Nanoparticulate impurities in the pharmaceutical excipient trehalose induce an early immune response.

NPIs from trehalose elicited an immune response in vitro, and the immune response to trehalose may be related to NPIs and not the excipient itself. Different batches of trehalose showed different immune response effects. The currents research suggests that when trehalose is applied in high-risk administration routes, NPIs should be assessed and reasonably controlled.