NDLI: Pilot Investigation on Long-Term Subcutaneous Microdialysis: Proof of Principle in Humans

Content Provider	Springer Nature Link
Author	Simmel, Franziska Kirbs, Claudia Erdogan, Zeynep Lackner, Edith Zeitlinger, Markus Kloft, Charlotte
Copyright Year	2012
Abstract	Reliable drug concentration measurements at the target site are increasingly demanded and can be achieved by microdialysis. The aim of this pilot study was to demonstrate the proof of principle of long-term subcutaneous microdialysis in humans. For long-term microdialysis, a special setting implementing both concentric and linear catheters has been developed ensuring good clinical practice compliance, tolerability, and convenience for participants and personnel. As a model compound, moderately lipophilic voriconazole was selected as a well-characterized drug in in vitro microdialysis experiments. Multiple in vivo relative recovery (RR) determinations for microdialysis were performed by retrodialysis during the entire study (n = 48 samples). Continuous microdialysis was successfully applied and well tolerated over 87 h in three adults for the first time. RR revealed low intra-individual (coefficient of variation (CV) = 4.4–12.5%) and inter-individual variability (CV = 4.3–12.5%) across all samples and catheters. Lower RR values were consistently determined for linear catheters. One catheter leakage was managed without an impact on the reliability of the RR values. Overall, RR values were calculated to be 73.3% (linear: CV = 18.5%, n = 23) and 84.9% (concentric: CV = 5.6%, n = 23). Long-term microdialysis application over almost 4 days was feasible by reliable multiple RR (proof of principle), well tolerated, and reduced the burden in humans avoiding several catheter insertions, thereby allowing to monitor concentration–time courses continuously. Moreover, a moderately lipophilic drug has been proven suitable for in vivo microdialysis, as previously suggested by in vitro microdialysis.
Starting Page	95
Ending Page	103
Page Count	9
File Format	PDF
ISSN	12341234
Journal	The AAPS Journal
Volume Number	15
Issue Number	1
e-ISSN	15507416
Language	English
Publisher	Springer US
Publisher Date	2012-10-13
Publisher Institution	American Association of Pharmaceutical Scientists
Publisher Place	Boston
Access Restriction	One Nation One Subscription (ONOS)
Subject Keyword	Pharmacology/Toxicology Biochemistry Biotechnology Pharmacy
Content Type	Text
Resource Type	Article

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1	Ministry of Education (GoI), Department of Higher Education	Sanctioning Authority	https://www.education.gov.in/ict-initiatives
2	Indian Institute of Technology Kharagpur	Host Institute of the Project: The host institute of the project is responsible for providing infrastructure support and hosting the project	https://www.iitkgp.ac.in
3	National Digital Library of India Office, Indian Institute of Technology Kharagpur	The administrative and infrastructural headquarters of the project	Dr. B. Sutradhar bsutra@ndl.gov.in
4	Project PI / Joint PI	Principal Investigator and Joint Principal Investigators of the project	Dr. B. Sutradhar bsutra@ndl.gov.in Prof. Saswat Chakrabarti will be added soon
5	Website/Portal (Helpdesk)	Queries regarding NDLI and its services	support@ndl.gov.in
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