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

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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.
Keywords
STABILITY, COUNTERFEIT, IN-VITRO DISSOLUTION, SUB-SAHARAN AFRICA, VIVO BIOAVAILABILITY, ANTIMALARIAL-DRUGS, STORAGE-CONDITIONS, SUBSTANDARD DRUGS, FAKE DRUGS, GLOBAL BURDEN

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Chicago
Twagirumukiza, Marc, An Cosijns, Eveline Pringels, Jean Paul Remon, Chris Vervaet, and Lucas Van Bortel. 2009. “Influence of Tropical Climate Conditions on the Quality of Antihypertensive Drugs from Rwandan Pharmacies.” American Journal of Tropical Medicine and Hygiene 81 (5): 776–781.
APA
Twagirumukiza, Marc, Cosijns, A., Pringels, E., Remon, J. P., Vervaet, C., & Van Bortel, L. (2009). Influence of Tropical Climate Conditions on the Quality of Antihypertensive Drugs from Rwandan Pharmacies. AMERICAN JOURNAL OF TROPICAL MEDICINE AND HYGIENE, 81(5), 776–781.
Vancouver
1.
Twagirumukiza M, Cosijns A, Pringels E, Remon JP, Vervaet C, Van Bortel L. Influence of Tropical Climate Conditions on the Quality of Antihypertensive Drugs from Rwandan Pharmacies. AMERICAN JOURNAL OF TROPICAL MEDICINE AND HYGIENE. 2009;81(5):776–81.
MLA
Twagirumukiza, Marc, An Cosijns, Eveline Pringels, et al. “Influence of Tropical Climate Conditions on the Quality of Antihypertensive Drugs from Rwandan Pharmacies.” AMERICAN JOURNAL OF TROPICAL MEDICINE AND HYGIENE 81.5 (2009): 776–781. Print.
@article{835273,
  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.},
  author       = {Twagirumukiza, Marc and Cosijns, An and Pringels, Eveline and Remon, Jean Paul and Vervaet, Chris and Van Bortel, Lucas},
  issn         = {0002-9637},
  journal      = {AMERICAN JOURNAL OF TROPICAL MEDICINE AND HYGIENE},
  keyword      = {STABILITY,COUNTERFEIT,IN-VITRO DISSOLUTION,SUB-SAHARAN AFRICA,VIVO BIOAVAILABILITY,ANTIMALARIAL-DRUGS,STORAGE-CONDITIONS,SUBSTANDARD DRUGS,FAKE DRUGS,GLOBAL BURDEN},
  language     = {eng},
  number       = {5},
  pages        = {776--781},
  title        = {Influence of Tropical Climate Conditions on the Quality of Antihypertensive Drugs from Rwandan Pharmacies},
  url          = {http://dx.doi.org/10.4269/ajtmh.2009.09-0109},
  volume       = {81},
  year         = {2009},
}

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