Analytical Tools and Strategic Approach to Detect Poor Quality Medicines, Identify Unknown Components, and Timely Alerts for Appropriate Measures: Case Study of Antimalarial Medicines

Védaste Habyalimana^1,2, Jérémie Kindenge Mbinze^1,3, Nicodème Kalenda Tshilombo^1,3, Amandine Dispas¹, Achille Yemoa Loconon^1,4, Pierre-Yves Sacré¹, Joëlle Widart⁵, Pascal De Tullio⁶, Stéphane Counerotte⁶, Justin-Léonard Kadima Ntokamunda⁷, Eric Ziemons¹, Philippe Hubert¹, Roland Marini Djang’eing’a¹

¹Department of Pharmacy, CIRM, Laboratory of Analytical Chemistry, Quartier Hôpital, University of Liege (ULg), Liège, Belgium.
²Rwanda Biomedical Center/Medical Procurement and Production Division, Butare, Rwanda.
³Faculté des Sciences Pharmaceutiques, Université de Kinshasa, Kinshasa XI, République Démocratique du Congo.
⁴Ecole de Pharmacie, Faculté des Sciences de la Santé, Université d’Abomey Calavi, Cotonou, Bénin.
⁵Department of Pharmacy, CIRM, Quartier Hôpital, University of Liege (ULg), Liège, Belgium.
⁶Department of Pharmacy, CIRM, Laboratory of Medicinal Chemistry, Quartier Hôpital, University of Liege (ULg), Liège, Belgium.
⁷School of Medicine and Pharmacy, University of Rwanda, Butare, Rwanda.

DOI: 10.4236/ajac.2015.613093                

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.

Keywords

Poor Quality Medicines, Antimalarial Medicines, Visual Inspection, Simple and Complex Analytical Tools

Conflicts of Interest

The authors declare no conflicts of interest.

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