COSMECEUTICALS

PRESENTED BY :PRAVIN PATEL (PE/2013/310)M.S PHARMACEUTICS

What is cosmeceutical?

A cosmeceutical is an ingredient with medicinal properties, which manifests beneficial topical actions and provides protection against degenerative skin conditions

The term cosmeceutical was coined in 1980 by the dermatologist Albert kligman

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.

www.fda.gov

“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"

DRUG"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

COSMETICS

According to FD&C Act.

CosmeticsNo extensive testing like drugsLess time consuming and costProhibit the false advertisements.

Cosmeceuticals Cosmecuticals are not regulated by the U.S.FDA are not subject to premarket requirements for proof of safety or efficacy.Cosmecuticals products in vitro studies using silicone replicas of skinclinical trials (supported by the cosmetic companies themselves)The rigorous testing required for pharmaceuticals, is not mandatory for cosmeceuticals products

International Regulatory Policies

A deodorant is a cosmetic but an antiperspirant is a drug

A shampoo is a cosmetic but an antidandruff shampoo is a drug

A toothpaste is a cosmetic but an anticaries toothpaste is drug

A mouthwash is cosmetic but an antigingivitis mouth wash is a drug

A suntan product is a cosmetic but a sunscreen product is a drug

A skin moisturizer is a cosmetic but a wrinkle remover is a drug

A skin product to hide acne is cosmetic but an antiacne product is a drug

An antibacterial deodorant soap is a cosmetic but an antibacterial anti-

infective soap is a drug

Cosmetic versus drug

•UV protection•Exfoliants•Alpha hydroxy acids

Lactic acidGlycolic acid

•Beta hydroxy acids•Retinoids•Moisturizers•Antioxidants•Peptides•De-pigmenting agents

List of common ingredient used in cosmeceuticals

UVA wavelengths penetrate deeply into the dermis, causing skin to wrinkle.UVB radiation is associated with many skin cancers.

The SPF number on sun blockers only applies to UVB protection and has no connection with UVA protection.

A SPF number of 30 is recommended for daily use. Higher numbers do not proportionately increase protection.

Uv protection

ExfoliantsExfoliants remove dead cells and the outer layers of thickened skin, encouraging skin turnover.

Alpha hydroxy acidsSoftens fine wrinkles, lightens pigmentation spots, generally tightens and improves skin texture. Makes skin look healthier and more radiant.

RetinoidsTreats mild to moderate acne and photo-damaged skin, removes dead surface cells, Claims to build collagen, regenerate the skin’s elasticity.

Antioxidants

MoisturizersMoisturizers smooth the surface of the skin, lubricate its outer layers, and lock in moisture.

Antioxidants, the ingredients meant to defend against free radical damage.

Vitamin A & C Resveratrol Green tea Co-enzyme Q-10 Algae

peptides that may stimulate skin metabolism and repair, while others may inhibit hyperpigmentation, slow the breakdown of collagen

Peptides

Eg: Argireline

It acts by inhibiting conversion of tyrosine to melanin

Depigmentation agents

Eg: Hydroquinone, aloesin, arbutin, azelaic acid, glycolic acid

Aging results from cumulative damage to tissues that overwhelm the body's natural ability to repair them. The tell tale signs of aging on the skin include discoloration, wrinkles, and texture loss

These effects result from•Genetically programmed chronological aging•Photoaging - sun exposure•Environmental and lifestyle factors – damage by chemicals, pollutants, smoking, etc.

Why Does Skin Age??

Certain synthetic organic substances or sunscreens have molecular structures that are capable of "filtering out" the harmful UV rays by mechanisms including absorption, reflection or diffusion.

Examples include avobenzone, aminobenzoic acid, titanium oxide, zinc oxide and others.

Such ingredients appear in the FDA monograph on sunscreen agents. Sunscreens are regulated as over the counter drugs by the FDA. 

The efficacy of sunscreens is measured as SPF (sun protection factor).

What are Sunscreens?

UV damage is manifested as

• sunburn,

• skin discoloration

•texture loss.

UV rays also trigger skin aging through:

Free radical reactions and oxidative stress.

Increased activity of enzymes such as collagenase

and elastase that are catalyzed by metal ions.

Effect of UV Rays

Photoaging - sun exposure

The results are:

Abnormal cross linking of Collagen fibers

Scar tissue build up and visible wrinkles and skin discoloration

Ravages of chronological aging are accelerated

Drug Name Concentration % Absorbance

Aminobenzoic acid up to 15 UVB

Avobenzone 2-3 UVA I

Cinoxate up to 3 UVB

Dioxybenzone II up to 3 UVB, UVA I & II

Homosalate up to 15 UVB

Menthyl anthranilate up to 5 UVA II

Octyl methoxycinnamate up to 7.5 UVB

Octisalate up to 5 UVB

Oxybenzone up to 5 UVB

Padimate O up to 8 UVB

Phenylbenzimidazole sulfonic acid up to 4 UVB

Sulisobenzone up to 10 UVB, UVA II

Titanium dioxide 2-25 Physical

Trolamine salicylate up to 12 UVB

Zinc oxide 2-20 Physical

The sunscreens listed in the FDA OTC monograph

 Several natural extracts protect the skin from the damaging effects of UV rays:

•Tetrahydrocurcuminoids•SabiWhite•Green tea Extract•Sesame antioxidants•Umbelliferin•Xylosin•Rosemary extract•Rosmarinic acid•Lupeol•Arjunolic acid

•In vitro testing•Cumulative Irritation testing•Repeat Insult Patch Tests (RIPT)•Sensitization•Ocular Irritation•Facial Sting•Phototoxicity•Photoallergy•Dermal irritation •Acnegenicity

Product Safety Testing

Testing needs are determined by the company marketing the product .May include:

Defined as the production of “reversible damage of the skin following the application of a test substance for up to 4 hours”. Tests used to study dermal irritation: 1. EPISKIN™ human

skin model.2. EpiDerm™ human

skin model.3. PREDISKIN™

human skin model.4. Pig ear test.

Dermal irritation

Examples of Instrumental Measurements

Parameter InstrumentMoisturization Conductance/Impedance

Skin barrier function TEWL(Transepidermal Water Loss)

Skin texture Topography

Skin elasticity Elastometer

Skin thickness Ultrasound

Blood flow Laser Doppler

Sebum (oiliness) Sebumeter

Color Chromameter

•Safe for long-terms use

•Promote beauty throught health and wellness of skin

•cosmeceuticals with natural ingredients are preferred.

Advantage of cosmeceuticals

1) Kligman AM. Cosmetics A dermatologists look to the future: Promises and problems. Dermatol Clin 2000; 18:699-709.

2) Food & Drug Administration (FDA) http://www.fda.gov/

3) Cosmetic, Toiletry, and Fragrance Association (CTFA) http://www.ctfa.org

4) Thornfeldt C. Cosmeceuticals containing herbs: fact, fiction, and future. Dermatol Surg. Jul 2005;31(7 Pt 2):873‐80;

5) Amer.M, Maged M. Cosmeceuticals versus pharmaceuticals. Clinics in Dermatology 2009; 27:428–430.

REFERENCE

THANK YOU