Avaliação da qualidade de comprimidos de hidroclorotiazida em apresentação referência, genérico e similar.

Abstract

Hypertension is a Noncommunicable Chronic Disease (NCD) characterized by the persistent elevation of systolic and/or diastolic blood pressure. Hydrochlorothiazide belongs to the class of thiazide diuretics, one of the main choices for initial hypertension therapy. Its primary action is the blockage of the NaCl cotransporter in the distal convoluted tubule, reducing extracellular volume and cardiac output, and decreasing peripheral vascular resistance, thus promoting a reduction in blood pressure. The aim of this study was to evaluate the physicochemical quality of hydrochlorothiazide tablets obtained from private community pharmacies, including the brand-name, similar, and generic presentations. Parameters such as visual appearance, average weight, friability, hardness, disintegration, and drug content were analyzed according to the methodologies described in the Brazilian Pharmacopoeia (2019). Five samples were analyzed: one brand-name, one similar, and three generic samples. All samples were intact tablets, circular in shape, white in color, with a diameter ranging from 6 to 6.5 mm and a thickness of 2 to 4 mm. In terms of average weight, all samples were within the recommended limits. The hardness of the tablets varied from 24 N to 45.6 N, while friability ranged from 0.04% to 0.43%. The disintegration time ranged from 15 seconds to 2 minutes and 49 seconds, and the active ingredient content varied from 95.51% to 103.41%. Therefore, all samples met the proposed parameters, demonstrating the pharmaceutical equivalence between the different presentations of hydrochlorothiazide tablets. Thus, quality control of medications is essential, as it ensures the efficacy and safety of the products.