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    Engineering Insulin Cold Chain Resilience to Improve Global Access

    Year: 2021

    Journal: Biomacromolecules, Volume 22, AUG 9, page 3386–3395

    Authors: Maikawa, Caitlin L.; Mann, Joseph L.; Kannan, Aadithya; Meis, Catherine M.; Grosskopf, Abigail K.; Ou, Ben S.; Autzen, Anton A. A.; Fuller, Gerald G.; Maahs, David M.; Appel, Eric A.

    Organizations: NIDDK R01 (NIH) [R01DK119254]; Stanford Diabetes Research Center (NIH) [P30DK116074]; American Diabetes Association [1-18-JDF-011]; Stanford Maternal and Child Health Research Institute through the SPARK Translational Research Program; NSERC Postgraduate Scholarship; Stanford BioX Bowes Graduate Student Fellowship; Department of Defense NDSEG Fellowship; Stanford Graduate Fellowship; Novo Nordisk Foundation [NNF18OC0030896]; Stanford Bio-X Program

    There are 150 million people with diabetes worldwide who require insulin replacement therapy, and the prevalence of diabetes is rising the fastest in middle- and low-income countries. The current formulations require costly refrigerated transport and storage to prevent loss of insulin integrity. This study shows the development of simple drop-in amphiphilic copolymer excipients to maintain formulation integrity, bioactivity, pharmacokinetics, and pharmacodynamics for over 6 months when subjected to severe stressed aging conditions that cause current commercial formulation to fail in under 2 weeks. Further, when these copolymers are added to Humulin R (Eli Lilly) in original commercial packaging, they prevent insulin aggregation for up to 4 days at 50 degrees C compared to less than 1 day for Humulin R alone. These copolymers demonstrate promise as simple formulation additives to increase the cold chain resilience of commercial insulin formulations, thereby expanding global access to these critical drugs for treatment of diabetes.
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