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Healthcare Professionals
Retention of Structural / Potency Characteristics of Insulin
Investigator — Mark Sarno, Vision Biotechnology Consulting
The study was designed to determine whether multiple forms of insulin
retain their molecular structure and / or potency post-injection with
the Injex 30 Needle Free Injector. Comparison to delivery via a
standard syringe as well as a control retention were performed.
Table 1 Insulin Studied
| Insulin |
Activity |
Source |
Formulation |
Manufacturer |
 |
|
|
|
|
| Humalog |
Rapid |
Human |
Solution |
Eli Lilly |
| Humulin R |
Short |
Human |
Solution |
Eli Lilly |
| Novolin R |
Short |
Human |
Solution |
Novo Nordisk |
| Humulin N |
Intermediate |
Human |
Crystal Suspension |
Eli Lilly |
| Humulin L |
Intermediate |
Human |
Crystal Suspension |
Eli Lilly |
| Humulin U |
Long |
Human |
Crystal Suspension |
Eli Lilly |
| Lantus |
Long |
Human |
Solution |
Aventis |
Results
Table 2 displays the results from the immunoassay analysis. Means and
standard deviation (SD) of retention are reported for each insulin
injected with the Injex 30 Needle Free Injector, device, the syringe,
and the control.
| Insulin |
Control
Mean U/ml (SD) |
0.3 ml INJEX
Mean U/ml (SD) |
Syringe
Mean U/ml (SD) |
|
|
|
|
| Humalog |
89.94 (4.64) |
86.54 (9.35) |
87.94 (5.77) |
| Humulin R |
93.33 (2.36) |
94.53 (4.84) |
89.79 (1.81) |
| Novolin R |
96.16 (3.62) |
86.34 (13.51) |
92.72 (9.61) |
| Humulin N |
104.86 (0.11) |
92.57 (11.34) |
93.88 (10.58) |
| Humulin L |
104.77 (3.01) |
97.66 (14.57) |
101.08 (10.85) |
| Humulin U |
110.33 (1.89) |
109.52 (0.88) |
103.35 (6.51) |
| Lantus |
52.0 (2.83) |
49.5 (2.12) |
50.5 (2.12) |
The results demonstrate no loss in insulin potency after injection by
either the Injex Needle Free Injector device or the syringe in
comparison to the control.
Conclusion
This in-vitro study demonstrates complete retention of molecular
identity of insulin molecules injected via the INJEX. Multiple types
of insulin were explored including insulin from varying activities,
of varying formulation, and produced by various manufacturers. In
each case, the immunoassay reactivity was retained.
Post Script
Other studies have been performed by Injex testing structural
integrity of various compounds outside of diabetes. The range of
molecular weights for the compounds tested range from 700 daltons
to 1 million daltons. Structural integrity has been intact
demonstrating the safety and ease of pressure in delivering
different products with the Injex 30 Needle Free Injector.
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