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IN VIVO STUDIES FURTHER DETAILS


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In Vivo Study No: 231

METHODS

ChemicalMembraneConcentration mg/mlConcentration mg/mlloading (mg/cm2)SpeciesSiteArea (cm2)Occluded?Exposure Time (h)Analytical Method
Progesterone0.020.50.004AcetoneHumanVentral Forearm2.5224Radiolabelled (14C)

RESULTS

Length of Study (h)% Recovery+/-Dose remaining on surface (mg)% remaining on SurfaceDose remaining in stratum corneum (mg)% remaining in stratum corneumDose remaining in the viable skin% remaining in the viable skinAmount Absorbed (mg)% Absorbed+/-% Absorbed
16895.5 0.0082582.5    0.0013136.313
Maximal Flux (mcrg/cm2/h)Average Flux (mcrg/cm2/h)+/-Time Plasma/Blood Levels Peaked (h)Peak Blood Concentration (mg/l)nkp (cm/h)Lag Time (h)
     6  

NOTES

A polypropylene Hilltop Chamber (HTC) was applied but several holes were bored into the plastic, so that the chamber protected the site but did not occlude it. The HTC was removed after 24h and the skin was washed, then a new HTC was added for the duration of the experiment. The Dose left at the surface was determined by adding the amount left in both HTCs to the amount obtained in the wash. % Absorption was calculated by measuring the amount exctreted in the urine (not given). This was corrected for incomplete urinary excretion by comparing with the amount excreted after a parenteral dose.

REFERENCE

Bioavailability Of Topically Administered Steroids:: A "Mass Balance" Technique (1988) J. Investig. Dermatol., :29-33