COSMECEUTICALS

A CATEGORY BETWEEN COSMETIC AND DRUGBY

HAMMAD YOUSAF (Pharm-D, M.Phil)YASIR MEHMOOD ((Pharm-D, M.Phil, MBA)

WHAT ARE “COSMECEUTICALS”?

• Cosmeceuticals are cosmetic products with biologically active ingredients purporting to have medical or drug-like benefits.

• The FD&C Act does not recognize any such category as "cosmeceuticals." A product can be a drug, a cosmetic, or a combination of both, but the term "cosmeceutical" has no meaning under the law.

Wijesinghe, W.A.J.P. and Jeon, Y.J., 2011. Biological activities and potential cosmeceutical applications of bioactive components from brown seaweeds: a review. Phytochemistry Reviews, 10(3), pp.431-443.

WHAT ARE “COSMECEUTICALS”?

The term “cosmeceutical” was introduced by dermatologist Dr Albert Kligman in 1984 and is derived from a combination of the words cosmetic and pharmaceutical.

Cosmeceuticals are products that have both cosmetic and therapeutic (medical or drug-like) effects, and are intended to have a beneficial effect on skin health and beauty. Like cosmetics, they are applied topically as creams or lotions but contain active ingredients that have an effect on skin cell function. In some cases, their action is limited to the skin surface (such as exfoliants), while others can penetrate to deeper levels, either enhancing or limiting normal skin functions. Cosmeceuticals are available “over-the-counter” (without prescription) and are generally used as part of a regular skin care regime to help improve skin tone and texture, pigmentation and fine lines.

DO COSMECEUTICALS REALLY WORK?

Ideally cosmeceuticals should be clinically tested to ensure they have a proven benefit and can substantiate their claims, however, the cosmeceutical industry is largely unregulated. Unlike medicines, cosmeceuticals are not subject to review by the Food and Drug Administration (FDA) in the United States or the Therapeutic Goods Administration (TGA) in Australia. Although they are usually tested for safety, they do not have to undergo testing to ensure the claims they make regarding efficacy (effectiveness) are accurate. Unfortunately, many creams do not live up to their advertised hype.

Cosme ceutical

THE MARRIAGE OF COSMETICS TO PHARMACEUTICALS

HOW DOES THE LAW DEFINE A COSMETIC?• The Federal Food, Drug, and Cosmetic Act (FD&C Act) defines

cosmetics by their intended use, as "articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body...for cleansing, beautifying, promoting attractiveness, or altering the appearance" [FD&C Act, sec. 201(i)]

HOW DOES THE LAW DEFINE A DRUG?

• The FD&C Act defines drugs, in part, by their intended use, as "articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease" and "articles (other than food) intended to affect the structure or any function of the body of man or other animals" [FD&C Act, sec. 201(g)(1)].

HOW CAN A PRODUCT BE BOTH A COSMETIC AND A DRUG?• Some products meet the definitions of both cosmetics and drugs. This

may happen when a product has two intended uses. For example, a shampoo is a cosmetic because its intended use is to cleanse the hair. An antidandruff treatment is a drug because its intended use is to treat dandruff. Consequently, an antidandruff shampoo is both a cosmetic and a drug. Among other cosmetic/drug combinations are toothpastes that contain fluoride, deodorants that are also antiperspirants, and moisturizers and makeup marketed with sun-protection claims. Such products must comply with the requirements for both cosmetics and drugs.Kalustian, P., 1985. Pharmaceutical and cosmetic uses of palm and lauric products. Journal of the

American Oil Chemists’ Society, 62(2), pp.431-433.

DIFFERENCE BETWEEN “COSMETICS” & “COSMECEUTICALS”• Cosmeceuticals typically contain levels of active ingredients including

phytochemicals, vitamins etc… Like cosmetics, cosmeceuticals are topically applied, but contain ingredients that influence the biological function of the skin.

• Cosmeceutical products are intended to improve appearance from a functional standpoint whereas Cosmetics are used JUST to color and adorn the body in a stylish fashion, leaving the real problem unaddressed.

Elsner, P. and Maibach, H.I. eds., 2000. Cosmeceuticals: drugs vs. cosmetics (Vol. 23). CRC Press.

DIFFERENCE COSMETIC AND DRUG

WHAT ARE SOME COMMON INGREDIENTS IN COSMECEUTICALS?Sunscreens (titanium dioxide, zinc oxide)Antioxidants (Vitamin C, Alpha-lipoic acid, Nicotinamide)Hydroxy acids (improve skin texture and reduce the skin signs of ageing )Skin lightening agents (Ascorbic acid , Kojic acid)Peptides and proteins

“COSMECEUTICAL INGREDIENTS”

• The main ingredients used in Cosmeceuticals: • Vitamins • Fruit/Herb/Vegetable Extracts • Essential Oils • Minerals

Winter, R., 2009. A consumer's dictionary of cosmetic ingredients: complete information about the harmful and desirable ingredients found in cosmetics and cosmeceuticals. Harmony.

COSMETIC PRODUCTS INGREDIENTS

• beeswax and candelilla wax. • Various oils and fats

• olive oil• mineral oil• cocoa butter• lanolin• petrolatum.

COSMECEUTICAL PRODUCT INGREDIENTS

Common ingredients in anti-wrinkle creams• Retinol. ...• Vitamin C. Another potent antioxidant, vitamin C may help protect skin from sun damage. ...• Hydroxy acids. ...• Coenzyme Q10. ...• Peptides. ...• Tea extracts. ...• Grape seed extract. ...• Niacinamide.

Winter, R., 2009. A consumer's dictionary of cosmetic ingredients: complete information about the harmful and desirable ingredients found in cosmetics and cosmeceuticals. Harmony.

GLUTATHAION (SKIN WHITENING)

MOLECULAR STRUCTURE AND FUNCTION OF GLUTATHIONE

Glutathione (γ-glutamyl-cysteinylglycine) is a small, low-molecular weight, water-soluble thiol-tripeptide formed by three amino acids (glutamate, cysteine and glycine). It is a ubiquitous compound with a biologically active sulfhydryl group contributed by the cysteine moiety that acts as the active part of the molecule.[ This sulfhydryl group allows for interaction with a variety of biochemical systems, hence the abbreviation “GSH” for its active form. Glutathione is one of the most active antioxidant systems in human physiology

GLUTATHIONE AND HUMAN PIGMENTATION

Melanin in human skin is a polymer of various indole compounds synthesized from L-tyrosine by the Raper–Mason pathway of melanogenesis [Figure 2] with tyrosinase being the rate limiting enzyme. The ratio of the two different types of melanin found in skin, black-brown colored eumelanin and yellow-red pheomelanin, determines the skin colour. An increased proportion of pheomelanin is associated with lighter skin colour.

INTRAVENOUS GLUTATHIONE

Due to the low bioavailability of oral glutathione, intravenous injections are being promoted to provide desired therapeutic levels in the blood and skin and to produce “instant” skin-lightening. Interestingly, intravenous injections of glutathione have been used for years but there is not even a single clinical trial evaluating its efficacy. Manufacturers of intravenous glutathione injections recommend a dose of 600–1200 mg for skin lightening, to be injected once to twice weekly. The duration for which they should be continued is not specified. Intravenous administration is expected to deliver 100% bioavailability of glutathione, much more compared to that achieved by oral administration. However, there are no studies to support this hypothesis. Although intravenous glutathione delivers a much higher therapeutic dose that enhances its efficacy, it also provides a narrower margin of safety due to the possibility of overdose toxicity.

TOPICAL PHARMACOLOGICAL AGENTS WITH ANTI-AGING PROPERTIES

• Anti-aging creams may include conventional moisturising ingredients. They also usually contain specific anti-aging ingredients, such as:

• Retinol (for instance, in the form of retinyl palmitate). In various formulations it has been shown to reduce fine lines and pores.Epidermal growth factor, to stimulate cell renewal and collagen production in the skin, and strengthen elasticity and structure.

• Alpha hydroxy acids (AHAs) and beta hydroxy acids or other chemical peels. These help to dissolve the intracellular "glue" that holds dead cells together on the skin. The use of this type of product on a daily basis gradually enhances the exfoliation of the epidermis. This exposes newer skin cells and can help improve appearance. AHAs may irritate some skin, causing redness and flaking.

• Peptides, such as Matryxil and copper peptides.• Coenzyme Q10

BOTULINUM TOXIN

Botulinum toxin (BTX) has no effect on skin texture and cannot discontinue the skin aging process. However, regular BTX injections can slow down the visible aging process by helping in the management of certain dynamic facial lines and wrinkles. The mechanism of action of BTX makes it an ideal agent to target the major cause of these dynamic lines.

CATEGORY

COSMETIC DRUGS

Moistening shampoo Anti dandruff shampoo

Mustering creams whitening creams

Lipstick Anti-aging

Eye shadow Anti-wrinkle cream

Hair dye and colorant Acne Aiad soap

WHAT INGREDIENTS ARE PROHIBITED OR RESTRICTED BY FDA REGULATIONS?

• Bithionol: photocontact sensitization• Chlorofluorocarbon propellants• Chloroform: cancer• Halogenated salicylanilides: skin disorders • Hexachlorophene: • Mercury compounds: allergic reactions, skin irritation, or neurotoxic

problemsWinter, R., 2009. A consumer's dictionary of cosmetic ingredients: complete information about the harmful and desirable ingredients found in cosmetics and cosmeceuticals. Harmony.

THE ADVANTAGES OF COSMECEUTICALS

• Address the root-causes • Safe for long-terms use• Complementary role• Promote beauty through health & wellness of skin• Cosmeceutical with natural ingredients are preferred

THE FUTURE PERSPECTIVE & APPLICATIONS• Improving Skin Complexion • Preventing Visible Effects of Ageing • Controlling/Reducing Wrinkles • Freckle & Black Spot• Acne & Pimple scars• Controlling Sebum• Reducing Cellulite

“PAKISTAN SCENARIO”

• It is very heartening to note, that a comparatively newer concept of Cosmeceuticals has already been introduced in Pakistan which will surely provide Cosmetic Surgeons, Dermatologists, Beauticians, and Consumers a safe and effective alternative for maintaining a healthy and beautiful skin. “LEGAL Aspects” The term ‘cosmeceutical’ has no meaning under law. They are not subject to review by the Food, Drug and Cosmetic Act. Although some cosmeceuticals are tested for safety, testing to determine whether active ingredients actually live up to a manufacturer’s claim is not mandatory.

QUESTIONS?

FOR BRAIN STORMING

COSMECEUTICALS V/S OTHER OPTIONS

• Will they replace cosmetics? • Will they replace pharmaceutical products?• Will they replace cosmetic surgery?