Pharmaceutical equivalence and dissolution profile studies for tablets containing hydrochlorothiazide

Abstract

Hydrochlorothiazide (HCTZ) belongs to the thiazide diuretic class, widely used in the treatment of patients with mild to moderate edema and systemic arterial hypertension, being considered highly effective by health professionals. The
purpose of this work was to evaluate the pharmaceutical equivalence and to perform comparative dissolution profile studies between the Reference medicine (R) and three Generic medicines from different brands (G1, G2 and G3)
presented as immediate release tablets of hydrochlorothiazide (25 mg). Such studies were carried out according to the monograph presented in the Brazilian Pharmacopoeia 5th Ed. (2010) and the current national legislation. In the physical and physicochemical tests, G1, G2 and G3 were approved. However, in some cases they presented significant differences when compared to R. Regarding the dissolution profile, which aims to evaluate the similarity factor (F2), only G3 did not present similar profile as compared to R. Thereby, interchangeability between G3 and R may be impaired once the drug may not reach the required plasmatic levels at the desired absorption rate and extension. Data arising from this study may reflect the quality and reliability of the generic medicines widely used from the Brazilian population.