Ensuring Drug Quality

Innovations
CZ

 

Shedding light on your medications

The Problem
Estimates are 30-50% of available medications are of low quality or counterfeit in countries with failed governance and conflict. These fake medications are a serious clinical problem and becoming a public health concern.  Thirty-six distinct technologies have been described to prevent fake medicines but none meet the needs for point of care testing in low resource or conflict environments.

        A low-cost tool with high sensitivity and specificity that requires   little training and uses local available reagents is still needed

 

The Solution
We developed a point of care tool using properties of light spectroscopy and LED technology to quickly determine authenticity and quality of medications.

 

Methodology
Our tool recognizes the “fingerprint” of each pharmaceutical compound when light is transmitted through an authentic sample at wavelengths in the ultraviolet (UV) light spectrum. This is the wavelength where the active pharmaceutical compound is reactive to light and is called the Baseline Spectral Fingerprint (BSF). We leveraged the BSF & developed an algorithm to compensate for the randomness of field preparation using local sourced reagents.

 

For proof of concept, we tested 125 samples of random substances prepared by a third party clinical pharmacologist. 20 were authentic samples while the remainder were prepared so that each sample was visually indistinguishable from the authentic samples but were either counterfeit or low quality (right medication, wrong concentration). The results yielded 1 false negative and 0 false positives. 

 

Next Steps
We are currently designing a low cost hand-held tool which can be used at bedside and in hospital pharmacies to test & ensure the quality of medications being given to patients.

Learn how to get involved here.

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