THE PROBLEM:

A pharmaceutical manufacturer approached MVA with concern that a counterfeit of one of their products was on the market. Counterfeit pharmaceuticals are produced and sold illegally with the intent to deceive consumers about origin and authenticity. Many can be purchased as low-cost pharmaceuticals over the internet. They may be contaminated, missing the active ingredient, or contain the wrong active ingredient.

The threat of counterfeits is real and can be very harmful to public health, as well as to the reputation of pharmaceutical manufacturers.

THE ANALYSIS:

MVA provides crucial analytical expertise for detection of suspicious counterfeit drugs using a variety of microscopical techniques. An initial examination revealed differences in surface markings between a complaint tablet and a known control tablet.

Dimensional analysis of a complaint tablet, using calibrated light microscopes, showed slight deviation from a known control tablet.

Comparisons by polarized light microscopy (PLM) indicated that excipients used in the coating and core of the complaint tablet were consistent with the control, but scanning electron microscopy (SEM) coupled with energy dispersive x-ray analysis (EDS) showed that a key element related to the active ingredient, sulfur, was missing.

Analysis by Fourier transform infrared spectroscopy (FTIR) of solvent extractions confirmed the absence of the active ingredient.

THE OUTCOME:

Our examination/comparison of the complaint tablet to a control tablet supplied by the manufacturer suggested differences beyond the surface markings. In fact, the critical active ingredient was not present in the complaint tablet. The manufacturer’s concern proved valid.