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Introduction: Medical syringes are widely used in hospitals to store and administer drugs, and the contact time between the drugs and these syringes can vary from a few minutes to several weeks like for pharmaceutical preparations. The aim of this comparative study was to evaluate the potential sorption phenomena occurring between three drugs (paracetamol, diazepam and insulin aspart) and polypropylene syringes (PP) or syringes made of Cyclic Olefin Copolymer (COC). Materials and methods: 50 mL 3-part syringes made of either COC with crosslinked silicone on the barrel inner surface (COC-CLS) and a bromobutyl plunger seal, or PP lubricated with silicone oil (PP-SOL) with a polyisoprene plunger seal were used. Results: COC-CLS syringes induced less sorption of diazepam and insulin than PP-SOL syringes and the plunger seal material seemed to be the main cause of these interactions. An alkalinization of the medications in contact with the PP-SOL syringes was observed. It could be caused by leachable compounds and should be investigated further. Conclusion: This work shows once again that it is essential to consider content-container interactions to help improve the safe use of parenteral drugs. [ABSTRACT FROM AUTHOR]

Migration of molecules from packaging into products is a well-known phenomenon of which the studies in the food and medical industries are regulated in Europe by several legislations. However, for cosmetic packagings, there is no protocol nor specific migration limits available. The objective of this work was to use glycerin and liquid paraffin as cosmetic product simulants to perform a safety assessment on phthalates in 11 plastic packagings used in the cosmetic industry. To study these compounds in the matrices, 2 extraction techniques were compared: liquid-liquid extraction and solid-phase microextraction (SPME). The optimization of the 2 processes of extraction showed that SPME was more adapted to the study. Finally, samples of glycerin and liquid paraffin were analyzed by a SPME-GC-MS method to quantitate 10 regulated phthalates. In glycerin, only DEP was quantitated above the LOQ in 3 packagings, but the concentrations measured were under the set concentration threshold of 0.5 ppm. In liquid paraffin, DEP was quantitated above this concentration threshold. A safety evaluation was so performed by calculating the systemic exposure damage, and the results were finally considered to be safe for consumers. [ABSTRACT FROM AUTHOR]

Container-content interactions are common in the food and pharmaceutical industries. However, these studies are more complicated in the cosmetic industry, and it is necessary to ensure consumer safety. The objective of this work was to develop a strategy for the toxicological evaluation of leachables for cosmetic packagings. Eleven common plastic packagings were selected to evaluate interactions with 5 simulants (acidic, alkaline and neutral water, 30% and 96% ethanol) chosen to mimic cosmetics behavior. A GC-MS method was developed to screen for 12 non-intentionally added substances of particular concern: 10 phthalates, bisphenol A and distearyl thiodipropionate (European Pharmacopoeia plastic additive 17). Results were analyzed using a toxicological procedure established for this study. Some phthalates and bisphenol A were detected in several samples, but only one contaminant, diisobutyl phthalate (DiBP), was found to be above the set concentration threshold. Using toxicological data, this concentration was found to be safe for users. 96% ethanol appeared to be the strongest simulant in term of extraction, with a maximum concentration of 491 μg/L for DiBP in a 100% styrene-acrylonitrile copolymer packaging. In water simulants, less contaminants were extracted, with concentrations under 20 μg/L. Image 1 • A pragmatic approach for a toxicological evaluation of cosmetic packaging leachables is proposed. • Eleven plastic packagings were studied using five simulants to mimic interactions between container and content. • Twelves NIAS of concern (ten phthalates, bisphenol A and distearyl thiodipropionate) were screened by GC/MS. • DiBP was the only compound detected above the selected concentration threshold in one packaging. • The derived calculated exposure estimated using SED was not of safety concern. [ABSTRACT FROM AUTHOR]