Development and Optimization of The Delayed Release Pellets to Minimize The Nitrosamine and Related Impurities

Abstract

The pharmaceutical industry is increasingly worried about nitrosamine impurities because of their possible cancer-causing effects. The presence of these impurities in drug products has led to numerous product recalls and regulatory actions. This abstract presents an overview of nitrosamine impurities from a formulation perspective, focusing on their formation mechanisms, detection methods, and mitigation strategies. Mitigating the presence of nitrosamine impurities requires a comprehensive approach throughout the drug product development and manufacturing processes Key strategies include careful selection and evaluation of raw materials, including the assessment of their potential nitrosamine impurity profiles. Process optimization and control, such as maintaining appropriate pH, temperature, and reaction times, can also help mitigate nitrosamine formation. Additionally, packaging materials and storage conditions should be considered to prevent impurity formation during product shelf life. Regulatory agencies worldwide have implemented stringent guidelines to address the issue of nitrosamine impurities. Pharmaceutical manufacturers are required to assess the risk of nitrosamine presence in drug products and implement suitable measures to ensure patient safety. This includes establishing appropriate limits, conducting rigorous testing, and maintaining a robust quality control system.