Avaliação da qualidade dos comprimidos de maleato de enalapril disponíveis nas farmácias básicas de seis municípios paraibanos.

Abstract

Systemic arterial hypertension is a chronic non-transmissible disease (CNCD) and multifactorial. Enalapril maleate is an antihypertensive of continuous use, which acts as an inhibitor of the angiotensin converting enzyme widely used in the treatment of hypertension. The objective of this work was to perform the physical-chemical quality control of enalapril maleate tablets purchased through a bidding process and dispensed by the basic pharmacies of six municipalities in the state of Paraíba. The visual aspect, mean weight, friability, hardness, disintegration and drug content were analyzed according to the methodologies described by the Brazilian Pharmacopoeia (2010). All the samples were approved in the tests of average weight, friability and disintegration, however, of the six samples used, two presented a deviation of the quality in relation to the hardness and content of active principle. In the hardness test, the F sample had a mean hardness of 23.8 (N) lower than the acceptable minimum of 30 (N), which could compromise the effectiveness of the treatment, since the loss of active principle caused by the rupture of the tablet will result in an inadequate dosage. In the assay test only sample E shows a high value of 114.5% in relation to the values allowed by the Brazilian Pharmacopoeia from 90% to 110%, which can lead the patient to drug

intoxication and non adherence to the pharmacotherapeutic treatment. The physical- chemical control ensures that the medicines dispensed in basic pharmacies are of

adequate quality and can be used safely by patients. It is recommended to implement a quality management system that includes the qualification of suppliers.