Setting: In most developing countries, paediatric tuberculosis is treated with split tablets leading to potential inaccuracy in\nthe dose delivery and drug exposure. There is no data on the quality of first-line drugs content in split fixed-dose\ncombination tablets.\nObjective: To determine Isoniazid, Pyrazinamide and Rifampicin content uniformity in split FDC tablets used in the\ntreatment of childhood tuberculosis.\nDesign: Drug contents of 15 whole tablets, 30 half tablets and 36 third tablets were analysed by high performance liquid\nchromatography. The content uniformity was assessed by comparing drug content measured in split portions with their\nexpected amounts and the quality of split portions was assessed applying qualitative specifications for whole tablets.\nResults: All whole tablets measurements fell into the USP proxy for the three drugs. But a significant number of half and\nthird portions was found outside the tolerated variation range and the split formulation failed the requirements for content\nuniformity. To correct for the inaccuracy of splitting the tablets into equal portions, a weight-adjustment strategy was used\nbut this did not improve the findings.\nConclusion: In split tablets the content of the three drugs is non-uniform and exceeded the USP recommendations. There is\nan absolute need to make child-friendly formulations available for the treatment of childhood tuberculosis.
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