Cosmeceuticals

Puxvadee Chaikul, M.Sc.

School of Cosmetic Science
Email address: puxvadee@mfu.ac.th

Objectives
Definition of cosmeceuticals
Developing processes of cosmeceuticals
Regulations on the cosmeceuticals

Difference of Cosmeceuticals

Cosmeceuticals

Drugs

Cosmetics

Definitions
Drugs
substances intended to
be used in the
diagnosis, prevention or
treatment of disease in
man or in other animals
affect the structure or
function of the human
body or of animals

Cosmetics
substances applied to
the human body for the
purpose of
altering the
appearance
beautifying
cleansing
promoting
attractiveness

Definitions (cont.)
Cosmeceuticals
substances that have
characteristics combining
the aesthetic appeal and
benefits of traditional
cosmetics with
therapeutic component
(pharmaceutical
products)
NOT drug products

History of Cosmeceuticals
One simple function of cosmetics and toiletries
Increase more benefits from cosmetics and
toiletries
Multifunctional products
Intense competition between companies, coupled
with expressed consumer social needs
Cosmeceuticals: multifunctional products which
claim as close as possible to the drug definition

Terms used in Cosmeceuticals

Cosmetic terms

Cosmeceutical terms

Moisturizes, rehydrates, protects

Prevent signs of aging, antiaging

Beautifies, conceals, highlights,

enhances

Reduce the appearance of fine

lines and wrinkles

Softens, conditions, lubricates

Regenerate damaged skin

Smoothes rough skin

Firm

Absorbs excess skin oils

Heal, stimulate skin repair

Cleanses, tones, refreshes,

clarifies deodorizes

Penetrate into the skin to act

Fade hyperpigmentation spots

Development of Cosmeceuticals
Get information on the cosmeceutical product
product concept
product type
required ingredients
omitted ingredients
product performance
regulatory input: quality control & marketing
claims
timetable

Development of Cosmeceuticals (cont.)

Formulation the active ingredients in the
cosmeceutical product
a. properties of active ingredients
b. safety of active ingredients
c. concentration of active ingredients
d. active forms
e. special ingredients used in the formulation
f. excipients

Development of Cosmeceuticals (cont.)

a. properties of active ingredients
necessary for formulation techniques to
maintain stability
evaluate the conflicts between the
combining actives
molecular size, pH, ionization parameters,
buffer requirements, solubility, odor, color,
etc.
A1

A2
A3

Development of Cosmeceuticals (cont.)

b. safety of active ingredients
irritation potential and toxicity profiles of
each actives
screen for safe cosmeceutical product
c. concentration of active ingredients
maintain until the consumer has finishes
the cosmeceutical product
careful evaluation of each active to ensure
the claims of cosmeceutical product

Development of Cosmeceuticals (cont.)

d. active forms
available in various types e.g. salt, active in
polar or non-polar vehicles
possess different abilities to produce the
therapeutic effect as well as different
stabilities
e. special ingredients used in the formulation
combining of numerous actives to meet a
particular consumer need
examples of special ingredients which
contain therapeutic effect and common use
in the cosmeceutical product

Development of Cosmeceuticals (cont.)

e. special ingredients used in the formulation
(cont.)
1. antioxidants

prevent harmful oxygen species from

damaging skin cells and accelerating
aging
incorporate to enhance product stability

vitamin C, vitamin E, botanical and

herbal extracts

Development of Cosmeceuticals (cont.)

e. special ingredients used in the formulation
(cont.)
2. collagen
70% of dermal proteins

produce by the body and contain high

levels of water

possess the flexibility and elasticity of

skin
large molecular size

NOT absorb through the skin

Development of Cosmeceuticals (cont.)

e. special ingredients used in the formulation
(cont.)
3. elastin
insoluble protein
present in dermis of skin

give the ability of skin to retain its shape

after being stressed
large molecular size

NOT absorb through the skin

Development of Cosmeceuticals (cont.)

e. special ingredients used in the formulation
(cont.)
4. enzymes

protein that promote the chemical

reactions within the body and help digest

food, including the shedding of dead skin
cells from the stratum corneum

depend on pH, temperature and

concentration of substrates

also use enzyme inhibitors if the enzyme

reactions are unwanted effects

Development of Cosmeceuticals (cont.)

e. special ingredients used in the formulation
(cont.)
5. glycosaminoglycans (GAGs)

maintain the water content in skin and

give the elasticity to the skin

very high molecular weight linear

polymer which possess anionic charge at
physiological pH
hyaluronic acid (HA), chondroitin
NOT penetrate through intact skin

Development of Cosmeceuticals (cont.)

e. special ingredients used in the formulation
(cont.)
6. herbal & botanical extracts
have therapeutic efficacy because of
several ingredients in the extracts
source of allergens
need to consider both therapeutic benefits
and safety information

Development of Cosmeceuticals (cont.)

e. special ingredients used in the formulation
(cont.)
7. lipids
composition of skins barrier layer

regulate the permeability of substances

and maintain moisture in the stratum
corneum

trap water in the layer of skin and

prevent water loss

ceramides, cholesterol and fatty acids

Development of Cosmeceuticals (cont.)

e. special ingredients used in the formulation
(cont.)
8. vitamins

fat-soluble and water-soluble vitamins,

including -carotene and panthenol

choose the appropriate vitamins for the

benefit of cosmeceutical product

Development of Cosmeceuticals (cont.)

f. excipients
portion of a formulation which does not
include the actives
many excipient ingredients for using in the
formulation e.g. surfactants, emulsifiers,
thickeners, water, etc.
enhance the ability of actives to render their
therapeutic effects as well as contribute the
multifunctional nature of cosmeceutical
product
consider the product stability (> 2 years)

Development of Cosmeceuticals (cont.)

Developing the product vehicle
Y use as a carrier for actives to deliver to the
applied sites
Y maintain the efficacy of cosmecutical
product
Y consider the usage of cosmecutical
product, including the best procedure for
preparing
Y verify the actives, performance and stability
of cosmeceutical product
A1

A2

A3

Regulations
Pharmaceutical classification
Cosmetic classification
Product classification (Cosmeceuticals)

Cosmeceuticals??

Regulations on Pharmaceutical classification

Regulations on Pharmaceutical classification (cont.)

USFDA enforce USFDC Act
USFDC Act: require a greater amount of
drug profiles in following
5 safety testing
5 effective treatment of disease
Europe Court directives follow the practice in
Europe Union

Regulations on Cosmetic classification

Not extensive testing like drug products
Less time-consuming and cost for introducing a new
cosmetic into the marketplace
Cosmetic, Toiletry, and Fragrance Association (CTFA)
act as liaison between manufacturers and FDA
propose and secure the adoption of industry standards
propose simplified cosmetic ingredient labeling names
(INCI names)
review ingredient safety and toxicity data
aid in meeting FDA label requirements

Regulations on Cosmetic classification (cont.)

USA
NOT require the pre-marketing proof of claims, but
prohibit the false advertisements
authorities controlling cosmetic claims
Government
Food Drug Cosmetic Act (FDC Act)
Fair Packaging and Labeling Act (FPL Act)
Federal Trade Commission (FTC)
Non-government
National Advertising Division of the Council of
Better Business Bureaus

Regulations on Cosmetic classification (cont.)

Europe Union
 6th Amendment to the cosmetic directive
 demonstrate the proof of claims which may be
written in English or in the language where it is
deposited
 NO clear definition about the meaning of proof of
claims
 exist the big difference regarding
how to monitor the proof of claims
in individual state laws

Regulations on Cosmetic classification (cont.)

Japan
review claims before marketing of the cosmetic
product
get the license from the Ministry of Health and
Welfare before the marketing
cosmetics, quasi-drugs, drugs

Regulations on Product classification

USA
USFDA and USFDC Act
establish separate definitions for
cosmetics and pharmaceuticals
NOT acknowledge this term
Europe Union (EU)
 European Court (EC) directives
 separately discuss cosmetics and
drugs
 NO provision for this term

Regulations on Product classification (cont.)

Japan
make a new product classification
Quasi-drugs
products which include substances
causing the mild action on the body
and demonstrate to be safe

Conclusion of Regulations
on Product classification

Controversy over how to classify and register into this

new classification without a major advantage for
doing so

Conclusion of Regulations
on Product classification (cont.)

Depend on the claims which are made about the

product
Not fairly flexible when reviewing the claims
Issue the warning letters to the manufacturers when
claims become too drug-like
Vary degrees of claims

References
Barel AO, Paye M, Maibach HI. Handbook of
cosmetic science and technology. USA:Marcel
Dekker;2001.
Elsner P, Maibach HI. Cosmeceuticals and
active cosmetics: drugs versus cosmetics. 2nd ed.
Florida:Taylor&Francis;2005.
Katzung BG. Basic and clinical pharmacology.
9th ed. USA:McGraw-Hill Medical;2003.