CRYSTAL LAKE, Illinois, May 7, 2026
Aptar Pharma announced continued progress under its multi-year U.S. Food and Drug Administration (FDA)-funded research contract focused on supporting the transition of metered-dose inhalers (MDIs) toward environmentally sustainable next-generation propellants (NGPs). The contract, originally awarded by the FDA in September 2023, is designed to expand scientific understanding of how inhaler formulation composition, device engineering, aerosol physics, and patient variability interact as the pharmaceutical industry moves away from legacy propellants toward lower global warming potential alternatives. The initiative represents one of the most important ongoing collaborative regulatory research programs within the inhalation drug delivery sector as pharmaceutical manufacturers prepare for major global sustainability-driven changes affecting respiratory medicines.
FDA-Funded Research Supports Transition to Sustainable Inhaler Technologies
The ongoing research program aims to establish scientific frameworks that may help future NGP-based inhalers achieve comparable Critical Quality Attributes (CQAs) to currently approved MDIs while also identifying advanced in vitro testing methods potentially suitable for supporting bioequivalence assessments. As global healthcare systems increasingly prioritize sustainability and environmental impact reduction, the transition toward low global warming potential inhaler propellants has become a major strategic objective for both regulators and respiratory drug manufacturers. Traditional metered-dose inhalers rely on hydrofluoroalkane propellants, which contribute to greenhouse gas emissions and are expected to face growing regulatory pressure globally over the coming decade.
According to Aptar Pharma, scientific activities conducted under the FDA contract are intended to improve understanding of complex interactions between drug formulation characteristics, inhaler device design, propellant systems, aerosol delivery behavior, and patient anatomical variability. Since the contract’s initiation in 2023, Aptar Pharma has completed several major scientific activities, including a first experimental formulation design study performed in 2025 that evaluated factors potentially influencing inhaler target product profiles. These studies included pilot-scale filling operations, analysis of different valve variants, and realistic in vitro performance testing under conditions intended to simulate actual inhaler use scenarios. The company confirmed that a second drug formulation evaluation program is currently ongoing in 2026.
Computational Modeling and Aerosol Science Drive Development Efforts
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A major component of the contract involves development of advanced computational modeling systems designed to better understand aerosol physics across multiple propellant platforms. Aptar Pharma stated that researchers are evaluating the behavior of different propellant systems both independently and in combination with suspension and solution-based drug formulations. These investigations are expected to generate valuable scientific insights regarding aerosol generation, particle distribution, formulation stability, and drug delivery efficiency — all critical performance factors for next-generation inhaler products.
The company emphasized that scientific learnings and interim findings generated through the program have been presented to the FDA in an open and transparent manner throughout the contract period. Aptar Pharma noted that the work remains entirely research-oriented and is not intended to support any specific commercial products, regulatory filings, or promotional claims. Instead, the broader goal is to strengthen scientific understanding that may eventually support industry-wide development of future environmentally sustainable inhalation therapies.
Additional future contract options under consideration could include an exploratory pharmacokinetic (PK) study designed to evaluate relationships between laboratory-based findings, computational modeling outputs, and real-world in vivo observations. Such studies could play an important role in helping regulators and developers establish future bioequivalence and performance evaluation standards for inhalers utilizing alternative propellant technologies.
Respiratory Drug Delivery Innovation Remains a Key Industry Priority
The transition toward next-generation inhaler propellants has emerged as one of the most significant technical and regulatory challenges facing the respiratory pharmaceutical industry. Millions of patients worldwide rely on MDIs for treatment of asthma, chronic obstructive pulmonary disease (COPD), and other respiratory disorders, making preservation of clinical performance and patient usability critical during any reformulation transition. At the same time, healthcare companies face increasing pressure to reduce carbon emissions and adopt more sustainable manufacturing and product development strategies.
Aptar Pharma stated that findings from the FDA-funded research program will continue to be disseminated through major scientific conferences and peer-reviewed publications. The company confirmed that additional data will be presented at the upcoming Respiratory Drug Delivery (RDD) Conference scheduled to take place in the United States during May 2026. Guillaume Brouet, Vice-President Scientific Affairs at Aptar Pharma, stated that the project demonstrates the company’s commitment to advancing both scientific innovation and sustainability within inhalation drug delivery technologies. He noted that Aptar Pharma’s combined expertise across scientific affairs, device engineering, regulatory science, Nanopharm, and Aptar Pharma Services has created an integrated development platform capable of supporting a broad range of inhalation product innovation initiatives for global healthcare customers.
Source: Aptar Pharma press release
