ANTIMALARIAL DRUG QUALITY IN AFRICA
J Clin Pharm Ther. 2007 October; 32(5): 429–440.
http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=2653781
AA Amin, (PhD)1* and GO Kokwaro, (PhD)1,2†
1Centre for Geographic Medicine Research-Coast, Kenya Medical Research
Institute/Wellcome Trust Research Programme, P.O. Box 43640-00100 GPO,
Nairobi, Kenya
2Department of Pharmaceutics and Pharmacy Practice, University of Nairobi,
P.O Box 19676-00202, KNH, Nairobi, Kenya
*Corresponding author, Abdinasir A. Amin, Malaria Public Health &
Epidemiology Group, Centre for Geographic Medicine Research-Coast, Kenya
Medical Research Institute/Wellcome Trust Research Programme, P.O. Box
43640-00100 GPO, Nairobi, Kenya, aamin@nairobi.kemri-wellcome.org
<mailto:aamin@nairobi.kemri-wellcome.org>
†gkokwaro@nairobi.kemri-wellcome.org
<mailto:gkokwaro@nairobi.kemri-wellcome.org>
Abstract
Background and objective
There are several reports of sub-standard and counterfeit antimalarial drugs
circulating in the markets of developing countries; we aimed to review the
literature for the African continent.
Methods
A search was conducted in PubMED in English using the medical subject
headings (MeSH) terms: “Antimalarials/analysis”[MeSH] OR
“Antimalarials/standards”[MeSH] AND “Africa”[MeSH]” to include articles
published up to and including 26/02/07. Data were augmented with reports on
the quality of antimalarial drugs in Africa obtained from colleagues in the
World Health Organization. We summarised the data under the following
themes: content and dissolution; relative bioavalability of antimalarial
products; antimalarial stability and shelf life; general tests on
pharmaceutical dosage forms; and the presence of degradation or
unidentifiable impurities in formulations.
Results and discussion
The search yielded 21 relevant peer-reviewed articles and three reports on
the quality of antimalarial drugs in Africa. The literature was varied in
the quality and breadth of data presented, with most bioavailability studies
poorly designed and executed. The review highlights the common finding in
drug quality studies that 1) most antimalarial products pass the basic tests
for pharmaceutical dosage forms, such as the uniformity of weight for
tablets 2) most antimalarial drugs pass the content test 3) in vitro product
dissolution is the main problem area where most drugs fail to meet required
pharmacopoeial specifications, especially with regard to
sulfadoxine-pyrimethamine products. In addition, there are worryingly high
quality failure rates for artemisinin monotherapies such as dihydroartemisin
(DHA); for instance all five DHA sampled products in one study in Nairobi,
Kenya, were reported to have failed the requisite tests.
Conclusions
There is an urgent need to strengthen pharmaceutical management systems such
as post-marketing surveillance and the broader health systems in Africa to
ensure populations in the continent have access to antimalarial drugs that
are safe, of the highest quality standards and that retain their integrity
throughout the distribution chain through adequate enforcement of existing
legislation and enactment of new ones if necessary, and provision of the
necessary resources for drug quality assurance.
Keywords: Antimalarial drugs, Africa, quality, content, dissolution,
bioavailability, impurity
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