posted on 2021-07-02, 19:44authored byCaitlin
L. Maikawa, Joseph L. Mann, Aadithya Kannan, Catherine M. Meis, Abigail K. Grosskopf, Ben S. Ou, Anton A. A. Autzen, Gerald G. Fuller, David M. Maahs, Eric A. Appel
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
°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.