Migrability of PVC plasticizers from medical devices into a simulant of infused solutions

[Display omitted] Medical devices (MD) for infusion and artificial nutrition are essentially made of plasticized PVC. The plasticizers in the PVC matrix can leach out into the infused solutions and may enter into contact with the patients. In order to assess the risk of patient exposure to these pla...

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Bibliographic Details
Published in:International journal of pharmaceutics 2015-05, Vol.485 (1-2), p.341-347
Main Authors: Bernard, L., Cueff, R., Breysse, C., Décaudin, B., Sautou, V.
Format: Article
Language:English
Subjects:
Benzoates - analysis
Cyclohexanecarboxylic Acids - analysis
Dicarboxylic Acids - analysis
Diethylhexyl Phthalate - analysis
Diffusion
Equipment Design
Ethanol - chemistry
Humans
Infusions, Parenteral - adverse effects
Infusions, Parenteral - instrumentation
Life Sciences
Materials Testing
Microbiology and Parasitology
Nutritional Support - adverse effects
Nutritional Support - instrumentation
Plasticizers - adverse effects
Plasticizers - analysis
Polyvinyl Chloride - adverse effects
Polyvinyl Chloride - analysis
Protistology
Risk Assessment
Solubility
Time Factors
Water - chemistry
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Summary:[Display omitted] Medical devices (MD) for infusion and artificial nutrition are essentially made of plasticized PVC. The plasticizers in the PVC matrix can leach out into the infused solutions and may enter into contact with the patients. In order to assess the risk of patient exposure to these plasticizers we evaluated the migration performance of DEHP, DEHT, DINCH, and TOTM using a model adapted to the clinical use of the MDs. Each PVC tubing sample was immersed in a simulant consisting of a mixture of ethanol/water (50/50v/v) at 40°C and migration tests were carried out after 24h, 72h, and 10 days.DEHP had the highest migration ability, which increased over time. The amount of TOTM released was more than 20 times less than that of DEHP, which makes it an interesting alternative. DEHT is also promising, with a migration level three times smaller than DEHP. However, the migration ability of DINCH was similar to DEHP, with the released amounts equaling 1/8th of the initial amount in the tubing after 24h of contact. Taking into account the available toxicological data, TOTM and DEHT appear to be of particular interest. However, these data should be supplemented and correlated with clinical and toxicological studies on plasticizers and their metabolites.
ISSN:0378-5173
1873-3476
DOI:10.1016/j.ijpharm.2015.03.030