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IN VITRO STUDIES FURTHER DETAILS

In Vitro Study No: 31

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

Minipig

Dermatomed to 0.6mm

Unknown

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)
										0.011	0.005	0.0011	3

% Recovery

+/-

% In Stratum Corneum

+/-

% in Viable Skin

+/-

% Penetrated

+/-

% Absorbed

+/-

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

+/-

kp (cm/h)

Lag Time (h)

0.011

0.005

0.0011

NOTES

No integrity test was mentioned. They also measured the concentration of chemical remaining in the skin after the stratum cormeum had been removed by stripping with adhesive tape. They found this skin concentration to be 75+/-10 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