A Hand Held Portable Device Based on LEDS for Use in The Detection of Counterfeit Pharmaceutical Drugs and Packaging

Technology Summary

The FDA is seeking a device company to commercialize its patent pending hand held portable device for the detection of counterfeited pharmaceuticals. The device is the subject of two issued U.S. patents listed below. will be based on the technology described below. FDA scientists have built highly reliable prototypes of two different models of the device and demonstrated the validity of the device for multiple applications.

A hand held portable device was designed and developed for use in the detection of counterfeit pharmaceutical products and packaging. The light source of the device emits different wavelengths of light onto a sample. The device incorporates the use of single wavelength light emitting diodes (LEDs) which generate intense single wavelengths of light. Two models of the device have been developed and manufactured. The first model incorporates only LEDs at specific wavelengths and the second model incorporates a camera and display along with the LEDs at specific wavelengths. The different LED wavelengths of light interact with the sample by either being absorbed, reflected or by generating an apparent color change in the sample. The absorption, reflection or apparent color change by the sample may be observed using different colored goggles (yellow, orange, red). The fluorescence profiles of suspect pills can be compared with the authentic article to determine legitimacy. The device can be used for field examination of suspect counterfeit pharmaceutical products, packaging and diverted pharmaceutical products. Due to its size, and the simplicity in design and use, the hand held portable LED light source can be used by health safety officials (e.g. FDA investigators), by law enforcement authorities, or by the pharmaceutical companies themselves, to rapidly screen samples for suspect counterfeit products improving the safety of that the US drug distribution chain.

Potential Commercial Applications	Competitive Advantages
Testing for authenticity of pharmaceutical products Combating the ever growing problem of counterfeiting in pharmaceutical products to protect public safety Traditional law enforcement activities	Current methods of detecting counterfeit pharmaceuticals include vibrational spectroscopy, x-ray diffraction, gas chromatography, liquid chromatography, and mass spectrometry. These methods require expensive and bulky instrumentation, and are generally performed in a laboratory by highly trained operators. The LED devices based on the subject technology offer the following advantages: Tests can be performed at desired location outside of lab setting Small size, light and portable Simple to use and does not require special technical skills Low cost and simple to manufacture Reliable and provides reproducible results

Potential Commercial Applications

Competitive Advantages

Testing for authenticity of pharmaceutical products
Combating the ever growing problem of counterfeiting in pharmaceutical products to protect public safety
Traditional law enforcement activities

Current methods of detecting counterfeit pharmaceuticals include vibrational spectroscopy, x-ray diffraction, gas chromatography, liquid chromatography, and mass spectrometry. These methods require expensive and bulky instrumentation, and are generally performed in a laboratory by highly trained operators. The LED devices based on the subject technology offer the following advantages:

Tests can be performed at desired location outside of lab setting
Small size, light and portable
Simple to use and does not require special technical skills
Low cost and simple to manufacture
Reliable and provides reproducible results

Development Stage: Prototype

Inventors: Nicola Ranieri

Intellectual Property:

United States patent: US 9,476,839 B2, issued 10.25.2016

United States patent: US 10,101,280 B2, issued 10.16.2018

Product Area: Devices, Drugs

FDA Reference No: E-2008-017

Licensing Contact:
Whitney Hastings, MS, PhD
FDA Technology Transfer Program
Email: FDAInventionlicensing@fda.hhs.gov
Phone: 240-402-2232