Aptar Active Material Science, part of AptarGroup, Inc., has announced the approval of its patent application for its N-Sorb SM technology by the United States Patent and Trademark Office (USPTO).
The NSorb SM technology reduces nitrosamine impurities in packaging and can be deployed across multiple packaging configurations, including blister systems, bottle formats and film-based structures, enabling integration without changes to formulation or manufacturing processes.
The patent application encompasses both the proprietary material composition and the validated reduction of nitrosamines across multiple active pharmaceutical ingredients (APIs) known to be vulnerable to nitrosamines.
Aptar Active Material Science's statement noted that the patent application included provisions that could support a potential listing in the FDA Orange Book, a public registry of all FDA-approved drugs based on safety and effectiveness and said the application demonstrated the technology's performance on drug products within the scope of the claims.
Additionally, the application explicitly names many APIs with nitrosamine susceptibility. As such, pharmaceutical partners utilising NSorb SM technology may have the opportunity to pursue enhanced regulatory and commercial protection strategies tied to finished product performance.
"This milestone marks a fundamental shift in how the industry can address nitrosamine risk," said Badre Hammond, VP, Global Commercial Operations and GM, APAC for Aptar Active Material Science.
"For the first time, we are bringing together advanced material science and demonstrated drug product performance within a single IP framework."
That combination creates a powerful new lever for our pharmaceutical partners to mitigate risk and establish differentiated regulatory and commercial positions (i.e. Orange Book listing).
"This is a platform innovation with broad implications for product integrity, lifecycle management and patient safety."
The approval of the patent application follows N-Sorb SM technology's acceptance into the US Food & Drug Administration’s (FDA) Emerging Technology Program (ETP) in 2024, which aims to identify and address potential technical and regulatory issues related to novel technologies prior to regulatory submission.
The programme encourages innovative approaches to product design and manufacturing, enabling industry modernisation while reducing timeframes and costs for introducing new solutions.