[encore une étude sur la qualité des antimalariques en Afrique et qui montre la présence de contrefaçons et de produits de qualité substandard...
Pour avoir l'étude en entier :
http://www.malariajournal.com/content/pdf/1475-2875-6-22.pdf
CB]
Informal medicine market in Congo, Burundi and Angola: counterfeit and
sub-standard antimalarials
Malaria Journal 2007, 6:22 doi:10.1186/1475-2875-6-22
Maria Cristina Gaudiano (mariacristina.gaudiano@iss.it)
Anna Di Maggio (annadimaggio79@libero.it)
Emilia Cocchieri (emiliacocchieri@katamail.com)
Eleonora Antoniella (eleonora.antoniella@iss.it)
Paola Bertocchi (paola.bertocchi@iss.it)
Stefano Alimonti (stefano.alimonti@iss.it)
Luisa Valvo (luisa.valvo@iss.it)
Abstract
Background: The 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.
Methods: In 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.
Results: The 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.
Conclusions: This 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.
ISSN 1475-2875
Article type Research
Submission date 10 October 2006
Acceptance date 22 February 2007
Publication date 22 February 2007
Article URL http://www.malariajournal.com/content/6/1/22
This peer-reviewed article was published immediately upon acceptance. It can be downloaded, printed and distributed freely for any purposes (see copyright notice below).
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