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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
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