Migration of plasticizers from PVC medical devices: Development of an infusion model.

Bernard, Lise; Cueff, R.; Chagnon, Mc.; Abdoulouhab, F.; Décaudin, Bertrand; Breysse, C.; Kauffmann, S.; Cosserant, Bernard; Souweine, Bertrand; Sautou, V.

doi:10.1016/j.ijpharm.2015.08.033

Cited by 33 publications

(23 citation statements)

References 17 publications

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“…Exposure firstly depends on the solution purchased, which means that it is extremely difficult to determine real exposure to GDPs. To estimate it, we consider that the maximum fluid volume perfused is 2 litres/day 39 . If all infusions are based on glucose, the highest average perfused amount of 5-HMF would be 25.67 ± 1.48 mg/day.…”

Section: Discussionmentioning

confidence: 99%

Factors Generating Glucose Degradation Products In Sterile Glucose Solutions For Infusion: Statistical Relevance Determination Of Their Impacts

Haybrard¹,

Simon²,

Danel³

et al. 2017

Sci Rep

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Sterilising glucose solutions by heat promotes the generation of a large number of glucose degradation products (GDPs). It has been shown that high levels of GDPs may result in Advanced Glycation End products that have an impact on cellular homeostasis and health in general. If data is available for peritoneal dialysis solutions, little has been published for glucose infusion fluids. It is essential to identify the parameters causing the formation of GDPs and so limit the risk of exposing patients to them. After quantifying both 5-hydroxymethyl-2-furfural, considered as an important indicator of degradation, and 2-furaldehyde, an ultimate GDP of one degradation pathway, in marketed solutions, the aim of this work is to build a model integrating all the parameters involved in the formation rates of these two GDPs: supplier, glucose amount, container material, oxygen permeability coefficient and time-lapse since manufacture. Our results show a good logarithmic relationship between GDP formation rates and time-lapse since manufacture for both GDPs. The amount of GDPs in the glucose solutions for infusion depends on the initial glucose amount, the polymer of the container, the time elapsed since manufacturing and the supplier.

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Section: Discussionmentioning

confidence: 99%

Factors Generating Glucose Degradation Products In Sterile Glucose Solutions For Infusion: Statistical Relevance Determination Of Their Impacts

Haybrard¹,

Simon²,

Danel³

et al. 2017

Sci Rep

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“…Migration assays were performed in the same conditions described by Bernard et al as regard to the choice of the simulant, and of the contact temperature and time [ 3 ]. Only the flow rate was modified.…”

Section: Methodsmentioning

confidence: 99%

“…simulant: we chose a 50/50 ethanol/water (v/v) solution which reflects lipid emulsions able to extract plasticizers from PVC medical devices. 3% acetic acid (also proposed in the infusion model) was not selected because the migration appears to be insignificant in it [ 3 ].…”

Section: Methodsmentioning

confidence: 99%

“…To assess the exposure risk of inpatients, the evaluation of their migration in such conditions is required. An infusion model was developed to estimate if a medical device could be considered safe for infusion use according to the leaching of plasticizers [ 3 ]. Nevertheless, this model doesn’t take into account of the flow rate at which drug solutions are administrated to the patients, thus considering the exposure risk to be the same whatever the flow rate of the infusion.…”

Section: Introductionmentioning

confidence: 99%

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Effects of flow rate on the migration of different plasticizers from PVC infusion medical devices

et al. 2018

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Infusion medical devices (MDs) used in hospitals are often made of plasticized polyvinylchloride (PVC). These plasticizers may leach out into infused solutions during clinical practice, especially during risk-situations, e.g multiple infusions in Intensive Care Units and thus may enter into contact with the patients. The migrability of the plasticizers is dependent of several clinical parameters such as temperature, contact time, nature of the simulant, etc… However, no data is available about the influence of the flow rate at which drug solutions are administrated. In this study, we evaluated the impact of different flow rates on the release of the different plasticizers during an infusion procedure in order to assess if they could expose the patients to more toxic amounts of plasticizers. Migration assays with different PVC infusion sets and extension lines were performed with different flow rates that are used in clinical practice during 1h, 2h, 4h, 8h and 24h, using a lipophilic drug simulant. From a clinical point of view, the results showed that, regardless of the plasticizer, the faster the flow rate, the higher the infused volume and the higher the quantities of plasticizers released, both from infusion sets and extension lines, leading to higher patient exposure. However, physically, there was no significant difference of the migration kinetics linked to the flow rate for a same medical device, reflecting complex interactions between the PVC matrix and the simulant. The migration was especially dependent on the nature and the composition of the medical device.

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“…High MW (HMW) PEs such as di-(2-ethylhexyl) phthalate (DEHP) and di-iso-nonyl phthalate (DiNP) are primarily used in polyvinyl chloride (PVC) products including floor polishing, wall coatings, children's toys, medical products and food packaging [4][5][6] . Their low migration stability and vapour pressure influence PE release to the indoor environment, resulting in their classification as major indoor organic contaminants 7,8 .…”

Section: Introductionmentioning

confidence: 99%

In Vitro Inhalation Bioaccessibility of Phthalate Esters and Alternative Plasticizers Present in Indoor Dust Using Artificial Lung Fluids

Kademoglou

Giovanoulis

Palm-Cousins

et al. 2018

Environ. Sci. Technol. Lett.

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Phthalate esters (PEs) are plasticiser additives imparting durability, elasticity and flexibility to consumer products. The low migration stability of PEs along with their ubiquitous character and adverse health effects to humans and especially children has resulted in their classification as major indoor contaminants. This study assesses inhalation exposure to PEs via indoor dust using an in vitro inhalation bioaccessibility test (i.e. uptake) for of dimethyl phthalate (DMP), diethyl phthalate (DEP) and di-(2-ethylhexyl) phthalate (DEHP) and the alternative non phthalate plasticisers bis(2-ethylhexyl) terephthalate (DEHT) and cyclohexane-1,2-dicarboxylic acid diisononyl ester (DINCH), exposure. Using artificial lung fluids, which mimicktwo distinctively different pulmonary environments, namely artificial lysosomal fluid (ALF, pH = 4.5) representing the fluid that inhaled particles would contact after phagocytosis by alveolar and interstitial macrophages within the lung and Gamble's solution (pH = 7.4), the fluid for deep dust deposition within the pulmonary environment. Low molecular weight (MW) PEs such as DMP and DEP were highly bioaccessible (> 75 %) in both artificial pulmonary media, whereas highly hydrophobic compounds such as DEHP, DINCH and DEHT were < 5 % bioaccessible via the lung. Our findings show that the in vitro pulmonary uptake of PEs is primarily governed by their hydrophobicity and water solubility, highlighting thus the need for the establishment of a unified and biologically relevant inhalation bioaccessibility test format, employed within the risk assessment framework for volatile and semi-volatile organic pollutants.

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Migration of plasticizers from PVC medical devices: Development of an infusion model.

Cited by 33 publications

References 17 publications

Factors Generating Glucose Degradation Products In Sterile Glucose Solutions For Infusion: Statistical Relevance Determination Of Their Impacts

Factors Generating Glucose Degradation Products In Sterile Glucose Solutions For Infusion: Statistical Relevance Determination Of Their Impacts

Effects of flow rate on the migration of different plasticizers from PVC infusion medical devices

In Vitro Inhalation Bioaccessibility of Phthalate Esters and Alternative Plasticizers Present in Indoor Dust Using Artificial Lung Fluids

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