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Original Research

Technology-derived storage solutions for stabilizing insulin in extreme weather conditions I: the ViViCap-1 device

ORCID Icon, &
Pages 709-714 | Received 23 Dec 2016, Accepted 03 Apr 2017, Published online: 13 Apr 2017
 

ABSTRACT

Background: Injectable life-saving drugs should not be exposed to temperatures <4°C/39°F or >30°C/86°F. Frequently, weather conditions exceed these temperature thresholds in many countries. Insulin is to be kept at 4–8°C/~ 39–47°F until use and once opened, is supposed to be stable for up to 31 days at room temperature (exception: 42 days for insulin levemir). Extremely hot or cold external temperature can lead to insulin degradation in a very short time with loss of its glucose-lowering efficacy.

Methods: Combined chemical and engineering solutions for heat protection are employed in ViViCap-1 for disposable insulin pens. The device works based on vacuum insulation and heat consumption by phase-change material. Laboratory studies with exposure of ViViCap-1 to hot outside conditions were performed to evaluate the device performance.

Results: ViViCap-1 keeps insulin at an internal temperature < 29°C/84.2°F for a minimum of 12 h without external power requirement, even when constantly exposed to an outside temperature of 37.8°C/100°F. Bringing the device into an ambient temperature < 26°C/78.8°F reverses the phase-change process and ‘recharges’ the device for further use.

Conclusions: ViViCap-1 performed within its specifications. The small and convenient device maintains the efficacy and safety of using insulin even when carried under hot weather conditions.

Declaration of interest

A Pfützner and G Pesach have received consulting fees from TempraMed Inc, R Nagar is a founder and shareholder of TempraMed Inc. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Additional information

Funding

No funding was received in the preparation of this manuscript

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