Excipient Effects on in Vitro Cytotoxicity of a Novel Paclitaxel Self-Emulsifying Drug Delivery System

Journal of Pharmaceutical Sciences

Volumn 92, Issue 12, 2003, Pages 2411-2418

  Gursoy, Neslihan ^a,c   Garrigue, Jean Sebastien ^b   Razafindratsita, Alain ^b   Lambert, Gregory ^b   Benita, Simon ^a,d  

^a HEBREW UNIVERSITY OF JERUSALEM   (Israel)

^b Novagali Pharma   (France)

^c HACETTEPE UNIVERSITY   (Turkey)

^d HEBREW UNIVERSITY OF JERUSALEM   (Israel)

Author keywords

Caco 2 cells; Cytotoxicity; Microemulsion; Paclitaxel; Self emulsifying drug delivery system (SEDDS)

Indexed keywords

EXCIPIENT; PACLITAXEL;

ANTINEOPLASTIC ACTIVITY; ARTICLE; CELL STRAIN CACO 2; COLORIMETRY; CONTROLLED STUDY; DRUG CYTOTOXICITY; DRUG DEGRADATION; DRUG DELIVERY SYSTEM; DRUG FORMULATION; DRUG STABILITY; EMULSION; HUMAN; HUMAN CELL; MICROEMULSION; SELF EMULSIFYING DRUG DELIVERY SYSTEM; ZETA POTENTIAL;

EID: 0344443710     PISSN: 00223549     EISSN: None     Source Type: Journal    
DOI: 10.1002/jps.10501     Document Type: Article

References (26)

1. Rowinsky EK, Onetto N, Canetta RM, Arbuck SG. 1992. Taxol: The first of the taxanes, an important new class of antitumor agents. Semin Oncol 19:646-662.
2. Rowinsky EK, Eisenhauer EA, Chaudhry V, Arbuck SG, Donehower RC. 1993. Clinical toxicities encountered with paclitaxel (Taxol). Semin Oncol 20:1-15.
3. Gregory RE, DeLisa AF. 1993. Paclitaxel: A new antineoplastic agent for refractory ovarian cancer. Clin Pharm 12:401-415.
4. Malingre MM, Beijnen JH, Schellens JHM. 2001. Oral delivery of taxanes. Invest New Drugs 19:155-162.
5. Sonnichsen DS, Hurwitz CA, Pratt CB, Shuster JJ, Relling MV. 1994. Saturable pharmacokinetics and paclitaxel pharmacodynamics in children with solid tumors. J Clin Oncol 12:532-538.
6. Terwogt JMM, Malingre MM, Beijnen JH, Ten Bokkel Huinink WW, Rosing H, Koopman FJ, van Tellingen O, Swart M, Schellens JHM. 1999. Coadministration of oral cyclosporin A enables oral therapy with paclitaxel. Clin Cancer Res 5:3379-3384.
7. Dunn CG, Wagstaff AJ, Perry CM, Plosker GL, Goa KL. 2001. Cyclosporin: An updated review of the pharmacokinetic properties, clinical efficacy and tolerability of a microemulsion-based formulation (Neoral) in organ transplantation. Drugs 61:1957-2016.
8. Porter CJ, Charman WN. 2001. In vitro assessment of oral lipid-based formulations. Adv Drug Del Rev 50:S127-S147.
9. Andreeva M, Niedmann PD, Binder L, Armstrong VW, Meden H, Binder M, Oellerich M. 1997. A simple and reliable reverse-phase high-performance liquid chromatographic procedure for determination of paclitaxel (taxol) in human serum. Ther Drug Monit 19:327-332.
10. Mossman T. 1983. Rapid colorimetric assay for cellular growth and survival: Application to proliferation and cytotoxicity assays. J Immunol Methods 65:55-63.
11. Zhang Y, Benet LZ. 2001. The gut as a barrier to drug absorption: Combined role of cytochrome P450 3A and P-glycoprotein. Clin Pharmacokinet 40:159-168.
12. Constantinides PP, Lambert KJ, Tustian AK, Schneider B, Lalji S, Ma W, Wentzel B, Kessler D, Worah D, Quay SC. 2000. Formulation development and antitumor activity of a filter-sterilizable emulsion of paclitaxel. Pharm Res 17:175-182.
13. Chang T, Benet LZ, Hebert MF. 1996. The effect of water-soluble vitamin E on cyclosporine pharmacokinetics in healthy volunteers. Clin Pharmacol Ther 59:297-303.
14. Boudreaux JP, Hayes DH, Mizrahi S, Maggiore P, Dick D. 1993. Use of water-soluble liquid vitamin E to enhance cyclosporine absorption in children after liver transplant. Trans Proc 25:1875.
15. Dintaman JM, Silverman JA. 1999. Inhibition of P-glycoprotein by D-α-tocoferyl polyethylene glycol 1000 succinate (TPGS). Pharm Res 16:1550-1556.
16. National Cancer Institute. 1994. One-year chronic oral (intubation) study in rats and in dogs. Bethesda, MD: National Institutes of Health.
17. Krasavage WJ, Terhaar CJ. 1977. D-α-tocoferyl polyethylene glycol 1000 succinate. Acute toxicity, subchronic feeding, reproduction, and teratologic studies in the rat. J Agric Food Chem 25:273-278.
18. Mu L, Feng SS. 2002. Vitamin E TPGS used as an emulsifier in the solvent evaporation/extraction technique for fabrication of polymeric nanospheres for controlled release of paclitaxel (Taxol®). J Controlled Release 80:129-144.
19. Sakai M, Imai T, Ohtake H, Azuma H, Otagiri M. 1999. Simultaneous use of sodium deoxycholate and dipotassium glycyrrhizinate enhances the cellular transport of poorly-absorbed compounds across Caco-2 cell monolayers. J Pharm Pharmacol 51:27-33.
20. Riggins RT, Hunter WL, Burt HM. 1997. Solid-state characterization of paclitaxel. J Pharm Sci 86:1458-1463.
21. Long W, Corbet A, Cotton R, Courtney S, McGuiness G, Walter D, Watts J, Smyth J, Bard H, Chernick V, the American Exosurf Neonatal Study Group I, the Canadian Exosurf Neonatal Study Group. 1991. A controlled trial of synthetic surfactant in infants weighing 1,250 g or more with respiratory distress syndrome. N Engl J Med 325:1696-1703.
22. Westesen K. 1994. Phase diagram of tyloxapol and water - I. Int J Pharm 102:91-100.
23. Westesen K, Koch MHJ. 1994. Phase diagram of tyloxapol and water - II. Int J Pharm 103:225-236.
24. Gershanik T, Benita S. 2000. Self-dispersing lipid formulations for improving oral absorption of lipophilic drugs. Eur J Pharm Biopharm 50:179-188.
25. Westesen K, Bunjes H, Koch MHJ. 1995. Phase behavior of tyloxapol/Triton X100/water mixtures. J Pharm Sci 84:544-549.
26. Staub NC, Longworth KE, Serikov V, Jerome EH, Elsasser T. 2001. Detergent inhibits 70-90% of responses to intravenous endotoxin in awake sheep. J Appl Physiol 90:1788-1797.