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Aptar CSP Technologies, part of AptarGroup, Inc. and a leader in active material science, announced that its N-Sorb nitrosamine mitigation solution has been accepted into the U.S. Food & Drug Administration’s (FDA) Emerging Technology Program (ETP), which helps promote the adoption of innovative approaches to pharmaceutical product design and manufacturing.
N-Sorb leverages Aptar CSP Technologies’ proven 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 trusted by global brands to protect sensitive Active Pharmaceutical Ingredients (APIs) from degradation due to moisture and oxygen exposure. Alternatively, the technology can be seamlessly integrated into a container closure system. N-Sorb’s intelligent design allows it to react with nitrosamine precursors in the packaging headspace to inhibit nitrosamine formation and scavenge nitrosamine impurities post-formation.
