Use of a Synthetic, Animal-Free Membrane for Transdermal and Topical Delivery of Actives: A Powerful Tool for Pharmaceutical/Personal Care Formulation Development

EuroCosmetics: The International Magazine for Cosmetics & Fragrances November/December 2017 Volume No. 25

[Vivek Joshi, Ph.D.]

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Abstract

Transdermal or topical administration of skin actives, whether for pharmaceuticals or cosmeceuticals can offer a number of advantages over oral/intravenous/nutraceutical delivery routes.

Transdermal or topical administration of skin actives, whether for pharmaceuticals or cosmeceuticals can offer a number of advantages over oral/intravenous/nutraceutical delivery routes. For conditions affecting the skin itself, topical formulations offer delivery of API (active pharmaceutical/cosmeceutical ingredient) where it is needed, without the side effects associated with systemic delivery. Similarly, personal care and cosmetic formulations also primarily target skin and the various layers within the skin. Hence, topical formulations are best suited for delivery of personal care actives (eg: cosmeceuticals) to where they are needed. Transdermal and topical delivery offer advantages in patient/consumer compliance and ease of stopping/starting treatment/application in both pharmaceutical and personal care applications. During development of transdermal and topical formulations, assessment of API percutaneous adsorption is critical. These studies are typically conducted using human cadaver skin or animal models. Unfortunately, a number of drawbacks exist for these models. Strat-M® membrane is a synthetic, animal-free membrane that can be used as a model for transdermal diffusion. It is an ultrafiltration membrane composed of polyether sulfone. Multiple layers of the membrane create a morphology similar to human skin. Membrane layers are increasingly more porous and open and increase in thickness from top to bottom. The membrane includes a top layer supported by a porous substructure bound to a non-woven fabric support. Both human skin and the membrane display a layered structure with a very tight top layer. The membrane is also treated with a synthetic lipid mixture that mimics the phospholipids and ceramides present in human skin. It is these skin components that are implicated in control of diffusion in human skin. This article compares diffusion of multiple compounds through Strat-M® membrane versus human cadaver skin. These data highlight how this synthetic model can be used for transdermal diffusion studies, providing an alternative to current animal based models.

Cumulative Amount, Strat-M Membrane

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