Influence of tropical climate conditions on the quality of antihypertensive drugs from Rwandan pharmacies.
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.
Twagirumukiza
Marc
M
Department of Internal Medicine, University Hospital, Kigali, Rwanda. Marc.Twagirumukiza@UGent.be
Cosijns
An
A
Pringels
Eveline
E
Remon
Jean Paul
JP
Vervaet
Chris
C
Van Bortel
Luc
L
D000959:Antihypertensive Agents / Q000737:chemistry*; D004355:Drug Stability; D004356:Drug Storage / Q000379:methods*; D006358:Hot Temperature; D006813:Humidity; D012432:Rwanda; D014329:Tropical Climate
D000959:Antihypertensive Agents