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IN VITRO STUDIES FURTHER DETAILS

In Vitro Study No: 39

METHODS

Chemical

Conc. (mg/ml)

Volume (ml)

Loading (mg/cm2)

Vehicle

Species

Membrane

Site

Area (cm2)

Cell Type

Receptor Fluid

Temp. (oC)

Temp. Measured

Exposure Time (h)

Study Length (h)

Occluded

Analytical Method

Terbinafine

0.01

0.3

0.0012

Propylene glycol

Graftskin TM

support membrane was removed

N/A

2.54

Static

PBS/Ethanol 3:1

Water Bath

reversed phase HPLC

RESULTS

% Recovery	+/-	% In Stratum Corneum	+/-	% in Viable Skin	+/-	% Penetrated	+/-	% Absorbed	+/-	s-s-flux (mcrg/cm2/h)	+/-	kp (cm/h)	n	Lag Time (h)
										0.28	0.21	0.028	3

% Recovery

+/-

% In Stratum Corneum

+/-

% in Viable Skin

+/-

% Penetrated

+/-

% Absorbed

+/-

s-s-flux (mcrg/cm2/h)

+/-

kp (cm/h)

Lag Time (h)

0.28

0.21

0.028

NOTES

Obtained from Organogenesis (Canton, MA) No integrity test was mentioned. They also measured the conc. Of chemical remaining in the skin after the stratum cormeum had been stripped. They found this skin concentration to be 2400+/-200 micrograms/gram. The Kp was not mentioned in the paper. I calculated it by dividing the steady state flux by the concentration

REFERENCE

Comparison Of Human Skin Or Epidermis Models With Human And Animal Skin In In Vitro Percutaneous Absorption (2001) Int. J. Pharm., 215 :51-56