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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
Contents…
 Dentifrices
 Toothpaste
 Mouthwashes
 Toothpowder
Purposes
 Cleaning of tooth
 Polishing of tooth root
 Removal of strains from teeth
 Reduce incidence of tooth decay
 Reduction of mouth odors.
Qualities of good Dentifrices
 Bactericidal & Bacteriostatic
 Economical
 Non- toxic
 Properly sweetened & flavored
 Give fresh & clean sensation
 Remove food strains & foreign particles
 Clean teeth
Tooth Paste
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
Formulation of Toothpaste
 Abrasives
 Binders
 Humectants
 Detergents
 Flavoring agents
 Preservatives
 Color
 Sweetening agents
 Therapeutic agents
 Water
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%
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
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
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
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.
Types and examples of Binders
 Natural Polymers
 Carboxymethyl Cellulose (CMC)
 Carrageenans
 Xanthan Gum
 Synthetic Polymers
 Others
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
SWEETENERS
 Function:
 An important part of toothpaste flavoring
system
 Characteristics:
 Government regulations
 Examples:
 Sodium Saccharin
 Sodium Cyclamate
 Acesulfame K
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
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
Surfactants examples
 Sodium Lauryl Sulfate
 Sodium N-Lauryl Sarcosinate
 Sodium Dodecyl Benzene Sulfonate
 PEG
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
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.
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.
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.
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
Herbals used in Toothpaste
 Acacia
 Aloe
 Cinnamon
 Eucalyptus
 Fennel Seeds
 Ginger
 Holy Basil
 Mentha spicata
 Neem
 Peppermint
 Toothache Tree Seeds (Zanthoxylum armatum,
Zanthoxylum alatum)
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
MOUTHWASH
(MOUTHRINSE)
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
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.
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.
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%
Types of Mouthwashes
 Containing antibacterials,
 Containing fluoride,
 Containing minerals (astringent).
Components of Mouthwash
 Antibacterial agents ,
 Alcohol,
 Humectants,
 Surfactants,
 Flavoring agents,
 Coloring agents,
 Fluorides,
 Sweetening agents,
 Minor ingredients
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
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.
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.
 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
Components of Mouthwash
 FLUORIDES:
 Fluoride, Pyrophosphate ions, Triclosan,
Chlorhexidine, H2O2
 SWEETENING AGENTS:
 Saccharin
 MINOR INGREDIENTS:
 Preservative: Sodium benzoate, Parabens
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.
Evaluation of mouthwashes
 Antiseptic activity:
 In-vivo &
 In-vitro
 Soft tissue examination
 Deodorizing effect
 Volatile sulphur compound
 Odor measurement
 Stability study
 Determination of pH
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.

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Dental products

  • 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
  • 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
  • 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
  • 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.