Faixa de degradação forçada requerida pela Agência Nacional de Vigilância Sanitária para fármacos e as principais técnicas envolvidas na identificação de produtos de degradação

Abstract

The Forced Degradation Study (EDF) is a tool for developing stability-indicating methods and thereby allowing degradation products and other impurities to be monitored along the stability studies to ensure the quality of the drug. However, the absence of clear guidelines on what conditions and for how long a substance must undergo degradation can lead to unfounded demands for increased stress conditions only to meet regulatory requirements. Thus, the objective of this work was to verify if the current regulatory requirements for the forced degradation range and the identification of impurities are in compliance with the Brazilian legislation. To do so, all the Public Assessment of Medication (PPAM) of disapproval available on ANVISA's website were evaluated and verified which of these PPAMs were related to non-compliance with Articles 6 and 9 of the RDC 53/2015. The retrospective analysis of rejection opinions revealed that 12% of PPAM related to new drugs did not comply with RDC No. 53/2015, while 27% were related to generic drugs. Of the drugs that did not comply with art. 6 of RDC 53/2015, in only one it was possible to conclude that ANVISA's request to submit the drug and the IFA to more aggressive stress conditions was in accordance with the literature. Finally, it was verified that the chromatographic and spectroscopic techniques are the most used for the identification of impurities of degradation in drug substances. Keywords: Forced degradation study