Low API vexes Africa's anti-malarials

Anti-malaria drugs in use in Sub-Saharan Africa are often of substandard quality, according to research conducted by the US Pharmacopeial for an U.S. humanitarian assistance agency. The poor-quality drugs--artemisinin-based combination therapy products and sulfadoxine-pyrimethamine products--suffer from several shortcomings, among them insufficient levels of API and impurities. Some, of course, are counterfeits.

USP researchers find that 26 percent to 44 percent of the anti-malarials tested in Uganda, Senegal and Madagascar didn't make the grade. The study examined about 500 samples collected from public and regulated sectors as well as "informal markets," according to an announcement. The researchers find that the ACT products most often fail purity tests while the SP products most often fail dissolution tests. Quality problems appear to originate at the source, say researchers.

Researchers used a two-step test method to evaluate the drugs: An on-site initial screen using Global Pharma Health Fund's portable Minilab--a mobile unit for quick quality checks and counterfeit detection--and full-scale QC confirmatory testing of about 40 percent of the samples at USP facilities.

The substandard drugs may contribute to the growth of a virulent drug-resistant strain of malaria.

- here's the announcement


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