The efficacy of chemical decontamination of cytotoxic work surfaces depends not only on the cleaning solution used, but also on the cleaning protocol. It is necessary to adapt the protocol to the surface to clean and it must be standardized and validated. This work is an example of an experimental procedure to evaluate the efficacy of cleaning solutions and protocols used at a workstation after exposure to antineoplastic drugs.
Nirmatrelvir is an antiviral drug approved for the treatment of COVID-19. The available dosage form consists of tablets marketed under the brand name PAXLOVID®. Although knowledge of nirmatrelvir’s intrinsic stability may be useful for any potential development of other pharmaceutical forms, no data regarding this matter is available to date. Preliminary forced degradation studies have shown that the molecule is stable under oxidative and photolytic conditions, while hydrolytic conditions, both acidic and basic, have proven deleterious. Indeed, the molecule presents a priori several functions that can undergo hydrolysis, i.e., three amide moieties and a nitrile function. However, considering the degradation products formed under forced conditions and which were detected and identified by LC-UV-HRMSn, the hydrolysis process leading to their formation is selective since it involved only 2 of the 4 hydrolysable functions of the molecule. Ab initio studies based on density functional theory (DFT) have helped better understand these reactivity differences in aqueous media. Some hydrolyzable functions of nirmatrelvir differ from others in terms of electrostatic potential and Fukui functions, and this seems to correlate with the forced degradation outcomes.
The major degradation mechanisms of dabigatran etexilate were deduced in the context of stress testing. Under hydrolytic stress conditions, O-dealkylation may occur along with formation of benzimidic acid derivatives.
The main degradation pathways of apixaban, a novel anticoagulant drug acting as factor Xa inhibitor, has been established based on the degradation products identification using liquid chromatography coupled to multistage high resolution mass spectrometry.
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