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N-Nitrosamine Formation in Pharmaceutical Solid Drug Products: Experimental Observations by Justin Moser; Ian W. Ashworth; Laurence Harris; Michael C. Hillier; Kausik K. Nanda; Garry Scrivens is a Chemistry article available to read on EtoBox.
What is N-Nitrosamine Formation in Pharmaceutical Solid Drug Products: Experimental Observations about?
The potential presence of N-nitrosamines in medicinal products has become a matter of concern for health authorities and pharmaceutical companies. However, very little information is available in published literature on N-nitrosamine formation within pharmaceutical drug products. In response, experiments were undertaken to test if secondary and tertiary amines present in solid drug products could undergo nitrosation due to the presence of nitrite in the excipients used in the manufacture of the drug product. This work focused on solid dosage forms exploring several model amines of varying chemical structure, solubility and pKa which were formulated using common excipients with and without added nitrite. Monitoring the formation of the N-nitrosamines after processing and upon stressed stability conditions showed that N-nitrosamine formation can occur in solid drug product formulations. The results show that the rate and extent of N-nitrosamine formation depend upon the solubility of the amine, level of nitrite, expected local acidity in water layers within the drug product and mode of processing. Our findings agree with the rank order of dosage form risk from the published EFPIA wor
Who reads N-Nitrosamine Formation in Pharmaceutical Solid Drug Products: Experimental Observations?
It is typically read by researchers, students, and practitioners in Chemistry.
- Author
- Justin Moser; Ian W. Ashworth; Laurence Harris; Michael C. Hillier; Kausik K. Nanda; Garry Scrivens
- Publisher
- Elsevier BV
- Published
- 2023
- Language
- EN
- Field
- Chemistry (Physical Sciences)