A post-market quality assessment of first-line, fixed-dose combination antiretrovirals in South Africa

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dc.contributor.authorWard, Kim
dc.contributor.authorSuleiman, Reem
dc.contributor.authorKippie, Yunus
dc.date.accessioned2022-10-28T09:43:19Z
dc.date.available2022-10-28T09:43:19Z
dc.date.issued2019
dc.description.abstractSouth 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.en_US
dc.identifier.citationWard, 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.2019.90213en_US
dc.identifier.issn2231-3354
dc.identifier.uri10.7324/JAPS.2019.90213
dc.identifier.urihttp://hdl.handle.net/10566/8085
dc.language.isoenen_US
dc.publisherJournal of Applied Pharmaceutical Scienceen_US
dc.subjectQuality controlen_US
dc.subjectAntiretroviralsen_US
dc.subjectPharmacologyen_US
dc.subjectSouth Africaen_US
dc.titleA post-market quality assessment of first-line, fixed-dose combination antiretrovirals in South Africaen_US
dc.typeArticleen_US

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