Insulin Storage: A Critical Reappraisal

Abstract

Insulin, as a peptide hormone drug, is susceptible to changes in stability when exposed to environmental factors under storage. Proper storage according to the manufacturer's recommendations is important to maintain its potency and enable precise dosing for people with diabetes (PwD). While it is reasonable to assume that transport conditions and temperature are well controlled during the supply chain, little is known about insulin storage after dispensing and insulin potency at the moment of administration. Insulin is exposed to various environmental factors when carried by PwD and storage recommendations are often not met when it is stored in household refrigerators. It is difficult to assess changes in insulin potency in clinical practice, and there is a gap in the current scientific literature on insulin stability. Package leaflet recommendations only give limited information on the impact of improper storage conditions on insulin stability and guidelines by health organizations are inconsistent. Given the importance of precise dosing in diabetes care, there is a need for more transparency on insulin stability, awareness for proper storage among health care professionals and PwD as well as clear guidelines and practical storage recommendations from manufacturers and health organizations.

Keywords: HPLC; diabetes therapy; insulin; insulin concentration; insulin stability; insulin therapy.

Figure 1.

Number of insulin products per in-use shelf life recommendation and packaging for insulin products authorized by European Medicines Agency and Food and Drug Administration, respectively (information taken from the Summary of Product Characteristics (SmPC) from FDA or EMA, resp. Accessed May 4, 2019).