Synthetic, non-animal based model* for transdermal diffusion testing

July 2012

Performance data indicate that diffusion through Strat-M membrane is predictive of diffusion through human skin for a wide range of active pharmaceutical ingredients (API), cosmetic actives, formulations, personal care products, pesticides and chemicals.

In most cases, the correlation of Strat-M membrane to human skin is much better than that of animal skin models commonly used for in vitro testing of transdermal formulations. Furthermore, because it is a synthetic test model with low variability and no special storage or hydration requirements, Strat-M membrane simplifies experimental design and data analysis.

Sophisticated membrane technology
The Strat-M synthetic membrane is an ultrafiltration membrane composed of polyether sulfone. Multiple layers of the membrane create morphology similar to human skin. Membrane layers are increasingly more porous and open and also increasingly larger in thickness. The membrane includes a top layer supported by a porous substructure bound to a non-woven fabric support. The porous structure is impregnated with a proprietary blend of synthetic lipids, imparting additional skin-like properties to the synthetic membrane.

Broad compatibility and versatility
Whether safety testing a slowly diffusing sunscreen active, or optimising a rapidly diffusing NSAID formulation for pain relief, Strat-M membrane provides the versatility to generate meaningful data.  Results indicate that the Strat-M synthetic membrane can be successfully used in place of human or animal skin for in vitro diffusion studies to provide meaningful and reproducible information about permeation characteristics of a range of compounds and formulations. Addition of an enhancer to a formulation leads to higher diffusion of analyte through Strat-M membrane, similar to enhancer effects seen in human cadaver skin.  The synthetic membrane can therefore be used in evaluating formulations as well as for compound screening.

Eliminates time-consuming steps and storage requirements
Unlike skin models, Strat-M membrane is shelf-stable and does not require any special storage considerations. Because the membrane arrives pretreated, time-consuming steps for hydration are not necessary. The pre-cut Strat-M membrane disc can simply be removed from its pouch and loaded into a Franz cell to begin testing.

*For research use only. Not for use in diagnostic procedures.