Formulation Classes and Raw Materials2 [PDF]

Zitiervorschau

Benedictine University Cosmetic Chemistry Course Topics Date

Module Focus

Speaker

Company

11-Sep

Introduction to Cosmetics - Trends, Size of Industry, Products, Chemical Classes, Raw Materials Used, Formulation Types

Scott Wenzel

Kimberly-Clark

18-Sep

Surfactants - Types of Surfactants, Surfactant Chemistry, Formulation of Surfactants

Tom Schoenberg

Schoenberg Consulting, Inc.

25-Sep

Emulsions - Types of Emulsions, Emulsion Theory, Formulation of Emulsions

Perry Romanowski

Alberto Culver

2-Oct

Formulation Module - What is Formulating, How to Formulate Various Types of Products in the Industry

Perry Romanowski

Alberto Culver

9-Oct

OTC Sunscreen Development and Chemistry

Craig Bonda

Hallstar

16-Oct

Polymer Science - Polymer Chemistry, Use of Polymers in Hair and Skin Care

TBD

BASF or ISP

23-Oct

Delivery of Actives and Molecules in Cosmetics

TBD

BASF

30-Oct

The Use of Active Ingredients in Personal Care

Anna Gripp

DSM

6-Nov

Cosmetic Product Manufacturing - How to Take a Formulation from Lab Scale to Manufacturing Scale, What are the Challenges of the Contract Manufacturing Business

Gene Frank

Raani Corporation

13-Nov

Claim Substantiation for Cosmetic and OTC Products for Skin and Hair - Types of Claims, Types of Testing, How to Design Studies

Barb Dvoracek

Kimberly-Clark

1

Who is Scott Wenzel? •Educational and Work History –May 1994 - Graduated from UW-LaCrosse with a B.S. in Biology/Chemistry

–Sept 1994 – Tsumura International hires Scott as a Jr. Formulation Chemist –Dec 1998 – Northwest Cosmetic Laboratories hires Scott as R&D Mgr

–April 2002 – NuSkin hires Scott as Sr. Research Scientist –Dec 2004 – Kimberly-Clark hires Scott as Sr. Research Scientist –Aug 2007 – Currently Technical Leader for R&D Formulation Team 2

Who is Scott Wenzel? •SCC Background –Member of SCC since 1994 –Sept 1997 – Treasurer of Twin Cities Chapter of SCC

–Jan 2003 – Founder of the Intermountain West Chapter of SCC –Jan 2003 – First Chair of the Intermountain West Chapter of SCC –Aug 2003 – Coordinated first annual Intermountain West Chapter SCC Golf Outing

–Jan 2004 – Serve a 2nd term as Chair of the Intermountain Chapter of SCC –Sept 2006 – Chair-Elect of Midwest Chapter of SCC –Sept 2007 – Chair of Midwest Chapter of SCC

3

Society of Cosmetic Chemists •Dedicated to the advancement of cosmetic science, the Society strives to increase and disseminate scientific information through meetings and publications. •Promotes research in cosmetic science and industry and improves the qualifications of cosmetic scientists. •Founded in 1945, it now has over 4,000 members •There are now 18 chapters with membership from 35 to 1100 members •For further information, visit www.scconline.org

4

Midwest Chapter of Society of Cosmetic Chemists •Was the first chapter formed in 1948 •Today has almost 400 members •Chapter holds 7 educational meetings/year as well as 1-2 social events/year in the Chicago area •Chapter also hosts a vendor supplier day, which will occur in March 2008 •Publishes a newsletter called SCCoop •For more information, visit www.midwestscc.org

5

Cosmetic Overview

6

Overview of Presentation • How large is the cosmetic industry? • What are the trends?

• What types of products are in the market? • What ingredients are used? • What types of formulations are utilized?

7

Cosmetic Industry • Size and Growth

– Globally $253 Billion Revenue in 2005 (Euromonitor); – 3.7% Growth through 2010 $300 Billion • Highly Fragmented – Thousands of finished good companies from garage scale to multibillion dollar corporations – Thousands of raw material suppliers – Low barriers to entry (not capital intensive) – Trend increasing with direct to consumer channels

• Marketing Intensive

8

Overview of Cosmetics and Toiletries Worldwide Category Size CAGR to 2011 projected at 3.0%

9

Overview of Cosmetics and Toiletries Breakdown by Sub-Category 1.1%

2.4%

1.7%

7.8%

Baby Care 4.5%

23%

Bath and Show er Products 18.6%

Deodorants Hair Care Color Cosmetics Men's Grooming Products Oral Hygiene Fragrances Skin Care

10.9 %

Depilatories 9.4%

12.8%

Sun Care

7.8%

Hair Care and Skin Care are biggest subcategories. ©Copyright and database Euromonitor International 2007 10

Overview of Cosmetics and Toiletries – Channel 2006 World Cosmetics and toiletries Supermarkets/hypermarkets Independent food stores Convenience stores Pharmacies/drugstores Discounters Department stores Specialists Direct sales Outdoor markets Others

25.5 3.1 2.4 18 7.6 12.6 12.7 12.9 1.4 3.6

©Copyright and database Euromonitor International 2007

11

Overview of Cosmetics and Toiletries – Sales by Region 2001 Cosmetics and World Asia Pacific Australasia Eastern Europe Latin America Africa and Middle East North America Western Europe

2006

196,375.60 269,909.10 48,926.70 64,971.30 2,388.50 4,138.10 9,233.50 19,301.90 22,991.30 36,342.90 14,244.80 11,827.90 48,762.00 55,903.50 49,828.70 77,423.50

©Copyright and database Euromonitor International 2007

12

Overview of Cosmetics and Toiletries –Key Trends and Influences Demographics: ->Falling birth rates ->Aging Populations ->Age Compression ->Wellness

Economic: -> Non-Essentials

-> Polarization of Wealth

©Copyright and database Euromonitor International 2007 13

Overview of Cosmetics and Toiletries –Key Trends and Influences Social Trends: ->Urbanization -> Changing Lifestyles -> Nutrition -> Celebrity Culture -> Environmental/Ethical

Political Activity: -> Globalization -> Regulation

©Copyright and database Euromonitor International 2007 14

Overview of Cosmetics and Toiletries –Key Trends and Influences

Technology: ->Efficacy, multi-functionality -> New Media

Company Activity: -> Consolidation -> Education -> Mega-Branding -> Cross-Industry Innovation 15 ©Copyright and database Euromonitor International 2007

Overview of Cosmetics and Toiletries –Baby Care

Earth’s Best Baby Body Care

Gerber’s Products With “Skin Nutrients”

Baby Spa with Oatmeal

16 ©Copyright and database Euromonitor International 2007

Overview of Cosmetics and Toiletries –Bath and Shower Vitamins

Moisturizers Minerals

Antibacterial

17 ©Copyright and database Euromonitor International 2007

Overview of Cosmetics and Toiletries –Deodorants

Body Sprays

Sticks and Roll-On

Unisex Products Split to Gender 18 ©Copyright and database Euromonitor International 2007

Overview of Cosmetics and Toiletries –Hair Care

19 ©Copyright and database Euromonitor International 2007

Overview of Cosmetics and Toiletries –Color Cosmetics

20 ©Copyright and database Euromonitor International 2007

Overview of Cosmetics and Toiletries –Skin Care

21 ©Copyright and database Euromonitor International 2007

Overview of Cosmetics and Toiletries –Depilatories

22 ©Copyright and database Euromonitor International 2007

Overview of Cosmetics and Toiletries –Sun Care

23 ©Copyright and database Euromonitor International 2007

Cosmetic Industry Jobs •Types of Companies –Contract Manufacturers –Multi-level Companies –Direct Sales Companies –Raw Material Vendors –Fragrance Suppliers –Distributors

•Science Related Jobs in these Companies –Formulation Chemist

–Analytical Chemist –Quality Control Specialist –Microbiologist and Life Scientists –Perfumers –Technical Sales

–Science Related Intellectual Property and Law

24

Classes of Formulations and Raw Material Overview

25

Overview • What is a cosmetic and drug?

• What is formulating? • Classes/functions of raw materials

– Definitions – Examples of some raw materials in each class • Product types in the industry

26

What is a Cosmetic • The 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)].

• Said another way… • A substance or preparation intended for placement in contact with any external part of the human body, including: the mucous membranes of the oral cavity and the teeth; with a view to: altering the odours of the body; or changing its appearance; or cleansing it; or maintaining it in good condition; or perfuming it; or protecting it.

27

Are All Cosmetics Created Equally???

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

28

Formulation Defined • The act, process, or result of formulating or reducing to a formula. Webster's Revised Unabridged Dictionary (1913) • A.K.A “Advanced Baking” or “Bucket Chemistry”

+

+

29

Formulation Defined • Formulating is a: Complex…Iterative….Combination of Art and Science

Performance

Aesthetics

Stability Scale Up Preservative Efficacy

30

What Ingredients Do We Choose? 2006 International Cosmetic Ingredient Dictionary and Handbook features: •13,000 INCI names recognized in the United States, the European Union (EU), and many other countries as the labeling names that MUST be used on cosmetic and personal care product packages. These INCI names are crossreferenced to 59,000 trade names associated with more than 3,000 suppliers from 95 countries. •15 Sections containing all the critical information needed to identify INCI labelling names, CAS and EINECS registry numbers, Empirical formulas, CIR Index, OTC Index, EU Index, sources to find additional information about specific ingredients, and much more. 31

General Classes of Raw Materials • Surfactants – Cleansing agents – Emulsifiers

• Skin Conditioning Agents • • •

Humectants Emollients Occlusive Agents/Film Formers

• Rheology Modifiers (Viscosity Increasing Agents) – Aqueous – Nonaqueous

• Preservatives • Chelating Agents • Active Ingredients

32

Surfactants Surfactants – Cleansing agents

• Used for skin/hair cleansing purposes. In this function, surfactants wet body surfaces, emulsify or solubilize oils, and suspend soil. • It is characteristic, and expected by most consumers that these should contribute foam/lather to cleansing products. • Examples: – Sodium Lauryl Sulfate (SLS) – Ammonium Laureth Sulfate (ALES)

33

Surfactants What is a surfactant? • A surface active agent that reduces the surface or interfacial tension by its tendency to adsorb at the surface or interface. • How a surfactant functions in a system depends on its HLB (hydrophobic-lipophyllic balance. • Surfactants contain a polar and a non-polar region within the same molecule and generally can be characterized via the “Head & Tail” approach. The elongated hydrophobic end is the tail, while the hydrophilic end is the head

34

Micelle Formation

(1) At very low concentrations surfactants aggregate at the surface (2) As the concentration is increased the surfactants aggregate in the solution and form micelles, reducing surface tension

The concentration of surfactant at which micelles first appear is called the critical micelle concentration (CMC) Increasing surfactant concentration does not result in in a further decrease of surface tension.

Surface Tension (N/m) Concentration

35

Surfactants Surfactants – Emulsifying Agents • Are employed in cosmetics to prepare emulsions. • Their efficacy depends on their ability to: – Reduce surface tension – Form complex films on the surface of emulsified droplets – Create a repulsive barrier on emulsified droplets to prevent their coalescence. • Examples: – Ceteareth-20 – PPG-2 Isoceteth-20 Acetate – Glyceryl Stearate SE

36

General Classification of Emulsifiers •CTFA website lists 1893 materials of emulsifiers! Emulsifier

Non-ionic

Ionic

Anionic GMS-SE TEA-Stearate Sodium Cetearyl Sulfate

Cationic

Amphotheric

Lecithin Cetylpyridinium (Phospholipids) Chloride Distearyldimonium Chloride 37

Non-Ionic Emulsifiers •

• • • •

Fatty-alcohol ethoxylates dominate but also includes PEG, Glyceryl, Sucrose and Polyglyceryl esters, ether and, in many instances, silicone based compounds – Typical alkyl chain for alcohol ethoxylates distributed between C12-18. Broad compatibility Inexpensive Generally organized by hydrophilic/hydrophobic character (HLB) Best stability & effectiveness is achieved through combinations of emulsifiers – E.G. Arlacel 165 is a commercial blend of 50% Glyceryl Stearate (HLB 12) and 50% PEG-100 Stearate (HLB 18.8) allow for a broad range or materials to be emulsified. – Achieves: smallest droplet size, highest stability, lowest amount of surfactant

38

Typical Non-Ionic Emulsifiers • • • • • • • • • • •

Glyceryl Stearate PEG-100 Stearate Stearyl Alcohol Cetyl Alcohol Laureth-23 Steareth Alcohol Cetyl/PEG/PPG 10 Dimethicone Stearic Acid Polyglyceryl 2 Diisostearate PEG 30 Dipolyhydroxystearate Many are more effective as rheology modifiers 39

Anionic • Cetyl Phosphate

• Sodium Dihydroxycetyl Phosphate • Sodium Lauroyl Lactylate • C10-C30 Alkyl/Acrylate Crosspolymer (Pemulen TR-2)

40

Cationic • Consumer Products Using Cationic Emulsifiers

Distearyldimonium chloride

Dry, powdery, smooth skin feel is able to mask high lipophilic content 41

Oil and Water Don’t Mix…

42

Unless you are a formulator!

43

Normal Oil/Water Interaction • Oil and water alone cannot form an emulsion. • The phases will separate once energy is removed from the system (kinetically unstable).

• Something needs to be added to stabilize the emulsion…

44

Love?

Oil + Water 4 Ever

Well, maybe a little…

45

Surfactants - Emulsifiers • Surfactant = Surface Active Agent • A molecule with a polar “head” group and a non-polar “tail” Polar Non-polar

• For emulsions, these are usually nonionic surfactants although there are others

46

Surfactants - Emulsifiers • Surfactants can have more non-polar character than polar character and vice-versa. These represent different HLB values. Less polar (low HLB) More Polar (High HLB) • Specific oils need specific surfactant polar/non-polar character to be effectively emulsified. 47

Examples of matching HLB values to application needs • • • • • • • • • • • • • •

mixing unlike oils together –use surfactants with HLB’s of 1 to 3 making water-in-oil emulsions –use surfactants with HLB’s of 4 to 6 wetting powders into oils –use surfactants with HLB’s of 7 to 9 making self emulsifying oils –use surfactants with HLB’s of 7 to 10 making oil-in-water emulsions –use surfactant blends with HLB’s of 8 to16 making detergent solutions –use surfactants with HLB’s of 13 to 15 for solubilizing oils ( micro-emulsifying ) into water –use surfactant blends with HLB’s of 13 to 18

The HLB System A Time Saving Guide To Surfactant Selection. Uniqema. Presentation to the Midwest Chapter of the Society of Cosmetic Chemists.48 09 March 2004.

Surfactants - Emulsifiers • When added to oil and water, a surfactant will arrange itself such that it’s non-polar tail is within the oil and its polar heads are exposed to the water. • Spherical arrangement of surfactant is known as a micelle. Polar heads Oil Droplet

Non-polar tails 49

Emulsion! • An emulsion is a suspension of two immiscible liquids in which one phase is dispersed as small globules within the other. • Continuous phase and dispersed phase

• The surfactant maintains the small droplet size of the oil, keeps the droplets from aggregating (steric hinderance) and the surfactant/oil complex is soluble in the water.

• This is known as an oil in water emulsion (O/W)

50

Skin Moisturization

51

Moisturizers Are Everywhere!

Lotions and Creams

Hand Soaps

Body Washes

Lip Balms

Hand Sanitizers

Sunscreens 52

The importance of skin moisture

Too Wet • • • • •

Skin maceration Loss of barrier function Reduced rate of barrier repair Corneocyte swelling Wrinkling

Just Right

Too Dry • • • • • •

Skin flaking Loss of skin barrier Loss of skin elasticity Skin cracks/fissures Painful and/or pruritic skin Skin roughness 53

Factors that effect skin moisture • Skin’s ability to control water diffusion (Skin Barrier Function)

• Skin’s ability to retain water (Natural Moisturizing Factors)

54

How Do Moisturizers Work?

• Enhancing barrier function • This is generally done with skin conditioning agents

55

Skin Conditioning Agents Emollient

• Help maintain the soft, smooth, and pliable appearance of skin. • They function by their ability to remain on the skin surface or in stratum corneum • Act as lubricants, to reduce flaking, and to improve the skin’s appearance.

56

Skin Conditioning Agents Emollients can be:

• Hydrocarbons – Mineral Oil • Natural Oils – Jojoba Oil • Esters – Isopropyl Palmitate, Myristyl Myristate

• Triglycerides – Caprylic/Capric Triglyceride • Silicones – Cyclomethicone

57

Skin Conditioning Agents Occlusive • Retard the evaporation of water from the skin surface and, therefore, increase the water content of the skin. • Occlusive formulations are sometimes used to enhance delivery of active ingredients into the skin. i.e. Hydrocortisone Creams • Examples: – Petrolatum – Beeswax – Paraffin Wax – Dimethicone – Shea Butter

58

Skin Barrier: The Brick and Mortar Model The stratum corneum is composed of corneocytes (bricks) embedded within a lipid matrix (mortar)

= Corneocyte (cell remnant) = Lipids 59

Skin lipids help maintain normal barrier H2O H2O H2O

H2O

H2O

Vs. Normal Skin w/ Normal Barrier

Dry Skin w/ Damaged Barrier

Inflammation

60

Barrier Function Repair H2O

H2O

H2O Apply Lipids

Dry Skin w/ Damaged Barrier

H2O

Irritant H2O

Lipids Repair Barrier Damage 61

Formulation Considerations • Most are water insoluble, so must be delivered either in the oil phase of an emulsion system or in an anhydrous system. • Too much of a barrier material can result in a formulation that feels greasy, waxy, or heavy. • Fatty materials can go rancid over time; preservatives should be used to delay or prevent this.

62

How Do Moisturizers Work?

• Enhancing water absorption and retention

• This is generally done with humectants

63

Skin Conditioning Agents Humectant

• Includes primarily hygroscopic agents intended to increase the water content (conductance) of the top layers of skin. • Examples: Glycerin, Propylene Glycol

64

Humectants in Formulations Stratum corneum (dried and cracked)

Relief !!! 65

Raw Materials that Enhance Moisture Retention • Glycerin

• Alpha-hydroxy acids • Urea • Pyrrolidone Carboxylic Acid (PCA)

• Glycols (propylene, butylene) • Amino acids

Glycerin is by far the most commonly seen

66

Formulation Considerations • Most humectants are water-soluble, and can easily be incorporated in water-based formulations. Use in anhydrous formulations is limited.

• Many formulations (especially washes, soaps, or hand sanitizers) that state “with moisturizers” on the label contain glycerin or another humectant.

67

Skin Benefits Attributable to Moisturizers • Decrease dry, flaky appearance

• Reduce the incidence of fine lines and fissures • Increase skin elasticity and suppleness • Provide relief from itching or pain

68

Moisturizers Result in More Elasticity

69 Shai, A. et al. Eds. Handbook of Cosmetic Skin Care (2001)

Moisturizing Formulas on the Market • Water, Glycerin, Stearyl Alcohol, Mineral Oil, Glyceryl Stearate, Myristyl Myristate, PEG 100 Stearate, C12 - 15 Alkyl Benzoate, Dimethicone, Cetyl Alcohol, Stearic Acid, Phenoxyethanol, Fragrance, Carbomer, Methylparaben, Potassium Hydroxide, Ethylparaben, Disodium EDTA, Propylparaben, Butylparaben, Xanthan gum, Microcrystalline Wax, BHT, Butylene Glycol, Aloe Barbadensis (Leaf Extract), Calendula Officinalis (Calendula) Flower Extract, Camellia Oleifera Leaf Extract, Cucumis Sativus (Cucumber) Fruit Extract, Retinyl Palmitate, Tocopheryl acetate 70

Moisturizing Formulations • Active Ingredients: Dimethicone • Inactive Ingredients: Water, Glycerin, Distearyldimonium Chloride, Petrolatum, Isopropyl Palmitate, Cetyl Alcohol, Oat Flour (Avena Sativa), Benzyl Alcohol, Sodium Chloride

71

Additional Ingredients

72

Film Formers • Materials which, upon drying, produce a continuous film on skin, hair, or nails • Uniform films can enhance the efficacy of an “active” such as a sunscreen, skin protectant or moisturizer. • Can be used to improve the wash off or removal of an “active” ingredient from the skin surface. • Examples: – PVP – PVA – Ethylene Vinyl Acetate Copolymer

73

Viscosity Increasing Agents Aqueous • Are used to thicken the aqueous portions of cosmetic products. • Ability to thicken is related to the water solubility or hydrophilic nature. • Examples of aqueous thickeners:

– Salts – Sodium Chloride, Ammonium Chloride – Cellulose Type – HEC, HPMC, CMC –

Gums – Guar, Xanthan, Acacia

–

Modified Starch – Potato, Tapioca

–

Polymers - Pemulen TR-1, Carbomer

74

Polysaccharide Thickening Mechanism • Formation of Colloidal Network – High yield value

– Excellent pH and electrolyte tolerance • Effective across a broad pH range • Excellent temperature and electrolyte stability • Good solubility in hot and cold water • Rheology may be too stiff for some applications • Synergy with other rheology modifiers (e.g. clays) 75

Clays • Magnesium Aluminum Silicate (e.g. VEEGUM©) • Smectite clay platelets – Hydrates in water

– Forms necessary colloidal structure; “house of cards” • Positively charged edges of platelets interact with negatively charged faces to build structure

76

Clay Platelets • Negatively charged platelet faces and positively charged edges

77

Forms Structure • When hydrated, clay assembles a 3D structure

• Traps solids, oils, and gasses

78

Viscosity Increasing Agents-Anhydrous Nonaqueous • Used to thicken the lipid portions of cosmetic products. • Ability to thicken is the result of their water insolubility and compatability with lipids. • Examples of aqueous thickeners: – Waxes – Beeswax, Microcrystalline Wax – Alcohols – Cetyl, Stearyl – Butters – Shea Butter – Hydrogenated Oils

79

Preservatives • Ingredients which prevent or retard microbial growth and thus protect products from spoilage. • Use is required to prevent rancidity, appearance/odor changes to the product caused by microorganisms • Protects activity/functionality of the product • Protects from inadvertent contamination by consumer during use or production. • The functionality of many classes is determined by the pH, conditions of manufacturing and order of addition. To prevent microbial growth in a product • Examples: – DMDM Hydantoin – Parabens – Phenoxyethanol – Quaterniary Amines

80

Types of preservation • Radiation • Heat or cold

• Packaging • Chemical and Natural Preservatives – Water activity reducers

– Antioxidants – Chelators – pH adjusters

– Antimicrobials 81

Brief History of Preservatives • 3000BC Salt, honey and oils used to preserve mummies in Egypt. • ???? BC Salt used to preserve meats around the world. • 1810 Napoleon rewards Nicolas Appert for discovering that heating and sealing jars preserves food longer. • 1875 Benzoic acid’s preservative properties are discovered. Gum benzoin had been discovered in 1556 by Nostradamus • 1876 Refrigerators invented – cold known to help preserve. • 1888 Louis Pasteur discovers micro-organisms and finds that heat can kill them – Pasteurization. • 1924 Parabens introduced into cosmetics for preservation. • 1939 Sorbic acids preservative properties are discovered. • 1945 After WWII, new chemistries develop new needs for preservatives. Synthetic preservatives flourish. • 1970s Regulations are tightened on cosmetics around the world, affecting preservative choices.

82

Microbial Paradise • Cosmetics contain food numerous food sources for microbes: water, proteins, trace metals, carbon, amino acids. • pH of products can enhance microbial growth – Most bacteria flourish in pHs between 6.5-7.5, but actual range of growth is 4.5-9.0 – Yeasts abound around 4.0-6.5, but can be seen as low as 1.5 and up to 9.6 – Molds enjoy a pH between 4.5 and 6.8, but can found between 1.2 (A. niger) and 11. • High water activity is preferred – Most bacteria need activity above 0.90, S. aureus can go to 0.84 – Most yeasts prefer above 0.87, osmophilic yeasts can survive down to 0.60 – Most molds are prefer water activity above 0.60

83

Things to Consider • What are we concerned with as formulators? – Gram negative bacteria – Gram positive bacteria – Yeast/mold • Best preservative system is one that is broad a broad spectrum blend – Paragon MEPB (McIntyre) is a blend of phenoxyethanol and parabens – Optiphen® Plus (ISP) is a blend of phenoxyethanol, caprylyl glycol, and sorbic acid • Use preservative boosting techniques – Chelating agents such as EDTA – pH modification with acids/bases – Water activity reducers (glycols,

84

CTFA’s 28-Day Micro Challenge •

• • •

Inoculum consists of Escherichia coli (G-), Enterobacter cloacae (G-), Pseudomonas aeruginosa (G-), Burkholderia cepacia (G-), Staphylococcus aureus (G+), Candida albicans (Y), and Aspergillus niger (M) All are added to formula to be tested for a final concentration between 1 x 105 to 1 x 106 CFU/mL Colonies are counted at 1, 7, 14, 21 and 28 days The preservative is effective if there is: – Bacteria: at least a 99.9% reduction within 7 days following each challenge and no increase for the duration of test period, and; – Yeast and Mold: at least a 90% reduction within 7 days following each challenge and no increase for the duration of the test period.

85

Chelating Agents (Sequestrants) • Can complex with and inactivate metallic ions to prevent their adverse effects on the stability or appearance of cosmetic products. • At times it is important to complex calcium or magnesium ions which are incompatible with a variety of cosmetic ingredients. • Chelation of ions, such as iron or copper, helps retard oxidative deterioration of finished products.

• Chelating agents are used to help boost preservative efficacy in cosmetic formulations. • Examples: – Tetrasodium EDTA – Disodium EDTA – Gluconic Acid

86

Active Ingredients • Exact definition is dependent on desired claims and the associated regulatory status of the claim or ingredient used. • Incorporated to alter the structure and function of the skin. • Within cosmetics, over-the-counter products (rash creams, sunscreens) are regulated by the FDA under an appropriate monograph. • Are all products which change the structure or function of skin regulated by the FDA: No!!! • Is there consistent agreement as to what it means to change the function & structure of skin: No!!! • Claim language is the fine line to distinguish cosmetic from a drug:

– Cosmetics: smoothes, soothes, moisturizes, plumps, etc.

– Drug: cures, treats, prevents, etc.

87

Skin Protectants • OTC (over the counter) active drug ingredients that temporarily protect injured or exposed skin or mucous membrane surfaces from harmful stimuli, and may help provide relief to such surfaces. • Examples: – Allantoin – Dimethicone – Petrolatum

– Zinc Oxide

88

Other Examples of Active Ingredients • OTC Regulated Cosmetics: – – – – – – –

Sunscreens Rash Creams Anti-Puritic (Itch Anti-Dandruff Anti-Perspirants External Analgesics (Pain Reduction) Hand Sanitizers

• Non-Regulated Products with “Actives” – – – –

Anti-wrinkle Anti-cellulite Stretch marks Skin Lighteners (US)

89

Fragrance, Colorants, Aesthetic Enhancers, and Label Ingredients

90

Overview • Why are they used in formulations

• Classes/functions of raw materials – Definitions – Examples of some raw materials in each class

• Product types in the industry

91

Why are they used in formulations? • Additives can be: – Functional • Deliver an end benefit. • If used in low quantities, functional ingredients enhance appeal

– Enhance appeal • Enhance the five senses of the consumer (sight, smell, touch, taste, hearing)

• Create a story and also be functional – Powders create a silky feel (appeal) and diffuse light to disguise wrinkles (functional)

92

General Classes of Raw Materials • Fragrance – Fragrance blends – Essential Oils – Extracts or Waters • Flavor • Colorants – Dyes – Pigments – Natural colorants • Marketing Ingredients – Extracts – Moisturizers – Vitamins – Antioxidants 93

General Classes of Raw Materials • Aesthetic Enhancers – Visual • Beads • Glitter • Swirls • Opacifiers or pealizing agents – Sensory • Warming • Cooling • Tactile – Powdery finish • Exfolliants

– Natural – Synthetic 94

Aroma Compounds • Chemicals that are somewhat volatile so they can be transported to the upper part of the nose in a high enough concentration to be detected by the olfactory receptors • Types of aroma compounds –

Fragrance • A mixture of fragrant essential oils, aroma compounds, solvents, and fixatives • Can be extremely complex and contain a top note (perceive immediately upon application), middle note (heart of the fragrance), and base note (perceived after dry down)

–

Essential Oils • Hydrophobic portion of a steam distillate • Large interest due to the popularity of aromatherapy • Examples are Lavender Oil, Peppermint Oil

–

Hydrosols • Aqueous phase of a steam distillate and often referred to as essential water, floral water, or herbal distillate • Example are Rose Water, Orange Water 95

Flavorant • A substance added to impart a pleasant taste to the final formulations • Product Examples – Toothpaste

– Mouthwash – Lip Balm – Adult novelty products

96

Colorants • Materials which impart a visual color to a finished product • Types of colorants –

Dyes • Generally soluble and appear to be colored because they absorb some wavelengths of light preferentially • Examples are FD&C Yellow No. 5 and D&C Orange No. 4

–

Pigments • Generally insoluble and changes the color of light it reflects as a result of selective color absorption of wavelengths of light. • Examples are FD&C Yellow No. 5 Aluminum Lake and D&C Orange No. 4 Aluminum lake

–

Natural • Examples are Walnut Extract and Beet Extract 97

Marketing Ingredients • Materials which do not add to the end benefit of the product, but help to create the product story and reason to believe • Generally these are added in very small amounts • Examples: – Extracts • Helianthus Annuus (Sunflower) Extract

– Moisturizers • Jojoba oil, Aloe

– Vitamins • Vitamin A, Vitamin E, Vitamin C

– Antioxidants • Green Tea Extract, Vitamin C

98

Aesthetic Enhancers - Visual • Materials and or effects that are added to formulations to entice the consumer buy by creating a “wow” for the eyes. • Examples: –

Beads • Generally suspended within the formulation and contain known consumer friendly ingredients (vitamins, oils)

–

Glitter or iridescent pigments • Generally suspended within the formulation and will deposit onto the skin or hair to leave a shine.

–

Swirls • Can be layers of two separate products or an internal swirl (alternate benefits)

–

Opacifiers or pearlizing agents • Suspended fatty acids, powders, or other to create a white or luminescent appearance to the product

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Aesthetic Enhancers - Sensory • Materials added to formulations to stimulate the senses or elicit a response from touch • Examples: – Warming Agents • Generally warm due to heat of hydration – Examples would be glycols, magnesium chloride, calcium chloride

– Cooling Agents • Due to volatile evaporation or from a neurosensory response – Examples would be ethanol, menthol, camphor

– Tactile Agents • Examples would be powders or silicones to elicit a smooth, powdery finish on the skin

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Exfoliants • Materials added to formulations aimed at improving skin's appearance by removing dead skin cells from the surface of the skin. • Examples: – Physical • Synthetic – Polyethylene beads

• Natural – Walnut shells – Rice bran

• Chemical – Alpha Hydroxy Acids (AHA’s) such as Glycolic Acid, Lactic Acid, Citric Acid – Beta Hydroxy Acids (BHA’s) such as Salicylic Acid – Polyhydroxy Acids (PHA’s) such as Gluconolactone, Lactobionic Acid

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Industry Examples

Warming Facial Cleanser (Biore)

Suspended Antibacterial Beads (B&BW)

Pigments for color transfer

Enriched with Aloe & Vitamin E (J&J)

Suspended Exfoliant Apricot Shells (St. Ives)

Lavender Aromatherapy

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Formulation Systems • Solutions • Oil Based Solutions/Anhydrous • Water Based Surfactant Solutions • Emulsions • Suspensions • Powders

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Solutions • Homogeneous mixture of two or more substances. • Examples: – Astringents (Hydro-alcoholic) – Anti-septic/microbial Hand Gels

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Anhydrous Formulations • Systems which do not contain water • Contains mostly hydrophobic/lipophilic ingredients. – Examples: Ointments, Lip balm/sticks, Vaseline

• Advantages: Lipophilic material has direct contact with the skin, best film formation, and film is not water dispersible (water resistant/proof), ease of preservation.

• Disadvantage: Poor aesthetics and more costly.

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Foaming surfactant systems • Dispersion of hydrophilic surfactants in water. (Micellular Surfactant Solutions) • Examples: – Shampoos – Baby Washes and Bath – Liquid Hand Soaps

– Shower Gels – Wet Wipe Solutions

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Examples of Cleansing Products Bubble Bath Body Wash

Baby Wash Shower Gel

Bubble Bath

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Emulsions • An emulsion is a two phase system consisting of two completely immiscible liquids, one of which is dispersed in the other. • Many types of Emulsions: – Oil-in-Water (O/W)

– Water-in-Oil (W/O) – Multiple emulsions (O/W/O, W/O/W)

• The majority of Skin Care Products are emulsions.

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Oil-in-Water Emulsions • Emulsions with a oil phase dispersed as fine droplets in aqueous external phase (O/W). • Advantages: Typically have better Aesthetics, easier to formulate, greater choice of emulsifiers, & lower cost. • Disadvantage: Typically does not provide substantivity, water proofing and film formation.

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Oil in Water Emulsion • The surfactant maintains the small droplet size of the oil, keeps the droplets from aggregating (steric hinderance) and the surfactant/oil complex is soluble in the water. • This is known as an oil in water emulsion (O/W)

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Example Products •

StriVectin-SD Wrinkle and Stretch Mark Cream ($135) Water (Aqua), C12-15 Benzoate, Sesamum Indicum Seed Oil (Sesame), Caprylic/CapricTriglyceride, Prunus Amygdalus Dulcis Oil (Sweet Almond), Cetearyl Olivate, Sorbitan Olivate, Striadril Complex (see product details for ingredients list), Glycerin, Glyceryl Stearate and PEG-100 Stearate, PPG 12/SMDI Copolymer, Stearic Acid, Theobroma Cacao Seed Butter (Cocoa), Butyrospermum Parkii (Shea Butter), Tocopheryl Acetate, Mangifera Indica (Mango), Mentha Piperita Oil (Peppermint), Methylparaben, Xanthan Gum, Triethanolamine, Butylparaben, Ethylparaben, Disodium EDTA, Propylparaben, Retinyl Palmitate, Tetrahexyldecyl Ascorbate Active Ingredients: 4% Octyl Salicylate, 2% Avobenzone, 1% Phenylbenzimidazole Sulfonic Acid, 1% Octocrylene Inactive Ingredients: Water, Glycerin, Dimethicone, Niacinamide (Vitamin B3), Isopropyl Isostearate, Polyacrylamide, Triethanolamine, Titanium Dioxide, C13-14 Isoparaffin, Cetearyl Glucoside, PTFE, Panthenol (Pro-Vitamin B5), Tocopheryl Acetate (Vitamin E), Stearyl Alcohol, Behenyl Alcohol, Cetyl Alcohol, Sucrose Polycottonseedate, Benzyl Alcohol, Dimethiconol, Carbomer, Methylparaben, Ethylparaben, Propylparaben, PEG 100 Stearate, Disodium EDTA, Laureth-7, Stearic Acid 111

Example Products • Aveeno Baby Soothing Relief Moisture Cream, Fragrance Free Water, Glycerin, Petrolatum, Mineral Oil, Cetyl Alcohol, Dimethicone, Avena Sativa (oat) Kernel Flour, Carbomer, Ceteareth 6, Ethylparaben, Sodium Citrate, Stearyl Alcohol, Propylparaben, Methylparaben, Sodium Hydroxide, Tetrasodium EDTA, Benzalkonium Chloride, Citric Acid, Butylparaben, Butylene Glycol, Hydrolyzed Milk Protein, PEG 25 Soy Sterol, Benzaldehyde, Hydrolyzed Oats, Hydroylzed Soy Protein, Isobutylparaben, Phenoxyethanol, Ethyl Alcohol

• Aveeno Foot Cream, Intense Relief Water, Glycerin, Petrolatum, Mineral Oil, Cetyl Alcohol, Dimethicone, Avena Sativa (oat) Kernel Flour, Butyrospermum Parkii (Shea Butter) Extract, Mentha Piperita (Peppermint) Oil, Rosmarinus Officinalis (Rosemary) Leaf Oil, Salicylic Acid, Menthyl Lactate, PEG 25, Soy Sterol, Carbomer, Ceteareth 6, Stearyl Alcohol, Tetrasodium EDTA, Methylparaben, Ethylparaben, Butylparaben, Propylparaben, Isobutylparaben, C12-16 Alkyl Hydroxyethyl Ethylcellulose, Sodium Citrate, 112 Benzalkonium Chloride, Citric Acid, Sodium Hydroxide

Water-in Oil Emulsions • Emulsions with a water or hydrophilic ingredients dispersed as fine particles in oil based external phase (W/O). • Advantages: Oil phase has direct contact with the skin, better film formation, and film is less water dispersible and continuous (water resistant and provides best “protection”). • Disadvantage: Poor aesthetics and more costly.

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Water-in-Oil Emulsion

• The inverse is also possible with the oil phase being the continuous phase and the water phase being the internal phase • This is known as a water in oil emulsion (W/O)

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W/O Emulsions- Product Examples Active Ingredients: Ointment contains:: Dimethicone 1% (diaper rash cream), Zinc Oxide 10% (diaper rash cream) Inactive Ingredients: Aloe Barbadensis Extract, Benzyl Alcohol, Coconut Oil, Cod Liver Oil (contains vitamin a & vitamin d), Fragrance, Glyceryl Oleate, Light Mineral Oil, Ozokerite, Paraffin, Propylene Glycol, Sorbitol, Synthetic Beeswax, Water

Active Ingredients: Zinc Oxide (10%) Inactive Ingredients: Water, Mineral Oil, Propylene Glycol Dioctanoate, Methyl Glucose Dioleate, Titanium Dioxide, PEG 45 Docecyl Glycol Copolymer, Glycerin, Ceresin, Ethyl Linoleate, Shea Butter, PEG 8, Panthenol, Potassium Sorbate, Fragrance, Magnesium Sulfate, Methylparaben, Caprylyl Glycol, Propylparaben, Sodium Polyacrylate

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Water-in-Oil Product Example

Philosophy hope in a tube, eye and lip firming cream • Water (aqua), Squalane, Mineral Oil, Glycerin, Isocetyl Stearoyl Stearate, Petrolatum, Butylene Glycol, Polyglyceryl 2 Diisostearate, PEG 30 Dipolyhydroxystearate, Ceresin, Polyethylene, Microcrystalline Wax, Magnesium Sulfate, Phytosteryl/Octyldodecyl/Lauroyl Glutamate, Dipalmitoyl Hydroxyproline, Tocopheryl Acetate, Polysorbate 80, Bisabolol, Potassium Ascorbyl Tocopheryl Phosphate, Iron Oxide (CI 77492, CI 77491 and CI77499), Methylparaben, Diazolidinyl Urea, Ethylparaben, Tetrasodium EDTA

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Multiple Emulsions • Emulsions formed when a W/O emulsion is emulsified in water or when an O/W emulsion is emusified in oil. • Advantages: Good aesthetics and can provide protection of actives within the emulsion. • Disadvantage: Can be difficult to stabilize.

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Emulsifying emulsions • With the addition of certain surfactants, an oil in water emulsion can be emulsified within an external oil phase. • This is known as an oil in water in oil (O/W/O) emulsion

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Emulsifying Emulsions • With the addition of certain surfactants, a water in oil emulsion can be emulsified within an external water phase • This is known as a water in oil in water (W/O/W) emulsion

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Suspensions • A dispersion of solid particles in a liquid medium. • Examples: – Anti-acids

– Calamine Lotion (ZnO/FeO in Water) – Antiperspirants (Al salts in Silicone) – Lipsticks (Pigments in Castor Oil and Waxes)

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Powders • Dry solids composed of numerous fine particles • Generally used to absorb moisture and or deliver active ingredients to the skin • Examples: – Baby Powder – Powder Make-ups – Pressed Powders

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Conclusions • Cosmetic industry is extremely large and continues to grow yearly • Multiple trends shape the industry and affect consumer buying intent

• Multiple product types exist and changes occur due to consumer preference and technology shifts • Vast number of ingredients in the industry each with unique attributes and functionality • Numerous formulations are used as delivery vehicles in the industry

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QUESTIONS?

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