Toothpaste Formulations

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Session II 8 250714 Vijay K Gadkari - Confidential

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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Session II 8 250714 Vijay K Gadkari - Confidential

SAFETY

RHEOLOGY TEXTURE

EXTENDED
STABILITY

SENSORY

COST

Toothpaste
Ingredients

Mfg. Process
Order of Addition,
Temperature, Shear

Binder
Selection

Session II 8 250714 Vijay K Gadkari - Confidential

Screening

Particle
Morphology

Interactions
Cation
Solubility
Amount

Toothpaste Formulations
Determined by

Availability of
Ingredients

Cost

Effectiveness

Type of
Formulation

Local Needs

Identified by
Base
DiCalcium
Phosphate
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

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Session II 8 250714 Vijay K Gadkari - Confidential

TYPICAL TOOTH PASTE FORMULATION

Ingredients

Percentage

Requirement

Choice

Humectant

20 - 25

Essential

Limited choice

Binder

0.50 1.50

Essential

Limited choice

Sweetener

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

Optional

Various

Active
Ingredients

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Session II 8 250714 Vijay K Gadkari - Confidential

CHALK TOOTHPASTE FORMULATIONS

1

46.00
22.14
17.00
10.00
2.00
1.00
--0.60
0.76
0.30
0.20
100.00

46.00
21.84
27.00
--2.00
1.00
0.90

46.00
22.14
27.00
--2.00
1.00
--0.60
0.76
0.30
0.20
100.00

INGREDIENTS

Precipitated Chalk (Medium Density)

Water
Sorbitol ( 70 % solution )
Glycerine
Sodium Lauryl Sulfate
Flavor
Viscarin TP 329 binder
Viscarin TP 399 binder
--Sodium Monofluorophosphate
Sodium Benzoate
Sodium Saccharin
Total

46.00
21.84
17.00
10.00
2.00
1.00
0.90
0.60
0.76
0.30
0.20
100.00

0.76
0.30
0.20
100.00

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Session II 8 250714 Vijay K Gadkari - Confidential

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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Session II 8 250714 Vijay K Gadkari - Confidential

DICALCIUM PHOSPHATE TOOTHPASTE

FORMULATIONS
INGREDIENTS

DCP
50.00
Water
22.94
Glycerine
22.00
Sorbitol (70% Solution)
--Sodium Lauryl Sulfate (SLS)
2.00
Flavour
1.00
Viscarin TP 329 binder
0.85
Viscarin TP 348 binder
--Sodium Monofluorophosphate(optional) 0.76
Tetrasodium Pyrophosphate (TSPP)
0.25
Sodium Saccharin
0.20
Total

100.00

50.00
17.94
10.00
17.00
2.00
1.00
0.85
--0.76
0.25
0.20

50.00
23.04
22.00
--2.00
1.00
--0.75
0.76
0.25
0.20

50.00
18.04
10.00
17.00
2.00
1.00
--0.75
0.76
0.25
0.20

100.00

100.00

100.00
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Session II 8 250714 Vijay K Gadkari - Confidential

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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Session II 8 250714 Vijay K Gadkari - Confidential

SILICA TOOTHPASTE FORMULATIONS

INGREDIENTS
Sorbitol 70 % solution
Water
Glyerine
Zeodent 113 silica
Zeodent 165 silica
Sodium Lauryl Sulfate
Flavour
Viscarin TP 389 binder
Viscarin TP 399 binder
Sodium Benzoate
Sodium Saccharin
Sodium Fluoride
Titanium Dioxide (TiO2)
Colour
Total

Transparent Gels
1
2
%
%
68.00
68.00
9.60
9.65
----11.00
11.00
7.00
7.00
2.00
2.00
1.00
1.00
0.50
----0.45
0.50
0.50
0.20
0.20
0.20
0.20
----Q.S.
Q.S.
100.00
100.00

Translucent gels
3
4
%
%
18.00
18.00
41.40
41.40
18.00
18.00
11.00
11.00
7.00
7.00
2.00
2.00
1.00
1.00
0.70
----0.55
0.50
0.50
0.20
0.20
0.20
0.20
----Q.S.
Q.S.
100.00
100.00

Opaque Gels
5
6
%
%
68.00
68.00
9.60
9.65
----11.00
11.00
7.00
7.00
2.00
2.00
1.00
1.00
0.50
----0.45
0.50
0.50
0.20
0.20
0.20
0.20
0.50
0.50
Q.S.
Q.S.
100.00 100.00
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Session II 8 250714 Vijay K Gadkari - Confidential

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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Session II 8 250714 Vijay K Gadkari - Confidential

Refractive Indices
Materials

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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Session II 8 250714 Vijay K Gadkari - Confidential

Childrens Toothpaste
Silica formulations
Minimum abrasivity, hence ratio
of gelling silica & abrasive silica
modified
Typically, Glycerin as humectant
Characterized by fruity flavours,
attractive colour
Packaging to complement child
positioning
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Session II 8 250714 Vijay K Gadkari - Confidential

High Salt Systems

Baking Soda
Tartar Control
Sensitive

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Session II 8 250714 Vijay K Gadkari - Confidential

HIGH SALT SYSTEMS

BAKING SODA TOOTHPASTE FORMULATIONS

INGREDIENTS

% BY WEIGHT
Silica
Pr Chalk

Sorbitol (70% Soln.)

Precipitated Chalk
Sodium Bicarbonate ( Baking Soda)
Water
Zeodent 113 silica
Glycerine
Sident 22 S silica
Sodium Lauryl Sulfate (SLS)
Viscarin TP 206 binder
Flavour
Sodium Saccharin
Sodium Benzoate
Total

52.00
--15.00
11.80
10.00
--6.50
2.00
1.00
1.00
0.50
0.20
100.00

15.00
35.00
15.00
20.10
--10.00
--2.00
1.20
1.00
0.50
0.20
100.00
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Session II 8 250714 Vijay K Gadkari - Confidential

TARTAR CONTROL TOOTHPASTE

FORMULATION
INGREDIENTS
Sorbitol
Water
Zeodent 113 silica
Glycerine
Sident 22 S silica
Tetrapotassium pyrophosphate (TKPP)**
Tetrasodium pyrophosphate (TSPP)**
Sodium lauryl sulfate (SLS)
Flavor
Viscarin TP 206 binder
Titanium dioxide (Ti02)
Sodium saccharin
Sodium fluoride

%
26.00
25.76
17.00
15.00
5.00
4.50
1.50
2.00
1.00
1.10
0.50
0.40
0.24
100.00
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Session II 8 250714 Vijay K Gadkari - Confidential

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 these

formulations
Flavours designed to mask salt taste
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Session II 8 250714 Vijay K Gadkari - Confidential

Comparative Formulations
Chalk

DCP

Silica

B. Soda

Tartar Control

Appearance

Opaque

Opaque

Opaque /
Translucent /
Transparent

Opaque

Opaque

pH

>9

~8

6-7

>8

78

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

2.0

Flavour

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

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Session II 8 250714 Vijay K Gadkari - Confidential

Teeth Whitening Products

Tooth 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 of
enamel & oxidizes inter prismatic stain deposits. Over a period, the dentine
layer, lying underneath the enamel is also bleached.

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Session II 8 250714 Vijay K Gadkari - Confidential

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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Session II 8 250714 Vijay K Gadkari - Confidential

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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Session II 8 250714 Vijay K Gadkari - Confidential

Whitening Toothpaste
Toothpaste

Whitening
Ingredient

Action Mechanism

Effective Against

Crest
Colgate

Special Silica
Abrasives

Prevent the formation of

stains and Remove stain from
the tooth surface

Stains

Aquafresh

Sodium
Tripolyphosphate

Surfactant & Chelator

Calcified Stains

Rembrandt

Citroxane
Papaine
Citrate
Aluminium Oxide

Citroxane*, a patented
formula that chemically
disrupts stain through the
combined action of papain,
citrate and aluminum oxide

Papain is a proteolytic enzyme that

is thought to whiten by dissolving
the proteinacious component of the
stain. Citrate is added to enhance
the activity of papain

Other

Aluminium Oxide

Whiten by removing stained

pellicle on the tooth surface

Surface Stains

* Citroxain is a combination of an enzyme in the papaya plant that naturally helps clean your teeth and a
scientific whitener. The two work together to remove surface stains and get teeth as white as they can be
without bleach or other harsh chemicals
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Session II 8 250714 Vijay K Gadkari - Confidential

Requirements of ADA Seal

Efficacy Data

Safety Data and Toxicity

Toothpaste manufacturers conduct extensive fluoride

testing. This testing includes

Measurement of fluoride concentration,

Fluoride release in one minute (comparable to

normal brushing habits) and

Incorporation of fluoride into enamel.

Whitening toothpastes submitted to the Acceptance

program must complete the following evaluations
demonstrating safety:

The ADA laboratory conducts some fluoride testing as

well. In addition to the fluoride data,

Two independent clinical studies must be conducted

demonstrating the ability of the toothpaste to whiten
teeth.

The criteria for the clinical studies are doubleblinding,

Study duration of six to eight weeks (with

assessments - pretreatment, mid treatment and post
treatment) and

Control groups (at least 25 subjects per group),

Assessments of at least four maxillary anterior teeth

and

Color change measurements by either devices (such

as

Measurement of enamel hardness to identify any

damage to dental enamel and dentin with extreme
use of the toothpaste;

Assessments of enamel morphology to identify any

degradation of the enamel surface;

Testing to identify any effect of the whitener on

restorative 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.

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

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Session II 8 250714 Vijay K Gadkari - Confidential

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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Session II 8 250714 Vijay K Gadkari - Confidential

High Moisture Toothpaste

Recent trend
Developing markets
Competition pressures
Market reach

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Session II 8 250714 Vijay K Gadkari - Confidential

HIGH MOISTURE TOOTHPASTE

FORMULATIONS - CHALK
Ingredients
Precipitated chalk
Water
Sorbitol 70% solution
Sodium lauryl sulfate
Zeodent 165 silica
Flavour
Viscarin binder
Sodium saccharin
Sodium benzoate

%
44.00
34.90
15.00
2.00
2.00
1.00
0.70
0.20
0.20
----------100.00

%
46.00
34.90
15.00
2.00
-1.00
0.70
0.20
0.20
-------100.00
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Session II 8 250714 Vijay K Gadkari - Confidential

High Moisture Toothpaste

Formulations - Silica
Ingredients
Binder - Viscarin
Sorbitol 70 %
Na Saccharin

Conventional

HMTP

0.45

0.60

68.00

30.00

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

11.00

11.00

Flavour

1.00

0.95

Na Lauryl Sulphate

2.50

2.50

Water

9.09

56.97

100.00

100.00

Zeodent 113 (Abrasive Silica)

Total
Session II 8 250714 Vijay K Gadkari - Confidential

27

Thank You

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Session II 8 250714 Vijay K Gadkari - Confidential