A Basic Guide to Cosmetic and Toiletry Development.pdf

A Basic Guide to Cosmetic & Toiletry Development John Woodruff

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A Basic Guide to Formulating Cosmetics & Toiletries 

What is a cosmetic?

 

Understanding From concept toproduct productbriefs formulation     

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Sources of information EU cosmetic regulations The global marketplace Cost effective formulation Product stability & preservation

Example formulation techniques

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A Basic Guide to Formulating Cosmetics & Toiletries   

What is a cosmetic? Understanding product briefs From concept to product formulation



Sources of information EU cosmetic regulations The global marketplace Cost effective formulation



Product stability & preservation

  

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What is a cosmetic product? European Regulations specify 6 functions for cosmetic products, namely:

to perfume

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to clean

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to change the appearance

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to protect

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to keep in good condition

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to correct body odours

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To perfume  

Perfume

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Toilet waters Mists & sprays

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Aromatherapy preparations

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Bath additives

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Shower gels

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Deodorants

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Body lotions

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These should products not penetrate the skin but perfume compounds including essential oils may do so.

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To clean 

Soap

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Syndet bars Bath additives Shower gels Cleansing emulsions Scrubs Cleansing masks

These products should not penetrate the skin but they do affect the skin surface (Stratum corneum – SC), they can remove skin lipids, affect skin barrier properties, increase cell turn - over, change

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Shampoos

pH & cause loss of moisture

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To change the appearance 

Decorative cosmetics     

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Foundation creams Blushers Lipsticks & eye shadows Fake tans Cover fine lines & wrinkles

These products not penetrate theshould skin.

Plump out fine lines & wrinkles* Freeze facial muscles*

*These products need

DHA tanning* Skin lightening*

to penetrate the S.C.

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To protect   

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Sun protection Barrier creams Antiseptic washes Anti-oxidants* Protect immune system*

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These products not penetrate theshould skin.

*These products need to penetrate the S.C.

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To keep in good condition 

Moisturise NMF = Urea, cholesterol,   

  

Occlusive film Humectants NMF*

sodium lactate, lactic acid, amino acids, phospholipids, sodium PCa, water

Anti-oxidants* Support immune system* Plump out fine lines & wrinkles*

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*Generally these products need to penetrate the S.C.

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To correct body odours   

Deodorants Antiperspirants Cleansing* 

e.g.washing

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These products not penetrate theshould skin. *These products may affect the S.C.

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Field of application The field of application of cosmetics is to one or more of the following:  the epidermis  the hair system  the nails  the lips  the external genital organs  the teeth  the mucous membranes of the oral cavity [email protected]

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A Basic Guide to Formulating Cosmetics & Toiletries Field of Application – anywhere visible, with or without swimming costumes

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The Brief 

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A clear concise document marketing department afterproduced extensiveby the market research with intended claims clearly defined.

Or 

Woolly description full of pitfalls like “Natural” & “Organic” and claims changing as new ideas occur to srcinator.

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A Basic Guide to Formulating Cosmetics & Toiletries

The Packaging 



Already identified selected as the the ideal pack form to and contain and deliver product. Or 

To be decided! 

Usually after 2 months stability testing on a product with a quite unsuitable rheology for the final pack choice.

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The Bench Mark 

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An exciting & innovative product with clear functional benefits & with a similar selling price to the product required.

Or 

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Two or three totally different products, all 3x the selling price of the product required. Does the bench mark meet the product requirements?  Claims, market niche, legislation?

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The Time Table 

A program agreed time between all concerned, allowing sufficient for formulation, testing and proceeding to manufacture via pilot scale batches. 

Or 

Marketing has a slot promised by a major store 5 months ahead. That is plenty of time surely! 

Remember formulations can fail at any stage.

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Tip 

Read the brief and also read between the lines: 

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If “natural” claims then reduce non-naturals to a minimum & no animal ingredients If “organic” avoid all proscribed ingredients  

E.g. Ethoxylated materials Most preservatives / colours / minerals / petroleum-based materials etc.etc.

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Tip 

Read the brief and also read between the lines:  

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If one customer, obey special requirements If for sensitive areas, mucous membranes etc. avoid unsuitable colours & preservatives

Mucous membranes    

in the vicinity of the eyes on the lips in the oral cavity on the external genital organs

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Tip 

Read the brief and also read between the lines: 

Identify target consumer 

Young – greasy, acne 

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Old – mature, dry, sensitive, lacking radiance & resilience 

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Cleanse, tone & leave alone

Cleanse, desquamate, moisturise, cover up

Middle – combination skin 

Protect & moisturise

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What is a cosmetic?



Understanding product briefs

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From concept to product formulation     

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Sources of Information 

Look at the bench mark & competitors products?  

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Do they deliver their claims? If so how?

cosmeticsdesign-europe.com Chemidex.com Cosmeticsbusiness.com Suppliers representatives & web sites Trade press & relevant articles Conference presentations Patent literature Text books

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The Regulations Ignore at your peril 

EU 76/768/EEC – The 7 th Amendment 

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And all subsequent amendments

The Cosmetic Products (Safety) Regulations 2004 SI 2185 

Customer-specific requirements 

e.g. Boots GR-10

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The Regulations  



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EU 76/768/EEC – The 7 th Amendment It lists those materials that cosmetics must not contain Those materials subject to restrictions in field of application and/or maximum allowed % A positive list of colours A positive list of antiperspirant materials A positive list of preservatives A positive list of UV absorbers

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Mucous membranes Be aware 

More prone to irritant reactions  Restrictions on colours  Restrictions on preservatives  More stringent microbial rules  Only ingestible products i.e.those with A.D.I., should be applied to the lips 

Tip - match pH to area of application e.g. Eyes are 7+/- 0.2 / Skin is ~5.3

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Formulating Cosmetics & Toiletries for the Global Marketplace 

EU / USA / Japan / Brazil etc. 

Each area has own regulations 

Particularly affecting    



Colours Preservatives Antiperspirants Sunscreens

Also  Labelling 

Names of ingredients

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What is a cosmetic? Understanding product briefs From concept to product formulation     

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Cost effective formulation of Cosmetics & Toiletries  

Start with current material inventory Don’t add cost without adding value Colin Hession 

 

Keep it simple – but effective Look at methods of production  

Process plant availability Heating costs / cooling costs / mixing costs / processing time costs



Fill using current machinery

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Tip 

Think commercially 

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Use materials that are already in current stock wherever possible Use laboratory mixing equipment which represents that available in the factory Think of the likely batch sizes 

Can they be made with existing equipment? 

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If there is a problem can the formula be revised?

Can the product be filled with existing equipment?

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Tips 

Use laboratory mixing equipment which represents that available in the factory

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Tips Use laboratory mixing equipment which represents that available in the factory

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Example formulation Techniques

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Stability and preservation of Cosmetics & Toiletries 

Preservative choice affected by  

Regulations Type of product 

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pH of product 

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Leave-on or Wash-off? pH < 6 / pH > 7

Other ingredients  

Parabens inactivated by ethoxylates Phenoxyethanol thins many emulsions

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Stability and preservation of Cosmetics & Toiletries 

Stability checking is essential 

Minimal requirements are stability testing at 4C / RT / 40C for 3 months plus light where applicable    

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45C used by some companies Freeze / thaw cycles Test in final packaging A product should remain stable for minimal 36 months at RT Continuing preservative efficacy over testing period is essential PAO = Period After Opening – depends on product type and packaging

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Tip 

Decide which preservatives can or cannot be used Talk to marketing. Talk to microbiologist 

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The choice could affect your product stability

Make selection of perfume a priority 

Talk to marketing and talk to the supplier 

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The choice could affect your product stability

If possible incorporate these two items in development samples from the outset

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A Basic Guide to Formulating Cosmetics & Toiletries Formulation Techniques

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Cosmetic functions  

to perfume to clean

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to change the appearance

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to protect



to keep in good condition

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to correct body odours

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Functional products are those for which a claim can be made, and which meet that claim.

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They consist of the vehicle and the active ingredient(s). 

The two parts must be compatible and the final product must be pleasant to use.

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Claims substantiation 

All proposed claims and methods of substantiation should so be that agreed at the start of product development a clear justification of claims can be provided from controlled laboratory trials.



User trial results (responses from 50 people) or raw material data or a combination of the above can be used. 

From Boots document to own label suppliers

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Functional skin care 

The vehicle and the active ingredient(s). 



The two parts must be compatible and the final product must be pleasant to use.

Which comes first? 

Depends on many factors   

Product form Packaging Claim

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A Basic Guide to Formulating Cosmetics & Toiletries

To keep in good condition  

Remove dead skin cells Protect from UV radiation

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Support immune system

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Protect from free radical species /ROS

 

Replace lost lipids Moisturise

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Narrowing the choice  

Cost Supporting the claim  

   

Check that claim support data is realistic and believable Will the product support the level of use on which claims data is based?

Compatibility with vehicle Compatibility with packaging Safety assessment Patent search

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Remove dead skin cells

Wash 

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Scrub Tape stripping! Peels including enzymes e.g. Papain

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Alpha hydroxy acids – AHAs

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

Glycolic acid / citric acid / lactic acid / malic acid / salicylic acid 

Fruit acids

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AHAs: Selecting the active 

Glycolic acid / citric acid / lactic acid / malic acid / salicylic acid 

Proprietary mixtures e.g. Acifructol Complex ex Gattefosse 

Aqua (Water)

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Citric Acid

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Citrus Grandis (Grapefruit) Fruit Extract

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Citrus Medica Limonum Extract

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Lactic Acid

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Malic Acid

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Propylene Glycol

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Solanum Lycopersicum (Tomato) Extract

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Vaccinium Myrtillus (Bilberry) Extract

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AHAs: Safety & legal issues 

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The CIR Expert Panel concluded that glycolic and lactic Acid are safe for use in cosmetic products at concentrations <10%, at final formulation pH >3.5 Boots recommendations 

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Glycolic acid must be less than 4% in formula and pH of final product must be > 3.8. Lactic acid must be less than 2.5% in formula and pH of final product must be > 5.  If total AHAs are more than 4% then wording must appearuse on products pack recommending consumers with AHAs in conjunction with sunscreen products.

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AHAs: Selecting the active



Possible choice  

Glycolic acid Plus proprietary mixture 

Combines effectiveness with natural claims

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AHAs: Designing the vehicle 

Parameters     

pH 4– 5 Electrolytes Low oil content Penetration required Possible forms   

o/w emulsion foaming mousse light scrub

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AHAs: Designing the vehicle 

o/w emulsion   

Emulsifier fortopH 4 –hydrolysis 5 Oil or estersuitable resistant acid Penetration enhancer ? 

Balance efficacy against safety  

 

Urea or ethoxydiglycol Or soften SC with emollients

Anti-irritation ingredient e.g. Bisabolol Perfume / Preservatives / Rheology modifier

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AHAs: Possible formulation              

3.00% 1.00%

Glyceryl stearate PEG-100 stearate

3.00% Caprylic / capric triglyceride 1.00% Paraffinum liquidum Aqua to 100% 0.05% Disodium EDTA 2.50% Glycolic acid 3.00% Mixed fruit acids 5.00% Ethoxydiglycol 0.50% Bisabolol 0.20% Xanthan gum Fragrance Preservatives e.g. Methyl + propyl paraben pH adjusted to 3.8 – 4.3

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To keep in good condition

Protect from solar radiation

Why we should do so!

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To keep in good condition 

Protect from solar radiation

Sunscreen Actives 

Organic screens  

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Less expensive Well known properties & technology  But possible irritation  Possibly unstable  Product / pack interactions

Inorganic 

Safe

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Broad spectrum  But whitening on skin  Drag on application

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UV Protect: Selecting the active 

Dependent on    

Required SPF Is UVA protection required? Intended market – legislation? Intended vehicle & pack form     

Clear gel o/w emulsion w/o emulsion Oil Spray

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UV Protect: Selecting the active 

Possible answer 

Organic UV absorber 

plus inorganic dispersion 

 

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Not suitable for oil or clear gel

e.g. Ethylhexyl methoxycinnamate – UVB TiO2 dispersion in oil phase to extend UV protection into UVA or ZnO dispersion for increased UVA protection

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UV Protect: Designing the vehicle Design parameters 

pH 

    

ZnO approx 8

Effect of inorganic dispersion aid Solubility of active Skin penetration not wanted Water-resistant Pleasant to apply

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UV Protect: Possible formulation              

3.00% 2.00%

Propylene Glycol Dicaprylate Ethylhexyl Palmitate

5.00% Ethylhexyl Methoxycinnamate 1.50% Dimethicone &/or cyclopentasiloxane 0.50% Potassium Cetyl Phosphate 12.50% Titanium Dioxide dispersion in oil 3.50% Cera Alba (Beeswax) 3.50% Sorbitan Palmitate Aqua (Water) to 100% 2.00% Hydroxypropyl Starch Phosphate 2.00% Magnesium Aluminum Silicate + silica 3.50% Polysorbate 20 0.30% Sodium Lactate Fragrance / Preservatives

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Support immune system

Abstract USP 6,843,995 

The invention relates to a cosmetic preparation containing an active complex comprised of an extract from truffles (Tuberaceae) in a cosmetically acceptable gel while being stabilized. A preferred active complex is one that additionally contains a champagne product. Cosmetic preparations containing this active complex lead to an improved stimulation of the immune system, an improved regenerative effect and thus to an improved balance in the ecosystem of the skin.

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Support immune system 

Possible formulation  

Truffles Champagne

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Protect against free radicals

Anti- oxidants      

Vitamin E - Tocopherol Vitamin C – Ascorbic acid & ascorbyl compounds Ferulic acid Superoxide dismutase BHT / BHA / Propyl gallate / Thio compounds Numerous plant extracts e.g.  Lycopene from tomatoes  Rosmarinus officinalis (Rosemary) extract  Camellia sinensis (Green tea) extract   

Punica granatum (Pomegranate) extract Rubus idaeus (Raspberry) leaf extract Salix nigra (Willow) bark extract

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To keep in good condition 





Replace lost lipids

As skin ages the ceramide content of the SC decreases. Ceramides, cholesterol and fatty acids are effective in restoring lost lipids and the barrier functions of the skin.  Ceramides AKA Sphingosines (9 identified)  Fatty acid = linoleic acid particularly effective Together with cholesterol, lamella structures are formed, which penetrate upper SC.

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Moisturise

There is a water- gradient from the lower levels of the skin to its surface where it evaporates as transepidermal water loss (TEWL) There is a decrease in moisture content from the base layers to the surface (70%- >10%) As skin ages it loses more moisture but all skin may be subject to increased moisture loss through environmental conditions Moisturising is the basic requirement for nearly all skin care products

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Moisturise 

Select the active 

The choice of moisturising ingredients is very wide  Petrolatum & other oils & fats form an occlusive film, virtually preventing TEWL  Lanolin has moisture holding properties and can penetrate upper SC

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Moisturise 

Select the active 



 

Glycerin & other hygroscopicwith humectants attract water to themselves; more moisture on the skin there is a reduction in loss through evaporation Proteins hold moisture and are substantive to skin NMF duplicates the skin moisturising system Lamellar structures penetrate SC, restoring its natural barrier properties

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Moisturise Narrowing the choice 



The brief  Target skin type & area of application  Claims The cost  Petrolatum / glycerin etc are cheap  Ceramides / yeast ferments etc are expensive



Botanicals have consumer appeal

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Moisturise Narrowing the choice 





The pack form  Spray / bottle / tube / jar The vehicle  Gel / lotion / cream Other actives 

Multi-functional

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Moisturise 

Narrowing the choice 

If a gel  What thickening system? 

 

Carbomers / cellulose / mineral / alginates? pH restraints? Clarity required? 

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Oils & Fragrance create problems Compatibility issues?

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Moisturise 


If a gel 

What thickening system?  Exposed to light?  Photo-degradation  Thinning and/or discolouration  Preservative system? 

Mixing requirements?  Heating / cooling / high shear / slow mixing

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Moisturise 


Select gel form 

Carbomer       

pH 5.5- 7.5 No electrolytes Water- soluble actives Chelate ions Protect against UV Cold mixing possible High shear not required

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Moisturising gel 

Carbomer based 

 

Chelate + UV Absorber (EDTA2Na +B4) + Neutraliser (e.g. NaOH or TEA or AMP) + Preservative system (e.g. Parabens) Humectant (e.g. Glycerin or PG or Sorbitol) Active e.g.  

Aloe barbadensis leaf juice Hydrolysed wheat protein

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Moisturise 


If a lotion 

What emulsifying system?    

  

Anionic / cationic / non - ionic w/o or o/w or w/Si/w pH restraints? Compatibility issues?  Fragrance / polar & non - polar oils Stability Preservative system? Mixing requirements  Heating / cooling / high shear / slow mixing

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Moisturise 


If a cream 

What emulsifying system?     

 

Anionic / cationic / non - ionic w/o or o/w or w/Si/w pH restraints? Compatibility issues? Stability  Use of hydrocolloid Preservative system? Mixing requirements  Heating / cooling / high shear / slow mixing

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Moisturising emulsions       

Aqueous Phase Oil phase Emulsifier system Rheological modifier Preservative system Active ingredients Fragrance

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Moisturising emulsions 

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Aqueous Phase  Humectant / Moisturiser – CTFA makes no difference but JW thinks humectants as hygroscopic materials used as much to keepofthe product moist as for moisturising skin. Humectants  Glycerin / Sorbitol / Propylene glycol / Polyethylene glycol (PEG) & various sugars Moisturisers  Innumerable – 398 from Acetamide MEA to Zymomonas Ferment Extract in CTFA Dictionary, including sea water! Actives  Most actives are water-soluble Preservative system

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Oil Phase: Selecting the emoll ients: Cognis

Cascading theory means select a number of emollients so that the sensorial feel is spread throughout the time of application. Cosmetics should feel good!

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Oil Phase: Selecting the emollients: Degussa surface tension [mN/m]

PP = pour point, CP = cloud point

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No.I NCIName 1 2 3 4 5

20

32 9

31 30

7

29 3

28

4

5

6

8 12

17 13

10

21 23 24

14

11

18 15

19

2

caring, rich

27 26 25

light, light, fresh fresh

24 16

23 22

25 21

22

20 1

17 2

Decyl Cocoate EthylhexylPalmitate C12-15AlkylBenzoate EthylhexylStearate Cetearyl Ethylhexanoate CetylEthylhexanoate Decyl Oleate Cetearyl Isononanoate IsocetylPalmitate Caprylic/Capric Triglyceride Cetyl Dimethione PPG-3 Myristyl Ether Mineral Oil Octyldodecanol Avocado Oil

<-30 <-30 8 -11(-2) 14 16 1 -6 8 0 (2) -2(5) (4) -6 9 (12) 0 -4 14 (18) (3) 0 -19 -30 (-20) < -30

21 Dimethicone PPG-11 Stearyl Ether (-1) -11 22 0 (13) 23 PPG-14 Butyl Ether < -30 24 Triisostearin < -30 25 Cetyl Dimethione -5 Size of circles: proportional to spreadability

19 18

6 7 8 9 10 11 12 13 14 15 16 17 18 19 20

PP(CP)[°C]

Cyclopentasiloxane Diethylhexylcarbonate Isopropyl Myristate HexylLaurate IsopropylPalmitate

10

viscosity [mPas]

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100

Color of circles:

polar

non-polar

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Oil Phase 

Watch out for  

Rancidity Oil phase incompatibilities e.g.  



Waxes crystallising Dimethicone / Mineral oil  Melt & mix oil phase together; is it clear? Does it stay homogenous when cooled?

Dragging / greasiness / odours

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What emulsifying system? 

Anionic  

 

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o/w More commonly associated with cleansing surfactants SLS - irritant TEA-Stearate – OK for cleansers / not leave-on Potassium cetyl phosphate – forms liquid crystals, worth attention

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Cationic  w/o 

 

More commonly associated with hair conditioning Irritancy concerns However at least one material supplier is promoting their use with the following claims:

Cationic based on renewable materialsO/W with emulsifier excellent emulsifying propertiesraw

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What emulsifying system?    

   

Cationic Excellent emulsification behaviour Light emulsions, matte finish Powdery, smooth and dry skin feel after application Low greasiness, stickiness or tack Inherent moisturisation Substantive to skin Extraordinary and unique skin feel

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Non-ionic   

o/w or w/o Selection using HLB system possible Sorbitan esters / ethoxylated pair 

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e.g. Sorbitan stearate / Polysorbate - 20

Alkoxylated alcohols 

e.g. Ceteareth - 20 

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But move against ethoxylates!

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What emulsifying system? 

Recent introductions of sucrose esters and understanding the benefits of liquid crystal formation is driving new formulations

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Benefits of liquid crystal formation

Water, fatty acids, cholesterol, triglycerides and ceramides form the lamellar (layered) gellike lipid system of the horny layer.

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Non-ionic liquid crystal forming emulsifiers       

Cetearyl glucoside Cetearyl olivate / Sorbitan olivate Sucrose cocoate / Sorbitan stearate Sorbitan stearate / Sorbityl laurate Cetearyl polyglucoside Polyglyceryl-3 methylglucose distearate Cetearyl polyglucoside / polyglyceryl-2 dipolyhydroxystearate

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Moisturising emulsions

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Liquid crystals are states of matter that exist in between the solid and the ordinary liquid phase. The main characteristic of the phase is the existence of partial ordering (positional and orientational) like that of the crystal phase but the phase haslike thea ability to flow liquid.

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Oil Phase  

Refer to Cognis cascading theory of emollients Degussa selection chart

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Cyclopentasiloxane stops soaping up

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Vegetable oils are polar (& popular)

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Capric/caprylic triglyceride is good stuff

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Cetyl or cetearyl alcohol and/or glyceryl stearate helps stabilise LC structures

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Moisturising emulsions 

Rheology modifier           

Xanthan gum Minerals – e.g. Bentonite / Veegum / Laponite Carbomer Acrylates copolymer Sclerotium Gum Mannan Modified starch Gum tragacanth Alginates Silica Cellulose derivatives

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Moisturising emulsions •Preservative system •Affected by other ingredients •pH •Market trends •Active ingredients •Affected by marketing claims •Other ingredients •pH •Fragrance •No Fragrance / Perfume / Essential Oils •Affected by named allergens [email protected]

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Moisturising emulsions: possible formulation

7.00% 2.50% 5.00%

Caprylic/capric triglyceride Cetearyl alcohol Prunus amygdalus dulcis (Sweet almond) oil

1.50% Cyclopentasiloxane 0.01% Ceramide 0.10% Tocopherol Aqua (Water) to 100% 0.08% Disodium EDTA 1.50% Cetearyl polyglucoside (emulsifier) 0.20% Xanthan gum 0.50% Niacinamide 5.00% Glycerin 1.00% Sodium PCa 3.00% Aloe barbadensis leaf juice 2.00% Punica granatum (Pomegranate) extract Preservatives / Fragrance / pH adjusters

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DLC Question A major brand of moisturising lotion lists its ingredients as  Aqua, Cetyl Palmitate, Glycerin, Paraffinum liquidum, Petrolatum, Cetyl Alcohol, Glyceryl Hydroxystearate, Stearic Acid, Steareth 100, Dimethicone, Octyldodecyl Myristate, Fragrance, Potassium Hydroxide, DMDM Hydantoin, Iodopropynyl Butylcarbamate, Tetrasodium EDTA, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Carbomer, Red 4. [email protected]

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DLC Question Claims are: Softens and smoothes for radiant skin. 

Light, Non - Greasy Formula. Dermatologist Tested.  Non - Comedogenic (Won't Clog Pores). Moisturizes- Penetrates quickly, providing your skin with immediate surge of active moisture to soothe dryness without greasy feel. Improves- Helps your skin replenish its own essential fluids so skin is softer, smoother and more supple. 







Restoresthe essential abundant young skin Works to helplike restore skin to itsfluids natural beauty in and diminish the appearance of fine lines and wrinkles.

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DLC Question 

Using your knowledge of ingredients briefly the function of each ingredient in describe this product, give your best guess for the % by weight of the individual ingredients and in no more than 100 words write a label description of the properties of this product aimed to sell it to a consumer.

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DLC Question Aqua Cetyl Palmitate

Octyldodecyl Myristate Fragrance

Glycerin Paraffinum liquidum Petrolatum Cetyl Alcohol Glyceryl Hydroxystearate

Potassium Hydroxide DMDM Hydantoin Iodopropynyl Butylcarbamate Tetrasodium EDTA Acrylates/C10-30 Alkyl

Stearic Acid Steareth 100 Dimethicone

Acrylate Crosspolymer Carbomer Red 4

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DLC Question 



It is your task as head of product development to reformulate this product in order to make strong moisturising claims and to avoid using materials that are no longer perceived as appealing to consumers. There are no financial restraints on the material costs. Finally, list the reformulated product ingredients in descending order of concentration, show their approximate % in the new formula and rewrite the label copy to appeal to the target consumer.

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If you get it right!

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And if you get it wrong!

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A Basic Guide to Cosmetic and Toiletry Development.pdf

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