Aptar CSP Technologies, part of AptarGroup, Inc. announced that its N-Sorb nitrosamine mitigation solution has been accepted into the U.S. FDA Emerging Technology Program (ETP), which aims to help promote the adoption of innovative approaches to pharmaceutical product design and manufacturing.
 
N-Sorb leverages Aptar CSP Technologies’ 3-Phase Activ-Polymer platform technology to address the pressing issue of N-nitrosamine impurities in pharmaceuticals. These impurities, classified as probable human carcinogens, have raised significant regulatory concerns and prompted numerous drug product recalls. Nitrosamines can form during drug product storage or transport, posing risks to patient health. 
 
N-Sorb technology can be deployed in multiple formats by integrating active material science into polymers. For example, the technology can be incorporated into a blister format that integrates a piece of N-Sorb Activ-Film material into each individual Activ-Blister™ cavity. This same platform is currently used by global brands to protect sensitive Active Pharmaceutical Ingredients (APIs) from degradation due to moisture and oxygen exposure. Alternatively, the technology can be integrated into a container closure system. N-Sorb’s design allows it to react with nitrosamine precursors in the packaging headspace to inhibit nitrosamine formation and scavenge nitrosamine impurities post-formation.
 
By delivering this Generally Recognized as Safe (GRAS) material directly within the packaging, N-Sorb can eliminate the need for pharmaceutical developers to reformulate their drug products, which could support compliance with US FDA and EU EMA regulations regarding safe nitrosamine levels. 
 
By addressing nitrosamine concerns with active packaging, N-Sorb technology can help accelerate drug product development and help alleviate drug shortages due to recalls.
 
“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.”