Avaliação da partição de comprimidos: implicações para a segurança e eficácia terapêutica.

Abstract

Tablet splitting is a widely used practice in hospitals and homes. Its main purposes are to adjust the dose, facilitate swallowing of tablets and reduce the costs of therapeutic treatment. It can be performed either with the aid of specific tools or manually. It is a practice with a significant impact, especially because it is often applied to adjust the dose of pediatric and elderly patients. This study evaluated the impact of splitting on scored tablets of ASA 100 and ASA 500 mg. The ASA 100 mg tablets were split using a knife, a tablet splitter and manually, and the ASA 500 mg tablets were split using only the splitter. Average weight, titration assay and mass loss tests were used to perform quality control of the tablet splits. The results of the average weight test of the tablets were within the established standards. The fraction assays by all partition methodologies were relatively uniform, with no major variations for both 100 mg and 500 mg ASA tablets. However, the content losses between the methodologies showed different results. The methodology that presented the least content loss was the manual one, with an average loss of 0.78%, followed by the partition with the fractionator, with an average of 2.83% for 500 mg ASA and 1.52% for 100 mg ASA. The partition with the worst loss results was the partition with a knife, with a loss of 7.46%. However, the main result observed was the notable difference between the two fractions resulting from the partition.With the conclusion of the studies, it can be stated that, although the variations in the active ingredient content between the fractions were not significant in most cases, the discrepancy in the masses of the halves obtained by partition represents the main limitation of this practice. This difference compromises the accuracy of the administered dose, especially in drugs with a narrow therapeutic margin. Therefore, tablet partitioning should be avoided whenever possible, and it is preferable to resort to safer alternatives, such as individualized pharmaceutical compounding for dose adjustment.