Abstract
BackgroundThe presence of counterfeits and sub-standards in African medicines market is a dramatic problem that causes many deaths each year. The increase of the phenomenon of pharmaceutical counterfeiting is due to the rise of the illegal market and to the impossibility to purchase branded high cost medicines.MethodsIn this paper the results of a quality control on antimalarial tablet samples purchased in the informal market in Congo, Burundi and Angola are reported. The quality control consisted in the assay of active substance by means of validated liquid chromatographic methods, uniformity of mass determination, disintegration and dissolution tests. Moreover, a general evaluation on label and packaging characteristics was performed.ResultsThe results obtained on thirty antimalarial tablet samples containing chloroquine, quinine, mefloquine, sulphadoxine and pyrimethamine showed the presence of different kinds of problems: a general problem concerning the packaging (loose tablets, packaging without Producer name, Producer Country and sometimes without expiry date); low content of active substance (in one sample); different, non-declared, active substance (in one sample); sub-standard technological properties and very low dissolution profiles (in about 50% of samples). This last property could affect the bioavailability and bioequivalence in comparison with branded products and could be related to the use of different excipients in formulation or bad storage conditions.ConclusionThis paper evidences that the most common quality problem in the analysed samples appears to be the low dissolution profile. Here it is remarked that the presence of the right active substance in the right quantity is not a sufficient condition for a good quality drug. Dissolution test is not less important in a quality control and often evidences in vitro possible differences in therapeutic efficacy among drugs with the same active content. Dissolution profile can be dramatically affected by the choice of excipients in the oral solid formulation and, in many cases, is out of specifications due to the absence of formulation studies by producers of developing countries.
Highlights
The presence of counterfeits and sub-standards in African medicines market is a dramatic problem that causes many deaths each year
From data reported in each form, it was observed that the price of medicines in small pharmacies is not higher than that in the illegal market; on the contrary, sometimes the illegal market sells the same drug at higher price
The samples were considered "in specifications" (IS) when the assay for the active substance was in the 90–110% range, based on the larger specifications among those reported in the US, British, European and International Pharmacopeias [24,27,28,29]
Summary
The presence of counterfeits and sub-standards in African medicines market is a dramatic problem that causes many deaths each year. Storage and selling conditions are inadequate: in many developing countries, drugs are maintained at high temperature and humidity, not in the original packaging and not protected from the sun These conditions accelerate the drug degradation process with, in some cases, a lowering of the active substance strength and an increase of degradation products and, possibly, of toxicity [3]. The low quality (sub-standard) medicines and the presence of counterfeits, together with a poor adherence to therapy by the patient, are important causes of death in developing countries [5,6]. In most of sub-Saharan countries, the patients have no choice, because the only chance to purchase medicines, when they exist, is through the informal market This situation favours the development of the illegal traffic of counterfeits. Considering the WHO definition of a counterfeit medicine, how should one consider medicines in plastic bags or enveloped in pieces of paper without any producer name, batch number or expiry date, being sold by non-authorized vendors? What is the real quality of these medicines? What are the real strength, the impurities quantity, the pharmaceutical-technological properties and the bioavailability of these medicines?
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