The U.S. Food & Drug Administration has accepted Crystal Lake, Ill.-based Aptar Pharma's N-Sorb nitrosamine mitigation solution into its Emerging Technology Program, which works with companies on new product design and manufacturing technology to identify and resolve potential issues prior to regulatory submission.
The drug delivery supplier's new technology, which would pull unwanted compounds out of drugs, could be used in many formats, including pill blister packages that integrate a piece of N-Sorb Activ-Film into each blister cavity, the company said in a press release, previously reported by Crain's Chicago Business.
Nitrosamines can form during drug product storage or transport, posing risks to patient health, the release said. While nitrosamines are common in water and foods, including cured and grilled meats, dairy products and vegetables, the FDA has recommended recalls for drugs that contain more than the internationally recognized acceptable daily intake limits for the chemicals.
Aptar's film would react with nitrosamine precursors in the packaging that inhibit nitrosamine formation and to pick up, or "scavenge," nitrosamine impurities after they've formed, the release said. The technology uses the same format pharmaceutical companies use to protect sensitive active pharmaceutical ingredients from degrading because of exposure to moisture and oxygen.
Among the types of drugs the FDA says contain nitrosamines are the antacid nizatidine; the diabetes drug metformin; the smoking cessation aid varenicline, branded as Chantix; tuberculosis medicines rifampin and rifapentine; and blood pressure medications using angiotensin II receptor blockers, such as valsartan, losartan and irbesartan.
On Sept. 4, the FDA released its latest guidelines to drug companies giving manufacturers a timeline for implementing recommendations for detecting and preventing unacceptable levels of nitrosamine impurities in their products.
The regulator provided guidance on root causes of nitrosamine impurities, detection of them and recommendations for risk assessments, testing and implementation of controls, including packaging that would prevent nitrosamine formation.
Aptar, in its release, said that N-Sorb packaging can eliminate the need for pharmaceutical developers to reformulate their drug products yet remain compliant with the FDA and European drug regulators' standards.
"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," the release said. "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 that recognizes packaging changes as a potential mitigation strategy."
"Our ability to mitigate nitrosamine formation with active material science introduces a critical quality control element, designed to ensure patient safety," Badre Hammond, vice president of global commercial operations and general manager for Aptar CSP Technologies, said in the release.
