Can solutions of docetaxel be conditioned in PVC bags?;Peut-on conditionner les solutions de docétaxel dans des poches en PVC?

Journal de Pharmacie Clinique

Volumn 25, Issue 3, 2006, Pages 147-152

  Dalle, M ^a   Sautou Miranda, V ^a,b   Balayssac, D ^a   Bourlon, S ^a   Bagel, S ^a   Chopineau, J ^a,b  

^a UNIVERSITY HOSPITAL OF CLERMONT FERRAND   (France)

^b UNIVERSITÉ CLERMONT AUVERGNE   (France)

Author keywords

Di(2 ethyl hexyl)phthalate leaching; Docetaxel stability; Low density polyethylene; Polyvinylchloride

Indexed keywords

DOCETAXEL; PHTHALIC ACID BIS(2 ETHYLHEXYL) ESTER; POLYETHYLENE; POLYSORBATE 80; POLYVINYLCHLORIDE; SODIUM CHLORIDE;

ARTICLE; CHROMATOGRAPHY; CONCENTRATION RESPONSE; CONTAINER; DILUTION; DRUG RELEASE; DRUG SOLUTION; DRUG STABILITY; DRUG STORAGE; DRUG SYNTHESIS;

EID: 33749461376     PISSN: 02911981     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (24)

1. Aventis Pharma. Documentation scientifique sur Taxotère®, 2006.
2. Bourdeaux D, Sautou-Miranda V, Bagel-Boithias S, Boyer A, Chopineau J. Analysis by liquid chromatography and infrared spectrometry of di(2-ethylhexyl)phtalate released by multilayer infusion tubing. J Pharm Biomed Anal 2004; 35: 57-64.
3. Hanawa T, Muramatsu E, Asakawa K, Suzuki M, Tanaka M, Kawano K, et al. Investigation of the release behavior of diethylhexyl phtalate from the polyvinyl chloride tubing for intravenous administration. Int J Pharm 2000; 210: 109-15.
4. Health Canada, Medical devices Bureau. DEHP in medical devices: an exposure and toxicity assessment, 2002.
5. Anduze-Acher V, Jaouen-Hakkou C, Vanheerswynghels S, Cabrol E. Ecoflac®, poche pour perfusion en polyethylene. ADPHSO 1997; 22: 75-81.
6. Trissel LA. Avoiding common flaws in stability and compatibility studies of injectable drugs. Am J Hosp Pharm 1993; 40: 1159-60.
7. Trissel LA, Flora KP. Stability studies: five years later. Am J Hosp Pharm 1988; 45: 1569-71.
8. Stability testing of new drug sustances and products (Q1AR2), ICH Harmonised tripartite Guideline.
9. Thiesen J, Kramer I. Physico-chemical stability of docetaxel premix solution and docetaxel infusion solutions in PVC bags and polyolefine containers. Pharm World Sci 1999; 21: 137-41.
10. Mazzo DJ, Nguyen-Huu JJ, Pagniez S, Denis P. Compatibility of docetaxel and paclitaxel in intravenous solutions with polyvinyl chloride infusion materials. Am J Health-Syst Pharm 1997; 54: 5566-9.
11. Théou N, Havard L, Maestroni ML, Prognon P, Bonan B. Leaching of di(2-ethylhaxyl)phthalate from plyvinyl chloride medical devices: recommendations for taxanes infusion. EJHP-S 2005; 11: 55-61.
12. Jobet-Hermelin I, Mallevais ML, Jacquot C, Prugnaud JL. Proposition d'une concentration limite acceptable du plastifiant libéré par le poly(chlorure de vinyle) dans les solutions injectables aqueuses. J Pharm Clin 1996; 15: 132-6.
13. US Food and Drug Administration, Center for Devices and Roadiological Health. Safety assessment of Di(2-ethylhexyl) phtalate (DEHP) released from PVC medical devices. Rockville, 2001.
14. Tickner JA, Schettler T, Guidotti T, Mc Cally M, Rossi M. Health risks posed by use of di(2-ethylhexyl)phthalate-(DEHP) in PVC medical devices: a critical review. Am J Ind Med 2001; 39: 100-11.
15. National Toxicology Program. Center for the evaluation of risks to human reproduction: phtalate expert panel report on the reproductive developmental toxicity of di(2-ethylhexyl) phtalate. Reprod Toxicol 2002; 16: 529-653.
16. Huber WW, Grasl-Karaup B, Schulte-Hermann R. Hepatocarcinogenic potential of di(2-ethylhexyl)phthalate in rodents and its implications on human risk. Crit Rev Toxicol 1996; 26: 365-481.
17. Park JD, Habeebu SS, Klaassen CD. Testicular toxicity of di(2-ethylhexyl)phthalate in young Sprague Dawley rats. Toxicology 2002; 171: 105-15.
18. Doull J, Cattley R, Elcombe C, Lake BG, Swenberg J, Wilkinson C, et al. A cancer assessment of di(2-ethylhexyl)phthalate: application of the new U.S. EPA Risk Assessment Guidelines. Regul Toxicol Pharmacol 1999; 29: 327-57.
19. Latini G. Monitoring phthalate exposure un humans. Clin Chim Acta 2005; 361: 20-9.
20. Koch HM, Drexler H, Angerer J. An estimation of the daily intake of di(2-ethylhexyl)phthalate-(DEHP) and other phtalates in the general population. Int J Hyg Environ Health 2003; 206: 77-83.
21. CSTEE (scientific committee for toxicilogy, ecotoxicity and the environment). Opinion on phthalate migration from soft PVC toys and child-care articles expressed at the 6th CSTEE plenary meeting, Brussels, 26/27 November 1998. http://europa.eu.int/comm/health/ph_risk/committees/sct/docshtml/ sct_out19_en.htm.
22. Okita RT, Okita JR. Characterisation of a cytochrome P450 from di(2-ethylhexyl)phthalate-treated rats with hydroxylates fatty acids. Arch Biochem Biophys 1992; 294: 475-81.
23. Kambia K, Dine T, Gressier B, Benaji B, Faouzi MA, Dupin-Spriet T, et al. Induction of propranolol metabolism in isolated rats hepatocytes treates by di(2-ethylhexyl)phthalate (DEHP) and mono (2-ethylhexyl) phthalate (MEHP). Eur J Drug Metab Pharmacokinet 2003; 3: 217-22.
24. Kraynak MA. Pharmaceutical aspects of docetaxel. Am J Health Syst Pharm 1997; 54 (Suppl. 2): S7-S10.