This document discusses oral care products and formulations. It begins by introducing the importance of oral hygiene and common dental diseases like dental caries and periodontal disease. It then discusses the causes of oral health problems like plaque, calculus, and stains. The document outlines common dental care products like toothpastes, mouthwashes, and their ingredients and formulations. Specific formulations are provided for a sensitivity toothpaste, whitening toothpaste, and mouthwash. Requirements, manufacturing methods, and references are also covered.

1. Oral Care
&
It’s Formulations
By:-
Rakesh. G
B. Pharm 4th Year
K.R College of Pharmacy,
Bangalore.

2. Introduction
Oral care is the practice of keeping oral cavity (teeth,
gums) clean, free from infections/diseases and other
problems like bad breathe etc.
It is important that oral hygiene be carried out on regular
basis to prevent dental diseases and keep your teeth
attractive

3. Common Dental Diseases
Dental Caries
Dental caries is universal problem affecting all age groups
and all geographic locations around the globe. It is the
breakdown and destruction of the hard tissue of the tooth due
to demineralization.
Three factors influencing the dental caries:
1. Caries-producing bacteria
2. Susceptible teeth
3. Foods and drinks with caries production potential

4. Contd.
Periodontal disease
Periodontal disease is simply known as gum disease that
destroy the supporting tissues of the teeth (gums) and the
retention of the teeth in the jaw.
This disease initially starts with gingivitis caused by plaque
bacteria around the gums produce toxins and enzymes which
irritate the gums exposing the roots of the tooth
In adults, periodontal disease is more common cause of tooth
loss.

5. Causes of Oral health problems
Pellicle is formed on freshly cleaned tooth surface by deposition
and absorption of salivary proteins and is invisible to naked eye.
Plaque is formed on the pellicle of cleaned tooth surface. Plaque is
mostly invisible but can be observed as yellowish-white deposition
on teeth.
Dental Calculus: Dental plaque which mineralizes and become a
hard deposit called calculus. Calculus is porous covered by a thin
layer of plaque causing irritation of gums.
Other problems like Tooth Erosion, Stain Teeth, and Cavities

6. Dental Care Products
Toothpastes and dentifrices
Desensitizing agents
Anticaries agents
Mouthwashes
Polishing Agents
Oral antiseptic
Cement and fillers

7. Toothpastes
A toothpaste or dentifrice is a substance used with a
toothbrush for the purpose of cleaning and removal of
plaque.
Purpose:
• Minimizing plaque buildup
• Removal of stains and polishing teeth
• Anticaries action
• Reduce tooth decay problems
• Reduction of malodour

8. Requirements of Toothpaste
It should clean the teeth appropriately i.e. remove
debris, plaque and stains.
Leave fresh and clean sensation.
Should be harmless, pleasant and convenient to use.
Should be packed economically and should be stable in
storage during shelf-life.

9. Ingredients
 Cleaning and Polishing agents (Abrasives): Dental Grade Silica, Dicalcium
phosphate dihydrate, Sodium monofluorophosphate, Stannous fluoride
 Surfactants: Sodium lauryl sulphate
 Humectants: Glycerin, Sorbitol, Propylene Glycol, Xylitol
 Gelling agent: Sodium CMC, Carrageenan, Xanthan, Hydroxy ethyl cellulose
 Sweetening agent: Sodium saccharin
 Flavours: Eugenol, Cinnamon oil, Eucalyptus, aniseed
 Colours: Titanium dioxide, natural and semi synthetic colours, Sparklers
 Fluoride and Other API: These ingredients are chosen as per different types of
tooth paste formulation.
 Preservatives: Sodium benzoate, Benzoic acid, ethyl paraben
 Anti calculus agent: Zinc citrate, Zinc phosphate, Pyrophosphate

10. General Formulation
Ingredients Formula % (w/w) Examples
Abrasive 10 - 50 SiO2, Calcium carbonate
Surfactant 1.0 – 2.0 SLS
Humectant 10 - 30 Glycerin, Sorbitol, Propylene
glycol
Gelling agent 0.5 – 1.5 CMC, Carrageenan
Sweetener 0.05 – 0.5 Sodium Saccharin
Flavour 1.0 – 3.0 Spearmint, Peppermint
Fluoride < 0.5 Sodium fluoride
Other API for better
therapeutic benefit
< 10.0 Triclosan, Pyrophosphate
salts, Hydrogen peroxide
Preservative 0.5 – 1.0 Sodium benzoate, Benzoic
acid
Colour < 1.0 Titanium dioxide, sparklers
Purified water to 100

11. Manufacture methods
General Method A
Stage 1: Abrasives, Gelling agents, Powdered therapeutic agents,
Sweeteners, Colours and all powdered components are blended
with gelling agents without aggregation
Stage 2: Mix the blend with all the aqueous and liquid
components of the paste i.e. Humectants, flavours and purified
water in heavy-duty mixer

12. General Method B
Stage 1: Gelling agents is fully hydrated with purified water and all
the soluble salts are added i.e. Humectants, Gelling agents,
Powdered API, Purified water,
Stage 2: Mixing fully dispersed gel and Abrasives, Sweeteners,
Colours and other powders in heavy-duty mixer forming a
homogenous paste
Stage 3: Addition of flavours and surfactants to the paste and
mixing under vacuum
After manufacture necessary analytical tests must be done to
verify the concentration of therapeutic ingredients within the
ranges.

13. Toothpaste for Sensitivity
Ingredients % by weight
Sorbitol (70%) 33.1
Saccharin (30%) 1.0
Strontium Acetate 8.0
Potassium Acetate 4.9
Sodium N-methyl-N Cocyl Laurate 2.0
Xanthan 1.0
Glycerin 11.0
Titanium oxide 1.0
Silica (thickening) 6.5
Silica (Abrasive) 14.0
Preservative 0.1
Flavour 1.0
Water to 100.0

14. Toothpaste for whitening
Ingredients % weight
Sodium Bicarbonate 30.0
Glycerin 27.6
CMC 0.3
Silica Abrasive 14.0
Silica Thickening 4.5
SLS 0.15
Sodium lauroyl sarcosinate 0.15
Sodium Saccharin 0.9
Flavour 0.76
Sodium Fluoride 0.22
Water to 100.0

15. Mouthwashes
Mouthwashes are clear, coloured solution which is used to refresh
the breathe by swishing the product in mouth and spitting the
liquid.
It is usually composed of hydro alcohols with flavours, essential
oils and other ingredients to provide long lasting deodorising
effect.
Anionic and non-ionic surfactants can be used to remove bacteria
and debris from the mouth/
Benefits: Prevention from tooth decay, Gingivitis, Plaque and
Tartar formation.
Mouthwash contains Active & Inactive Ingredients

16. Active ingredients
Teeth Whitening agent: Sodium hexametaphosphate.
Hydrogen peroxide
Antiplaque/Antigingivitic agent: Chlorhexidine,
Cetylpyridinium chloride, essential oils, triclosan
Antitartar agent: Pyrophosphate, Polyvinyl methyl
ether/Maleic acid
Antihypersensitivity agent: Potassium nitrate, strontium
chloride
Anticaries agent: Sodium fluoride, Stannous fluoride,
sodium monofluorophosphate

17. Inactive ingredients
 Solvents: Water and Alcohol (ethanol). Alcohol shows antibacterial, astringent
activity and solubilizes the flavours
 Humectants: Increase viscosity and gives mouthfeel. Example: Glycerine, Sorbitol
 Surfactants: Provide stability to the product and also provide foaming action and
cleansing. Example: Poloxamers, polysorbates, sodium methyl coocyl taurate and
SLS
 Colours: FDA permitted water soluble dyes are used in very small quantities.
 Astringent: Deodorises which masks the bad odour of mouth. Example: Zinc
Chloride, Witch hazel, Peppermint oil
 Preservatives: Additional preservatives apart from ethanol are used to prevent the
growth of microorganisms. Example: Sodium benzoate, Methyl paraben, Benzoic
acid
 Sweeteners and Flavouring agent: Sweeteners are used for masking the taste of
alcohol and other active ingredients. Whereas, flavouring agents are used give
refreshing effect and aroma to the breathe. Example: Mint, Menthol, Eucalyptus,
thymol, Methyl salicylate

18. Formulation Mouthwash
Ingredients % weight
Ethanol 12.5
Glycerin 10.0
PVM/MA copolymer 0.2
PEG 5.0
SLS 0.2
Triclosan 0.03
Flavour 0.4
Sodium Saccharin 0.2
Fluoride 1.5
Water to 100

19. References
Poucher’s Cosmetics and Soaps, 10th edition
SlideShare
NCBI Article
https://www.ncbi.nlm.nih.gov/pubmed/15628997