Laboratory evaluation and quality assurance of drugs distributed in the public health system of São Paulo cities: the enalapril maleate case

Abstract

Introduction: Drug quality monitoring and laboratory investigation of product complaints associated to suspicion of quality deviation are essential actions for the health    surveillance activity. Objective: To evaluate the physicochemical quality of samples of enalapril maleate tablets from a Drug Quality Monitoring Program and from product complaints in São Paulo cities. Method: The samples were composed by six batches of tablets from the Monitoring  Program and four batches from the product complaints, collected in 2013 and from 2013 to 2016, respectively. The aspect of the product, weight determination, identification and potency of the active substance, uniformity of dosage units and dissolution tests were performed. Results: Regarding the Monitoring Program, enalapril potency ranged from 91.3% to 94.5%, while the uniformity of dosage units varied  between 7.7 and 14.6. All dissolution results were above 85.7%. For the complaints samples, enalapril potency ranged between 91.8% and 100.3%. The uniformity test varied from 9.5 to 10.0, and the lowest value found for the dissolution test was 95.3%. One of the samples was found to contain foreign matter accompanying the  tablets. Conclusions: All samples from the Monitoring Program fulfilled the requirements according to the established quality standards, while one of the samples from the complaints was considered unsatisfactory due to an aspect nonconformity. A greater number of Monitoring Programs along with an incentive for health professionals to report product problems should be promoted in order to strengthen pharmacovigilance actions in the country.