-dose inhalers (MDIs), the ubiquitous puff-style devices relied upon by millions of patients with asthma and chronic obstructive pulmonary disease (COPD). While life-saving, these devices currently use hydrofluorocarbons (HFCs) as propellants—potent greenhouse gases with a global warming potential thousands of times greater than carbon dioxide. Aptar's work is laying the scientific groundwork for an industry-wide shift, a move mandated by international treaties and growing regulatory pressure.

A Mandate Driven by Climate Science

The urgency behind this transition is rooted in stark environmental data. The HFCs used in MDIs, such as HFA-134a, contribute significantly to healthcare's carbon footprint. In the United States alone, MDI emissions were once estimated to be equivalent to the annual tailpipe emissions of over half a million cars. Globally, MDIs can account for as much as 3-4% of the entire carbon footprint of national health systems like the UK’s National Health Service.

This impact has not gone unnoticed. Global regulations, including the 2016 Kigali Amendment to the Montreal Protocol, mandate a steep phasedown of HFC production and use. The European Union's stringent F-gas regulations, updated in early 2024, are accelerating this timeline, with HFC quotas set to tighten dramatically by 2030. Similarly, the U.S. Environmental Protection Agency (EPA) is implementing its own HFC restrictions under the American Innovation and Manufacturing (AIM) Act.

While lower-carbon alternatives like dry powder inhalers (DPIs) exist, MDIs remain clinically indispensable for many patients, including young children, the elderly, and those experiencing acute breathing emergencies. This makes reformulating MDIs with low global warming potential (GWP) propellants not just an environmental goal, but a public health necessity.

The Intricate Science of a Propellant Pivot

Replacing the propellant in an MDI is far from a simple swap. It is a complex scientific and engineering challenge that affects every aspect of the drug delivery system. A new propellant can alter the drug’s solubility, the stability of the formulation, the pressure inside the canister, and the way the medicine is aerosolized and delivered deep into the lungs. Even minor changes can have a major impact on the device's safety and effectiveness.

This is where the Aptar-FDA research becomes pivotal. The work is designed to de-risk the transition for the entire pharmaceutical industry by building a foundational scientific understanding. Since 2023, Aptar's activities have included:

• Advanced Formulation Studies: Characterizing how different next-generation propellant (NGP) formulations interact with drug compounds, with one major experimental design completed in 2025 and a second drug evaluation currently underway.
• Computational Modeling: Developing sophisticated computer models to simulate and predict the aerosol physics of different propellant systems, reducing the need for extensive physical trial and error.
• Device and Component Evaluation: Testing various valve designs and other MDI components to ensure they perform reliably and consistently with the new propellants.
• Bioequivalence Methods: A primary goal is to identify sensitive in vitro (laboratory-based) testing methods that can accurately predict how an NGP inhaler will perform in the human body. This could streamline the regulatory approval process by demonstrating that a new NGP MDI is bioequivalent to its HFC predecessor, potentially reducing the need for large-scale clinical trials for every reformulated product.

A Public-Private Blueprint for Modernizing Medicine

The FDA's decision to fund this foundational research highlights a proactive strategy to safeguard public health. By partnering with an industry leader like Aptar, the agency is ensuring that the inevitable transition away from HFCs is guided by robust science, regulatory foresight, and a primary focus on patient well-being.

This public-private partnership serves as a blueprint for future-proofing essential medicines against emerging environmental and supply chain challenges. As HFC phasedowns make existing propellants scarcer and more expensive, the lack of proven, approved alternatives could create a public health crisis. The FDA's investment is a preemptive measure to ensure a stable and continuous supply of respiratory medications for the millions who depend on them.

Guillaume Brouet, Vice-President of Scientific Affairs at Aptar Pharma, commented on the significance of the work in the company's announcement. “Aptar Pharma’s commitment to advancing both the science and sustainability of inhalation products is demonstrated through its successful completion of its research contract objectives, supporting a significant transition in the industry,” he stated. The project draws on expertise from across Aptar's divisions, including its specialized Nanopharm and Aptar Pharma Services units.

An Industry in Motion

Aptar is not alone in this endeavor; the entire pharmaceutical industry is mobilizing. Major companies like AstraZeneca, GSK, and Chiesi have all announced multi-billion dollar programs to develop their own low-GWP inhalers, with some targeting launches as early as 2025 or 2026. These companies are working with propellant manufacturers like Honeywell and Koura, who are developing the next-generation propellants, such as HFO-1234ze and HFA-152a, which offer a GWP reduction of over 99%.

As the industry moves forward, the scientific knowledge generated from the Aptar-FDA contract will be crucial. The findings are being shared openly to benefit the entire field, with the next major presentation scheduled for the Respiratory Drug Delivery (RDD) conference taking place this month. Peer-reviewed publications are also expected later this year.

The research may also expand to include an exploratory pharmacokinetic (PK) study, which would evaluate the relationship between laboratory findings and observations in human subjects, further bridging the gap between benchtop science and patient care. Ultimately, this collaborative effort aims to ensure that when patients reach for their inhaler, they receive a life-saving medicine that is safe for them and safer for the planet.