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Friday, 02 May 2014 12:10

PCCA VersaBase® Cream, Cosmetic HRT™, VersaBase® Gel and Special Micronized Progesterone Study®

PCCA Cream Bases Now Proven to Transport Progesterone Into and Through Human Skin Better Than Vanicream®

versabase 30-3653 003 layeredEvaluation Of The Percutaneous Absorption Of Progesterone, In Vitro, Using The Human Cadaver Skin Model

(Study performed by PRACS Institute, Ltd., an independent contract research facility.)

The study was designed to evaluate the percutaneous absorption pharmacokinetics of progesterone. Absorption was measured in human cadaver skin, in vitro, using the finite dose technique and Franz Diffusion Cells.

Important Note: This study should not be used as a means of determining dosing of progesterone topically. It is a study intended to evaluate the ability of certain cream vehicles to transport progesterone across a human skin sample, in vitro. It is not a substitute for in vivo pharmacokinetic studies. It also is important to note the formulations in this study are NOT rubbed into the skin, but simply applied to the skin via a pipette and left to diffuse.

Methods and Procedures

Percutaneous absorption was measured using the in vitro cadaver skin finite dose technique. Human cadaver trunk skin without obvious signs of skin disease, obtained within 24 – 48 hours of death, was used in this study. It was dermatomed, prepared for cryopreservation, sealed in a water impermeable plastic bag, and stored at ≤-70°C until the day of the experiment. Prior to use it was thawed in ~37°C water, then rinsed in water to remove any adherent blood or other material from the surface.

Skin from a single donor was cut into multiple smaller sections large enough to fit on static 1.0 cm2 Franz diffusion cells. All cells were mounted in a diffusion apparatus in which the dermal bathing solution was stirred magnetically at approximately 600 RPM and the skin surface temperature maintained at 32.0° ± 1.0°C. To assure the integrity of each skin section, its permeability to tritiated water was determined before application of the test products.

versabase-vanicream-graphsBases Tested

The bases used in the testing were: VersaBase® Cream, Cosmetic HRT™, a mixture of VersaBase® Cream and VersaBase® Gel (95% Cream/5% Gel) and the commercial cream Vanicream®*. The progesterone used was Progesterone USP, PCCA Special Micronized. Pentylene glycol was used as a wetting agent at a concentration of 10%. The concentration of progesterone in each preparation was 50 mg/gm.

Study Skin Preparation

Percutaneous absorption was measured using the in vitro cadaver skin finite dose technique. Human cadaver trunk skin without obvious signs of skin disease, obtained within ~24 – 48 hours of death, was used in this study. It was dermatomed, prepared for cryo-preservation, sealed in a water-impermeable plastic bag, and stored at ≤ -70° C until the day of the experiment. Prior to use it was thawed in ~37° C water, then rinsed in tap water to remove any adherent blood or other material from the surface.

Results

The data indicate that progesterone does penetrate into and through human skin, in vitro, from the test formulations evaluated in this study. In general, the penetration profile from all formulations is characterized by a rise in absorption to a peak at approximately 7 hours after dose application followed by a slow decline in flux over time. A transient lower secondary peak of penetration is observed at approximately 28 hours after dose application at approximately half the flux than seen at the maximum.

Download the complete PDF detailing the results of this study.

Click to learn more about VersaBase.