Estudo de equivalência farmacêutica de alopurinol comprimidos

Abstract

Gout is a disease characterized by the accumulation of monosodium urate crystals in joints, bones and skin that mostly affects men over 40 years of age. Hyperuricemia derives from several factors, from pre-existing diseases, protein-rich diet, the use of alcohol and substances that alter the process of uric acid excretion, it also influences the formation and accumulation of these crystals, in this way, allopurinol is the drug of choice in the treatment of gout by reducing uric acid levels. Interchangeability between drugs is guaranteed by proof of pharmaceutical equivalence, bioequivalence, good manufacturing practices and quality control. This study aimed to perform the quality control and dissolution profile of the reference and generic allopurinol tablets. The reference drug and three generic drugs were analyzed according to Pharmacopeial methods, and the following tests were performed: average weight, hardness, friability, disintegration, unit dose uniformity, assay, biological safety tests, dissolution test and dissolution profile. Generic 1 and 3 presented results according to specification and generic 2 was considered non-conform in the dosage test. The dissolution profile of generic 1, 2 and 3 were similar to the reference. With this, we can conclude that generic 1 and 3 are pharmaceutical equivalents to the reference drug and generic 2 has no equivalence.