AJTMH Transactions of the Royal Society of Tropical Medicine and Hygiene
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Am. J. Trop. Med. Hyg., 81(5), 2009, pp. 776-781
doi:10.4269/ajtmh.2009.09-0109;
Copyright © 2009 by The American Society of Tropical Medicine and Hygiene

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Influence of Tropical Climate Conditions on the Quality of Antihypertensive Drugs from Rwandan Pharmacies

Marc Twagirumukiza, An Cosijns, Eveline Pringels, Jean Paul Remon, Chris Vervaet, AND Luc Van Bortel*
Department of Internal Medicine, University Hospital, Kigali, Rwanda; Laboratory of Pharmaceutical Technology, Faculty of Pharmaceutical Sciences, Ghent University, Ghent, Belgium; Heymans Institute of Pharmacology, Ghent University, Ghent, Belgium

The objective of this study was to assess the quality of antihypertensive drugs and to investigate the influence of tropical storage conditions. Drug content and in vitro dissolution tests were performed on 10 test formulations (from Rwanda) and 6 reference formulations (from Belgium or France) after purchase and after 6-month storage under long-term (25 ± 2°C and 60 ± 5% relative humidity [RH]) and accelerated (40 ± 2°C and 75 ± 5% RH) testing conditions. Twenty percent of test formulations were of substandard content at the time of purchase. After 6 months at accelerated testing conditions, 7 of 10 test formulations were substandard in content and 8 were substandard for the combined criteria of drug content and dissolution, whereas no reference drug became substandard. This study shows that, apart from some drugs being already substandard from purchase, accelerated testing conditions (simulating tropical climate) have deleterious effects on the majority of antihypertensive drug formulations found in the Rwandan market.

Received February 26, 2009. Accepted for publication July 14, 2009.

Acknowledgments: The authors acknowledge the help of Jan Kips in data verification. They extend their thanks to the investigators who helped in collecting drug samples in Rwanda, as well as to the team of the Laboratory of Pharmaceutical Technology at Faculty of Pharmaceutical science of Ghent University for their help during experiments.

Financial support: Marc Twagirumukiza has a PhD Fellowship sponsored by VLIR (Vlaamse Interuniversitaire Raad: Flemish Interuniversity Council) in Belgium through Ghent University and the National University of Rwanda. All standards and reagents were kindly supplied by the laboratory of pharmaceutical technology at Ghent University.

Disclosure: The authors declare that there is no interest conflict to disclose.

* Address correspondence to Luc Van Bortel, Heymans Institute of Pharmacology, Ghent University, De Pintelaan 185, Block B, 1st Floor, Ghent 9000, Belgium. E-mail: Luc.VanBortel{at}UGent.be

Authors’addresses: Marc Twagirumukiza and Luc Van Bortel, Heymans Institute of Pharmacology, Ghent University, De Pintelaan 185, Block B 1st Floor, 9000 Ghent, Belgium, E-mails: Marc.Twagirumukiza{at}UGent.be and Luc.VanBortel{at}UGent.be. An Cosijns, Eveline Pringels, Jean Paul Remon, and Chris Vervaet, Laboratory of Pharmaceutical Technology, Ghent University, Harelbekestraat 72, 9000 Ghent, Belgium, E-mail: Chris.Vervaet{at}UGent.be.






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