QUALITY ASSESSMENT OF REFERENCE AND GENERIC ENALAPRIL MALEATE 10 MG TABLETS

Abstract

Cardiovascular diseases are responsible for high global mortality, and arterial hypertension is a risk factor due to its wide prevalence and clinical and social impact. Enalapril maleate, an angiotensin-converting enzyme (ACE) inhibitor, is commonly used to treat hypertension and heart failure. Pharmaceutical equivalence ensures that drugs with the same pharmaceutical form, route of administration and amount of active substance are equivalent in efficacy, safety and quality, even though they may have different excipients. The objective of this study was to evaluate the quality of 10 mg enalapril maleate tablets from two different laboratories (G1 and G2), in comparison with a reference drug (R), following the standards of the Brazilian Pharmacopoeia, 7th edition (2024), and RDC 31/2010. The tests revealed that all drugs met the criteria for average weight, friability and hardness, and obtained satisfactory results for the disintegration, dosage and dissolution tests. In the dissolution profile test, all drugs released more than 85% of the active ingredient in 15 minutes, therefore, the similarity factor (F2) cannot be discriminatory. Thus, the dissolution efficiency was evaluated, and the drugs showed great similarity, since p>0.05 with efficiencies of 109.31% for R, 116.51% for G1 and 117.58% for G2.