Pilot investigation on long-term subcutaneous microdialysis: Proof of principle in humans

AAPS Journal

Volumn 15, Issue 1, 2013, Pages 95-103

  Simmel, Franziska ^a   Kirbs, Claudia ^a,b   Erdogan, Zeynep ^c   Lackner, Edith ^c   Zeitlinger, Markus ^c   Kloft, Charlotte ^a,b  

^a MARTIN LUTHER UNIVERSITY HALLE WITTENBERG   (Germany)

^b FREIE UNIVERSITÄT BERLIN   (Germany)

^c MEDICAL UNIVERSITY OF VIENNA   (Austria)

Author keywords

concentric linear microdialysis catheter; long term microdialysis; proof of principle; relative recovery; retrodialysis

Indexed keywords

VORICONAZOLE;

ADULT; ARTICLE; CALIBRATION; CLINICAL TRIAL; DIALYSIS CATHETER; DRUG TOLERABILITY; GOOD CLINICAL PRACTICE; HUMAN; HUMAN EXPERIMENT; IN VIVO STUDY; MALE; MICRODIALYSIS; NORMAL HUMAN; PILOT STUDY; PROSPECTIVE STUDY; RELIABILITY; SUBCUTANEOUS MICRODIALYSIS; UNSPECIFIED SIDE EFFECT;

ADULT; HUMANS; MALE; MICRODIALYSIS; MIDDLE AGED; PILOT PROJECTS; PROSPECTIVE STUDIES; PYRIMIDINES; TRIAZOLES;

EID: 84871956336     PISSN: 15507416     EISSN: None     Source Type: Journal    
DOI: 10.1208/s12248-012-9412-z     Document Type: Article

References (37)

1. Plock N, Kloft C. Microdialysis - theoretical background and recent implementation in applied life-sciences. Eur J Pharm Sci. 2005;25(1):1-24. (Pubitemid 40602191)
2. Chaurasia CS, Muller M, Bashaw ED, Benfeldt E, Bolinder J, Bullock R, et al. AAPS-FDA Workshop White Paper: microdialysis principles, application, and regulatory perspectives. J Clin Pharmacol. 2007;47(5):589-603. (Pubitemid 46632149)
3. Buerger C, Plock N, Dehghanyar P, Joukhadar C, Kloft C. Pharmacokinetics of unbound linezolid in plasma and tissue interstitium of critically ill patients after multiple dosing using microdialysis. Antimicrob Agents Chemother. 2006;50(7):2455-63. (Pubitemid 43993186)
4. Dehghanyar P, Burger C, Zeitlinger M, Islinger F, Kovar F, Muller M, et al. Penetration of linezolid into soft tissues of healthy volunteers after single and multiple doses. Antimicrob Agents Chemother. 2005;49(6):2367-71. (Pubitemid 40734468)
5. Gattringer R, Urbauer E, Traunmuller F, Zeitlinger M, Dehghanyar P, Zeleny P, et al. Pharmacokinetics of telithromycin in plasma and soft tissues after single-dose administration to healthy volunteers. Antimicrob Agents Chemother. 2004;48(12):4650-3. (Pubitemid 39577667)
6. Persky AM, Muller M, Derendorf H, Grant M, Brazeau GA, Hochhaus G. Single- and multiple-dose pharmacokinetics of oral creatine. J Clin Pharmacol. 2003;43(1):29-37. (Pubitemid 36015440)
7. Traunmuller F, Fille M, Thallinger C, Joukhadar C. Multiple-dose pharmacokinetics of telithromycin in peripheral soft tissues. Int J Antimicrob Agents. 2009;34(1):72-5.
8. Traunmuller F, Zeitlinger M, Zeleny P, Muller M, Joukhadar C. Pharmacokinetics of single- and multiple-dose oral clarithromycin in soft tissues determined by microdialysis. Antimicrob Agents Chemother. 2007;51(9):3185-9. (Pubitemid 350067526)
9. Arner P, Bolinder J. Microdialysis of adipose tissue. J Intern Med. 1991;230(4):381-6.
10. Baumeister FA, Rolinski B, Busch R, Emmrich P. Glucose monitoring with long-term subcutaneous microdialysis in neonates. Pediatrics. 2001;108(5):1187-92. (Pubitemid 33021197)
11. Bolinder J, Ungerstedt U, Arner P. Microdialysis measurement of the absolute glucose concentration in subcutaneous adipose tissue allowing glucose monitoring in diabetic patients. Diabetologia. 1992;35(12):1177-80.
12. Bolinder J, Ungerstedt U, Arner P. Long-term continuous glucose monitoring with microdialysis in ambulatory insulin-dependent diabetic patients. Lancet. 1993;342(8879):1080-5. (Pubitemid 23338740)
13. Edsander-Nord A, Rojdmark J, Wickman M. Metabolism in pedicled and free TRAM flaps: a comparison using the microdialysis technique. Plast Reconstr Surg. 2002;109(2):664-73. (Pubitemid 34118436)
14. Hashiguchi Y, Sakakida M, Nishida K, Uemura T, Kajiwara K, Shichiri M. Development of a miniaturized glucose monitoring system by combining a needle-type glucose sensor with microdialysis sampling method. Long-term subcutaneous tissue glucose monitoring in ambulatory diabetic patients. Diabetes Care. 1994;17(5):387-96.
15. Hildingsson U, Sellden H, Ungerstedt U, Marcus C. Microdialysis for metabolic monitoring in neonates after surgery. Acta Paediatr. 1996;85(5):589-94. (Pubitemid 26178508)
16. Holzinger A, Bonfig W, Kusser B, Eggermann T, Muller H, Munch HG. Use of long-term microdialysis subcutaneous glucose monitoring in the management of neonatal diabetes. A first case report. Biol Neonate. 2006;89(2):88-91. (Pubitemid 43254163)
17. Horal M, Ungerstedt U, Persson B, Westgren M, Marcus C. Metabolic adaptation in IUGR neonates determined with microdialysis - a pilot study. Early Hum Dev. 1995;42(1):1-14.
18. Lutgers HL, Hullegie LM, Hoogenberg K, Sluiter WJ, Dullaart RP, Wientjes KJ, et al. Microdialysis measurement of glucose in subcutaneous adipose tissue up to three weeks in type 1 diabetic patients. Neth J Med. 2000;57(1):7-12. (Pubitemid 30339396)
19. Persson L, Valtysson J, Enblad P, Warme PE, Cesarini K, Lewen A, et al. Neurochemical monitoring using intracerebral microdialysis in patients with subarachnoid hemorrhage. J Neurosurg. 1996;84(4):606-16. (Pubitemid 26104228)
20. Hillered L, Valtysson J, Enblad P, Persson L. Interstitial glycerol as a marker for membrane phospholipid degradation in the acutely injured human brain. J Neurol Neurosurg Psychiatry. 1998;64(4):486-91. (Pubitemid 28195950)
21. Hutchinson PJ, O'Connell MT, Maskell LB, Pickard JD. Monitoring by subcutaneous microdialysis in neurosurgical intensive care. Acta Neurochir Suppl. 1999;75:57-9.
22. During MJ, Fried I, Leone P, Katz A, Spencer DD. Direct measurement of extracellular lactate in the human hippocampus during spontaneous seizures. J Neurochem. 1994;62(6):2356-61. (Pubitemid 24179519)
23. Kennergren C, Mantovani V, Lonnroth P, Nystrom B, Berglin E, Hamberger A. Monitoring of extracellular aspartate aminotransferase and troponin T by microdialysis during and after cardioplegic heart arrest. Cardiology. 1999;92(3):162-70. (Pubitemid 30162736)
24. Konings IR, Engels FK, Sleijfer S, Verweij J, Wiemer EA, Loos WJ. Application of prolonged microdialysis sampling in carboplatin-treated cancer patients. Cancer Chemother Pharmacol. 2009;64(3):509-16.
25. Kopacz DJ, Bernards CM, Allen HW, Landau C, Nandy P, Wu D, et al. A model to evaluate the pharmacokinetic and pharmacodynamic variables of extended-release products using in vivo tissue microdialysis in humans: bupivacaine-loaded microcapsules. Anesth Analg. 2003;97(1):124-31. (Pubitemid 36736549)
26. Stahle L, Alm C, Ekquist B, Lundquist B, Tomson T. Monitoring free extracellular valproic acid by microdialysis in epileptic patients. Ther Drug Monit. 1996;18(1):14-8. (Pubitemid 26033353)
27. Lindberger M, Tomson T, Stahle L. Validation of microdialysis sampling for subcutaneous extracellular valproic acid in humans. Ther Drug Monit. 1998;20(3):358-62. (Pubitemid 28248860)
28. Simmel F, Kloft C. Microdialysis feasibility investigations with the non-hydrophilic antifungal voriconazole for potential applications in nonclinical and clinical settings. Int J Clin Pharmacol Ther. 2010;48(11):695-704.
29. World Medical Association. Declaration of Helsinki Ethical Principles for Medical Research Involving Human Subjects. 1964 (amended by the 59th WMA General Assembly, Seoul, October 2008). http://www.wma.net/en/30publications/ 10policies/b3/index.html. Accessed 27 Oct 2009.
30. Note for Guidance on Good Clinical Practice (CPMP/ICH/135/95) Step 5. 1996.
31. Stahle L, Arner P, Ungerstedt U. Drug distribution studies with microdialysis. III: Extracellular concentration of caffeine in adipose tissue in man. Life Sci. 1991;49(24):1853-8.
32. Simmel F, Soukup J, Zoerner A, Radke J, Kloft C. Development and validation of an efficient HPLC method for quantification of voriconazole in plasma and microdialysate reflecting an important target site. Anal Bioanal Chem. 2008;392(3):479-88.
33. Guidance for Industry. Bioanalytical Method Validation. Food and Drug Administration. 2001. http://www.fda.gov/downloads/Drugs/ GuidanceComplianceRegulatoryInformation/Guidances/UCM070107.pdf. Accessed 27 October 2009.
34. Saunte DM, Simmel F, Frimodt-Moller N, Stolle LB, Svejgaard EL, Haedersdal M, et al. In vivo efficacy and pharmacokinetics of voriconazole in an animal model of dermatophytosis. Antimicrob Agents Chemother. 2007;51(9):3317-21. (Pubitemid 350067546)
35. Araujo BV, Conrado DJ, Palma EC, Dalla Costa T. Validation of rapid and simple LC-MS/MS method for determination of voriconazole in rat plasma. J Pharm Biomed Anal. 2007;44(4):985-90. (Pubitemid 47095189)
36. Araujo BV, Silva CF, Haas SE, Dalla Costa T. Microdialysis as a tool to determine free kidney levels of voriconazole in rodents: a model to study the technique feasibility for a moderately lipophilic drug. J Pharm Biomed Anal. 2008;47(4-5):876-81.
37. Joukhadar C, Thallinger C, Poppl W, Kovar F, Konz KH, Joukhadar SM, et al. Concentrations of voriconazole in healthy and inflamed lung in rats. Antimicrob Agents Chemother. 2009;53(6):2684-6.