Avaliação da qualidade de medicamentos genéricos de cloridrato de amitriptilina 25 mg comercializados na cidade de Itacoatiara - AM

Abstract

Amitriptyline hydrochloride is a gold standard tricyclic antidepressant (TCA), characterized by the presence of a tertiary amine and commercially available in 10 mg, 25 mg and 75 mg coated tablets. The quality of a tablet is given by a set of actions that define the attributes necessary for efficacy. The aim of this study was to evaluate the physicochemical quality of generic amitriptyline hydrochloride tablets by comparing 3 brands available on the market in order to make inferences about the quality and efficacy of generics. Experimental research was carried out in the laboratory using analyses of average weight, hardness, disintegration, dosage and dissolution. In terms of average weight, the limits of variation for brands A, B and C were 2.05%, 2.19% and 1.85%. In the hardness test, the 3 brands of generic tablets showed differences in values, the average hardness of brand A, B and C was 4.04 kgf, 5.25 kgf and 7.32 kgf respectively. The 3 brands disintegrated in less than 15 minutes, in the dosage test the contents were 98.6%, 100.2% and 109.4% and in the dissolution test values above 80% of the active substance dissolved in the medium were obtained for all 3 brands. It was concluded that the 3 brands analyzed passed the test specifications of the Brazilian Pharmacopoeia 6th edition, thus ensuring the quality and reliability of the tablets.