Aptar Pharma Advances FDA-Supported Research on Next-Generation Propellants for Metered-Dose Inhalers
Aptar Pharma, a global company specializing in drug delivery systems, dosing technologies, protection solutions, and pharmaceutical services, has announced continued progress in its multi-year research collaboration with the U.S. Food and Drug Administration focused on the future development of next-generation propellants for metered-dose inhalers (MDIs).
The research initiative, originally awarded by the FDA in September 2023, is designed to improve scientific understanding surrounding the transition from traditional inhaler propellants to newer, more environmentally sustainable alternatives. The contract supports research aimed at identifying target product profiles for next-generation propellant MDIs while also evaluating methods that could support future bioequivalence assessments and regulatory pathways.
The collaboration reflects growing industry and regulatory attention on reducing the environmental impact of inhalation therapies while ensuring patients continue receiving safe, effective, and reliable respiratory medications. Metered-dose inhalers remain one of the most widely used drug delivery systems for respiratory conditions such as asthma and chronic obstructive pulmonary disease (COPD), but conventional propellant systems have faced increasing scrutiny because of their greenhouse gas impact.
As pharmaceutical manufacturers and healthcare organizations pursue more sustainable technologies, the transition toward next-generation propellants has become a major focus within the respiratory drug delivery industry. However, replacing existing propellant systems involves substantial scientific and technical challenges because even small formulation or device changes can affect aerosol performance, dose delivery, and therapeutic outcomes.
According to Aptar Pharma, the FDA-supported research program is intended to generate a stronger scientific foundation for understanding how formulation composition, inhaler device design, and patient anatomical variability interact within next-generation propellant systems.
The company stated that several important scientific activities have already been completed since the start of the contract in 2023. Among the most notable developments was the completion of a first drug formulation experimental design study conducted in 2025. This work was designed to identify factors that may critically influence the target product profile of next-generation propellant inhalers.
The experimental program included pilot-scale filling operations, evaluation of multiple valve variants, and realistic in vitro testing intended to simulate practical inhaler performance under clinically relevant conditions. These studies were designed to better understand how various device and formulation variables influence aerosol characteristics and delivery consistency.
Aptar Pharma also confirmed that a second drug evaluation study is currently ongoing in 2026 as part of the broader research initiative. The additional work is expected to expand understanding of how different active pharmaceutical ingredients and formulations behave within alternative propellant systems.
Another major component of the research program involves the development of advanced computational modeling capabilities. According to the company, these models are being used to investigate the underlying aerosol physics associated with different propellant technologies. Computational modeling can provide valuable insights into particle generation, dispersion behavior, and lung deposition patterns while helping researchers predict how inhalers may perform across diverse patient populations.
The research team has additionally been studying the physical and chemical properties of different propellant systems both independently and in combination with drug formulations. This includes evaluations involving both suspension-based and solution-based inhaler formulations.
Understanding these interactions is considered particularly important because propellant characteristics can directly influence particle stability, spray performance, drug distribution, and overall therapeutic delivery. Achieving comparable performance between existing inhalers and next-generation alternatives remains one of the key objectives of ongoing industry research efforts.
Aptar Pharma noted that scientific findings and interim observations generated throughout the project have been shared with the FDA in an open and transparent manner during the course of the contract. The company emphasized that the collaboration is intended to support broader scientific understanding and regulatory research objectives rather than any single commercial product or specific regulatory filing.
The company also highlighted its ongoing use of internal scientific, regulatory, and technical expertise to support the FDA’s efforts in evaluating future pathways for next-generation propellant inhalers.
The transition to newer propellant systems is expected to represent one of the most significant technological shifts in the respiratory drug delivery sector in decades. Historically, the inhalation industry has already undergone major propellant transitions, including the movement away from chlorofluorocarbon (CFC)-based systems following global environmental agreements targeting ozone depletion.
The current transition toward lower global warming potential propellants introduces another complex phase of innovation and regulatory evaluation for pharmaceutical companies and device manufacturers. Industry stakeholders must balance environmental objectives with strict requirements for therapeutic equivalence, product stability, patient usability, and manufacturing scalability.
The FDA contract awarded to Aptar Pharma seeks to contribute important scientific evidence supporting these efforts. In particular, the research aims to identify sensitive in vitro methodologies that may help evaluate bioequivalence between existing inhalers and future next-generation propellant products.
Bioequivalence assessment remains a critical component of regulatory approval pathways because inhaled therapies involve highly complex interactions between devices, formulations, aerosol properties, and patient physiology. Unlike many oral medications, inhalation products require careful evaluation of aerodynamic particle behavior and deposition patterns to ensure comparable clinical performance.
According to Aptar Pharma, additional future phases of the contract could include an exploratory pharmacokinetic study if contract options are awarded following applicable approvals and contracting procedures. Such a study would aim to evaluate the relationship between laboratory-generated data, computational findings, and in vivo observations.
Pharmacokinetic research could potentially provide further insight into how next-generation propellant inhalers behave within the body and how closely they replicate the performance of currently marketed products.
Beyond the research itself, Aptar Pharma indicated that scientific dissemination remains an important component of the overall initiative. Findings from the contract are expected to be presented at major scientific conferences and shared through peer-reviewed publications.
The next scheduled scientific presentation related to the program is expected to take place at the Respiratory Drug Delivery Conference 2026, commonly known as RDD, which is scheduled to be held in the United States in May 2026. The Respiratory Drug Delivery conference is widely recognized as one of the leading global scientific forums dedicated to pulmonary and nasal drug delivery technologies.
Aptar Pharma stated that peer-reviewed scientific publications are also expected later this year as part of the company’s broader dissemination strategy.
Guillaume Brouet, Vice-President of Scientific Affairs at Aptar Pharma, emphasized the company’s commitment to supporting both scientific advancement and sustainability within the inhalation sector.
According to Brouet, the successful execution of the research contract objectives reflects Aptar Pharma’s broader efforts to help support a significant industry transition toward environmentally improved inhalation technologies. He also highlighted the collaborative contributions from the company’s Scientific and Medical Affairs teams, as well as support from Nanopharm, an Aptar Pharma company, and Aptar Pharma Services.
Brouet noted that combining expertise across these specialized groups enables Aptar Pharma to support a broad range of pharmaceutical customers developing respiratory products for patients worldwide.
As healthcare systems and pharmaceutical companies increasingly prioritize sustainability initiatives, research programs like the FDA-Aptar collaboration are expected to play an important role in shaping the future of respiratory medicine. The development of scientifically validated, lower-impact inhaler technologies may ultimately help the industry achieve environmental goals while maintaining the high standards of safety and therapeutic performance required for respiratory care.
With continued research activities, expanding computational analysis, and potential future clinical investigations, Aptar Pharma’s ongoing collaboration with the FDA represents a significant contribution to the evolving landscape of next-generation inhalation therapies and sustainable drug delivery innovation.
About Aptar Pharma
Aptar Pharma is part of AptarGroup, Inc., a global leader in drug delivery, dosing and protection technologies, and consumer product dispensing. Aptar partners with the world’s top healthcare and consumer brands to deliver medicines and create exceptional user experiences. Serving diverse markets, from pharmaceutical to beauty to food and beverage, Aptar combines market expertise with proprietary design, engineering and science to develop innovative solutions that help improve lives worldwide. Headquartered in Crystal Lake, Illinois, Aptar employs 14,000 dedicated people across 20 countries.
