Insulin Crystals Removal Platform

Description:

A platform technology for improving insulin delivery by removing insulin-derived fibrils through polyester membrane filtration.

This invention employs membrane filters integrated into insulin delivery systems to selectively remove insulin-derived fibrils (IDFs) from insulin formulations. By filtering out fibrils while preserving active insulin concentration, it enhances the stability, safety, and effectiveness of insulin therapy, especially in continuous subcutaneous insulin infusion (CSII) systems, including automated insulin delivery (AID).

Key Advantages:

• Effective removal of insulin-derived fibrils without reducing active insulin levels
• Improved stability and safety of insulin delivery systems
• Reduces risk of inflammation and complications caused by fibril formation
• Compatible with existing insulin pump technologies
• Supported by experimental evidence demonstrating enhanced fibril reduction.
• Eliminates insulin fibril formation that can clog delivery systems
• Prevents inflammation and adverse reactions associated with fibrils
• Enhances reliability and consistency of insulin dosing
• Addresses mechanical and chemical stress-induced insulin degradation

Market Opportunities:

• Continuous subcutaneous insulin infusion (CSII) pumps
• AID systems
• Insulin pen devices requiring improved formulation stability
• Diabetes management devices seeking enhanced safety profiles
• Medical tubing and delivery line filtration solutions
• Pharmaceutical formulations requiring fibril control

Stage of Development:

Experimental Studies

Patent Status:

Pending

    Publications & References:

2021 Lewis BE, Mulka A, Mao L, U Klueh,  et al. Insulin Derived Fibrils Induce Cytotoxicity in vitro and Trigger Inflammation in Murine Models. Journal of Diabetes Science and Technology. 2021;17(1):163-171. doi:10.1177/19322968211033868

2022 G. Zhang, O. Cohen, S. Chattaraj, Development of the Extended Infusion Set and Its Mechanism of Action. J Diabetes Sci Technol, 19322968221112120

2022 G. Zhang, O. Cohen, S. Chattaraj, Development of the Extended Infusion Set and Its Mechanism of Action. J Diabetes Sci Technol, 19322968221112120

2018 W. T. Cefalu, D. E. Dawes, G. Gavlak, D. Goldman, W. H. Herman, K. Van Nuys, A. C. Powers, S. I. Taylor, A. L. Yatvin, Insulin Access and Affordability Working Group: Conclusions and Recommendations. Diabetes Care 41, 1299-1311

2009 J. H. Choi, B. C. May, H. Wille, F. E. Cohen, Molecular modeling of the misfolded insulin subunit and amyloid fibril. Biophys J 97, 3187-3195

2009 M. I. Ivanova, S. A. Sievers, M. R. Sawaya, J. S. Wall, D. Eisenberg, Molecular basis for insulin fibril assembly. Proc Natl Acad Sci U S A 106, 18990-18995.

2008 R. N. Rambaran, L. C. Serpell, Amyloid fibrils: abnormal protein assembly. Prion 2, 112-117.

2001 L. Nielsen, R. Khurana, A. Coats, S. Frokjaer, J. Brange, S. Vyas, V. N. Uversky, A. L. Fink, Effect of environmental factors on the kinetics of insulin fibril formation: elucidation of the molecular mechanism. Biochemistry 40, 6036-6046.