Aptar’s N-Sorb Nitrosamine Mitigation Solution Accepted to US FDA’s Emerging Technology Program
N-Sorb leverages company’s proven 3-Phase Activ-Polymer™ platform technology to address recent concerns related to N-nitrosamine impurities in pharmaceuticals
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Aptar’s N-Sorb Nitrosamine Mitigation Solution. (Photo: Business Wire)
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.
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
“The FDA’s Emerging Technology Program is highly selective, reserved for the most promising pharma and healthcare sector solutions,” said
As part of the program, industry representatives meet with the FDA’s Emerging Technology Team members to discuss, identify and resolve potential technical and regulatory issues related to the development and implementation of novel technologies prior to regulatory submission. This multi-stakeholder effort aligns with the FDA’s mission to facilitate modernization in the pharmaceutical industry, reducing time and cost requirements for introducing novel solutions.
About Aptar
Aptar is a global leader in drug and consumer product dosing, dispensing and protection technologies. Aptar serves a number of attractive end markets including pharmaceutical, beauty, food, beverage, personal care and home care. Aptar CSP Technologies leverages its active material science expertise to transform ideas into market opportunities, accelerate and de-risk the product development process, and provide complete solutions that improve consumers’ and patients’ lives. The company offers a complete set of services from concept ideation, to design and engineering, to product development, global production, quality control, and regulatory support that results in expedited speed-to-market. For more information, please visit www.csptechnologies.com and www.aptar.com.
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