AptarGroup, Inc. (NYSE: ATR) has announced that its N-Sorb nitrosamine mitigation solution has been accepted into the U.S. FDA's Emerging Technology Program (ETP). This program aims to foster innovative approaches to pharmaceutical product design and manufacturing.
N-Sorb leverages Aptar CSP Technologies’ 3-Phase Activ-Polymer™ platform to tackle the issue of N-nitrosamine impurities in pharmaceuticals. These impurities are classified as probable human carcinogens, raising regulatory concerns and leading to drug recalls. Nitrosamines can form during drug product storage or transport, posing risks to patient health.
How N-Sorb Works
N-Sorb technology can be integrated into blister packaging or container closure systems. The active material reacts with nitrosamine precursors in the packaging headspace, inhibiting nitrosamine formation and scavenging existing impurities. This approach delivers a Generally Recognized as Safe (GRAS) material directly within the packaging.
Potential Benefits
By using N-Sorb, pharmaceutical developers may avoid the need to reformulate their drug products, facilitating compliance with US FDA and EU EMA regulations regarding safe nitrosamine levels. According to Aptar, this active packaging intervention represents a shift in managing impurities and degradation, enhancing overall mitigation strategies and aligning with the latest FDA guidance that recognizes packaging changes as a potential mitigation strategy. The company states that by addressing nitrosamine concerns with active packaging, N-Sorb technology can help accelerate drug product development and help alleviate the burden of drug shortages due to recalls.
Expert Commentary
"The FDA’s Emerging Technology Program is highly selective, reserved for the most promising pharma and healthcare sector solutions," said Badre Hammond, VP Global Commercial Operations and GM for Aptar CSP Technologies. "Our ability to mitigate nitrosamine formation with active material science introduces a critical quality control element, designed to ensure patient safety. We are eager to collaborate with the FDA’s Emerging Technology team to empower pharma brands with this innovative offering."
Implications of ETP Acceptance
Acceptance into the ETP provides an opportunity for Aptar to engage with the FDA’s Emerging Technology Team to address potential technical and regulatory issues related to the technology’s development and implementation. This collaboration aligns with the FDA’s mission to facilitate modernization in the pharmaceutical industry, potentially reducing the time and cost associated with introducing novel solutions.
