Analysis of preservatives and fragrances in topical medical devices: The need for more stringent regulation.

INTRODUCTION: Medical devices (MDs) have a long history of use, and come with regulatory frameworks to ensure user safety. Although topically applied MDs in the form of gels and creams might be used on damaged skin, their composition is often similar to that of cosmetic products applicable to intact skin, especially in terms of preservatives and fragrances. However, unlike cosmetics, these products are not subject to compound-specific restrictions when used in MDs. OBJECTIVE: This study aimed to identify and quantify preservatives and fragrances in topically applied MDs and assess their safety towards the Cosmetic Regulation (EC) 1223/2009. METHOD: Sixty-nine MDs available on the EU market were subjected to previously validated liquid chromatography tandem mass spectrometry (LC-MS/MS) and gas chromatography-mass spectrometry (GC-MS) methods to identify and quantify occurring preservatives and fragrances. RESULTS: Findings revealed that 32% of the examined MDs did not provide comprehensive ingredient lists, leaving users uninformed about potential risks associated with product use. Furthermore, 30% of these MDs would not meet safety standards for cosmetic products and, most significantly, 13% of the analysed samples contained ingredients that are prohibited in leave-on cosmetics. CONCLUSION: Results highlight the pressing demand for more stringent requirements regarding the labelling and composition of MDs to enhance patient safety. Improved regulation and transparency can mitigate potential risks associated with the use of topically applied MDs.

Full Characterisation of Heroin Samples Using Infrared Spectroscopy and Multivariate Calibration.

The analysis of heroin samples, before use in the protected environment of user centra, could be a supplementary service in the context of harm reduction. Infrared spectroscopy hyphenated with multivariate calibration could be a valuable asset in this context, and therefore 125 heroin samples were collected directly from users and analysed with classical chromatographic techniques. Further, Mid-Infrared spectra were collected for all samples, to be used in Partial Least Squares (PLS) modelling, in order to obtain qualitative and quantitative models based on real live samples. The approach showed that it was possible to identify and quantify heroin in the samples based on the collected spectral data and PLS modelling. These models were able to identify heroin correctly for 96% of the samples of the external test set with precision, specificity and sensitivity values of 100.0, 75.0 and 95.5%, respectively. For regression, a root mean squared error of prediction (RMSEP) of 0.04 was obtained, pointing at good predictive properties. Furthermore, during mass spectrometric screening, 10 different adulterants and impurities were encountered. Using the spectral data to model the presence of each of these resulted in performant models for seven of them. All models showed promising correct-classification rates (between 92 and 96%) and good values for sensitivity, specificity and precision. For codeine and morphine, the models were not satisfactory, probably due to the low concentration of these impurities as a consequence of acetylation. For methacetin, the approach failed.

A systematic review of analytical methodologies capable of analysing phytocannabinoids in cosmetics.

As cannabidiol (CBD) is not considered to be a drug and because of its potential health claims, it is an interesting compound that is often found in cosmetics. However, the safety of CBD, as well as the presence of trace amounts of other phytocannabinoids, including the psychoactive substance ∆9 -tetrahydrocannabinol (THC), is still being debated. A robust analytical technique capable of analysing cosmetic products and determining their phytocannabinoid content will be crucial in assessing the safety of these products. This systematic review aims to highlight the current analytical tools that could be used to analyse phytocannabinoids in cosmetics. The ideal method would be able to analyse high levels of CBD in combination with trace levels of THC and their acids. The method should provide good recoveries and accuracies in a variety of matrices while providing information on up-coming phytocannabinoids such as cannabichromene (CBC), cannabigerol (CBG) and cannabinol (CBN). The systematic review approach was based on the Preferred Reporting Items for Systematic review and Meta-Analyses method. The research focused on studies published from January 2010 to December 2022 in PubMed and Scopus. A total of 15 datasets met the inclusion and exclusion criteria and were tabulated to allow easy comparison. Although some of the reviewed methods can handle multiple matrices and provide satisfactory recoveries, this review process did not identify an ideal method. The most suitable methods either could not quantify phytocannabinoid acids or were not sensitive enough to quantify trace levels of psychoactive phytocannabinoids.

The use of nitrous oxide whippets as a recreational drug: Hidden health risks.

Whipped cream canisters, also known as nitrous oxide whippets, are traditionally used in the culinary arts to prepare food foams. In recent years, however, these gas canisters have been cracked open and inhaled to produce a "legal" high. Users of these whippets have reported the presence of an oily residue containing metallic particles. This contamination was investigated using liquid chromatography-, gas chromatography- and inductively coupled plasma-mass spectrometry (ICP-MS) and optical emission spectrometry (ICP-OES). The particulate matter was also analyzed by scanning transmission electron microscopy (STEM) combined with energy-dispersive X-ray spectroscopy (EDX). The presence of cyclohexyl isothiocyanate was confirmed at a maximum concentration of 67 µg per whippet. ICP-MS and ICP-OES analysis revealed the presence of mainly iron and zinc, but also, traces of aluminum, chromium, cobalt, nickel, and lead were found. STEM-EDX analysis confirmed the presence of nano-sized particles containing iron and zinc. When simulating inhalation, using the multiple path particle dosimetry model, it was confirmed that these nano-sized particles can reach the deeper parts of the lungs. Most users assume that inhaling a food-grade nitrous oxide whippet for a "legal" high poses no risks. However, this research shows that users are exposed to cyclohexyl isothiocyanate, a substance classified as a respiratory sensitizer. The presence of zinc in the particulate matter could potentially be linked to lung lesions.