Complement activation by polyethoxylated pharmaceutical surfactants: Cremophor-EL, tween-80 and tween-20

European Journal of Pharmaceutical Sciences

Volumn 45, Issue 4, 2012, Pages 492-498

  Weiszhár, Zsóka ^a,b   Czúcz, Judit ^a   Révész, Csaba ^a   Rosivall, László ^a,b   Szebeni, János ^a,b   Rozsnyay, Zoltán ^a  

^a SeroScience Ltd   (Hungary)

^b SEMMELWEIS UNIVERSITY   (Hungary)

Author keywords

Complement system; Drug carrier; Infusion hypersensitivity; Micelle; Nanoimmunosafety; Taxane formulation

Indexed keywords

ANTINEOPLASTIC AGENT; CARBOPLATIN; CETUXIMAB; COMPLEMENT COMPONENT C3A; COMPLEMENT COMPONENT C5A; COMPLEMENT MEMBRANE ATTACK COMPLEX; CREMOPHOR; CYCLOPHOSPHAMIDE; DOCETAXEL; DOXORUBICIN; FLUOROURACIL; GEMCITABINE; IRINOTECAN; MITOMYCIN C; OXALIPLATIN; PACLITAXEL; PLATIDIUM; POLYSORBATE 20; POLYSORBATE 80; TRASTUZUMAB; UNCLASSIFIED DRUG; VINBLASTINE; ZYMOSAN;

BLOOD; COMPLEMENT ACTIVATION; CONCENTRATION RESPONSE; CONFERENCE PAPER; CONTROLLED STUDY; DISPERSION; DRUG FORMULATION; HUMAN; HUMAN EXPERIMENT; LIGHT SCATTERING; NORMAL HUMAN; PLASMA; PRIORITY JOURNAL; SERUM;

ANTINEOPLASTIC AGENTS; COMPLEMENT ACTIVATION; GLYCEROL; HUMANS; PACLITAXEL; POLYSORBATES; SURFACE-ACTIVE AGENTS; TAXOIDS;

EID: 84856245990     PISSN: 09280987     EISSN: 18790720     Source Type: Journal    
DOI: 10.1016/j.ejps.2011.09.016     Document Type: Conference Paper

References (43)

1. A. Ardavanis, D. Tryfonopoulos, I. Yiotis, G. Gerasimidis, N. Baziotis, and G. Rigatos Non-allergic nature of docetaxel-induced acute hypersensitivity reactions Anticancer Drugs 15 6 2004 581 585 (Pubitemid 38932325)
2. G. Biesecker The complement SC5b-9 complex mediates cell adhesion through a vitronectin receptor J. Immunol. 145 1990 209 214 (Pubitemid 20217403)
3. S. Bhakdi, B. Bhakdi-Lehnen, O.J. Bjerrum, and J. Tranum-Jensen Difference in antigenic reactivity and ultrastructure between fluid-phase C5b-9 and the C5b-9 membrane attack complex of human complement FEBS Lett. 99 1979 15 19
4. S. Bhakdi, B. Bhakdi-Lehnen, and J. Tranum-Jensen Proteolytic transformation of SC5b-9 into an amphiphilic macromolecule resembling the C5b-9 membrane attack complex of complement Immunology 37 1979 901 912 (Pubitemid 9256332)
5. D. Bissett, A. Setanoians, J. Cassidy, M.A. Graham, G.A. Chadwick, P. Wilson, V. Auzannet, N. Le Bail, S.B. Kaye, and D.J. Kerr Phase I and pharmacokinetic study of taxotere (RP 56976) administered as a 24-hour infusion Cancer Res. 53 1993 523 527 (Pubitemid 23059430)
6. H. Burris, R. Irvin, J. Kuhn, S. Kalter, L. Smith, D. Shaffer, S. Fields, G. Weiss, J. Eckardt, and G. Rodriguez Phase I clinical trial of taxotere administered as either a 2-hour or 6-hour intravenous infusion J. Clin. Oncol. 11 1993 950 958 (Pubitemid 23146093)
7. A. Christiansen, T. Backensfeld, K. Denner, and W. Weitschies Effects of non-ionic surfactants on cytochrome P450-mediated metabolism in vitro Eur. J. Pharm. Biopharm. 78 2011 166 172
8. E.A. Coors, H. Seybold, H.F. Merk, and V. Mahler Polysorbate 80 in medical products and nonimmunologic anaphylactoid reactions Ann. Allergy Asthma Immunol. 95 2005 593 599 (Pubitemid 43010488)
9. N. Desai, V. Trieu, Z. Yao, L. Louie, S. Ci, A. Yang, C. Tao, T. De, B. Beals, D. Dykes, P. Noker, R. Yao, E. Labao, M. Hawkins, and P. Soon-Shiong Increased antitumor activity, intratumor paclitaxel concentrations, and endothelial cell transport of Cremophor-free, albumin-bound paclitaxel, ABI-007, compared with Cremophor-based paclitaxel Clin. Cancer Res. 12 2006 1317 1324 (Pubitemid 43342524)
10. T.D. Dimitrova, and F. Leal-Calderon Colloid forces in model food-type emulsions Prog. Colloid Polym. 115 2000 156 160 (Pubitemid 32726232)
11. J.L. Ding, and B. Ho Endotoxin detection from limulus amebocyte lysate to recombinant factor C Subcell. Biochem. 53 2010 187 208
12. D. Dye, and J. Watkins Suspected anaphylactic reaction to Cremophor-EL Brit. Med. J. 280 1980 1353
13. A. Einstein Über die von der molekularkinetischen Theorie der Wärme geforderte Bewegung von in ruhenden Flüssigkeiten suspendierten Teilchen Annalen der Physik 17 1905 549 560
14. A. Eschalier, J. Lavarenne, C. Burtin, M. Renoux, E. Chapuy, and M. Rodriguez Study of histamine release induced by acute administration of antitumor agents in dogs Cancer Chemother. Pharmacol. 21 1988 246 250
15. E. Friche, P.B. Jensen, M. Sehested, E.J. Demant, and N.N. Nissen The solvents Cremophor-EL and Tween-80 modulate daunorubicin resistance in the multidrug resistant Ehrlich ascites tumor Cancer Commun. 2 1990 297 303 (Pubitemid 20380453)
16. J.B. Glen, and S.C. Hunter Pharmacology of an emulsion formulation of ICI 35 868 Br. J. Anaesth. 56 1984 617 626 (Pubitemid 14083289)
17. M. Hacker, M. Koeferl, C.B. Hong, and M.A. Fagan Cremophor and Emulphor induced alterations of serum lipids and lipoprotein electrophoretic patterns of dogs Res. Commun. Chem. Pathol. Pharmacol. 31 1981 119 128 (Pubitemid 11173800)
18. I. Hamad, A.C. Hunter, J. Szebeni, and S.M. Moghimi Poly(ethylene glycol)s generate complement activation products in human serum through increased alternative pathway turnover and a MASP-2-dependent process Mol. Immunol. 46 2008 225 232
19. U. Hanke, K. May, V. Rozehnal, S. Nagel, W. Siegmund, and W. Weitschies Commonly used nonionic surfactants interact differently with the human efflux transporters ABCB1 (p-glycoprotein) and ABCC2 (MRP2) Eur. J. Pharm. Biopharm. 76 2010 260 268
20. M. Hart, and S. Acott Physical and chemical stability of Taxotere® (docetaxel) one-vial (20 mg/ml) infusion solution following refrigerated storage Cancer 4 2010 202
21. I.C. Henderson, and V. Bhatia Nab-paclitaxel for breast cancer: a new formulation with an improved safety profile and greater efficacy Expert Rev. Anticancer Ther. 7 2007 919 943 (Pubitemid 47180894)
22. M.S. Hüttel, A. Schou Olesen, and E. Stoffersen Complement-mediated reactions to diazepam with Cremophor as solvent (Stesolid MR) Br. J. Anaesth. 52 1980 77 79 (Pubitemid 10203718)
23. J.S. Kloover, M.A. den Bakker, H. Gelderblom, and J.P. van Meerbeeck Fatal outcome of a hypersensitivity reaction to paclitaxel: a critical review of premedication regimens Br. J. Cancer. 90 2004 304 305 (Pubitemid 38250619)
24. M.G. Kris, J.P. O'Connell, R.J. Gralla, M.S. Wertheim, R.M. Parente, P.B. Schiff, and C.W. Young Phase I trial of taxol given as a 3-hour infusion every 21 days Cancer Treat. Rep. 70 1986 605 607 (Pubitemid 16121007)
25. W.J. Loos, J. Szebeni, A.J. Ten Tije, J. Verweij, D.M. van Zomeren, K.N. Chung, K. Nooter, G. Stoter, and A. Sparreboom Preclinical evaluation of alternative pharmaceutical delivery vehicles for paclitaxel Anticancer Drugs 13 2002 767 775
26. W. Lorenz, H.J. Reimann, A. Schmal, P. Dormann, B. Schwarz, E. Neugebauer, and A. Doenicke Histamine release in dogs by Cremophor E1 and its derivatives: oxethylated oleic acid is the most effective constituent Agents Actions 7 1977 63 67 (Pubitemid 8070781)
27. S.M. Moghimi, A.C. Hunter, C.M. Dadswell, S. Savay, C.R. Alving, and J. Szebeni Causative factors behind poloxamer 188 (Pluronic F68, Flocor)-induced complement activation in human sera. A protective role against poloxamer-mediated complement activation by elevated serum lipoprotein levels Biochim. Biophys. Acta 1689 2004 103 113 (Pubitemid 38766145)
28. S.M. Moghimi, A.J. Andersen, S.H. Hashemi, B. Lettiero, D. Ahmadvand, A.C. Hunter, T.L. Andresen, I. Hamad, and J. Szebeni Complement activation cascade triggered by PEG-PL engineered nanomedicines and carbon nanotubes: the challenges ahead J. Control. Release 146 2010 175 181
29. Moghimi, S.M., Andersen, A.J., Ahmadvand, D., Wibroe, P.P., Andersen, T.L., Hunter, A.C., 2011. Material properties in complement activation. Adv. Drug Delivery Rev. doi: j.addr.2011.06.02.
30. J. Montoro, A. Valero, A. Elices, N. Rubira, E. Serra-Baldrich, P. Amat, and A. Malet Anaphylactic shock after intra-articular injection of carboxymethylcellulose Allergol. Immunopathol. (Madr) 28 2000 332 333 (Pubitemid 32066210)
31. C.H. Hammer, A. Nicholson, and M.M. Mayer On the mechanism of cytolysis by complement: evidence on insertion of C5b and C7 subunits of the C5b, 6, 7 complex into phospholipid bilayers of erythrocyte membranes Proc. Natl. Acad. Sci. USA 72 1975 5076 5080
32. K.S. Price, and R.G. Hamilton Anaphylactoid reactions in two patients after omalizumab administration after successful long-term therapy Allergy Asthma Proc. 28 2007 313 319
33. D.W. Raisch, W. Campbell, V. Garg, Z.P. Qureshi, P.B. Bookstaver, L.B. Norris, and C.L. Bennett Description of anaphylactic reactions to paclitaxel and docetaxel reported to the FDA, with a focus on the role of premedication Expert Opin. Drug Saf. 10 2011 521 528
34. D. Ricklin, G. Hajishengallis, K. Yang, and J.D. Lambris Complement: a key system for immune surveillance and homeostasis Nat. Immunol. 11 2010 785 797
35. M. Røger, K. Høgsen, P.A. Holme, T.S. Halstensen, T.E. Mollnes, and T. Hovig The fluid-phase sc5b-9 terminal complement complex binds to the gpiib/iiia complex of thrombin-stimulated human blood platelets inhibiting platelet aggregation Platelets 6 1995 160 168
36. E. Rowinsky, and R.C. Donehower Taxol: twenty years later, the story unfolds J. Natl. Cancer Inst. 83 1991 1778 1781
37. M. Smoluchowski Zur kinetischen Theorie der Brownschen Molekularbewegung und der Suspensionen Ann. Physik 326 1906 756 780
38. J. Szebeni, F.M. Muggia, and C.R. Alving Complement activation by Cremophor-EL as a possible contributor to hypersensitivity to paclitaxel: an in vitro study J. Natl. Cancer Inst. 90 1998 300 306 (Pubitemid 28182386)
39. J. Szebeni, C.R. Alving, S. Savay, Y. Barenholz, A. Priev, D. Danino, and Y. Talmon Formation of complement-activating particles in aqueous solutions of Taxol: possible role in hypersensitivity reactions Int. Immunopharmacol. 1 2001 721 735 (Pubitemid 32206533)
40. J. Szebeni Complement activation-related pseudoallergy: a new class of drug-induced acute immune toxicity Toxicology 216 2005 106 121 (Pubitemid 41712000)
41. A.J. Ten Tije, J. Verweij, W.J. Loos, and A. Sparreboom Pharmacological effects of formulation vehicles: implications for cancer chemotherapy Clin. Pharmacokinet. 42 2003 665 685 (Pubitemid 36936530)
42. J.G. Theis, M. Liau-Chu, H.S. Chan, J. Doyle, M.L. Greenberg, and G. Koren Anaphylactoid reactions in children receiving high-dose intravenous cyclosporine for reversal of tumor resistance: the causative role of improper dissolution of Cremophor EL J. Clin. Oncol. 13 10 1995 2508 2516
43. L. van Zuylen, L. Gianni, J. Verweij, K. Mross, E. Brouwer, W.J. Loos, and A. Sparreboom Interrelationships of paclitaxel disposition, infusion duration and Cremophor-EL kinetics in cancer patients Anticancer Drugs 11 2000 331 337 (Pubitemid 30459468)