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Pharmaceutical Research

, Volume 28, Issue 9, pp 2165–2175 | Cite as

Assessment of Topical Bioequivalence Using Dermal Microdialysis and Tape Stripping Methods

  • Tuba Incecayir
  • Ilbeyi Agabeyoglu
  • Ulver Derici
  • Sukru Sindel
Research Paper

ABSTRACT

Purpose

To assess the bioequivalence of two commercial topical formulations of oxytetracycline HCl by tape stripping and microdialysis in healthy volunteers.

Methods

Tape stripping study was conducted on 12 healthy volunteers. After a 30-minute application of the formulations, adhesive tapes were used to sample stratum corneum at 0.25, 0.5, 1, 1.5, 2, 3, 4 hr. Ten of these volunteers were included in the microdialysis study with a period of 4 weeks between the experiments. Microdialysis probes were inserted into the dermis of the forearm. Following the application of the test and reference simultaneously, dialysates were collected in 30-minute sampling intervals up to 4 hr.

Results

Pharmacokinetic evaluation by microdialysis yielded that the test could not be said to be bioequivalent to the reference at 90% CI. The intersubject variability of oxytetracycline content in stratum corneum was moderate when it was compared to the dermal levels. The test was found to be bioequivalent to reference according to the dermatopharmacokinetic evaluation by tape stripping.

Conclusions

No significant correlations were found between microdialysis and tape stripping methods as regarding the topical bioequivalence of oxytetracycline HCl formulations.

KEY WORDS

bioequivalence microdialysis oxytetracycline tape stripping topical 

ABBREVIATIONS

AUC

area under the OTC content-time profile or area under the OTC concentration-time profile

BA

bioavailability

BE

bioequivalence

C

amount of OTC at SC

CI

confidence intervals

CL

clearance

Cmax

maximum observed OTC content of the DPK profile or maximum observed OTC concentration in dermis

CV

coefficient of variation

D

dose

DMD

dermal microdialysis

DPK

dermatopharmacokinetics

HPLC

high performance liquid chromatography

ka

absorption rate constant

kd

elimination rate constant

LOD

limit of detection

LOQ

limit of quantification

MD

microdialysis

OTC

oxytetracycline HCl

PK

pharmacokinetics

RR

relative recovery

SC

stratum corneum

SD

standard deviation

t1/2

half life

tmax

time point at which Cmax was observed

to

lag time

TS

tape stripping

UPLC-MS-MS

ultra performance liquid chromatography tandem mass spectroscopy

V

area of distribution

Vd

volume of distribution

Notes

ACKNOWLEDGMENTS

This study was supported by the research grant (107S177) from TUBITAK (The Turkish Scientific and Technological Research Council), which is gratefully acknowledged. The authors would like to thank Düzen-Norwest Laboratory, Ankara, Turkey, for the technical assistance in providing UPLC-MS-MS analysis.

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Copyright information

© Springer Science+Business Media, LLC 2011

Authors and Affiliations

  • Tuba Incecayir
    • 1
  • Ilbeyi Agabeyoglu
    • 1
  • Ulver Derici
    • 2
  • Sukru Sindel
    • 2
  1. 1.Department of Pharmaceutical Technology, Faculty of PharmacyGazi UniversityAnkaraTurkey
  2. 2.Department of Nephrology, Faculty of MedicineGazi UniversityAnkaraTurkey

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