In-vitro evaluation of the pharmacological and therapeutic equivalence of some acetaminophen trademarks

Abstract

There are currently many laboratories throughout the world that sell acetaminophen with legal registration. However, the fact that it is a legal drug does not ensure its quality, as it may undergo changes during its manufacture or marketing, which can affect its efficacy and pharmaceutical safety. Therefore, this project was developed, in which 30% of the brands of acetaminophen 500 mg tablets marketed in Colombia were analysed with the aim of determining their pharmacological and therapeutic equivalence. Know the pharmaceutical characteristics and therapeutic similarity between the different brands of acetaminophen analysed a methodology was followed in accordance with the parameters and guidelines of the United States Pharmacopeia 42, National Form 37, and Resolution 1124 of the Ministry of Health and Social Protection of the Colombian government. The samples' dissolving profiles at different pH values were then compared, and tests were run to check for impurities, content, uniformity, and dissolution. The results of these analyses are all totally consistent with the pharmacological and therapeutic equivalents. These comply both with the physical-chemical quality control parameters required as well as with therapeutic equivalence. From the findings of this investigation, it was concluded that since there is no evidence of significant differences between the brands analysed, it is recommended that those who need to buy acetaminophen or Tylenol from the brands surveyed can purchase any of them with complete confidence that any of them will have the same pharmaceutical quality and the same therapeutic performance.