TITLE:
Analytical Tools and Strategic Approach to Detect Poor Quality Medicines, Identify Unknown Components, and Timely Alerts for Appropriate Measures: Case Study of Antimalarial Medicines
AUTHORS:
Védaste Habyalimana, Jérémie Kindenge Mbinze, Nicodème Kalenda Tshilombo, Amandine Dispas, Achille Yemoa Loconon, Pierre-Yves Sacré, Joëlle Widart, Pascal De Tullio, Stéphane Counerotte, Justin-Léonard Kadima Ntokamunda, Eric Ziemons, Philippe Hubert, Roland Marini Djang’eing’a
KEYWORDS:
Poor Quality Medicines, Antimalarial Medicines, Visual Inspection, Simple and Complex Analytical Tools
JOURNAL NAME:
American Journal of Analytical Chemistry,
Vol.6 No.13,
December
2,
2015
ABSTRACT: Nowadays, the circulation of poor quality medicines is becoming an alarming worldwide phenomenon with serious public health and socio-economic concerns. The situation is particularly critical in developing countries where drug quality assurance and regulatory systems for drug manufacturing, importation, distribution and sales are weak. A sustained vigilance on poor quality medicines that regroup counterfeit/falsified, substandard and degraded medicines is therefore required to ensure patient safety and genuine medicines integrity. A case situation is illustrated including a strategic approach and analytical tools that were found useful to detect poor quality medicines, identify unknown components, and timely alerts for appropriate measures against the spread of those harmful products. Several suspected medicines randomly sampled in several strategic Rwandan areas were firstly check-controlled by means of visual inspection and then applying several analytical techniques from simple to more complex ones. The following medicines were studied: quinine sulfate tablets, artemisinin-based combination tablets, and artesunate powders for injection. Taking into account the pharmaceutical forms and the chemical characteristics, the following tests were applied: uniformity of mass, friability, disintegration, fluorescence, identification and assay. They were followed by more complex analytical techniques that allowed more comprehension of abnormal findings among which the presence of a wrong active pharmaceutical ingredient in quinine sulfate tablets which is mainly discussed in this paper to illustrate a strategic approach and various analytical tools that can be used in detecting and identifying unknown component in poor quality medicines.