Limitation of the migration of plasticizers from medical devices through treatment with low-pressure cold plasma, polydopamine coating, and annealing.

Morgane Masse (1) , Maude Jimenez (2) , Stéphanie Genay (1) , Alice Pettinari (1) , Séverine Bellayer (2) , Christine Barthelemy (1) , Bertrand Décaudin (1) , Nicolas Blanchemain (3) , Pascal Odou (1)

1 GRITA - Groupe de Recherche sur les formes Injectables et les Technologies Associées - ULR 7365
2 UMET - Unité Matériaux et Transformations - UMR 8207
3 MBLC - ADDS - Médicaments et biomatériaux à libération contrôlée: mécanismes et optimisation - Advanced Drug Delivery Systems - U 1008

Poly(vinyl chloride) (PVC) is widely used in the manufacture of medical devices. The plasticizers added to PVC are potentially toxic for humans, likely to migrate, and thus unintentionally administered to patients. The objective of the present study was to reduce the migration of plasticizer (1,2-cyclohexanedicarboxylic acid, diisononylester (DINCH) or trioctyltrimellitate (TOTM)) from PVC by implementing a three-step surface treatment process: (i) pretreatment with low-pressure argon cold plasma, (ii) polydopamine coating, and (iii) post-treatment with cold plasma exposure or thermal treatment at 140 °C. Samples were then characterized in terms of the water contact angle (WCA) and the aspect in scanning electron microscopy. Plasticizer migration (n = 5) was measured using an HPLC technique with ultraviolet detection and found to depend on the treatment and the plasticizer. Plasticized PVC was hydrophobic, with a measured mean ± standard deviation WCA of 96.7 ± 3.6° for PVC-DINCH and 110.2 ± 5.8° for PVC-TOTM. Plasma post-treatment and thermal post-treatment were respectively associated with a mean decrease in migration of 38.3 ± 1.9% for DINCH and 61.5 ± 4.4% for TOTM. Our results are promising with regard to limiting the migration of plasticizers into the patient’s blood and thus enabling the development of safer medical devices.

Domaines: Sciences du Vivant [q-bio]

Morgane Masse, Maude Jimenez, Stéphanie Genay, Alice Pettinari, Séverine Bellayer, et al.. Limitation of the migration of plasticizers from medical devices through treatment with low-pressure cold plasma, polydopamine coating, and annealing.. International Journal of Pharmaceutics, 2023, International Journal of Pharmaceutics, 645, pp.123422. ⟨10.1016/j.ijpharm.2023.123422⟩. ⟨hal-04313662⟩