With new global limits on NDSRIs (Nitrosamine Drug Substance Related Impurities), pharmaceutical companies must work to reduce nitrosamine risks in existing and new drug products. Aptar CSP’s proprietary N-Sorb technology offers a powerful alternative to excipient adjustments, delivering a faster, simpler solution for inhibiting nitrosamine formation inside the packaging headspace.

In a traditional approach to compliance, pharma companies often turn to drug reformulation via excipient adjustment to reduce nitrosamine formation. However, the bioequivalence studies required for reformulation can make the path to approval costly and time consuming. Additionally, in some cases, excipients introduce further challenges by preferentially reacting with nitrite before nitrosation occurs, causing unexpected and unacceptable side reactions like discoloration, malodor, increased degradants, and more.

Engineered to capture nitrosamine precursors from the headspace, N-Sorb inhibits nitrosamine formation at the source, bypassing the need for reformulation and minimizing risk. In a proof-of-concept study, Aptar CSP’s films generally outperformed bulk active inhibiting agents, reducing nitrosamine formation by up to 28%.

N-Sorb technology as an active packaging solution marks a paradigm shift in managing impurities and degradation for sensitive products. Click to view our technical brief exploring the use of N-Sorb films as a promising replacement and/or supplement to current reformulation-based nitrosamine mitigation strategies.