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

International Journal of Pharmaceutics
Lise BernardArmed Study Group

Abstract

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 meta...Continue Reading

References

Sep 10, 2002·JPEN. Journal of Parenteral and Enteral Nutrition·Steffan LoffManuela Langbein
Mar 20, 2004·Journal of Pharmaceutical and Biomedical Analysis·Daniel BourdeauxJean Chopineau
Sep 1, 2004·Reproductive Toxicology·Giuseppe LatiniAlberto Verrotti
Oct 26, 2005·European Journal of Pharmaceutical Sciences : Official Journal of the European Federation for Pharmaceutical Sciences·Dennis JenkeMitchell Poss
Jul 4, 2012·The Science of the Total Environment·Joshua KastnerViviane Yargeau
Mar 19, 2014·Journal of Toxicology and Environmental Health. Part B, Critical Reviews·Virunya S BhatJ Caroline English

❮ Previous
Next ❯

Citations

Dec 10, 2015·Environmental Toxicology and Pharmacology·Xian-Hua ChenChen-Huan Yu
Nov 13, 2015·International Journal of Pharmaceutics·H Al SalloumN Yagoubi
Nov 13, 2015·Journal of Pharmaceutical and Biomedical Analysis·Daniel BourdeauxUNKNOWN ARMED Study Group
May 12, 2015·International Journal of Pharmaceutics·Luba KozlovskayaDavid Stepensky
Apr 17, 2018·Expert Review of Medical Devices·Charlotte Fernandez-CanalUNKNOWN for Armed Study Group
Apr 28, 2019·Pediatric Nephrology : Journal of the International Pediatric Nephrology Association·Randall JenkinsDavid Rozansky
Jun 24, 2017·BMC Women's Health·Cécile MarieMarie-Pierre Sauvant-Rochat
May 6, 2020·Molecules : a Journal of Synthetic Chemistry and Natural Product Chemistry·Pauline MuratValérie Simon
Oct 3, 2020·Critical Reviews in Toxicology·Shalenie P Den Braver-SewradjEllen V S Hessel
Jul 22, 2018·Archives of Toxicology·Christine HöllererElisabeth Eckert
Sep 9, 2020·Regulatory Toxicology and Pharmacology : RTP·L SvobodovaT Heinonen
Mar 19, 2021·Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences·Laura KuhlmannElisabeth Eckert
Apr 17, 2021·Journal of Hazardous Materials·Thi Huyen DuongSung Kyu Maeng
May 22, 2021·Biomedical Instrumentation & Technology·Michelle Miller, Nicola Zaccheddu
May 28, 2021·Biomedical Instrumentation & Technology·Helin RäägelMatthew R Jorgensen
Sep 7, 2021·Annales pharmaceutiques françaises·P PlaidyL Bernard

❮ Previous
Next ❯

Related Concepts

Related Feeds

Cell Migration

Cell migration is involved in a variety of physiological and pathological processes such as embryonic development, cancer metastasis, blood vessel formation and remoulding, tissue regeneration, immune surveillance and inflammation. Here is the latest research.