| Literature DB >> 19861610 |
Marc Twagirumukiza1, An Cosijns, Eveline Pringels, Jean Paul Remon, Chris Vervaet, Luc Van Bortel.
Abstract
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 degrees C and 60 +/- 5% relative humidity [RH]) and accelerated (40 +/- 2 degrees 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.Mesh：
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Year: 2009 PMID： 19861610 DOI： 10.4269/ajtmh.2009.09-0109
Source DB: PubMed Journal: Am J Trop Med Hyg ISSN： 0002-9637 Impact factor: 2.345