Experimental protocols and models for assessing the permeation of antineoplastic drugs through gloves: From a scoping review to a guidelines proposition for future studies

Abstract

This work aimed to analyze published experimental protocols investigating glove resistance to antineoplastic drugs (ADs) permeation to propose guidelines for future research. A scoping review was performed using three databases and studying 32 experimental parameters. Twenty-four articles were included, testing 35 ADs and 12 glove materials. While some parameters, such as glove thickness, drug concentration, trade name and instrumentation were well documented, others were often missing such as temperature (reported in only 58.3 % of articles), tested glove area (29 %), glove thickness at the tested area (16.6 %) and methods sensitivity (50 %) used to detect the drugs that passed through the glove. A great heterogeneity in experimental conditions (7 temperatures tested; 17 contact times) was observed and in instrumentation used to perform the permeation tests (13 different experimental devices). To approximate real-life exposure and glove-wearing conditions, 83.3 % of articles tested ADs commercial forms, concentrations were those of clinical practice and some protocols added mechanical and/or chemical stresses to gloves. However, none examined potential synergistic effects between drugs and excipients despite known influences, such as polysorbate 80 affecting permeation process through nitrile gloves. Additionally, an overview of all the ADs permeation results from the studies was presented for a contact time of 30 min, whatever the other experimental conditions. These findings highlighted how heterogeneous experimental conditions and missing data complicate cross-study comparisons. To address these issues, guidelines were proposed to improve protocols and harmonize published data in future, which would enhance the comparability of glove permeation results across studies.

Keywords: Antineoplastic agents; Experimental model; Gloves; Occupational exposure; Permeation; Personal Protective Equipment.