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Toxicity of the pharmaceutical Simvastatin to the cyanobacterium
Microcystis aeruginosa: does good manufacturing practice
influence the biological response?
I. Neves 1 , M.S. Baptista 2 , V.M. Vasconcelos 1,2 , M.T.S.D. Vasconcelos 2
1 Department of Biology, Faculty of Sciences, University of Porto, Portugal.
2 CIMAR/CIIMAR, Centre of Marine and Environmental Research, University of Porto, Portugal.
Monitoring drug residues in the aquatic environment has gained importance in recent years, as
many pharmaceutical compounds can be found in sewage treatment plant effluents and
freshwater reservoirs. Generally, pharmaceuticals are specifically designed to penetrate
biological membranes and reach universal molecular systems, thereby increasing the
probability of unexpected consequences for a number of species. Freshwater phytoplankton
species are constantly exposed to these compounds. This work aimed at investigating the
effects, on freshwater phytoplankton, of simvastatin, a lipid-regulating drug of the statin class,
which inhibits the production of cholesterol by the liver. Cyanobacteria were chosen, since
they are common in eutrophic natural waters and may constitute an important part of the
phytoplankton community.
A strain of Microcystis aeruginosa, (LEGE 05195) isolated from Torrão reservoir (Tâmega
river) was grown in fraquil culture media doped with concentrations of simvastatin, that ranged
environmental levels to potentially toxic ones (10 ngL -1 to 100 mgL -1 ). Two batches of
simvastatin were tested in parallel, one manufactured according to the good manufacturing
practices (GMP) and the other manufactured without GMP. The M. aeruginosa response to
both batches of simvastatin was assessed trough monitoring the growth. Results have shown
that the growth of M. aeruginosa subjected to both GMP-simvastatin and non-GMPsimvastatin
is statistically different, non-GMP-simvastatin being causing a higher inhibition of
growth at a given concentration. For example, for a concentration of 100 μgL -1 the percentage
of inhibition of growth was 28% for GMP-simvastatin and 54% for non-GMP-simvastatin.
These results are valuable for the pharmaceutical manufactures since the European industry,
which observes expensive GMP, is subjected to competition from other countries, at lower
prices but without GMP.
Acknowledgements
This work was partially funded by Fundação para a Ciência e a Tecnologia, Portugal, (fellowship
awarded to M. Baptista (SFRH/BD/44373/2008) and the CONC-REEQ/304/2001 re-equipment project)
and U.Porto/Santander Totta, Portugal, through the “Investigação Jovem na U.Porto” program.
HOVIONE FarmaCiencia is gratefully acknowledged for providing the Simvastatin batches.
3 rd meeting of young researchers at UP 267