Leachables from plastic materials in contact with drugs. State of the art and review of current analytical approaches

Cuadros-Rodrı́guez, Luis; Lazúen-Muros, Marta; Ruíz-Samblás, Cristina; Navas-Iglesias, N

doi:10.1016/j.ijpharm.2020.119332

Cited by 36 publications

(31 citation statements)

References 56 publications

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“…The infused drug will therefore come into contact successively with numerous different polymers making up the devices. It has now been largely demonstrated that these polymers can interact with the drugs, leading to drug loss by sorption or release of unwanted and potentially toxic compounds (e.g., plasticizers released from polyvinyl chloride (PVC) tubings) [ 2 ].…”

Section: Introductionmentioning

confidence: 99%

Critical Drug Loss Induced by Silicone and Polyurethane Implantable Catheters in a Simulated Infusion Setup with Three Model Drugs

et al. 2021

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Silicone and polyurethane are biocompatible materials used for the manufacture of implantable catheters, but are known to induce drug loss by sorption, causing potentially important clinical consequences. Despite this, their impact on the drugs infused through them is rarely studied, or they are studied individually and not part of a complete infusion setup. The aim of this work was to experimentally investigate the drug loss that these devices can cause, on their own and within a complete infusion setup. Paracetamol, diazepam, and insulin were chosen as models to assess drug sorption. Four commonly used silicone and polyurethane catheters were studied independently and as part of two different setups composed of a syringe, an extension set, and silicone or polyurethane implantable catheter. Simulated infusion through the catheter alone or through the complete setup were tested, at flowrates of 1 mL/h and 10 mL/h. Drug concentrations were monitored by liquid chromatography, and the silicone and polyurethane materials were characterized by ATR-IR spectroscopy and Zeta surface potential measurements. The losses observed with the complete setups followed the same trend as the losses induced individually by the most sorptive device of the setup. With the complete setups, no loss of paracetamol was observed, but diazepam and insulin maximum losses were respectively of 96.4 ± 0.9% and 54.0 ± 5.6%, when using a polyurethane catheter. Overall, catheters were shown to be the cause of some extremely high drug losses that could not be countered by optimizing the extension set in the setup.

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Section: Introductionmentioning

confidence: 99%

Critical Drug Loss Induced by Silicone and Polyurethane Implantable Catheters in a Simulated Infusion Setup with Three Model Drugs

et al. 2021

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“…Next, compound (2) underwent the subsequent removal of two methoxy groups forming the final compound (4), containing two aldehyde functional groups. Meanwhile, compound (3) cleaved the −COOCH3 group to generate compound (5). In the second pathway, in which the addition of •OH at the aliphatic chain of the DMP molecule forms compound (6).…”

Section: Possible Reaction Pathways Of Tio2 Photocatalysis For Photod...mentioning

confidence: 99%

Insights into the Titania (TiO2) Photocatalysis on the Removal of Phthalic Acid Esters (PAEs) in Water

Tubillah

Chandren

2022

Bull. Chem. React. Eng. Catal.

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In this era of globalization, plastic is regarded as one of the most versatile innovations, finding its uses ranging from packaging, automotive, agriculture, and construction to the medical and pharmaceutical industries. Unfortunately, the single-use nature of plastics leads to ecological and environmental problems. Among conventional disposal management of plastic waste are landfilling dumping, incineration, and recycling. However, not all plastic waste goes into disposal management and ends up accumulating in lakes, rivers, and seas. In the aquatic environment, the action of photochemical weathering plastics has resulted in the release of chemical additives such as phthalic acid esters (PAEs), an important plasticizer added to plastic products to improve their softness, flexibility, and durability. Nowadays, PAEs have been ubiquitously detected in our environment and numerous organisms are exposed to PAEs to some extent. As PAEs carry endocrine disruptive and carcinogenicity properties, an urgent search for the development of an efficient and effective method to remove PAEs from the environment is needed. As a viable option, titania (TiO2) photocatalysis is a promising tool to combat the PAEs contamination in our environment owing to its high photocatalytic activity, cost-effectiveness, and its ability to totally mineralize PAEs into carbon dioxide and water. Hence, this paper aims to highlight the concerning issue of the contamination of PAEs in our aquatic environments and the summary of the removal of PAEs by TiO2 photocatalysis. This review concerning the significance of knowledge on environmental PAEs would hopefully spark huge interest and future development to tackle this plastic-associated pollutant. Copyright © 2022 by Authors, Published by BCREC Group. This is an open access article under the CC BY-SA License (https://creativecommons.org/licenses/by-sa/4.0).

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“…Ex vivo experiments are used to estimate exposure, as the mere presence of a certain plasticizer in a medical device is not fully informative of migration to a patient. Experimental study results must be interpreted critically since extraction is defined as removing compounds under laboratory conditions, while leaching is releasing compounds from devices under clinical conditions (Cuadros-Rodriguez et al, 2020). Estimated exposures from invasive medical devices or procedures in the NICU are summarized in Table 2.…”

Section: Sources Of Plasticizers In the Nicu: Medical Devicesmentioning

confidence: 99%

Plasticizers in the neonatal intensive care unit: A review on exposure sources and health hazards

Panneel

Malarvannan

Jorens

et al. 2021

Critical Reviews in Environmental Science and Technology

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Plasticizers, used to increase the flexibility of plastic materials, can leach into the environment and the human body. Various adverse health effects are attributed to exposure to plasticizers, particularly phthalates. Premature newborns admitted to a neonatal intensive care unit (NICU) are exposed to many indwelling plastic devices containing plasticizers while in a developmentally vulnerable period. This is the first comprehensive review of its kind, providing an overview of DEHP and alternative plasticizers (APs), their sources and degree of exposure in the NICU, and the resulting health risks in (premature) infants. Despite the 2017 EU Medical Devices Regulation (2017/745), di-(2-ethylhexyl) phthalate (DEHP) is still a commonly present plasticizer in plastic medical devices in the NICU, with current labelling being insufficient to guarantee absence. Estimated NICU exposures remain elevated above the tolerable daily intake. Medical procedures leading to the highest exposure of phthalates and APs, are extracorporeal membrane oxygenation, blood transfusion, parenteral nutrition and respiratory support.As traditional matrices, such as blood and urine, are not always readily available in neonates, the accumulation of plasticizers in alternative matrices, such as hair and nails, provides an opportunity to study long-term accumulation of toxic chemicals. Impaired respiratory and neurodevelopment correlate with phthalate exposure at both biological and epidemiological levels in childhood, yet knowledge gaps about the effects in neonates prevail. Some APs provide interesting opportunities to reduce toxicity, but human data regarding health effects remain limited. Although toxicologists and regulators have addressed the problem for some time, awareness is lacking mainly among healthcare professionals.

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Leachables from plastic materials in contact with drugs. State of the art and review of current analytical approaches

Cited by 36 publications

References 56 publications

Critical Drug Loss Induced by Silicone and Polyurethane Implantable Catheters in a Simulated Infusion Setup with Three Model Drugs

Critical Drug Loss Induced by Silicone and Polyurethane Implantable Catheters in a Simulated Infusion Setup with Three Model Drugs

Insights into the Titania (TiO2) Photocatalysis on the Removal of Phthalic Acid Esters (PAEs) in Water

Plasticizers in the neonatal intensive care unit: A review on exposure sources and health hazards

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