Testing Drug Quality Inexpensively - Chromatography Investigates

‘Substandard and falsified medical products may cause harm to patients and fail to treat the diseases for which they were intended’ is stated as one of the key facts in a recent World Health Organization (WHO) fact sheet. It is a problem that affects all regions of medicine and affects patients and health organizations around the globe. But it is a bigger problem in low- and middle-income countries (LMICs), where an estimated 1 in 10 medical products are substandard or falsified.

Researchers are developing methods to try and combat this practice, and a paper published in the Journal of Global Oncology - Paper Analytic Device to Detect the Presence of Four Chemotherapy Drugs - reports on a new device that could help in the detection of substandard or falsified chemotherapy drugs. Take a closer look at the issue and see how chromatography can play a role in developing new methods of detection.

Increasing demand for chemotherapy drugs

Demand for chemotherapy drugs in LMICs is increasing as more organizations commit time, effort and money in these regions in detecting and treating cancer. The researchers state that this increase in demand for chemotherapy drugs will create new opportunities for unethical manufacturers and distributors. It is a pattern that has been witnessed before when a program to reduce malarial deaths in Africa was rolled out.

Chemotherapy drugs are targets for falsification due to their high selling prices and low post-marketing monitoring in LMICs. The WHO define substandard and falsified as:

• Substandard - these are authorized medical products that fail to meet either their quality standards or specifications, or both.
• Falsified - medical products that deliberately/fraudulently misrepresent their identity, composition or source.

ChemoPAD - testing the drugs for APIs

One of the most common problems found in substandard or falsified anticancer drugs is the absence of an active pharmaceutical agent (API). In LMIC regions, this becomes an issue because of the difficulty in testing the quality of drugs using equipment found in laboratories in more developed countries. The paper referenced above reports on a paper pad- ChemoPAD - that has been developed to test for APIs in chemotherapy drugs.

To use the device, the user simply places a small sample of the drug on the application strip - a strip of absorbent paper. The card is simply folded over allowing the sample to impregnate the testing area - a portion of the card that is impregnated with reagents that will react with APIs in the sample. After simple processing, the user compares the colours obtained from the reaction between sample and reagents with a standard - they can see whether the drugs they are using are genuine or not.

The device is simply to use and gives a result in a few minutes. The device was validated using HPLC - a powerful and flexible method discussed in the article, Using Different HPLC Column Chemistries To Maximise Selectivity For Method Development.