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Neutral insulin solutions physically stabilized by addition of Zn2+
Diabetic Medicine : a Journal of the British Diabetic Association
|November 1, 1986
Summary
Adding extra zinc ions (Zn2+) enhances the physical stability of neutral insulin solutions, preventing fibril formation without impacting its effectiveness or safety for diabetic patients.
Area of Science:
- Biochemistry
- Pharmaceutical Science
- Materials Science
Background:
- Commercial neutral insulin solutions exhibit limited physical stability under stress conditions like heat and movement.
- Current insulin formulations contain 2-3 zinc atoms per hexamer, contributing to instability.
Purpose of the Study:
- To investigate methods for improving the physical stability of neutral insulin solutions.
- To determine the impact of additional zinc ions (Zn2+) on insulin stability and other critical properties.
Main Methods:
- Addition of two extra Zn2+ ions per insulin hexamer to neutral insulin solutions.
- Evaluation of physical stability, chemical stability, immunogenicity in rabbits, and absorption rates in diabetic patients.
Main Results:
- The addition of extra Zn2+ significantly enhanced the physical stability of both porcine and human neutral insulin solutions.
- No adverse effects were observed on insulin's chemical stability, immunogenicity, or subcutaneous absorption rate.
- Stabilization is attributed to strengthening the insulin hexameric structure, inhibiting fibril formation.
Conclusions:
- Extra Zn2+ can physically stabilize neutral insulin solutions, improving their performance in devices like insulin pumps.
- This stabilization method does not compromise essential insulin characteristics, including efficacy and safety.
- The findings support the use of additional zinc for developing more robust insulin preparations.