The Art and Science of New Advances in Cosmeceuticals

The need for cosmeceutical research is ever present. This article has tried to highlight the chemistry of botanic extracts in the current marketplace and review the best research available. In some ways, more questions have been raised than answered; yet, ideas for intellectual discourse have been provided. Herein lies the physician cosmeceutical challenge.

The cosmeceutical category is an undefined, unclassified, and unregulated area of skin treatment that is yet in its infancy. Traditional cosmeceuticals involve the topical application of biologically active ingredients, which affect the skin barrier and overall skin health. The ability of these ingredients to enhance skin functioning depends on how they are formulated into creams, lotions, and so forth, which can maintain the integrity of the active ingredients, deliver these ingredients in a biologically active form to the skin, reach the target site in sufficient quantity to exert an effect, and properly release the ingredients from the carrier vehicle.

In the United States and Europe, cosmeceuticals are sold as cosmetics, making marketing, packaging, and aesthetic appeal important considerations. However, in Japan, a novel category of quasi-drugs exists that encompasses these biologically active formulations sold directly to consumers. Because cosmeceuticals intend to deliver on a higher level than cosmetics that simply color and scent the skin, cosmeceuticals should be clinically tested for efficacy not only to insure a proven skin benefit but also to substantiate marketing claims.

Cosmeceuticals are viewed as cosmetics in the United States and must be careful to make only appearance claims. For example, they can claim to improve the appearance of wrinkles, but not get rid of wrinkles. Improving appearance is a cosmetic claim, whereas getting rid of wrinkles is a functional drug claim. Cosmeceuticals can also brighten skin and improve radiance, but they cannot treat abnormal pigmentation. Treating abnormal pigmentation is a drug claim. The recognition that there are governmental limitations on efficacy claims restricts cosmeceutical development because products can only be assessed in terms of their ability to improve skin appearance but not function. Improving function would remove the cosmeceutical from the cosmetic category and place it in the drug category.

Cosmeceutical development

Basically, cosmeceuticals are functional cosmetics, which means that the ingredients that are included in formulations must come from a list of raw materials that are generally recognized as safe, else the cosmeceutical would be classified as a drug. The easiest source of new cosmeceutical ingredients is the plant kingdom. Plants are rich in endogenous antioxidants because they must survive in an environment rich in UV radiation insults. Plant extracts are also thought to be safe and meet the Food and Drug Administration criteria for substances that can be put in over-the-counter (OTC) formulations. It is generally thought that substances that are safe for oral consumption can be assumed safe when applied topically. This thinking has led to a renewed interest in herbal preparations, which form the basis for functionality in many cosmeceuticals.

The search for novel herbs has led to the gathering of flowers, seeds, roots, leaves, twigs, and berries from plants all over the world. This gathering can be a complex process because the constituents of a plant extract are influenced by the season in which the plant material was picked, the growing conditions, and the processing of the botanic. Once a possible functional cosmeceutical active ingredient has been identified and synthesized, it is typically applied to a fibroblast cell culture and the supernatant is placed on a gene chip to look for upregulation or downregulation of key skin mediators. For example, the ingredient may downregulate matrix metalloproteinases (MMPs), leading to a decrease in collagen degradation, providing the data for an antiaging claim. Sometimes the ingredient is further tested in a rodent model for confirmation of the desired skin benefits. The active ingredient is then placed in a vehicle suitable for human application, and clinical studies are undertaken. Successful human clinical studies pave the way for successful introduction into the marketplace via ingredient licensing arrangements.

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