The Journal of Korean Medicine (대한한의학회지)

The Society of Korean Medicine (대한한의학회)
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Effects of mixed formulation of tamoxifen and blue honeysuckle on the pharmacokinetics profiles of tamoxifen after single oral administration

  • Hu, Jin-Ryul (Department of Anatomy and Histology, College of Korean Medicine, Daegu Haany University) ;
  • Jang, Tae-Woo (Department of Anatomy and Histology, College of Korean Medicine, Daegu Haany University) ;
  • Kang, Su-Jin (Department of Anatomy and Histology, College of Korean Medicine, Daegu Haany University) ;
  • Ku, Sae-Kwang (Department of Anatomy and Histology, College of Korean Medicine, Daegu Haany University) ;
  • Choi, Seong-Hun (Department of Anatomy and Histology, College of Korean Medicine, Daegu Haany University) ;
  • Lee, Young-Joon (Department of Preventive Medicine, College of Korean Medicine, Daegu Haany University)
  • Received : 2019.05.22
  • Accepted : 2019.11.18
  • Published : 2019.12.01
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Abstract

Objectives: Here, we investigated the effects of concentrated and lyophilized powders Blue honeysuckle (BH) on the PK of tamoxifen, to establish the pharmacokinetics (PK) profiles as one of essential process in new drug development. Methods: After single oral treatment of 0.4 mg/ml of tamoxifen or tamoxifen 0.4 with BH 40, 20 and 10 mg/ml, the plasma were collected at 0.5 hr before administration, 0.5, 1, 2, 3, 4, 6, 8 and 24 hr after end of single or mixed formula treatment. Plasma concentrations of tamoxifen were analyzed using LC-MS/MS methods. Tmax, Cmax, AUC, t1/2 and MRTinf were analyzed using noncompartmental PK data analyzer programs. Results: Tamoxifen and BH 40 mg/ml did not induce any significant change on the plasma tamoxifen concentrations, while significant decreases were observed in tamoxifen and BH 10 mg/ml from 2 to 8 hr as compared with tamoxifen only, respectively. Furthermore, significant increases of Tmax in tamoxifen and BH 40 mg/ml, significant decreases of Cmax in tamoxifen and BH 20 mg/ml, significant decreases of AUC0-t, AUC0-inf and MRTinf in tamoxifen and BH 10 mg/ml were demonstrated as compared with tamoxifen only. Conclusion: Taken together, tamoxifen and BH 10 mg/ml induced significant decrease of the oral bioavailability of tamoxifen, while tamoxifen and BH 40 or 20 mg/ml did not critically influenced, suggesting formulated BH concentration-independencies. It, therefore, seems to be needed that pharmacokinetic study after repeated administration should be tested to conclude the effects of BH on the pharmacokinetics of tamoxifen.

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References

  1. Ruiz-Garcia A, Bermejo M, Moss A, Casabo VG, Pharmacokinetics in drug discovery. Journal of pharmaceutical sciences, 2008;97(2): 654-90. https://doi.org/10.1002/jps.21009
  2. Kang SB, Shon HS, Park SJ, Song CH, Ku SK, Effects of Chungsinoryungsan, a polyherbal complex, on the pharmacokinetic profiles of perindopril in rats. Biomedical reports, 2014;2(6):855-60. https://doi.org/10.3892/br.2014.330
  3. Baek KM, Kwon OD, Kim HS, Park SJ, Song CH, Ku SK, Pharmacokinetic Profiles of Donepezil in Combination with Gwibi-Chongmyungtang in Rats. Int J Pharmacol, 2015;11(4):343-50. https://doi.org/10.3923/ijp.2015.343.350
  4. Kim DJ, Ryu HM, Park Si, Park SJ, Song CH, Ku SK, Pharmacokinetic properties of ondansetron in combination with ijintang -gamibang, polyherbal complex in rats. Int J Pharmacol, 2015;11:351-8. https://doi.org/10.3923/ijp.2015.351.358
  5. BIG 1-98 Collaborative Group, Mouridsen H, Giobbie-Hurder A, Goldhirsch A, Thurlimann B, Paridaens R, et al., Letrozole therapy alone or in sequence with tamoxifen in women with breast cancer. The New England journal of medicine, 2009;361(8):766-76. https://doi.org/10.1056/NEJMoa0810818
  6. Jordan VC, Fourteenth Gaddum Memorial Lecture. A current view of tamoxifen for the treatment and prevention of breast cancer. British journal of pharmacology, 1993;110(2):507-17. https://doi.org/10.1111/j.1476-5381.1993.tb13840.x
  7. Jordan VC, Tamoxifen (ICI46,474) as a targeted therapy to treat and prevent breast cancer. British journal of pharmacology, 2006;147 Suppl 1:S269-76. https://doi.org/10.1038/sj.bjp.0706399
  8. Massarweh S, Osborne CK, Creighton CJ, Qin L, Tsimelzon A, Huang S, et al., Tamoxifen resistance in breast tumors is driven by growth factor receptor signaling with repression of classic estrogen receptor genomic function. Cancer research, 2008;68(3): 826-33. https://doi.org/10.1158/0008-5472.CAN-07-2707
  9. Hurtado A, Holmes KA, Geistlinger TR, Hutcheson IR, Nicholson RI, Brown M, et al., Regulation of ERBB2 by oestrogen receptor -PAX2 determines response to tamoxifen. Nature, 2008;456(7222):663-6. https://doi.org/10.1038/nature07483
  10. Vehmanen L, Elomaa I, Blomqvist C, Saarto T, Tamoxifen treatment after adjuvant chemotherapy has opposite effects on bone mineral density in premenopausal patients depending on menstrual status. Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2006;24(4):675-80. https://doi.org/10.1200/JCO.2005.02.3515
  11. Grilli S, Tamoxifen (TAM): the dispute goes on. Annali dell'Istituto superiore di sanita, 2006;42(2):170-3.
  12. Decensi A, Maisonneuve P, Rotmensz N, Bettega D, Costa A, Sacchini V, et al., Effect of tamoxifen on venous thromboembolic events in a breast cancer prevention trial. Circulation, 2005;111(5):650-6. https://doi.org/10.1161/01.CIR.0000154545.84124.AC
  13. Osman KA, Osman MM, Ahmed MH, Tamoxifen -induced non-alcoholic steatohepatitis: where are we now and where are we going? Expert opinion on drug safety, 2007;6(1):1-4. https://doi.org/10.1517/14740338.6.1.1
  14. Paganini-Hill A, Clark LJ, Preliminary assessment of cognitive function in breast cancer patients treated with tamoxifen. Breast cancer research and treatment, 2000;64(2):165-76. https://doi.org/10.1023/A:1006426132338
  15. Eberling JL, Wu C, Tong-Turnbeaugh R, Jagust WJ, Estrogen- and tamoxifen-associated effects on brain structure and function. NeuroImage, 2004;21(1):364-71. https://doi.org/10.1016/j.neuroimage.2003.08.037
  16. Mortimer JE, Boucher L, Baty J, Knapp DL, Ryan E, Rowland JH, Effect of tamoxifen on sexual functioning in patients with breast cancer. Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 1999;17(5):1488-92. https://doi.org/10.1200/JCO.1999.17.5.1488
  17. Cella D, Fallowfield L, Barker P, Cuzick J, Locker G, Howell A, et al., Quality of life of postmenopausal women in the ATAC ("Arimidex", tamoxifen, alone or in combination) trial after completion of 5 years' adjuvant treatment for early breast cancer. Breast cancer research and treatment, 2006;100(3):273-84. https://doi.org/10.1007/s10549-006-9260-6
  18. Karimian E, Chagin AS, Gjerde J, Heino T, Lien EA, Ohlsson C, et al., Tamoxifen impairs both longitudinal and cortical bone growth in young male rats. Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research, 2008;23(8):1267-77. https://doi.org/10.1359/jbmr.080319
  19. Wilson SC, Knight PG, Cunningham FJ, Evidence for the involvement of central conversion of testosterone to oestradiol-17 beta in the regulation of luteinizing hormone secretion in the cockerel. The Journal of endocrinology, 1983;99(2):301-10. https://doi.org/10.1677/joe.0.0990301
  20. Nalbandian G, Paharkova-Vatchkova V, Mao A, Nale S, Kovats S, The selective estrogen receptor modulators, tamoxifen and raloxifene, impair dendritic cell differentiation and activation. Journal of immunology (Baltimore, Md. : 1950), 2005;175(4):2666-75. https://doi.org/10.4049/jimmunol.175.4.2666
  21. Berstein LM, Wang JP, Zheng H, Yue W, Conaway M, Santen RJ, Long-term exposure to tamoxifen induces hypersensitivity to estradiol. Clinical cancer research : an official journal of the American Association for Cancer Research, 2004;10(4):1530-4. https://doi.org/10.1158/1078-0432.CCR-0433-03
  22. Rousset-Jablonski C, Thalabard JC, Gompel A, Tamoxifen contraindicated in women with hereditary angioedema? Annals of oncology : official journal of the European Society for Medical Oncology, 2009;20(7):1281-2. https://doi.org/10.1093/annonc/mdp295
  23. Fisher B, Costantino JP, Wickerham DL, Redmond CK, Kavanah M, Cronin WM, et al., Tamoxifen for prevention of breast cancer: report of the National Surgical Adjuvant Breast and Bowel Project P-1 Study. Journal of the National Cancer Institute, 1998;90(18):1371-88. https://doi.org/10.1093/jnci/90.18.1371
  24. Pienta KJ, Redman BG, Esper PS, Flaherty LE, A phase II evaluation of oral tamoxifen and intermittent intravenous vinblastine in hormone-refractory adenocarcinoma of the prostate. American journal of clinical oncology, 1996;19(5):500-3. https://doi.org/10.1097/00000421-199610000-00014
  25. Zeneca Pharmaceuticals, Nolvadex (tamoxifen citrate) prescribing information. 1998.
  26. Braems G, Denys H, De Wever O, Cocquyt V, Van den Broecke R, Use of tamoxifen before and during pregnancy. The oncologist, 2011; 16(11):1547-51. https://doi.org/10.1634/theoncologist.2011-0121
  27. Karn A, Jha AK, Shrestha S, Acharya B, Poudel S, Bhandari RB, Tamoxifen for breast cancer. JNMA; journal of the Nepal Medical Association, 2010;49(177):62-7.
  28. Notley LM, Crewe KH, Taylor PJ, Lennard MS, Gillam EM, Characterization of the human cytochrome P450 forms involved in metabolism of tamoxifen to its alpha-hydroxy and alpha,4-dihydroxy derivatives. Chemical research in toxicology, 2005;18(10):1611-8. https://doi.org/10.1021/tx050140s
  29. Lien EA, Anker G, Lonning PE, Solheim E, Ueland PM, Decreased serum concentrations of tamoxifen and its metabolites induced by aminoglutethimide. Cancer research, 1990;50(18):5851-7.
  30. Ritchie LD, Grant SM, Tamoxifen-warfarin interaction: the Aberdeen hospitals drug file. BMJ, 1989;298(6682):1253. https://doi.org/10.1136/bmj.298.6682.1253
  31. Tenni P, Lalich DL, Byrne MJ, Life threatening interaction between tamoxifen and warfarin. BMJ, 1989;298(6666):93. https://doi.org/10.1136/bmj.298.6666.93
  32. Lamberts SW, Verleun T, Hofland L, Oosterom R, Differences in the interaction between dopamine and estradiol on prolactin release by cultured normal and tumorous human pituitary cells. The Journal of clinical endocrinology and metabolism, 1986;63(6):1342-7. https://doi.org/10.1210/jcem-63-6-1342
  33. Dowsett M, Pfister C, Johnston SR, Miles DW, Houston SJ, Verbeek JA, et al., Impact of tamoxifen on the pharmacokinetics and endocrine effects of the aromatase inhibitor letrozole in postmenopausal women with breast cancer. Clinical cancer research : an official journal of the American Association for Cancer Research, 1999;5(9):2338-43.
  34. Reid AD, Horobin JM, Newman EL, Preece PE, Tamoxifen metabolism is altered by simultaneous administration of medroxyproge -sterone acetate in breast cancer patients. Breast cancer research and treatment, 1992;22(2): 153-6. https://doi.org/10.1007/bf01833345
  35. Dehal SS, Brodie AM, Kupfer D, The aromatase inactivator 4-hydroxyandrostenedione (4-OH-A) inhibits tamoxifen metabolism by rat hepatic cytochrome P-450 3A: potential for drug-drug interaction of tamoxifen and 4-OH-A in combined anti-breast cancer therapy. Drug metabolism and disposition: the biological fate of chemicals, 1999;27(3):389-94.
  36. West CM, Reeves SJ, Brough W, Additive interaction between tamoxifen and rifampicin in human biliary tract carcinoma cells. Cancer letters, 1990;55(2):159-63. https://doi.org/10.1016/0304-3835(90)90027-U
  37. Mani C, Gelboin HV, Park SS, Pearce R, Parkinson A, Kupfer D, Metabolism of the antimammary cancer antiestrogenic agent tamoxifen. I. Cytochrome P-450-catalyzed N-demethylation and 4-hydroxylation. Drug metabolism and disposition: the biological fate of chemicals, 1993;21(4):645-56.
  38. Mani C, Pearce R, Parkinson A, Kupfer D, Involvement of cytochrome P4503A in catalysis of tamoxifen activation and covalent binding to rat and human liver microsomes. Carcinogenesis, 1994;15(12):2715-20. https://doi.org/10.1093/carcin/15.12.2715
  39. Williams JA, Ring BJ, Cantrell VE, Jones DR, Eckstein J, Ruterbories K, et al., Comparative metabolic capabilities of CYP3A4, CYP3A5, and CYP3A7. Drug metabolism and disposition: the biological fate of chemicals, 2002;30(8):883-91. https://doi.org/10.1124/dmd.30.8.883
  40. Kwak MA, Park SJ, Park SH, Lee YJ, Ku SK, Effect of Jaeumkanghwatang (JEKHT), a Polyherbal Formula on the Pharmacokinetics Profiles of Tamoxifen in Male SD Rats (1)-Single Oral Combination Treatment of Tamoxifen 50 mg/kg with JEKHT 100 mg/kg within 5 min -. J Korean Med, 2016;37(2):1-11. https://doi.org/10.13048/jkm.16016
  41. Park SJ, Kwak MA, Park SH, Lee YJ, Ku SK, Effect of Jaeumkanghwatang (JEKHT), a Polyherbal Formula on the Pharmacokinetics Profiles of Tamoxifen in Male SD Rats (2) - Oral Combination Treatment of Tamoxifen 50 mg/kg with JEKHT 100 mg/kg on JEKHT 6-day Repeated Pretreated Rats with 8-day Repeated Co-administration -. J Soc Preventive Korean Med, 2016;20(2):97-109.
  42. Ryu EA, Kang SJ, Song CH, Lee BH, Choi SH, Han CH, et al., Effect of Gamiondam-tang (GMODT), a Polyherbal Formula on the Pharmacokinetics Profiles of Tamoxifen in Male SD Rats J Korean Med, 2017;38(2):61-72. https://doi.org/10.13048/jkm.17018
  43. Ryu EA, Kang SJ, Song CH, Lee BH, Choi SH, Han CH, et al., Effect of Gamiondam-tang (GMODT), a Polyherbal Formula on the Pharmacokinetics Profiles of Tamoxifen in Male SD Rats (2) - Single Oral Combination Treatment of Tamoxifen 50 mg/kg with GMODT 100 mg/kg with 2.5 hr-intervals -. Journal of Society of Preventive Korean Medicine, 2017;21(2):127-37. https://doi.org/10.25153/spkom.2017.21.2.013
  44. Svarcova I, Heinrich J, Valentova K, Berry fruits as a source of biologically active compounds: the case of Lonicera caerulea. Biomedical papers of the Medical Faculty of the University Palacky, Olomouc, Czechoslovakia, 2007;151(2):163-74. https://doi.org/10.5507/bp.2007.031
  45. Zhao H, Wang Z, Ma F, Yang X, Cheng C, Yao L, Protective effect of anthocyanin from Lonicera Caerulea var. Edulis on radiation -induced damage in mice. International journal of molecular sciences, 2012;13(9):11773-82. https://doi.org/10.3390/ijms130911773
  46. Jurgonski A, Juskiewicz J, Zdunczyk Z, An anthocyanin-rich extract from Kamchatka honeysuckle increases enzymatic activity within the gut and ameliorates abnormal lipid and glucose metabolism in rats. Nutrition, 2013;29(6):898-902. https://doi.org/10.1016/j.nut.2012.11.006
  47. Palikova I, Valentova K, Oborna I, Ulrichova J, Protectivity of blue honeysuckle extract against oxidative human endothelial cells and rat hepatocyte damage. Journal of agricultural and food chemistry, 2009;57(15):6584-9. https://doi.org/10.1021/jf9003994
  48. Jin XH, Ohgami K, Shiratori K, Suzuki Y, Koyama Y, Yoshida K, et al., Effects of blue honeysuckle (Lonicera caerulea L.) extract on lipopolysaccharide-induced inflammation in vitro and in vivo. Experimental eye research, 2006;82(5):860-7. https://doi.org/10.1016/j.exer.2005.10.024
  49. Chen L, Xin X, Yuan Q, Su D, Liu W, Phytochemical properties and antioxidant capacities of various colored berries. Journal of the science of food and agriculture, 2014;94(2):180-8. https://doi.org/10.1002/jsfa.6216
  50. Vostalova J, Galandakova A, Palikova I, Ulrichova J, Dolezal D, Lichnovska R, et al., Lonicera caerulea fruits reduce UVA-induced damage in hairless mice. Journal of photochemistry and photobiology. B, Biology, 2013;128:1-11. https://doi.org/10.1016/j.jphotobiol.2013.07.024
  51. Kim HS, Park SI, Choi SH, Song CH, Park SJ, Shin YK, et al., Single oral dose toxicity test of blue honeysuckle concentrate in mice. Toxicological research, 2015;31(1):61-8. https://doi.org/10.5487/TR.2015.31.1.061
  52. AOAC (Association of Official Analytical Chemists), Official Methods of Analysis International. 17th ed. AOAC. 2000.
  53. Singleton VL, Timberlake CF, Lea AGH, The phenolic cinnamates of white grapes and wine. Journal of the science of food and agriculture, 1978;29(4):403-10. https://doi.org/10.1002/jsfa.2740290416
  54. Yang J, Meyers KJ, van der Heide J, Liu RH, Varietal differences in phenolic content and antioxidant and antiproliferative activities of onions. Journal of agricultural and food chemistry, 2004;52(22):6787-93. https://doi.org/10.1021/jf0307144
  55. Boyles MJ, Wrolstad RE, Anthocyanin Composition of Red Raspberry Juice: Influences of Cultivar, Processing, and Environmental Factors. J Food Sci, 1993;58(5):1135-41. https://doi.org/10.1111/j.1365-2621.1993.tb06132.x
  56. Bailer AJ, Testing for the equality of area under the curves when using destructive measurement techniques. Journal of pharmacokinetics and biopharmaceutics, 1988;16(3):303-9. https://doi.org/10.1007/BF01062139
  57. Chiou WL, Critical evaluation of the potential error in pharmacokinetic studies of using the linear trapezoidal rule method for the calculation of the area under the plasma level-time curve. Journal of pharmacokinetics and biopharmaceutics, 1978;6(6):539-46. https://doi.org/10.1007/BF01062108
  58. Kang SJ, Lee JE, Lee EK, Jung DH, Song CH, Park SJ, et al., Fermentation with Aquilariae Lignum enhances the anti-diabetic activity of green tea in type II diabetic db/db mouse. Nutrients, 2014;6(9):3536-71. https://doi.org/10.3390/nu6093536
  59. Adam HK, Patterson JS, Kemp JV, Studies on the metabolism and pharmacokinetics of tamoxifen in normal volunteers. Cancer treatment reports, 1980;64(6-7):761-4.
  60. Fabian C, Sternson L, Barnett M, Clinical pharmacology of tamoxifen in patients with breast cancer: comparison of traditional and loading dose schedules. Cancer treatment reports, 1980;64(6-7):765-73.
  61. Murphy C, Fotsis T, Pantzar P, Adlercreutz H, Martin F, Analysis of tamoxifen and its metabolites in human plasma by gas chromatography-mass spectrometry (GC-MS) using selected ion monitoring (SIM). Journal of steroid biochemistry, 1987;26(5):547-55. https://doi.org/10.1016/0022-4731(87)90006-9
  62. Jordan VC, Metabolites of tamoxifen in animals and man: identification, pharmacology, and significance. Breast cancer research and treatment, 1982;2(2):123-38. https://doi.org/10.1007/BF01806449
  63. Sun D, Sharma AK, Dellinger RW, Blevins -Primeau AS, Balliet RM, Chen G, et al., Glucuronidation of active tamoxifen metabolites by the human UDP glucuronosyltransferases. Drug metabolism and disposition: the biological fate of chemicals, 2007;35(11):2006-14. https://doi.org/10.1124/dmd.107.017145
  64. AstraZeneca Pharmaceuticals, Nolvadex (tamoxifen citrate) prescribing information. 2003.
  65. Hall WA, Doolittle ND, Daman M, Bruns PK, Muldoon L, Fortin D, et al., Osmotic blood-brain barrier disruption chemotherapy for diffuse pontine gliomas. Journal of neuro-oncology, 2006;77(3):279-84. https://doi.org/10.1007/s11060-005-9038-4