Estudos de equivalência farmacêutica e perfil de dissolução em comprimidos genéricos de paracetamol

Abstract

Paracetamol, also called acetaminophen, is one of the most widely used NSAIDs for pain and fever relief, as it is an over-the-counter medication. On the market it is possible to find the reference medicine, which has a higher cost. To facilitate access to quality and low-cost drugs, Generic Law No. 9,787 of 1999 / ANVISA was created, and in 2003 generic versions of 60.48% of the drugs sold were already available. The advent of this law excludes criteria for registering medicines in Brazil, introducing concepts that have never been used before, such as bioequivalence (proven through in vivo tests) and pharmaceutical equivalence (proven through in vitro tests). The approval in these cases, the interchangeability between generic and reference medicine. The main objective of this work is to compare batches of paracetamolcoated tablets, with a size to verify the pharmaceutical equivalence between three generic drugs and the reference drug (Tylenol®) both at a concentration of 750mg. The analyzes were carried out in accordance with the monograph of compressed paracetamol, analyzed in the Brazilian Pharmacopoeia 6th edition (2019) as: Identification, Weight Determination, Dosage, Uniformity of Unit Doses, Hardness Test, Disintegration Test, Dissolution Test and. Dissolution Profile. The results revealed no discrepancy in quality between the drugs. As for the dissolution profile, as 3 analyzed, dissolution changes with a behavior very similar to the reference medicine, which indicates that there is pharmaceutical equivalence between how administered studied.