Abstract
Testing was conducted on a novel polyvinyl chloride (PVC) -infusion line containing tris (2-ethylhexyl) trimellitate as the plasticizer (TOTM-PVC) to evaluate its performance in terms of drug sorption and release behavior of the plasticizer. The results were compared with those for a PVC-infusion line containing di (2-ethylhexyl) phthalate as the plasticizer (DEHP-PVC). Nitroglycerin (Millisrol® Inj.), cyclosporine (Sandimmun®), monoammonium glycyrrhizinate (Stronger Neo-Minophagen® C), and miconazole (Florid®-F Inj.) preparations for injection were diluted with saline and passed through both injection lines over a period of 12 h at a speed of 1mL/min. The amounts of drug residues and released plasticizer were quantified by HPLC. For cyclosporine and monoammonium glycyrrhizinate, there was little or no drug sorption. Sorption of Nitroglycerin and miconazole, however, was detected on both injection lines, and there was no difference in this regard between the infusion lines. As for the release of the plasticizer, that of DEHP was found to be significantly greater than that of TOTM. When Florid®-F Inj. was passed through the infusion lines, the maximum concentrations of DEHP and TOTM detected in the solution were 4.36 and 0.14, μg/mL, respectively. When Sandimmun® was passed through, TOTM was not detected (less than 0.1, μg/mL), while the concentration of DEHP in the solution was 4.37, μg/mL, these results suggesting that DEHP is released much more easily than TOTM. As our conclusion, the TOTM-PVC infusion set was excellent in terms of lack of plasticizer release and showed a drug sorption level similar to that observed with the DEHP-PVC infusion set.
