The pharmacokinetics Evaluation and bioequivalence of new docetaxel injections and Taxotere using healthy rats

Journal of Bioanalysis and Biomedicine

Volumn 2, Issue 1, 2010, Pages 23-27

  Wang, Rong ^a   Wu, Xiao Yu ^a   Xie, Hua ^a   Zhang, Juan Hong ^a   Ma, Jun ^a   Men, Xian Dong ^a   Wang, Juan ^a   Zhang, Jun Li ^a   Li, Wen Bing ^a   Jia, Zheng Ping ^a  

^a LANZHOU GENERAL HOSPITAL   (China)

Author keywords

Bioequivalence; Docetaxel of sterile freeze dried powder injections; LC MS MS; Pharmacokinetics evaluvation; Taxotere

Indexed keywords

DOCETAXEL; PACLITAXEL;

ACCURACY; ANIMAL EXPERIMENT; AREA UNDER THE CURVE; ARTICLE; BIOEQUIVALENCE; CONTROLLED STUDY; DRUG DOSAGE FORM COMPARISON; DRUG HALF LIFE; DRUG SCREENING; DRUG STABILITY; DRUG STRUCTURE; DRY POWDER; LIQUID CHROMATOGRAPHY; MALE; MASS SPECTROMETRY; MAXIMUM PLASMA CONCENTRATION; NONHUMAN; RAT; TIME TO MAXIMUM PLASMA CONCENTRATION;

EID: 79952600842     PISSN: None     EISSN: 1948593X     Source Type: Journal    
DOI: 10.4172/1948-593X.1000017     Document Type: Article

References (33)

1. Ardiet CJ, Tranchand B, Zanetta S, Guillot A, Bernard E, et al. (1999) A sensitive docetaxel assay in plasma by solid-phase extraction and high performance liquid chromatography-UV detection: validation and suitability in phase I clinical trial pharmacokinetics. Invest New Drugs 17: 325-333.
2. Baker SD, Zhao M, He P, Carducci MA, Verweij J, et al. (2004) Simultaneous analysis of docetaxel and the formulation vehicle polysorbate 80 in human plasma by liquid chromatography/tandem mass spectrometry. Anal Biochem 324: 276-284.
3. Bardelmeijer HA, Ouwehand M, Buckle T, Huisman MT, Schellens JH, et al. [2002] Low systemic exposure of oral docetaxel in mice resulting from extensive firstpass metabolism is boosted by ritonavir. Cancer Res 62: 6158-6164.
4. Brewster ME, Simpkins JW, Hora MS, Stern WC, Bodor N (1989) The potential use of cyclodextrins in parenteral formulations. J Parenter Sci Technol 43: 231-240.
5. Chin J, Song HM, Lee KC (1994) Effect of 2-hydroxypropyl-β-cyclodextrin on the stability of prostaglandin E2 in solution. Int J Pharm 106: 135-140.
6. Cortes JE, Pazdur R (1995) Docetaxel. J Clin Oncol 13: 2643-2655.
7. Eisenhauer EA, Vermorken JB (1998) The taxoids. comparative clinical pharmacology and therapeutic potential. Drugs 55: 5-30.
8. Garg MB, Ackland SP (2000) Simple and sensitive high-performance liquid chromatography method for the determination of docetaxel in human plasma or urine. J Chromatogr B 748: 383-388.
9. Hou WY, Watters JW, McLeod HL (2004) Simple and rapid docetaxel assay in plasma by protein precipitation and high-performance liquid chromatographytandem mass spectrometry. J Chromatogr B 804: 263-267.
10. Huang Q, Wang GJ, Sun JG, Hu XL, Lu YH, et al. (2007) Simultaneous determination of docetaxel and ketoconazole in rat plasma by liquid chromatography/electrospray ionization tandem mass spectrometry. Rapid communications in mass spectrometry 21: 1009-1018.
11. Jiang SG, Zu YG, Zhang L, Fu YJ, Zhang Y, et al. (2009) Determination of a hydrophilic paclitaxel derivative, 7-xylosyl-10-deacetylpaclitaxel in rat plasma by LC-MS/MS. Biomedical chromatography 23:472-479.
12. Li SM, Fu YJ, Zu YG, Sun R, Wang Y, et al. (2009) Determination of paclitaxel and other six taxoids in Taxus species by high-performance liquid chromatography-tandem mass spectrometry. J Pharm Biomed Anal 49: 81-89.
13. Loos WJ, Baker SD, Verweij J, Boonstra J, Sparreboom A (2003) Clinical pharmacokinetics of unbound docetaxel: role of polysorbate 80 and serum proteins. Clin Pharmacol Ther 74: 364-371.
14. Mortier KA, Lambert WE (2006) Determination of unbound docetaxel and paclitaxel in plasma by ultrafiltration and liquid chromatography-tandem mass spectrometry. J Chromatogr A 1108: 195-201.
15. Parise RA, Ramanathan RK, Zamboni WC, Egorin MJ (2003) Sensitive liquid chromatography-mass spectrometry assay for quantitation of docetaxel and paclitaxel in human plasma. J Chromatogr B 783: 231-236.
16. Paek IB, Ji HY, Kim MS, Lee GS, Lee HS (2006) Simultaneous determination of paclitaxel and a new P-glycoprotein inhibitor HM-30181 in rat plasma by liquid chromatography with tandem mass spectrometry. J Sep Sci 29: 628-634.
17. Piccart M (2003) The role of taxanes in the adjuvant treatment of early stage breast cancer. Breast Cancer Res Tr 79: S25-S34.
18. Pitha J, Pitha J (1985) Amorphous water-soluble derivatives of cyclodextrins: Nontoxic dissolution enhancing excipients. J Parm Sci 74: 987-990.
19. Pronk LC, Stoter G, Verweij J. (1995) Docetaxel (Taxotere): Single agent activity, development of combination treatment and reducing side-effects. Cancer Treat [21:] 463-478.
20. Rouini MR, Lotfolahi A, Stewart DJ, Molepo JM, Shirazi FH, et al. (1998) A rapid reversed phase high performance liquid chromatographic method for the determination of docetaxel (Taxotere) in human plasma using a column switching technique. J Pharm Biomed Anal 17: 1243-1247.
21. Rowinsky EK, Donehower RC (1995) Donehower, Paclitaxel (Taxol). N Engl J Med 332: 1004-1014.
22. Shou M, Martinet M, Korzekwa KR, Krausz KW, Gonzalez FJ, et al. (1998) Role of human cytochrome P450 3A4 and 3A5 in the metabolism of taxotere and its derivatives: enzyme specificity, interindividual distribution and metabolic contribution in human liver. Pharmacogenetics 8: 391-401.
23. Simon GR, Bunn PA Jr (2003) Taxanes in the treatment of advanced (stage III and IV) non-small cell lung cancer (NSCLC): recent developments. Cancer Invest [1:] 87-104.
24. Simpkins JW (1991) Solubilization of ovine growth hormone with 2-hydroxypropyl-beta-cyclodextrin. J Parenter Sci Technol 45: 266-269.
25. Sparreboom A, Zhao M, Brahmer JR, Verweij J, Baker SD (2002) Determination of the docetaxel vehicle, polysorbate 80, in patient samples by liquid chromatography-tandem mass spectrometry. J Chromatogr B 773: 183-190.
26. Tan Y, Zhou JP, Tong XY (2006) LC-MS/MS for determination of paclitaxel in rat tissues: Application to a biodistribution study of paclitaxel nanoliposome modified by PEO-PPO-PEO triblock copolymers. Anal Lett 39: 1349-1363.
27. Ten Tije AJ, Verweij J, Loos WJ, Sparreboom A (2003) Pharmacological effects of formulation vehicles: implications for cancer chemotherapy. Clin Pharmacokinet 42: 665-685.
28. Tong XY, Zhou JP, Tan Y (2006) Determination of paclitaxel in rat plasma by LC-MS-MS. J Chromatogr Sci 44: 266-271.
29. Van Oosterom AT, Schriivers D (1995) Docetaxel (Taxotere(R)), a review of preclinical and clinical experience. Part II: clinical experience. Anti-Cancer Drug 6: 356-368.
30. Wang LZ, Goh BC, Grigg ME, Lee SC, Khoo YM, et al. (2003) A rapid and sensitive liquid chromatography/tandem mass spectrometry method for determination of docetaxel in human plasma. Rapid Commun Mass Spectrom [17:] 1548-1552.
31. Wu Y, Wen J, Fan GR (2009) Development and Validation of a Selective and Robust LC-MS/MS Method, Employing Liquid-Liquid Extraction Based on 96-Well Format Plates, for High-Throughput Quantification of Docetaxel in Small Plasma Samples. Instrum Sci Technol 37: 1-22.
32. Yoshida A, Yamamoto M, Itoh T, Irie T, Hirayama F, et al. (1990) Utility of 2-hydroxypropyl-beta-cyclodextrin in an intramuscular injectable preparation of nimodipine. Chem Pharm Bull 38: 176-179.
33. Yu HY, Straubinger RM, Cao J, Wang H, Qu J (2008) Ultra-sensitive quantification of paclitaxel using selective solid-phase extraction in conjunction with reversed-phase capillary liquid chromatography/tandem mass spectrometry. J Chromatogr A 1210: 160-167.