Multi-platform technologies for the integral characterization of poor-quality medicines

MARÍA JULIA CULZONI; MARÍA EUGENIA MONGE; MANSHUI ZHOU; PRABHA DWIVEDI; JOEL KEELOR; MICHAEL PAYNE; CHRIS HARRIS; DAVIS JENKINS; PAUL N. NEWTON; PATRICIA TABERNERO; FACUNDO M. FERNÁNDEZ

Indianápolis

Congreso; 246th ACS National Meeting & Exposition; 2013

American Chemical Society

Falsified (counterfeit) drugs are so common in certain developing countries that patients with serious illnesses are at high risk of receiving poor-quality drugs instead of those needed for successful treatment of their illnesses. Falsified drugs may not contain the active ingredient, may contain incorrect ingredients or may even be contain toxic compounds. Consequently, assessing the prevalence of poor-quality drugs is essential to protect the welfare of patients. Furthermore, gathered evidence can be useful for the proper authorities to trace the origin of falsified drugs and act against criminal trading enterprises. Although falsified drugs tend to steal the spotlight, these developing countries are also negatively impacted by degraded and substandard medications. Degraded medicines arise from poor storage conditions, while substandard medicines are produced by legitimate manufacturers that do not meet quality standards. In this presentation, state-of-the-art analytical technologies that we have implemented to detect degraded, substandard and falsified poor-quality medicines will be discussed. The ability of multi-platform strategies to investigate falsified artesunate monotherapies, contraceptives, and artemisinin combination therapies (ACTs) acquired in developing countries as part of the Counterfeit Drug Forensic Investigation Network (CODFIN) of the ACT Consortium will be presented. These strategies, involving ultrahigh performance liquid chromatography and ion mobility spectrometry coupled to tandem mass spectrometry, ambient mass spectrometry, X-ray diffraction, and nuclear magnetic resonance, allow the detection of falsified medicines containing previously undetected wrong ingredients instead of the stated active pharmaceutical ingredients.