AptarGroup, Inc. (NYSE: ATR), a global leader in dosing, dispensing, and protection technologies for drug and consumer products, announced that its N-Sorb nitrosamine mitigation solution has been accepted into the U.S. Food & Drug Administration’s (FDA) Emerging Technology Program (ETP). This program encourages the adoption of innovative technologies in pharmaceutical product design and manufacturing.
N-Sorb, developed by Aptar CSP Technologies, utilizes the 3-Phase Activ-Polymer™ platform to address the growing concern of N-nitrosamine impurities in pharmaceuticals. These impurities, considered probable human carcinogens, have led to numerous drug recalls due to regulatory concerns. Nitrosamines can form during the storage or transportation of drugs, presenting a potential risk to patient safety.
The N-Sorb technology is adaptable and can be incorporated into various formats, such as a blister format where N-Sorb Activ-Film™ material is placed within each Activ-Blister™ cavity. This same platform is widely used by global brands to protect Active Pharmaceutical Ingredients (APIs) from moisture and oxygen degradation. Additionally, N-Sorb can be integrated into container closure systems. Its advanced design allows it to react with nitrosamine precursors in the packaging headspace, preventing nitrosamine formation and scavenging impurities post-formation.
By embedding this Generally Recognized as Safe (GRAS) material directly within the packaging, N-Sorb eliminates the need for pharmaceutical companies to reformulate their drug products. This approach helps ensure compliance with U.S. FDA and EU EMA regulations on nitrosamine safety levels. The active packaging technology represents a significant shift in managing impurities and degradation, aligning with the latest FDA guidance (updated Sept. 4, 2024), which highlights packaging as a potential strategy for mitigating nitrosamine risks. By addressing these concerns, N-Sorb can accelerate drug development and help prevent recalls that contribute to drug shortages.
“The FDA’s Emerging Technology Program is highly selective, recognizing only the most promising innovations in the pharmaceutical and healthcare sectors,” said Badre Hammond, VP of Global Commercial Operations and GM for Aptar CSP Technologies. “Our ability to mitigate nitrosamine formation with active material science introduces a key quality control measure aimed at ensuring patient safety. We look forward to working with the FDA’s Emerging Technology team to empower pharmaceutical companies with this innovative solution.”
As part of the program, Aptar will engage with the FDA’s Emerging Technology Team to address technical and regulatory challenges related to the development and implementation of novel technologies before they reach regulatory submission. This collaborative effort supports the FDA’s mission to modernize the pharmaceutical industry, helping to reduce the time and costs associated with introducing cutting-edge solutions.
