Abstract
This chapter discusses drug product degradation caused by the interaction between the active pharmaceutical ingredient (API) and components other than the API, including counter ions (if the API is an acid or base), excipients, impurities and degradants of excipients, and leachable impurities. In the first category of direct drug-excipient interaction, the mechanisms of the Maillard reaction including the Amadori rearrangement are discussed, followed by several examples involving secondary amine drugs and excipients containing reducing-end sugars. This chapter also examines a number of case studies where drug degradation is caused by impurities (hydrogen peroxide, formaldehyde, etc.) and degradants of excipients.
Publisher
The Royal Society of Chemistry
Cited by
1 articles.
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