1. ORAL CARE PRODUCTS-
DENTAL PRODUCTS
Dr. Prashant L. Pingale
Associate Professor,
Dept. of Pharmaceutics,
GES’s Sir Dr. M. S. Gosavi College of
Pharm. Edu. and Research,
Nashik-422005

2. Contents…
 Dentifrices
 Toothpaste
 Mouthwashes
 Toothpowder

3. Purposes
 Cleaning of tooth
 Polishing of tooth root
 Removal of strains from teeth
 Reduce incidence of tooth decay
 Reduction of mouth odors.

4. Qualities of good Dentifrices
 Bactericidal & Bacteriostatic
 Economical
 Non- toxic
 Properly sweetened & flavored
 Give fresh & clean sensation
 Remove food strains & foreign particles
 Clean teeth

5. Tooth Paste

6. Formulation of a toothpaste
 FDA regulations.
 Cleaning agent i.e. the “detergent" that is going
to remove food particles and clean the teeth,
 Abrasives to assist in the cleaning process.
 Flavor, must be pleasant, and must be
associated with a "clean" feeling. (mint flavors
are so popular)
 Consistency
 Foaminess

7. Formulation of Toothpaste
 Abrasives
 Binders
 Humectants
 Detergents
 Flavoring agents
 Preservatives
 Color
 Sweetening agents
 Therapeutic agents
 Water

8. Ingredient Percentage
Abrasives 20 – 40 %
Humectants 20 – 40 %
Water 20 – 40 %
Foaming agent 1 – 2 %
Binding agent Upto 2%
Flavor Upto 2%
Sweetening agents Upto 2%
Therapeutic agents Upto 5%
Color / Preservatives Less than 1%

9. Active Ingredients Inactive Ingredients
Fluoride
Antibacterial agents, most often
Triclosan is used to control plaque
Desensitizing agents
Anti-tartar agents
Sodium bicarbonate (baking soda)
Enzymes, to enhance the
antibacterial properties of saliva
Xylitol, a non-sugar sweetener,
which reduces levels of cariogenic
(decay causing) bacteria in the
mouth and enhances
remineralization
Water
Detergents, to make the
toothpaste foam
Binding agents
Humectants to retain moisture
Flavoring, sweetening, and
coloring agents like peppermint,
spearmint, cinnamon, wintergreen,
and menthol
Preservatives
Abrasives for cleaning and
polishing

10. ABRASIVE
 Also called as polishing agents
 Cleaning and polishing (function)
 Solid, insoluble particles
 Potential for fluoride interaction
 Causing abrasion.
 Used in dentistry for abrading, grinding, polishing
 Remove debris & residual strain from teeth

11. Types and examples of Abrasives
 Phosphates
 help the product to leave the teeth looking white and feeling clean
 Dicalcium phosphate dihydrate
 Calcium pyrophosphate
 Carbonates
 have been used for nearly 100 years to make a variety of
products and environments fresh-smelling, in addition to their
abrasive properties.
 Sodium bicarbonate: baking soda.
 Calcium carbonate: chalk
 Silicas
 are one of many products in the hydrated silica family, available in
many particle sizes & characteristics

12. BINDERS
 To provide consistency and shape.
 Binders keep the solid phase properly suspended
in the liquid phase to prevent separation of the
liquid phase out of the toothpaste.
 They also provide body to the dentifrice, especially
after extrusion from the tube onto the toothbrush.
 A binder or thickener can prevent the toothpaste
from drying out.
 They control the viscosity and contribute to give the
toothpaste a creamy consistency.

13. Types and examples of Binders
 Natural Polymers
 Carboxymethyl Cellulose (CMC)
 Carrageenans
 Xanthan Gum
 Synthetic Polymers
 Others

14. HUMECTANTS
 Function:
 Used in toothpaste to prevent loss of water and subsequent
hardening of the product upon exposure to air.
 Characteristics:
 Affect taste perception
 Proper usage level produce a clear translucent toothpaste
 Examples:
 Glycerine
 Sorbitol
 Polyethylene Glycol
 Xylitol
 Propylene Glycol

15. SWEETENERS
 Function:
 An important part of toothpaste flavoring
system
 Characteristics:
 Government regulations
 Examples:
 Sodium Saccharin
 Sodium Cyclamate
 Acesulfame K

16. FLAVORS
 Function:
 Improve taste of toothpaste
 Characteristics:
 One of the most important factors for consumer
 A mixture of flavoring agents
 Examples:
 Mint
 Fruity
 Cinnamon
 Own licensed

17. SURFACTANTS
 Function:
 Produce foam and aid in the removal of
debris
 Emulsifies flavoring agents
 Characteristics:
 May react with other toothpaste components
 High level may cause mucosal irritation

18. Surfactants examples
 Sodium Lauryl Sulfate
 Sodium N-Lauryl Sarcosinate
 Sodium Dodecyl Benzene Sulfonate
 PEG

19. FLUORIDE ACTIVES
 Function:
 Increase resistance to enamel solubility
 Characteristics:
 Regulated by Government
 Restricted usage level
 Soluble fluoride ion is essential for activity
 Examples:
 Sodium Fluoride NaF
 Sodium Monofluorophosphate MFP
 Stannous Fluoride SnF2

20. PRESERVATIVES
 Function:
 Prevent the growth of micro-organisms in toothpastes.
 Characteristics:
 Non-irritating, compatible with other ingredients,
 Should be used in combination.
 Examples:
 Sodium benzoate,
 Methylparaben,
 Propylparaben.

21. SOLVENTS
 Water is the most common solvent used
in toothpaste.
 It dissolves the ingredients and allows
them to be mixed.
 Alcohol is used in mouth rinses as a
solvent and taste enhancer.

22. THERAPEUTIC AGENTS
 One or more therapeutic agents are usually added to
toothpastes.
 Most toothpaste today contain fluorides to prevent
caries.
 Recently there has been a development of 8
different toothpastes with additional purposes, such
as stain and calculus removal, and prevention of
gingivitis, sensitive teeth and gum problems.

23. Examples of therapeutic
agents
 Anti-caries agents
 Fluoride
 Anti-plaque agents
 Sodium Lauryl Sulphate (SLS) ,
 Triclosan,
 Metal-ions: zinc (Zn++) & stannous (Sn++)
 Anti-calculus agents
 Pyrophosphate,
 Zinc
 Anti-dentine hypersensitivity agents
 Potassium salts
 Whitening agents
 Dimethicone, Papain

24. Herbals used in Toothpaste
 Acacia
 Aloe
 Cinnamon
 Eucalyptus
 Fennel Seeds
 Ginger
 Holy Basil
 Mentha spicata
 Neem
 Peppermint
 Toothache Tree Seeds (Zanthoxylum armatum,
Zanthoxylum alatum)

25. EVALUATION OF TOOTHPASTE
 Test for abrasiveness
 Particle size
 Cleansing property
 Test for fluoride
 Consistency
 pH of the product
 Foaming character & stability of foam
 Limit test for arsenic & lead
 Volatile matters & moisture
 Test for net content (commercial basis)
 Effect of special ingredients
 Test for active or therapeutic ingredients

26. MOUTHWASH
(MOUTHRINSE)

27. Definition
 Non-sterile aqueous solution.
 Used mostly for its:
 deodorant,
 refreshing or
 antiseptic effect
 Mouthwashes or rinses are designed to:
 reduce oral bacteria,
 remove food particles,
 temporary reduce bad breath and
 provide a pleasant taste

28. Classification
 Cosmetic
 Therapeutic
 Combination of both
 Cosmetic:
 commercial OTC products
 help to remove oral debris before or after brushing,
 temporary suppress bad breath,
 diminish bacteria in the mouth and
 refresh the mouth with a pleasant taste.

29. Classification
 Therapeutic:
 may be sold as OTC product
 have the benefits of their cosmetic counterparts
 help remove oral debris before or after brushing
 temporarily suppress bad breath
 diminish bacteria in the mouth
 refresh the mouth with a pleasant taste
 contain an added active ingredient that helps protect against
some oral diseases
 e.g. fluoride or chlorhexidine, that help protect against some
oral diseases.

30. Classification
 The amount of the different components in mouthwashes
varies from product to product.
 Some practically have the same composition as
toothpastes, although they do not contain abrasives.
 Distinct from toothpastes most mouth rinses contain
alcohol, as a preservative and a semi-active ingredient.
 The amount of alcohol is usually ranging from 10 – 20%

31. Types of Mouthwashes
 Containing antibacterials,
 Containing fluoride,
 Containing minerals (astringent).

32. Components of Mouthwash
 Antibacterial agents ,
 Alcohol,
 Humectants,
 Surfactants,
 Flavoring agents,
 Coloring agents,
 Fluorides,
 Sweetening agents,
 Minor ingredients

33. Components of Mouthwash
 ANTIBACTERIAL AGENTS:
 Cetyl pyridinium chloride (CPC): 0.05%
 Chlorhexidine : 0.12%
 Triclosan : 0.03%
 Saline : 0.9%
 Other antibacterial agents:
 Cinnamon oil, cassia, clove, eucalyptus, thyme,
peppermint, anise.
 Menthol, thymol and methyl salicylate

34. Components of Mouthwash
 ALCOHOL:
 present in the range of 10%-20%.
 enhances the flavour, provides sharpness to the
taste, aids in masking.
 unpleasant taste of active ingredients,
 functions as a solubilizing agent for some flavoring
agents.
 acts as a preservative.

35. Components of Mouthwash
 HUMECTANTS:
 glycerin & sorbitol
 5% to 20% of the mouthwash.
 these agents increases the viscosity of the
preparation & enhances the sweetness of
the product.

36.  SURFACTANTS:
 They aid in the solublization of flavors & in the
removal of debris by providing foaming action.
 Poloxamer 407 & 338, Polysorbate 80.
 Level 0 to 1%
 FLAVOURING AGENTS:
 They are used to overcome disagreeable tastes.
 COLOURING AGENTS:
 These are also used in these products.
Components of Mouthwash

37. Components of Mouthwash
 FLUORIDES:
 Fluoride, Pyrophosphate ions, Triclosan,
Chlorhexidine, H2O2
 SWEETENING AGENTS:
 Saccharin
 MINOR INGREDIENTS:
 Preservative: Sodium benzoate, Parabens

38. DIRECTION FOR LABELLING
 For external use only.
 Not to be swallowed in large amount.
 Rinse vigorously around teeth & gums & then spit out.
 Mouthwash remains in contact with oral mucosa for a short period
of time.
Storage
 Store below 250 C & protect from light.
Container
 Mouthwashes are dispensed in (white) fluted bottles.

39. Evaluation of mouthwashes
 Antiseptic activity:
 In-vivo &
 In-vitro
 Soft tissue examination
 Deodorizing effect
 Volatile sulphur compound
 Odor measurement
 Stability study
 Determination of pH

40. Marketed Products
 Clohex (Chlorhexidine Mouthwash B.P.) By
DRL
 Senquel – ad (Potassium nitrate with Sodium
fluoride mouthwash) By DRL
 Listerine Mouthwash By Pfizer.
 Colgate Plax Mouthwash By P & G.