ESTUDOS DE EQUIVALÊNCIA FARMACÊUTICA COM COMPRIMIDOS DO CLORIDRATO DE BUPROPIONA EM MEDICAMENTOS SIMILAR E DE REFERÊNCIA

Abstract

The bupropion hydrochloride is an antidepressant pharmacological used in treatment of smoking cessation; the drug increases the interstitial concentrations of dopamine, reducing the smoking habit. The objective was the achievement of physical and chemical tests of the tablets of bupropion hydrochloride, of a laboratory acquired in similar ethical and commercial pharmacies in Imperatriz city, the drug being used in the Smoking Cessation Program of the Ministry of Health, Brazil. Were evaluated twelve lots of tablets of bupropion hydrochloride and observed the conditions of air conditioning in commercial pharmacies using a digital thermometer of Sper Scient brand. The raw materials of bupropion hydrochloride was used as a reference standard, purchased at a masterful pharmacy and subjected to laboratory tests in Quality Control of Faculdade de Imperatriz. The temperature verification at pharmacies where the tablets were purchased ranged from 37 ° C to 40 ° C, which is above the specification of boxes of medicine, whose guidelines: keep the temperature between 15°C to 30°C, which can cause instability pharmaceuticals. When weighing values were observed within the variation limits allowed. The friability showed no variations. The disintegration occurred at the scheduled time of 45 minutes. The twelve lots subject to durometer to resistance verification were higher than 3 Kgf, it is possible to change the nature of the excipients. There was no significant dissolution of the samples showing a concentration of 0.95 μg / ml, less than 80% of predicted value. The content of the active principle, analyzed by non aqueous titration, samples were taken by present concentration of between 90% and 110% as stated in the American Pharmacopoeia. Pharmaceutical equivalence between the similar medicine and the ethical medicine becomes related that both possess the same fármaco, and similar results evaluated in vitro. One concludes that the process of dissolution and hardness can have been affected significantly for the peculiar characteristics to the proper fármaco, as well as for the presence of excipientes that had made it difficult the same dissolution or for the employed techniques of manufacture. Also suggesting an analysis in the process of production inside of the quality control in the Pharmaceutical Industry verifying the processes of validation for attainment of planned results.