{"id":2641,"date":"2024-09-25T10:47:56","date_gmt":"2024-09-25T14:47:56","guid":{"rendered":"https:\/\/www.packagingindustrynews.com\/?p=2641"},"modified":"2024-09-25T10:47:56","modified_gmt":"2024-09-25T14:47:56","slug":"aptar-earns-acceptance-to-fdas-emerging-technology-program-for-n-sorb-solution","status":"publish","type":"post","link":"https:\/\/www.packagingindustrynews.com\/?p=2641","title":{"rendered":"Aptar Earns Acceptance to FDA&#039;s Emerging Technology Program for N-Sorb Solution"},"content":{"rendered":"<p> <br \/>\n<br \/><\/p>\n<div>\n<p>Aptar CSP Technologies, part of <a href=\"https:\/\/aptar.com\/\" id=\"\" rel=\"noopener noreferrer\" target=\"_blank\">AptarGroup, Inc.<\/a> and a leader in active material science, announced that its N-Sorb nitrosamine mitigation solution has been accepted into the U.S. Food &amp; Drug Administration\u2019s (FDA) Emerging Technology Program (ETP), which helps promote the adoption of innovative approaches to <a href=\"https:\/\/www.packagingstrategies.com\/topics\/2998-pharma-medical-packaging\" id=\"\" rel=\"noopener noreferrer\" target=\"_blank\">pharmaceutical<\/a> product design and manufacturing.<\/p>\n<p>N-Sorb leverages Aptar CSP Technologies\u2019 proven 3-Phase Activ-Polymer\u2122 platform technology to address the pressing issue of N-nitrosamine impurities in pharmaceuticals. These impurities, classified as probable human carcinogens, have raised significant <a href=\"https:\/\/www.packagingstrategies.com\/keywords\/7742-regulatory-challenges\" id=\"\" rel=\"noopener noreferrer\" target=\"_blank\">regulatory concerns<\/a> and prompted numerous drug product recalls. Nitrosamines can form during drug product storage or transport, posing risks to patient health.<\/p>\n<p>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\u2122 material into each individual Activ-Blister\u2122 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\u2019s intelligent design allows it to react with nitrosamine precursors in the packaging headspace to inhibit nitrosamine formation and scavenge nitrosamine impurities post-formation.<\/p>\n<p>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. The active packaging intervention represents a paradigm shift in managing impurities and degradation, which could significantly enhance overall mitigation strategies and aligns with the latest FDA guidance (updated Sept. 4, 2024) that recognizes packaging changes as a potential mitigation strategy. 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.<\/p>\n<p>\u201cThe FDA\u2019s Emerging Technology Program is highly selective, reserved for the most promising pharma and healthcare sector solutions,\u201d said Badre Hammond, VP Global Commercial Operations and GM for Aptar CSP Technologies. \u201cOur 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\u2019s Emerging Technology team to empower pharma brands with this innovative offering.\u201d<\/p>\n<p>As part of the program, industry representatives meet with the FDA\u2019s 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\u2019s mission to facilitate modernization in the pharmaceutical industry, reducing time and cost requirements for introducing novel solutions.<\/p>\n<\/div>\n<p><br \/>\n<br \/><a href=\"https:\/\/www.packagingstrategies.com\/articles\/105015-aptar-earns-acceptance-to-fdas-emerging-technology-program-for-n-sorb-solution\">Source link <\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>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 &amp; Drug Administration\u2019s (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\u2019 [&hellip;]<\/p>\n","protected":false},"author":5,"featured_media":2642,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_et_pb_use_builder":"","_et_pb_old_content":"","_et_gb_content_width":"","footnotes":""},"categories":[165],"tags":[1253,879,1254,943,880,1175],"class_list":["post-2641","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-packaging-news","tag-aptar-pharma","tag-aptargroup","tag-drug-delivery-applications","tag-fda","tag-inc","tag-regulatory-challenges"],"_links":{"self":[{"href":"https:\/\/www.packagingindustrynews.com\/index.php?rest_route=\/wp\/v2\/posts\/2641","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.packagingindustrynews.com\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.packagingindustrynews.com\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.packagingindustrynews.com\/index.php?rest_route=\/wp\/v2\/users\/5"}],"replies":[{"embeddable":true,"href":"https:\/\/www.packagingindustrynews.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=2641"}],"version-history":[{"count":0,"href":"https:\/\/www.packagingindustrynews.com\/index.php?rest_route=\/wp\/v2\/posts\/2641\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.packagingindustrynews.com\/index.php?rest_route=\/wp\/v2\/media\/2642"}],"wp:attachment":[{"href":"https:\/\/www.packagingindustrynews.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=2641"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.packagingindustrynews.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=2641"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.packagingindustrynews.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=2641"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}