Abstract
Taxol® solution extracts the plasticizer DEHP (di(2-ethylhexyl)phthalate) from polyvinyl chloride (PVC) materials. In order to minimize patient exposure to DEHP, Taxol® solutions should be prepared and administered in PVC-free materials. Particulate matter may form in Taxol® infusion solution over time, so that in-line filtration with microporous membranes not greater than 0.22 μm is advisable. The purpose of this study was to evaluate the suitability of various administration- and in-line filter-sets for Taxol® application. The extent of leached DEHP was determined using a Reversed Phase HPLC assay specific for DEHP.
The four tested administration-sets labeled as PVC-free, were all found to be suitable for Taxol® application. The tested standard PVC-lined administration-set should not be used for Taxol® application. Baxter Intermate® LV 250 can be recommended as a disposable infusion device for ambulatory Taxol® application. It can be connected with all the tested filter sets.
Similar content being viewed by others
References
Krämer I, Heuser A. Paclitaxel-Pharmaceutical and pharmacological issues. EHP 1995; 1: 37–41
Taxol® package insert 1995, Bristol, Germany.
Moorhatch P, Chiou WL. Interactions between drugs and plastic intravenous fluid bags part II: leaching of chemicals from bags containing various solvent media. Am J Hosp Pharm 1974; 31: 149–52.
Venkataramanan R, Burckart GJ, Ptachchinski RJ, Blaha R, Logue LW, Bahnson A et al. Leaching of diethylhexyl phthalate from polyvinyl chloride bags into intravenous cyclosporine solution. Am J Hosp Pharm 1986; 43: 2800–2.
Waugh WN, Trissel LA, Stella VJ. Stability, compatibility and plasticizer extraction of taxol (NSC-125973) injection diluted in infusion solutions and stored in various containers. Am J Hosp Pharm 1991; 48: 1520–4.
Pearson SD, Trissel LA. Leaching of diethylhexyl phthalate from polyvinyl chloride containers by selected drugs and formulation components. Am J Hosp Pharm 1993; 50: 1405–9.
Calley D, Autian J, Guess WL. Toxicology of a series of phthalate esters. J Pharm Sci 1996; 55: 158–62.
Singh AR, Lawrence WH, Autian J. Teratogenicity of phthalate esters in rats. J Pharm Sci 1972; 61: 51–4.
Kevy SV, Jacobson MS. Hepatic effects of phthalate ester plasticizer leached from poly(vinyl chloride) blood bags following transfusion. Environ Health Perspect 1982; 45: 57–64.
Warren JR Narendra DL, Reddy JK. Phthalate esters as peroxisome proliferator carcinogens. Environ Health Perspect 1982; 45: 35–40.
Peters JW, Cook RM. Effect of phthalate esters on reproduction in rats. Environ Health Perspect 1973; 3: 91–4.
Dillingham EO, Autian J: Teratogenicity, mutagenicity and celluar toxicity of phthalate esters. Environ Health Perspect 1973; 3: 81–9.
Gesler RM. Toxicology of di-2-ethylhexyl phthalate and other phthalic acid ester plasticizer. Environ Health Perspect 1973; 3: 73–9.
Autian J. Toxicity and health threats of phthalate esters: review of the literature. Environ Health perspect 1973; 4: 3–26.
Gray TJB, Beamand JA, Lake BG, Foster JR, Gangolli SD. Peroxisome proliferation in cultured rat hepatocytes produced by clofibrate and phthalate ester metabolites. Toxicol Lett 1982; 10: 273–9.
Schulz CO, Rubin JR, Hucchins GM. Acute lung toxicity and sudden death in rats following the intravenous administration of the plasticizer, di(2-ethylhexyl)-phthalate, solubilized with Tween surfactants. Toxicol Appl Pharmacol 1975; 33: 514–525.
Barry JA, Labow RS, Rock G, Keon WJ. Cardiotoxic effects of the plasticizer metabolite, mono (2-ethylhexyl)phthalate (MEHP), on human myocardium. Blood 1988; 72: 1438–9.
Ganning AE, Brunk U, Dallner G.. Phthalate esters and their effect on the liver. Hepatology 1984; 4: 541–7.
Kevy S, Jacobson M. Hepatic effects of the leaching of phthalate ester plasticizer and silicon. Contr Nephrol 1983; 36: 82–9.
Trissel LA, XU Q, Kwan J, Martinez JF: Compatibility of paclitaxel injection vehicle with intravenous administration and extension sets. Am J Hosp Pharm 1994; 51: 2804–10.
Van Dooren AA. PVC as pharmaceutical packaging material. Pharm Weekbl Sci 1991; 13: 109–118.
Jaeger RJ, Rubin RJ. Migration of a phthalate ester plasticizer from polyvinyl chloride blood bags into stored human blood and its localization in human tissues. N Engl J Med 1972; 287: 1114–8.
Allwood C. Release of DEHP plasticizer into fat emulsion from IV administration sets. Pharm J 1985; 235: 600
Allwood C. Taxol® and PVC. Pharm J 1994; 252: 556
Allwood C, Martin H. Extraction of diethylhexylphthalate during administration of paclitaxel from PVC bags. J Oncol Pharm Practice 1995; 1: 38 (Poster presentation).
Needham TE, Luzzi LA. Particulate matter in polyvinyl chloride intravenous bags. N Engl J Med 1973; 289: 1256.
Flaminio LM, De Angelis L, Ferazza M, Marinovich M, Galli G, Galli CL. Leachability of a new plasticizer tri-(2-ethylhexyl)-trimellitate from haemodialysis tubing. Int J Artif Organs 1988; 11: 435–41.
Rathinam K, Srivastava SP, Seth PK. Hepatic studies of intraperitoneally administered Tris(2-ethylhexyl)trimellitate (TOTM) and di(2-ethylhexyl)phthalate in rats. J Appl Toxicol 1990; 10: 39–41.
Goldspiel BR. Pharmaceutical issues: Preparation, administration, stability and compatibility with other medications. Ann Pharm 1994; 28: 23–34.
Author information
Authors and Affiliations
Rights and permissions
About this article
Cite this article
Maas, B., Huber, C. & Krämer, I. Plasticizer extraction of Taxol®-infusion solution from various infusion devices. Pharm World Sci 18, 78–82 (1996). https://doi.org/10.1007/BF00579710
Issue Date:
DOI: https://doi.org/10.1007/BF00579710