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CHAPTER 5

Drug–Excipient Interactions and Adduct Formation

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.

Publication details


Print publication date
25 Sep 2012
Copyright year
2012
Print ISBN
978-1-84973-421-9
PDF eISBN
978-1-84973-536-0
From the book series:
Drug Discovery