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. 2010 Jan 1;4(1):104-10.
doi: 10.1177/193229681000400113.

Compatibility of insulin Lispro, Aspart, and Glulisine with the Solo MicroPump, a novel miniature insulin pump

Gil Senesh  1 , Doron Bushi, Avraham Neta, Ofer Yodfat
Affiliations

Compatibility of insulin Lispro, Aspart, and Glulisine with the Solo MicroPump, a novel miniature insulin pump

Gil Senesh et al. J Diabetes Sci Technol. .

Abstract

Background: This study compared the stability of commercially available, rapid-acting insulin in the novel tubeless, skin-adhering Solo insulin pump over 6 days at extreme environmental conditions.

Methods: Forty-eight pumps for each tested analog were loaded with three different insulin lots and operated at 30 U/day (three sets of 12 pumps) and 15 U/day (one set of 12 pumps) with basal/bolus delivery patterns for 6 days under extreme climatic (37 degrees C, 40% relative humidity) and mechanical (35 strokes/min) stresses. The insulin solutions dispensed were sampled periodically and analyzed for potency, related substances, high molecular weight proteins (HMWP), and preservative content by high-performance liquid chromatography techniques. Biological activity (bioidentity) was demonstrated by an abrupt decrease in blood glucose in rabbits. Solutions were inspected for visual appearance and measured for pH levels.

Results: During the 6-day sampling period, the potency of all insulin samples was maintained at 95.0-105.0% of the bulk solution concentration of the insulin vials. The levels of HMWP and related substances remained well below labeling limits. The preservative concentration decreased with time but remained bacteriostatic effective. Solutions maintained pH and clarity and were particulate free. The biological activity was verified.

Conclusions: Insulin analogs lispro, aspart, and glulisine maintained physical, chemical, and biological properties for 6 days when used in the Solo MicroPump device.

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Figures

Figure 1.
Figure 1.
(A) A side view of the Solo™ MicroPump: pump base and disposable insulin reservoir are paired and connected to the cradle with adhesive. (B) Solo remote.
Figure 2.
Figure 2.
(A) Cradle and cannula assembly—the cannula (see arrow) is inserted through a 2-ml vial cork. A metal needle was inserted for pressure equalization. (B) Pump and collecting vial—wires were connected to a personal computer for real-time monitoring. (C) Multipump holder assembled on a shaker. Shaker and holder were placed in an incubator at 37°C, 40% relative humidity, and 35 rpm agitation.
Figure 3.
Figure 3.
Insulin potency of Humalog®, Novolog®, and Apidra® at (A) 30-U/day test—results shown are the mean and SD of three lots— and at (B) 15-U/day test. Results are presented as relative percentages to Control T = 0 samples (bulk solutions of the insulin vial). “Control T = END” sample—insulin was exposed to thermal stresses but was not subjected to pumping action.
Figure 4.
Figure 4.
Preservative levels during a 30-U/day test of (A) m-cresol in insulin Humalog® and Apidra® and (B) m-cresol and phenol in insulin Novolog®/Novorapid®. Results shown are the mean and SD of three lots.
Figure 5.
Figure 5.
High molecular weight protein levels of Humalog®, Apidra®, and Novolog®/Novorapid® at (A) 30-U/day test—results shown are the mean and SD of 3 lots—and at (B) 15-U/day test.
Figure 6.
Figure 6.
Related substance levels of (A) Humalog®, (B) Novolog®/ Novorapid®, and (C) Apidra® at the 30-U/day test. Results shown are the mean and SD of three lots.
Figure 7.
Figure 7.
pH levels of Humalog®, Novolog®/Novorapid®, and Apidra® at the 30-U/day test. Results shown are the mean and SD of three lots.
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