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Session II 8 250714 Vijay K Gadkari - Confidential

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Toothpaste Formulations

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Product Development - PCP

Where / Which part the body product will be used? In depth knowledge / Substrate

What product is expected to deliver? Ingredients / Formulation / Consumer feedback / Market survey

Different ways in which product can be presented Product forms Toothpaste / Toothpowder / Mouthwash

How product will be delivered? Via toothbrush / Applicator / Hand washing Vs Machine washing

Suitable Packaging Bottles / Tubes / Sachets / Packaging material compatibility

Delivery of product package to consumer Advertising / Story / Claims

Validity of all of above

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Particle

Morphology

Particle

Morphology

Interactions

InteractionsCation

Solubility

Amount

Cation

Solubility

Amount

Mfg. Process

Order of Addition,

Temperature, Shear

Mfg. Process

Order of Addition,

Temperature, Shear

Binder

Selection

Binder

Selection

Toothpaste

Ingredients

Toothpaste

Ingredients

Screening

Screening

SAFETY

SAFETY RHEOLOGY

RHEOLOGY

TEXTURE

TEXTURE EXTENDEDSTABILITY

EXTENDEDSTABILITY

SENSORY

SENSORY COST

COST

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Toothpaste FormulationsIdentified by

Base

DiCalciumPhosphate

Chalk

Silica Gels

Transparent

Translucent

Opaque

Characterized by

Functionality

Tartar Control

Whitening

Sensitive Teeth

For Children

Basic requirements of aesthetics, functionality, shelf life are given

Determined by

Availability of

Ingredients Cost

Effectiveness

Type ofFormulation

Local Needs

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TYPICAL TOOTH PASTE FORMULATION

Ingredients Percentage Requirement Choice

Humectant 20 - 25 Essential Limited choice

Binder 0.50 1.50 Essential Limited choiceSweetener 0.10 0.50 Essential Saccharin ?

Abrasive 35 50 Essential Various

Foaming Agent 1.0 3.0 Optional ? SLS

Diluent 20 30 Essential Water

Flavour 0.80 1.30 Essential Various

ActiveIngredients

Optional Various

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CHALK TOOTHPASTE FORMULATIONS

1 2 3 4

INGREDIENTS

% % % %

Precipitated Chalk (Medium Density) 46.00 46.00 46.00 46.00Water 21.84 22.14 21.84 22.14

Sorbitol ( 70 % solution ) 17.00 17.00 27.00 27.00

Glycerine 10.00 10.00 --- ---

Sodium Lauryl Sulfate 2.00 2.00 2.00 2.00

Flavor 1.00 1.00 1.00 1.00

Viscarin TP 329 binder 0.90 --- 0.90 ---Viscarin TP 399 binder --- 0.60 0.60 0.60

Sodium Monofluorophosphate 0.76 0.76 0.76 0.76

Sodium Benzoate 0.30 0.30 0.30 0.30

Sodium Saccharin 0.20 0.20 0.20 0.20

Total 100.00 100.00 100.00 100.00

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CHALK TOOTHPASTE FORMULATIONS

Comparatively cheap formulation

Precipitated Chalk content can be reduced up to 35 %,if lower density chalk is used.

Natural Chalk can be partly substituted

pH of the formulation is above 9

Methyl Salicylate based flavours cannot be used

Fluoride stability is critical

Mainly prevalent in Asia, Latin America

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DICALCIUM PHOSPHATE TOOTHPASTE

FORMULATIONSINGREDIENTS 1 2 3 4

DCP 50.00 50.00 50.00 50.00

Water 22.94 17.94 23.04 18.04

Glycerine 22.00 10.00 22.00 10.00

Sorbitol (70% Solution) --- 17.00 --- 17.00

Sodium Lauryl Sulfate (SLS) 2.00 2.00 2.00 2.00

Flavour 1.00 1.00 1.00 1.00

Viscarin TP 329 binder 0.85 0.85 --- ---

Viscarin TP 348 binder --- --- 0.75 0.75

Sodium Monofluorophosphate(optional) 0.76 0.76 0.76 0.76

Tetrasodium Pyrophosphate (TSPP) 0.25 0.25 0.25 0.25

Sodium Saccharin 0.20 0.20 0.20 0.20

Total 100.00 100.00 100.00 100.00

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DICALCIUM PHOSPHATE TOOTHPASTE

FORMULATIONS

Mainly used by Colgate

DCP grade is critical, limited manufacturers

worldwide

Stabilizer like TSPP a must

Certain types of flavours deliver well

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SILICA TOOTHPASTE FORMULATIONS

Transparent Gels Translucent gels Opaque Gels

INGREDIENTS 1 2 3 4 5 6% % % % % %

Sorbitol 70 % solution 68.00 68.00 18.00 18.00 68.00 68.00Water 9.60 9.65 41.40 41.40 9.60 9.65

Glyerine --- --- 18.00 18.00 --- ---Zeodent 113 silica 11.00 11.00 11.00 11.00 11.00 11.00Zeodent 165 silica 7.00 7.00 7.00 7.00 7.00 7.00Sodium Lauryl Sulfate 2.00 2.00 2.00 2.00 2.00 2.00Flavour 1.00 1.00 1.00 1.00 1.00 1.00Viscarin TP 389 binder 0.50 --- 0.70 --- 0.50 ---Viscarin TP 399 binder --- 0.45 --- 0.55 --- 0.45Sodium Benzoate 0.50 0.50 0.50 0.50 0.50 0.50Sodium Saccharin 0.20 0.20 0.20 0.20 0.20 0.20Sodium Fluoride 0.20 0.20 0.20 0.20 0.20 0.20Titanium Dioxide (TiO2) --- --- --- --- 0.50 0.50Colour Q.S. Q.S. Q.S. Q.S. Q.S. Q.S.Total 100.00 100.00 100.00 100.00 100.00 100.00

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SILICA TOOTHPASTE FORMULATIONS

Formulation base of today & tomorrow Inert base hence preferred for therapeutic Both types of fluoride can be used Typically two grades of silica are used Use of Glycerin is almost non existent Lowest specific gravity For transparency, matching of refractive indices is critical

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Refractive IndicesMaterials Refractive Indices

Silica 1.45 1.46

Alumina 1.52 1.55

Calcium Carbonate 1.148 1.168

Sorbitol 70 % 1.455 1.461

Glycerin 1.4729

Water 1.333

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Childrens Toothpaste Silica formulations

Minimum abrasivity, hence ratio

of gelling silica & abrasive silicamodified

Typically, Glycerin as humectant

Characterized by fruity flavours,

attractive colour Packaging to complement child

positioning

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High Salt Systems

Baking Soda

Tartar Control

Sensitive

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HIGH SALT SYSTEMS

BAKING SODA TOOTHPASTE FORMULATIONS

% BY WEIGHT

INGREDIENTS Silica Pr Chalk

Sorbitol (70% Soln.) 52.00 15.00Precipitated Chalk --- 35.00Sodium Bicarbonate ( Baking Soda) 15.00 15.00Water 11.80 20.10Zeodent 113 silica 10.00 ---Glycerine --- 10.00Sident 22 S silica 6.50 ---

Sodium Lauryl Sulfate (SLS) 2.00 2.00Viscarin TP 206 binder 1.00 1.20Flavour 1.00 1.00Sodium Saccharin 0.50 0.50Sodium Benzoate 0.20 0.20Total 100.00 100.00

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TARTAR CONTROL TOOTHPASTE

FORMULATION

INGREDIENTS %

Sorbitol 26.00Water 25.76

Zeodent 113 silica 17.00Glycerine 15.00Sident 22 S silica 5.00Tetrapotassium pyrophosphate (TK PP)** 4.50Tetrasodium pyrophosphate (TSPP)** 1.50Sodium lauryl sulfate (SLS) 2.00Flavor 1.00

Viscarin

TP 206 binder 1.10Titanium dioxide (Ti02) 0.50Sodium saccharin 0.40Sodium fluoride 0.24

100.00

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Sensitive Teeth Toothpaste

Good formulations are Silica based, Chalk &Dical based formulations are also on market

Active ingredients Potassium Nitrate

Strontium Chloride

Typical levels ~ 5 %

Special gum systems necessary to stabilize theseformulations

Flavours designed to mask salt taste

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Comparative Formulations

Chalk DCP Silica B. Soda Tartar Control

Appearance Opaque Opaque Opaque /Translucent /

Transparent

Opaque Opaque

pH >9 ~8 6 - 7 >8 7 8

Abrasives % 46 50 18 17 - 35 22

Humectant % 27 22 - 27 36 - 68 25 - 52 41

Gum % 0.6 0.9 0.75 0.85 0.45 0.55 1.0 1.2 1.1

Foaming Agent 2.0 2.0 2.0 2.0 2.0Flavour 1.0 1.0 1.0 1.2 1.0

Sweetener 0.2 0.2 0.2 0.5 0.4

Water 22 18 - 23 9 - 41 12 - 20 26

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Teeth Whitening ProductsTooth Whitening = Cosmetic Dentistry

Childs decidous teeth are whiter than the adult teeth that follow Darkness is due to the changes in the mineral structure of the tooth, as the

enamel becomes more porous

Staining is due to Bacterial pigments / Foodstuffs / Tobacco

Whitening Agent Hydrogen peroxide in different forms / varying concentrations

Gentle polishing

Chemical chelation or some other non bleaching action

Action Oxidizing agent penetrates the porosity in the rod like crystal structure ofenamel & oxidizes inter prismatic stain deposits. Over a period, the dentinelayer, lying underneath the enamel is also bleached.

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Teeth Whitening Products Who should not use

Patients with many feelings, crowns and extremely dark stains

Children under 16 (as pulp chamber or nerve of tooth is enlarged)

Pregnant or lactating women

Harmful Effects Avoided / minimized by use of rubber dams to isolate gum tissues or protective gel

Temporary tooth sensitivity & occasional irritation of oral tissues

Chemical burns Rebound

Allergy

Effectiveness Can last for several months. Gets affected by smoking / tea-coffee consumption

Least effective if Teeth have white spots

Decayed or infected gums

Original tooth colour is greyish

Most effective on yellow discoloured teeth

Products Dentist dispensed professionally applied bleach whiteners

OTC home use products Trays, Strips, Toothpastes etc

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Whitening Toothpaste

Two mechanisms Physical

Chemical

Physical Special abrasives

Silica

Alumina

Chemical Bleaching Agents

Peroxides Hydrogen, Mg, Na perborate, stabilized peroxide compounds

Urea compounds

Toothpastes with ADA seal do not contain bleaches

Formulations challenging to stabilize

Special tubes used to maintain activity

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Whitening Toothpaste

Toothpaste WhiteningIngredient

Action Mechanism Effective Against

Crest

Colgate

Special SilicaAbrasives

Prevent the formation ofstains and Remove stain fromthe tooth surface

Stains

Aquafresh Sodium

Tripolyphosphate

Surfactant & Chelator Calcified Stains

Rembrandt Citroxane

Papaine

Citrate

Aluminium Oxide

Citroxane*, a patentedformula that chemicallydisrupts stain through thecombined action of papain,citrate and aluminum oxide

Papain is a proteolytic enzyme thatis thought to whiten by dissolvingthe proteinacious component of thestain. Citrate is added to enhancethe activity of papain

Other Aluminium Oxide Whiten by removing stainedpellicle on the tooth surface

Surface Stains

* Citroxain is a combination of an enzyme in the papaya plant that naturally helps clean your teeth and ascientific whitener. The two work together to remove surface stains and get teeth as white as they can bewithout bleach or other harsh chemicals

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Requirements of ADA Seal

Efficacy Data

Toothpaste manufacturers conduct extensive fluoride

testing. This testing includes

Measurement of fluoride concentration,

Fluoride release in one minute (comparable tonormal brushing habits) and

Incorporation of fluoride into enamel.

The ADA laboratory conducts some fluoride testing aswell. In addition to the fluoride data,

Two independent clinical studies must be conducteddemonstrating the ability of the toothpaste to whitenteeth.

The criteria for the clinical studies are double-blinding,

Study duration of six to eight weeks (withassessments - pretreatment, mid treatment and posttreatment) and

Control groups (at least 25 subjects per group),

Assessments of at least four maxillary anterior teethand

Color change measurements by either devices (suchas

Colorimeters or spectrophotometers) or Special color-matching scales (such as shade guides).

Safety Data and Toxicity

Whitening toothpastes submitted to the Acceptance

program must complete the following evaluations

demonstrating safety:

Measurement of enamel hardness to identify anydamage to dental enamel and dentin with extremeuse of the toothpaste;

Assessments of enamel morphology to identify anydegradation of the enamel surface;

Testing to identify any effect of the whitener onrestorative materials;

Toxicological assessments to identify cytotoxicity,mutagenicity and the potential for mucosal irritation.

In addition, periodontal health measurements must be

made and any adverse events must be reported.

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Herbal Toothpastes Formulation base can be Silica or Chalk

Herbal ingredients are generally extracts and

dosages are low Compatibility of ingredients and claim validity

important factors

Shelf life stability Colour / Discolouration

Flavour type

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High Moisture Toothpaste Recent trend

Developing markets

Competition pressures

Market reach

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HIGH MOISTURE TOOTHPASTE

FORMULATIONS - CHALK

Ingredients % %

Precipitated chalk 44.00 46.00

Water 34.90 34.90

Sorbitol 70% solution 15.00 15.00

Sodium lauryl sulfate 2.00 2.00

Zeodent 165 silica 2.00 --

Flavour 1.00 1.00

Viscarin binder 0.70 0.70

Sodium saccharin 0.20 0.20Sodium benzoate 0.20 0.20

----------- --------

100.00 100.00

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High Moisture Toothpaste

Formulations - SilicaIngredients Conventional HMTP

Binder - Viscarin 0.45 0.60

Sorbitol 70 % 68.00 30.00

Na Saccharin 0.20 0.20

Methyl Paraben 0.01

Propyl Paraben 0.01

Na mono fluorophosphate 0.76 0.76

Zeodent 165 (Gelling Silica) 7.00 7.00

Zeodent 113 (Abrasive Silica) 11.00 11.00

Flavour 1.00 0.95

Na Lauryl Sulphate 2.50 2.50

Water 9.09 56.97

Total 100.00 100.00

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Thank You

oral care 2-8 250714

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