Quality performance of metronidazole tablet products on the Kenyan market.
The in vitro performance of metronidazole tablet products by different manufacturers available on the Kenyan market was evaluated. It was found that a number of generic metronidazole tablet products have quality performance equal to that of Flagyl--the innovator product. All products confirmed to pharmacopoeial specifications. Three products with percent weight loss of 1.4, 11.08 and 14.93 failed the crucial friability test, for multidose packs. Two products failed the dissolution test releasing 46.8% and 45.8% of drug in 40 minutes. Drug release from tablet was found to vary between batches for one product. Ageing appears to decrease amount of drug released from tablets but longer storage periods and more samples are required before definite conclusions are drawn.
Department of Pharmacy, University of Nairobi, Kenya.
I O
IO
Kibwage
J
J
Thuranira
D
D
Migosi
D004356:Drug Storage / Q000592:standards; D006801:Humans; D007630:Kenya; D008795:Metronidazole / Q000493:pharmacokinetics / Q000592:standards* / Q000600:supply & distribution; D011786:Quality Control; D013810:Therapeutic Equivalency; D013997:Time Factors
D008795:Metronidazole