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Biocompatible optical physically unclonable function hydrogel microparticles for on-dose authentication
Mengmeng Zhang1, Aparna Raghunath1, An Zhao1
1Process & Energy Department, Delft University of Technology, Leeghwaterstraat 39, 2628 CB Delft, the Netherlands.
Heliyon
|January 1, 2024
Summary
This study introduces on-dose Physical Unclonable Functions (PUF) for pharmaceutical authentication, embedding microspheres in hydrogels to create unique drug fingerprints. This novel method allows patients to verify medications using mobile phones, enhancing drug security and preventing counterfeits.
Area of Science:
- Pharmaceutical Sciences
- Materials Science
- Cryptography
Background:
- On-dose authentication (ODA) uses unique tags to prevent counterfeit drugs.
- Graphical Physical Unclonable Functions (PUF) offer high security but have limitations in pharmaceutical applications due to toxicity and specific imaging needs.
- Existing methods struggle with non-replication and reverse engineering challenges.
Purpose of the Study:
- To develop a novel on-dose PUF system for pharmaceutical authentication.
- To create a secure, non-toxic, and easily implementable method for verifying medication authenticity.
- To enable patients to authenticate their drugs using accessible technology like mobile phones.
Main Methods:
- Embedding microspheres (superparamagnetic colloids or oil drops) randomly within biocompatible hydrogel particles to create unique drug fingerprints.
- Utilizing microsphere diameter and coordinates as input for cryptographic key generation.
- Employing a universal circle identification and binning program for data extraction.
- Validating the system using white light illumination and low-magnification microscopy.
Main Results:
- Demonstrated two types of on-dose PUFs: one with superparamagnetic colloids and another with sunflower oil drops.
- The single-diameter system successfully passed NIST Statistical tests, showing sufficient randomness, bit uniformity, and device uniqueness.
- The system enables authentication via mobile phones, requiring only white light and low-magnification imaging.
- The single-diameter system exhibited an encoding capacity of , indicating significant labeling potential.
Conclusions:
- The proposed on-dose PUF method provides a secure, user-friendly, and cost-effective solution for pharmaceutical authentication.
- This technology overcomes limitations of current graphical PUFs, making it suitable for widespread pharmaceutical use.
- On-dose PUFs have the potential to significantly enhance drug security, protect patients from counterfeit medications, and improve supply chain integrity.
