A post-market quality assessment of first-line, fixed-dose combination antiretrovirals in South Africa
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Date
2019
Authors
Journal Title
Journal ISSN
Volume Title
Publisher
Journal of Applied Pharmaceutical Science
Abstract
South Africa has the world’s largest antiretroviral (ARV) program and despite having stringent upstream medicine’s
regulatory oversight, the post-market reassessment of ARV quality is prohibitively resource intensive. The aim of this
study was to evaluate and compare the post-market quality of four fixed-dose combination (FDC) generics containing
efavirenz (EFV) 600 mg, emtricitabine 200 mg, and tenofovir 300 mg against the innovator, Atripla® and according
to the International Pharmacopoeia (IP). Generic tablet samples, sourced from a South African provincial depot, were
subjected to the identification, content assay, dissolution, uniformity of weight and disintegration tests. An in-house
reversed-phase high-performance liquid chromatography (RP-HPLC) method was developed and validated in lieu
of the RP-HPLC IP method which proved to be unsuitable. All samples passed the identification, assay, uniformity
of weight and disintegration tests and one generic FDC failed the dissolution test (at both stage 1 and 2), releasing
62.23% (standard deviation 20.43) of EFV in 30 minutes. One generic first-line ARV combination that is currently
supplied to the South African public health sector was found to be substandard and this reinforces the need for routine
ARV post-market surveillance, as well as reliable compendial methods to facilitate this undertaking.
Description
Keywords
Quality control, Antiretrovirals, Pharmacology, South Africa
Citation
Ward, K. et al. (2022). A post-market quality assessment of first-line, fixed-dose combination antiretrovirals in South Africa. Journal of Applied Pharmaceutical Science, 9(02), 97-104. 10.7324/JAPS.2019.90213