Aptar Pharma Announces Progress on Multi-Year U.S. FDA-Funded Research Contract

Contract is Focused on Advancing Transition of Metered‑Dose Inhalers Toward Next-Generation Propellants

CRYSTAL LAKE, Ill.--(BUSINESS WIRE)--Aptar Pharma, a global leader in drug delivery, dosing, protection technologies and services, today announced continued progress on its awarded research contract with the U.S. Food and Drug Administration (FDA) focused on advancing scientific understanding related to the transition of metered‑dose inhalers (MDIs) toward next-generation propellants (NGPs). The research contract, awarded by the FDA in September 2023, is designed to provide support for identifying potential target product profiles of NGP MDIs to achieve comparability in Critical Quality Attributes (CQAs) to existing MDIs, along with identifying sensitive in vitro methods that may be suitable for supporting a bioequivalence assessment.

Advancing Scientific Understanding

Scientific activities conducted within the contract aim to improve understanding of interactions between formulation composition, device design and anatomical variability.

Activities already performed since 2023 include:

• A first drug formulation experimental design performed in 2025 to characterize factors that may have a critical impact on the Target Product Profile, including pilot-scale filling, evaluation of different valve variants and realistic in vitro testing
• A second drug evaluation is ongoing in 2026
• Development of computational modeling to further understand fundamental aerosol physics with different propellant systems.
• Investigation of the properties of the different propellants in isolation, as well as evaluation of the addition of drug in suspension and solution formulations.

Scientific learnings and interim observations have been presented to the FDA throughout the contract in an open and transparent manner.

Through completion of the studies above, Aptar Pharma continues to use its scientific and regulatory expertise and technical capabilities to meet its contracted research objectives and support FDA’s research initiatives on understanding NGP MDIs.

These activities are research‑oriented and are not intended to support specific products, regulatory filings or commercial claims.

Next Steps of the Contract

Following three successful years of the research contract, additional contract options (if awarded following applicable approvals and contracting process) include the potential for an exploratory pharmacokinetic (PK) study designed to evaluate relationships between laboratory‑based and computational findings and in vivo observations.

Scientific Dissemination

Scientific outcomes from the contract will be shared at major scientific conferences, with the next scientific presentation scheduled to be delivered by Aptar Pharma at the Respiratory Drug Delivery (RDD) conference to be held in the United States in May 2026. Peer-reviewed publications are also expected to form part of the dissemination strategy later this year.

Guillaume Brouet, Vice-President Scientific Affairs, Aptar Pharma, stated, “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. Bringing together expertise from across Aptar Pharma’s Scientific and Medical Affairs teams, as well as Nanopharm, an Aptar Pharma company and Aptar Pharma Services, creates a very strong combined unit that can support a broad range of customers, to develop the best products for patients.”

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. Learn more at www.aptar.com.

Media Contact:

Aptar Pharma
Ciara Jackson
ciara.jackson@aptar.com

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