Análise das médias de teor do fármaco citrato de fentanila em lotes do medicamento injetável citrato de fentanila 0,05 mg/ml volume 10 ml

Abstract

The pharmaceutical industry has experienced a major challenge recently with the Covid-19 (SARS-CoV-2) pandemic. The areas of quality assurance and validation of processes and qualification of equipment and systems had to guarantee an increase in the production of medicines without loss of product quality and with a view to patient safety. A drug widely used for short-term analgesia during the anesthetic period and other clinical procedures is Fentanyl Citrate 0.05 mg/ml. Fentanyl citrate is the citric acid salt of fentanyl which is composed of equimolar amounts of these. Fentanyl has in its structure an amide, two benzyl rings and a piperidine analogue, which, in this case, can be classified as a tertiary amine. Among the various physical-chemical analyzes carried out in the quality control of medicines, the analysis of the dosage (content) of the drug is of great importance, aiming at delivering the correct dose of the medicine and, consequently, a better efficacy of the product. In this context, this study sought to perform a variance analysis of the means of the 11 sampled batches of Fentanyl Citrate 0.05 mg/ml - volume 10 ml that were produced during the year 2021 in a pharmaceutical industry located in the city of Montes Claros- MG.