Evaluation of the quality of pharmaceutical formulations containing ferrous sulfate supplied in the public health system

Abstract

For the control and prevention of temporary anemia of iron in the population, it is recommended to follow a proper supplementation, in which ferrous sulfate is the main drug of choice in these cases. Considering that this medicine is distributed by the government mainly to public hospitals and Basic Health Units, it becomes necessary to analyze for quality assessment in their many pharmaceutical forms. It was established between the Adolfo Lutz Institute and the Health Surveillance of São Paulo, the Program Quality Drug Monitoring to ensure the quality, safety, and efficacy of medicine. The aim of the present study was to analyze ferrous sulfate in oral solution, syrup, and tablet and evaluate the results to detect their impact on public health. The presentations were analyzed according to pharmacopoeial monographs concerning the
analysis of aspect, determination of weight/volume /pH, identification of ferrous sulfate and its content, and the labeling analysis was performed, by current legislation. The obtained analysis results from the Program for Quality Control of Drugs and techniques complaints in the period 2008-2014 were: 57% as satisfactory, and 43% unsatisfactory. Among the unsatisfactory, 7% were related to labeling analysis, 18% to aspect and 18% related to sulfate ferrous assay. It is of great importance for public health, the continuity of these Programs for Drug Quality Control to ensure the maintenance of Good Manufacturing Practices (GMP) to protect and promote the health of the population.