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Antiretrovirals from overseas meet content standards when stored appropriately
  NEW YORK (Reuters Health) - Antiretroviral drugs obtained in developing countries appear to usually contain the labeled amount of active drug ingredient, according to a brief report in the May 1 issue of Clinical Infectious Diseases.
Because of costs and demand, brand name drugs are likely to be mislabeled, diluted or substituted with less expensive ingredients, Dr. Scott R. Penzak, at the National Institutes of Health in Bethesda, Maryland and associates note.
For quality-control purposes, physicians traveling to Lithuania, South Africa, Jamaica and Zambia obtained samples of antiretroviral drugs and delivered them to the NIH. Drug content of each sample was analyzed.
Included were two lots each of efavirenz, ritonavir, saquinavir soft-gel capsules, and lopinavir-ritonavir; four lots of indinavir; and one lot of amprenavir. Two to four capsules of each were analyzed.
Except for ritonavir, the samples met USP standards, varying between < 12% and > 15% of labeled drug amount, even though the two saquinavir products had not been refrigerated as advised by the manufacturer. The one generic preparation of indinavir was on a par with the brand name drug produced by Merck.
Ritonavir content was 16% to 19% less than the labeled amount in three of the four preparations. The authors note that none had been kept refrigerated and at least one had expired.
"These data reinforce the importance of storing ritonavir-containing preparations according to manufacturer specifications," the authors write.
Drugs acquired in developing countries should undergo quality-control studies for content and bioequivalence, independently of sponsoring pharmaceutical companies, Dr. Penzak's group recommends.
Clin Infect Dis 2004;38:1317-1319.


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