Counterfeit, degraded, or substandard medications can pose health risks. Medications may be bulked up with fillers, compromised by heavy metal-laden colorants, or degrade because of improper storage.

The paper-based device tests medicine for quality and adulteration. Image source: Marya Lieberman and Sarah Bliese.The paper-based device tests medicine for quality and adulteration. Image source: Marya Lieberman and Sarah Bliese.Identifying poor-quality medications is challenging, as inspectors may not know in advance what chemical adulterants or degradation products they need to look for. Poor-quality medications may also contain at least some of the active ingredient, so simply detecting the presence of the real medication isn’t enough to rule out issues.

A paper-based device developed at the University of Notre Dame may help to determine the authenticity of medication. The $1 paper card identifies falsified or degraded antibiotics such as ciprofloxacin or ceftriaxone, both of which the World Health Organization lists as “essential.” The design includes 12 lanes separated by wax barriers. Each channel is embedded with a different set of reagents to detect compounds found in active pharmaceutical ingredients, degradation products, or common fillers.

A powdered pill is rubbed across the channels as the bottom of the card is dipped in water, wicking the fluid to ensure reagent contact with the sample. The researchers then compare the reagent color change with color patterns obtained from high-quality pharmaceutical products. The evaluation can be completed by eye or with a smartphone (see video).

Researchers subjected ceftriaxone, which degrades if storage temperatures are elevated, to high temperatures and ran the card test, simultaneously analyzing the degradation products via liquid chromatography-mass spectrometry. The colorimetric pattern for the degraded antibiotic was verified to be different from that of the correctly stored product. In addition to tests on the pure active ingredient, dozens of real-world ceftriaxone samples from Kenya and Uganda were tested.

The research was presented at the 252nd National Meeting & Exposition of the American Chemical Society in Philadelphia, Penn., in August 2016.

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