Drug Quality in South Africa: A Field Test

Differences in drug quality between South Africa and Germany

“…Dissolution tests results from a former study performed with Auro Amoxiclav 625 collected in South Africa 2016 . [Colour figure can be viewed at wileyonlinelibrary.com]…”

“…The South African wholesaler was only able to provide one batch (FN5016003‐A). To obtain a better overview of product performance, the results were compared to a study performed in the same year with samples from the same manufacturer but purchased in community pharmacies in South Africa …”

“…To obtain a better overview of product performance, the results were compared to a study performed in the same year with samples from the same manufacturer but purchased in community pharmacies in South Africa. [24] Six individual tablets were introduced into USP II apparatus (ERWEKA DT 720 dissolution tester, ERWEKA GmbH, Heusenstamm, Germany) and allowed to dissolve over 30 min. Prior to analysis, the equipment had been qualified mechanically and performance verification had been performed in accordance with USP.…”

“…As described in the Methods section, only one batch was accessible through the South African wholesaler. To compensate for this shortage of data, Figure 2 illustrates the mean dissolution results of stage two testing for eight samples of Auro Amoxiclav 625 that had been purchased in community pharmacies in South Africa [24] . The eight samples comprised four different batches (CD5014022-A, FN5016002-A, FN5016003-A, FN5016004-A) of Auro Amoxiclav 625.…”

“…Product (5), while complying with the qualitative and quantitative composition stated on the label, also showed Figure 2 Dissolution tests results from a former study performed with Auro Amoxiclav 625 collected in South Africa 2016. [24] [Colour figure can be viewed at wileyonlinelibrary.com] Figure 3 Release profiles for the German (Amoxy-Clavulan Aurobindo) and South African (Auro Amoxiclav) Amoxiclav products (n = 5, error bars depict standard deviations).…”