INTRODUCTION:

In recent days a new hot concept is trending in cosmetic industry which is known as “Cosmeceuticals”. Cosmeceuticals are the leading segment of the natural personal care industry. Basically cosmeceuticals are nothing but the combination of the cosmetics and pharmaceuticals. According to FD&C act, cosmetic is defined as a substance which is intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body for cleans, beautify, promote the attractiveness, or altering the appearance.

Pharmaceuticals are essentially drug products. According to FD&C act drugs are defined as a substance intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease or it is intended to affect the structure or any function of the human or any other animal’s body. Cosmeceuticals are the cosmetic products with the pharmaceutical activity ingredients and intended to enhance the health and beauty of skin. Raymond Reed coined the term ‘Cosmeceutical’ in 1961 while in 1971, Albert Klingman reintroduced the term cosmeceutical by developing a formula to improve the appearance of UV damaged and wrinkled skin, by using retinoic acid.

Cosmeceuticals are generally presented as lotions, creams, gels, pastes and dyes like formulations and are mostly targeted at dermatological issues. Cosmeceuticals improve appearance by providing nutrients required for healthy skin and hair. Ideal properties of cosmeceutical agents are efficacy, safety, formulation stability, novelty, and patent protection, metabolism within skin. Most of the cosmeceutical formulations use fundamental ingredients such as peptides, retinol, coenzyme Q- 10, ceramides, alpha lipoic acid, alpha hydroxy acids, beta hydroxy acids, aloe vera, panthenol, kinetin and vitamins A, C, E. The term cosmeceutical is not approved by the Federal Food, Drug, and Cosmetic Act. As we know cosmeceuticals are the topical formulations which were neither pure cosmetic nor pure drug like wise active cosmetics, nutricosmetics, performance cosmetics, functional cosmetics, and dermaceuticals are the alternative terms of cosmeceuticals. The science of beauty and health are making new advancements. In this article we try to summarize all the basic information related to beauty products, an also this attempt has been made to sum up the various types of cosmeceuticals and their regulatory aspects.

Cosmetics:

The Federal Food, Drug & Cosmetic Act (FD&C Act) defines cosmetics 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."^[12]

Pharmaceuticals (drugs):

The FD&C Act defines drugs 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."^[12] or Any substance or combination of substances which may be used in or administered to human beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis.^[8]

Cosmeceuticals:

Cosmeceuticals are cosmetic products with bioactive ingredients purported to have medical benefits. The name is a combination of "cosmetics" and "pharmaceuticals".^[9]

Traditional cosmetics are generally meant for beautifying the body and improving the skin’s external appearance superficially; whereas cosmeceuticals are scientifically validated, topical dermatological ingredients or preparations (creams, lotions, serums etc) containing active ingredients that can impart obvious and visible changes to the skin by influencing biological functions of the skin.^[14]

Nutricosmetics:

They are related to dietary supplement or food or beverage products with additives that are marketed as having medical benefits that affect appearance.^[9] Nutricosmetics is a relatively new term that refers to products and ingredients that act as nutritional supplements but carry the purpose of treating the skin. Nutricosmetics are more commonly known as Beauty Supplements and these supplements come in the forms of drops, pills, powders, shakes, and gummies^[10].

Dermocosmetics:

Dermocosmetic products have been specially formulated to restore skin health. They protect against the many stresses of contemporary life and natural skin ageing. Dermocosmetic products consist of fine molecules that penetrate to the dermis, the middle layer. At this depth, creams have an optimal impact in correcting problems, protecting skin tissue, preventing unwanted marks such as wrinkles ^[13]

CLASSIFICATION:

Terms like active cosmetics, nutricosmetics, performance cosmetics, functional cosmetics, and dermaceuticals, are similar to the term cosmeceutical. All of these terms follow the same definition that is cosmeceuticals formulations are neither pure cosmetics, nor pure drug, they are hybrid products which lies between drugs and cosmetics. Cosmeceuticals products classified into following categories:

1) Skin cosmeceutical product.

2) Hair cosmeceutical product.

3) Other cosmeceutical product.

1. Skin Care Cosmeceuticals Products:

Cosmetics and skin care products are widely used in everyday grooming. Skin is the largest organ in the body and it protects internal environment from external harmful radiations, air pollution, toxic materials as well as normal aging process which cause damage to building blocks of skin. Use of cosmetics or other beauty products will not cause the skin heals or maintains as it is. Cosmeceuticals products have medicinal or drug like properties that are able to affect the biological functioning of skin by the type of functional ingredients that they contain. Skin care cosmeceutical products enhance the appearance, texture or the functioning of the skin.

a) Sunscreen Agents:

Sunscreen agents are used to prevent sunburns, skin cancers. Chemical sunscreen agents and physical sunscreen agents are the two types of sunscreen agents. Chemical sunscreen agents are those which protect the skinfrom the sun by absorbing the ultraviolet (UV) and visible sun rays, while physical sunscreen agents are those which reflect, scatter, absorb, or block the rays. Creams, lotions, gels, ointments, pastes, oils, butters, sticks, and sprays are the common forms of sunscreens.

b) Moisturizing Agents:

Stratum corneum is the outermost layer of the epidermis which consists of keratinized cells. It is primary barrier between the body and the environment. It’smain purpose is to keep inside in & outside out. This layer is rich in cholesterol, free fatty acids, and ceramides. Various oily preparations like Mineral oil, Lanolin, Cyclomethicone, etc. have been used to maintain the fluidity of the skin. Moisturizers are used to reduce fine lies, smoothen and hydrate the skin. Some components like lycyrrhetinic acid, telmesteine, caramide-dominant barrier repair lipids have anti-inflammatory properties.

c) Skin Lightening Agents:

Skin lightening agents are applied to treat hyperpigmentation. Hyperpigmentation is the process of changing of colour intensity of the skin to darker hue, which occurs when melanin level get increased into the epidermis as well as the dermis, or both. Mainly two pathophysiologic processes are the reason for this change: one is melanocytosis (increased number of melanocytes) and another one is melanosis (increased amount of melanin). Agents which are main reason of skin lightening, works best when melanosis or melanocytosis is confined to the epidermis. When SLA used topically then it produces a reversible depigmentation of the skin by inhibiting of the enzymatic oxidation of tyrosine to 3, 4-dihydroxyphenylalanine (dopa).^[5] Melisma like disorders which occurs due to hyperpigmentation are also treated by the SLA. All SLA act on the natural production of melanin, and mostly used SLA are known as competitive inhibitors of tyrosinase, it one of the key enzymes in melanogenesis.^[4]Examples of some commonly used cosmeceutical ingredients are as follows:

· Tetrahydrocurcuminoids:

It is obtained from white (colour free) curcuminoids of turmeric (curcuma longa) carnosic acid, cosmarinic acid, ursolic acid from rosemary extract Rosemarimus officinalis as antioxidants are the compoundswhich are used to promotes the tissue damage and restoring the healthy status of skin.^{[6, 7]}

· Boswellic acids:

It is acquired from Boswellia serrata. The fundamental characteristic is to inhibit the enzymes responsible for inflammation (5 - lipoxygenase) and damage of the skin.^{[6, 7]}

· Antioxidants:

Antioxidants reduce free radical damage so that preventing impairment at cellular level. They also inhibit the inflammation which leads to the breakdown of collagen. In addition to external insults like UV radiation, drugs, air pollutants and the skin also has to cope with endogenous mitogens, most prominently reactive oxygen species and other free radicals. Common antioxidants are alpha-lipoic acid, L-ascorbic acid, niacinamide, N-acetyl-glucosamine, α-tocopherol, and ubiquinone.^[11]

Along with the external insults like UV radiation, drugs, air pollutants and heat and or cold, the skin also has to cope with endogenous mitogens, most importantly reactive oxygen species (ROS) and other free radicals. These species are constantly generated during physiological cellular metabolism. To respond to the harmful effects of ROS, the skin is armed with an antioxidant system to maintain equilibrium between the pro-oxidants, or damaging agents and the antioxidants, or protective agents; these antioxidants mediate at different levels in the protective process.^[1]

· Retinoid:

A great amount of research has concentrated on its use as an antiaging compound as well as its use for other cutaneous disorders. Vitamin A and its derivatives have 2 main functions: they act as antioxidants, and they activate specific genes and proteins. Structural changes underlying the cosmetic benefits include correction of epidermal atrophy, deposition of new collagen, generation of new vessels, and enhancement of mitogenesis. This enhanced mitogenesis promotes the shedding of melanin-laden keratinocytes, resulting in bleaching and subsequent depigmentation. The ability of topical tretinoin to improve the appearance of aged and photo-damaged skin by reducing wrinkles, decreasing laxity, bleaching hyperpigmented spots, and bringing about a smoother surface have been well studied and documented.

· Lipoic acid:

Lipoic acid is a unique free radical protector. It is fat and water soluble. Once lipoic acid crosses the cell membrane, it is broken down into dihydrofolic acid, which is also an antioxidant. Alpha lipoic acid also recycles other key antioxidants, such as vitamin C, vitamin E, and glutathione.

· Hydroxy acids:

Hydroxy acids are organic carboxylic acids classified into alpha hydroxy acids (AHAs) and beta hydroxy acids (BHAs) according to their molecular structure. Many are derived from natural sources and are often referred to as fruit acids. The different AHAs include the following: glycolic acid, lactic acid, citric acid, mandelic acid, malic acid, and tartaric acid. AHAs have been shown to decrease the signs of aging. The skin appears smoother and more uniform. BHAs are aromatic compounds. Salicylic acid is the reference BHA; it has dermolytic properties and helps in various xerotic and ichthyotic disorders. Other BHAs include 2-hydroxy-5-octanoyl benzoic acid, also known as beta-lipohydroxy acid (B-LHA), and tropic acid. Studies show that AHAs may increase sensitivity to UV radiation and that sunscreen application may be advisable when these products are used.

· Panthenol:

Panthenol, the alcohol analog of vitamin B-5, is a water-soluble humectant commonly found in various commercial skin creams, lipsticks, lotions, and hair preparations. It is stable in the presence of oxygen and light but unstable in the presence of acids, bases, andhigh temperatures. Panthenol is converted in the skin to pantothenic acid, which is an important component on coenzyme A essential for normal cellular metabolism.

· Vitamin C:

Vitamin C is necessary for the hydroxylation of procollagen, proline, and lysine. Vitamin C improves and normalizes the changes caused by photo-damage. Vitamin C has been used effectively to stimulate collagen repair, thus diminishing some of the effects of photo-aging on skin. However, vitamin C is easily degraded by heat and light, which along with its high acidity, presents certain challenges for use in a multipurpose skin care formulation. A recently introduced synthetic collagen fraction offers greater stability and compatibility, along with improved efficacy.

· Vitamin E:

Vitamin E (alpha-tocopherol) is the major lipophilic antioxidant in plasma, membranes, and tissues. The term vitamin E collectively refers to 8 naturally occurring molecules (4 tocopherols and 4 tocotrienols), all of which exhibit vitamin E activity. Its major role is generally considered to be the arrest of chain propagation in lipid peroxidation by scavenging lipid peroxyl radicals, hence protecting the cell membrane from destruction. Vitamin E topically applied before UV irradiation has been shown to reduce erythema, edema, sunburn cells, immunosuppression caused by sunlight, and DNA adduct formation.

· Niacinamide:

Niacinamide is stable in the presence of oxygen, acid, and high temperatures, and it is inexpensive to formulate. Most of its known effects are the result of increased epidermal turnover and exfoliation. Topical kinetin and niacinamide have been found to exert a synergistic antiaging cutaneous effect in people in the Republic of China.

· Allantoin:

Allantoin stimulates cell proliferation, assisting in the healing process. Allantoin has long been known to improve the effectiveness and desirability of cosmetic creams and lotions by its action as a skin protectant.^[1]Allantoin has been merged into shampoos, lipsticks, shaving creams, sun tanning products, bath foams, hair gels, baby powders, and various aerosol preparations. Allantoin has been named as a cell proliferant, an epithelization stimulant, and a chemical debrider. It is said to clean away necrotic tissue, rushing the growth of new healthy tissue^[7]

· Carnosine:

Carnosine (beta-alanyl-L-histidine) is a physiological dipeptide that can rejuvenate senescent cultured human fibroblasts. Carnosine has been shown to contain antioxidant, free radical- and metal ion– scavenging activities.

· Uric acid:

In the past, uric acid was generally looked upon as merely an end product of purine metabolism. More recently, uric acid has become increasingly recognized as an important biological antioxidant.

· Furfuryladenine:

Furfuryladenine (Kinerase) is a natural plant growth factor that retards the aging process in plants. Cut leaves dipped in a solution that contains furfuryladenine remain green, while untreated leaves turn brown. It is marketed as the natural evolution of antiaging treatment with similar effects in vitro on human skin cells as that in plants, helping to slow and reverse alterations that naturally occur in the cell-aging process.

· Catalase:

Catalase, an enzyme present in almost all cells of the human body, catalyzes the decomposition of hydrogen peroxide to water and oxygen. High amounts of this enzyme in the skin can impart antioxidative activity.

· Glutathione:

Glutathione is a tripeptide of glutamic acid, cysteine, and glycine. It is found in all active animal tissue. It is fundamental as an antioxidant, and significantly decreased amounts of glutathione are found after UV exposures.

· Superoxide dismutase:

Superoxide dismutase (SOD) is an enzyme that destroys superoxide (a highly ROS). Superoxide dismutase is a large molecule and has trouble in penetrating deep into the skin. In theory, once in the lower epidermis and dermis, SOD should decline UV erythema and damage and act as an excellent antioxidant.

· Polyphenols:

Polyphenolic compounds (eg, catechins, flavonols, thioflavins, thearubigins), also known as epicatechins, are antioxidant in nature. These compounds, tested against human keratinocyte cells stressed by UV-B irradiation, showed high antioxidative properties.

· Glucopyranosides:

Resveratrol and polydatins are glucopyranosides found in many fruits and vegetables, the highest concentrations being found in grape skins, which synthesize these compounds in response to exposure to UV-A and UV-B and fungal pathogens.

· Dimethylaminoethanol:

Topical preparations containing dimethylaminoethanol (DMAE) have been touted for their ability to improve skin firmness and to lift sagging skin. DMAE is able to diminish the cross-linking of proteins that occurs during aging, probably acting as a free-radical scavenger.

· Melatonin:

Melatonin, a hormone secreted by the pineal gland. This beneficial action of melatonin has been explained in terms of its ability to scavenge free radicals and to augment the activities of antioxidant enzymes. It has been shown to suppress UV radiation–induced erythema.

· Cysteine:

Several recent studies have shown that cysteine derivatives can protect against the negative effects of UV exposure. In particular, N- acetylcysteine (NAC) is shown to be an effective protector against UV-B–induced immunosuppression.

· De-pigmenting Agent:

Hyperpigmentation is the result of an increased amount of melanin in the epidermis, the dermis, or both. This pigmentary change can be divided into 2 pathophysiologic processes: melanocytosis (increased number of melanocytes) and melanosis (increased amount of melanin). Depigmenting agents work best when melanosis or melanocytosis is restricted to the epidermis. Depigmenting agents can be divided into several groups:

1.Phenolic compounds include the following:

i) Hydroquinone

ii) Monobenzylether of hydroquinone

iii) 4-Methoxyphenol

iv) 4-Isopropylcatechol

v) 4-Hydroxyanisol

vi) N -acetyl-4-S-cysteaminylphenol

2.Nonphenolic compounds include the following:

i) Corticosteroids

ii) Tretinoin

iii) Azelaic acid

iv) N -acetylcystein

v) L-ascorbyl-2-phosphate

vi) Kojic acid

3.Combination formulas include the following:

i) Kligman's formula

ii) Pathak's formula

iii) Westerhof's formula.

· Botulinum A exotoxin:

An exotoxin is a neurotoxin synthesised by the bacterium Clostridium botulinum. This toxin is now being used by cosmetically oriented specialists for the treatment of a huge variety of movement-associated wrinkles on the face and neck.^[2]

· Exfoliants:

Exfoliants stimulate skin turnover by removing adherent cells in the stratum corneum. Exfoliants that are commonly found in cosmeceutical preparations include salicylic acid (SA), lactic acid and glycolic acid. There are worries that frequent use of SA and AHAs could cause the dermis and epidermis to be more susceptible to penetration by UV radiation. Therefore, patients should be instructed to use adequate sun protection. The Cosmetic Ingredient Review Expert Panel concluded that SAs are safe to use when formulated to avoid skin irritation and to be non-photosensitizing, or when directions for use include the daily application of sun protection. Adequate data is not available to establish a limit on SA concentration or to detect the minimum pH of formulations to inhibit skin irritation.^[1]

· Progesterone:

Progesterone cream claims to heal skin conditions, such as acne, psoriasis, rosacea, seborrheal, and keratosis.

· Hormones:

Hormonal creams claim to be the most effective means to halt or slow the aging process by reversing the loss in tone and elasticity of the skin.

· Kinetin:

Clinical studies have shown that Kinetin reverses the signs of photo damaged skin and develops the overall appearance of the skin, thereby making it smoother and more even in colour and noticeably diminishes the appearance of fine lines and wrinkles. The studies has also showed that Kinetin significantly improves the skin barrier function, assisting skin to retain more moisture, thereby making the skin more softer and smoother.

2. Hair Care Cosmeceuticals Products:

The appearance of the hair is a feature of the body over which humans, unlike all other land mammals, has direct control. Hair care, colour, and style play an important role in people’s physical appearance and self perception. Among the earliest forms of hair cosmetic procedures in ancient Egypt were hair setting by the use of mud and hair colouring with henna. In ancient Greece and Rome, countless ointments and tonics wererecommended for the beautification of the hair, as well as remedies for the treatment of scalp diseases.^[7]Cosmetics for the treatment of hair are applied topically to the scalp and hair. While they can never be used for therapeutic purposes, they must be harmless to the skin and scalp, to the hair, and to the mucous membranes and should not have any toxic effect, general or local, in normal conditions of their use.^[6]

A hair cosmeceutical product contains – special care ingredients, conditioning agents, and hair growth stimulants. A number of ingredients are, fatty ingredients, quaternized cationic derivatives, hydrolyzed proteins, cationic polymers, and silicons. Therefore, current antidandruff ingredients are antifungal agents that are– octopirox, zinc pyrithione, and ketoconazole. A minoxidil-related compound (2, 4-diamino-pyrimidine-3-oxide) is a cosmetic agent acting as a topical hair growth stimulant used to prevent inflammation and perifollicular fibrosis.^[11]

3. Other Cosmeceutical Products:

Virtually, oil glands and subcutaneous fat poorly present in the skin beneath the eye. For the reduction of the signs of premature aging, it is needed to protection and plenty of moisture to replenish and repair the delicate skin. The skin becomes thinner, drier and rougher after the aging. This condition arises due to over-exposure to the elements. Many topical products intermediate in this process. The products intended for this area, should gentle and this ingredient work from inside out by interacting with cell under the skin surface without irritating the eyes. There are ever such cosmeceutical eye creams which nourish the skin along with natural emollients and beneficial nutrients. The other functional ingredients including butcher’s broom, chamomile, and vitamin E, antioxidants – vitamins A, C and E, green tea and tiare flower, Ginkgo biloba and also cucumber, calendula and α-bisabolol, an active constituent of chamomile, to calm irritated skin. Yeast is the chief ingredient and also protect against future skin damage and also helps to sleek up the wrinkles. The eye wrinkle cream helps forestall the signs of aging and generally contains wheat germ and corn oil, squalene and carrot extract. Eye firming fluid has aosain, an algae extract from seaweed that helps the skin to maintain elasticity. Lawlor had developed dental care compositions, which are useful for providing a substantive composition on the surfaces of oral cavity, which can provide prophylactic, therapeutic, and cosmetic.

REGULATORY ASPECTS:

The claims made about drugs are subject to high scrutiny by the Food and Drug Administration (FDA) review and approval process, but cosmetics are not subject to mandatory FDA review. Much confusion exist regarding the status of ‘cosmeceuticals.’ Although there is no legal class called cosmeceuticals, this term has found application and recognition to designate the products at the borderline between cosmetics and pharmaceuticals. Cosmeceuticals are not subject to FDA review and the Federal Food, Drug and Cosmetic Act do not recognize the term itself. It is also often difficult for consumers to determine whether ‘claims’ about the actions or efficacies of cosmeceuticals are in fact valid unless the product has been approved by the FDA or equivalent agency. Some experts are calling for increased regulation of cosmeceuticals that would require only proof of safety, which is not mandatory for cosmetics. Some countries have the classes of products that fall between the two categories of cosmetics and drugs: for example, Japan has ‘Quasi-drugs’; Thailand has ‘controlled cosmetics’ and Hong Kong has ‘cosmetic-type drugs. The regulations of cosmeceuticals have not been harmonized between the USA, European, Asian and other countries.

FUTURE PROSPECTS:

After adding small amount of cosmeceutical agents to the cosmetic formulations which do not require medical regulations and it would improve the production of cosmeceuticals that could help to improve the skin, nail, and body mass growth. New challenges will also be presented to government regulatory agencies as more chemicals with true biological activity are invented and tested.

CONCLUSION:

The usage of cosmeceuticals has drastically increased in early years, which enhance the range of products to increase the beauty of the patients associated with dermal problems. But, at times, where generations are intensely concerned for their beauty, various manufacturing companies are challenging and working hard to deliver conclusive results to meet requirements of the patients. Cosmeceuticals as like vitamins, sunscreens, hydroxyl acids & many more have proved their worth in treating skin diseases, which helps to enhancing the skin texture. Clinical trials of cosmeceuticals are important factor to know about the relations between skin and cosmeceuticals. The universal trend in the cosmetic industry towards emerging medicinally active cosmetics and in the pharmaceutical industry towards cosmetically concerned with medicinal products increases apart from the current ‘life-style’ ideology.The most influential angle over the coming 5 years will be the links between internal health, beauty, and anti-aging. The next big beauty trend will include skin gestibles that will promote beauty from the inside out, borrowing of pharmaceutical terms for cosmetic applications, amino peptides to make the skin more elastic, neuro mediators which are chemicals to tell the brain to be happy and the blurring of boundaries between surgery and cosmetics. The trend towards therapeutic cosmetics is sure to result in the need to obtain a better understanding of modern ingredients and assessment techniques. In conclusion, cosmeceuticals are not only the external beautification but also it improves the internal beauty through the health-related function. The health group professionals will show the importance to cosmeceutical products and develop the awareness about these products.

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Received on 09.12.2019 Accepted on 31.12.2019

Research J. Topical and Cosmetic Sci. 2020; 11(1):45-51.

DOI: 10.5958/2321-5844.2020.00008.4