Poly(trehalose methacrylate) as an Excipient for Insulin Stabilization: Mechanism and Safety.
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ABSTRACT: Insulin, the oldest U.S. Food and Drug Administration (FDA)-approved recombinant protein and a World Health Organization (WHO) essential medicine for treating diabetes globally, faces challenges due to its storage instability. One approach to stabilize insulin is the addition of poly(trehalose methacrylate) (pTrMA) as an excipient. The polymer increases the stability of the peptide to heat and mechanical agitation and has a low viscosity suitable for injection and pumps. However, the safety and stabilizing mechanism of pTrMA is not yet known and is required to understand the potential suitability of pTrMA as an insulin excipient. Herein is reported the immune response, biodistribution, and insulin plasma lifetime in mice, as well as investigation into insulin stabilization. pTrMA alone or
SUBMITTER: Gelb MB
PROVIDER: S-EPMC9412841 | biostudies-literature | 2022 Aug
REPOSITORIES: biostudies-literature
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