Dental Products

Md. Sohel Rana

Lecturer,
Department of Pharmacy
State University of Pharmacy
Introduction
 Tooth
Tooth are calcified structures firmly fixed in the
bony socket in the upper and lower jaws.

They are distinguished macroscopically by two

parts:

1. The Roots: It is the portion of tooth embedded

in the gum

2. The Crown: It is the portion of tooth above

the gum
 Structure of the Tooth
A tooth is
composed of 4
types of tissues:

i. Enamel
ii. Cementum
iii. Dentin
iv. Dental Pulp
Structure of the Tooth
 Enamel
 The outer surface of the crown
 Enamel is the hardest tissue of the body.
 Composition: It is highly mineralized and contains-
1) Inorganic material: 96%, The chief inorganic constitute
of enamel is Hydroxyapatite (3Ca3(PO4)2.Ca(OH)2)
and the rest being keratin and water.
2) Organic material: 0.8%, The organic constituents
include-1/4 insoluble keratin protein, 1/8 citric acid and
the remaining is other soluble protein and a little
amount of mucopolysaccharide.
3) Water: 2-3%
4) F, Cl, S, K,Sr etc.
 Cementum

 The bone-like substance that covers the root is

cementum.
 It is in the cellular part, but no blood vessel penetrates
the tissue.
 It is approximately 45% inorganic material (mainly
hydroxyapatite), 33% organic material (mainly
collagen) and 22% water.
 Dental Pulp
 Itis the tissue that is occupied in the so-called
pulp chamber in the center of the tooth

 This tissue contains blood vessels and nerves

that enter the tooth from a hole at the apex of
the root.
 Dentin
The layer of material beneath the enamel
 The dentin matrix is perforated by a number of tiny canals
which radiate from the pulp cavity to the surface, they are the
dentine tubules.
 Composition:
Dentine is less mineralized than enamel. It contains-
➢ Minerals: 70% ( Hydroxyapatite: approximately 70%)
➢ Others: 30% (Organic materials and some amount of water)
➢ Organic materials: Collagen (18%)
➢ Other proteins and peptides (1-2%)
➢ Citric acid (1%)
➢ Some amount of glycoprotein and mucopolysaccharide.
➢The most remarkable element present in dentin is fluorine.
 Dentin vs Enamel
Dentine Enamel

Hardness
Knoop’s scale 55-60 250-300
Moh’s scale 2 4
Specific gravity 2.14 2.9-3.0

Inorganic matter (%) 68 96

Phosphorus (%) 11.5 16.5

Calcium (%) 24 35

Fluorine (ppm) 240 100

Protein (%) 20 1

Protein Type collagen Keratin

DENTIFRICES
DENTIFRICE:
Dentifrices are the preparations that are used for
the purpose of cleaning the accessible surface of
the teeth. They are prepared as toothpaste or gel
or tooth powder.

FUNCTIONS:
1. Cleansing of teeth.
2. Prevention of formation of plaque, calculus.
3. Removal of trapped food particles and bad odor.
4. Reduction of tooth decay and different dental
diseases.
5. Maintaining healthy gingiva & polished
appearance of teeth.
BASIC REQUIREMENTS OF DENTIFRICE
1. When used properly with an efficient toothbrush, it
should remove food debris, plaque, stain etc.
2. It should leave the mouth with a fresh clean
sensation. (MINT provides fresh sensation & also
saliva stimulation. Sufficient foam formation is
necessary to have the feeling that the teeth are
cleaned properly.)
3. Its cost should be reasonable for regular use &
should be pleasant, convenient, and harmless to use.
4. Should be stable during storage & should not dry
out during use. So humectant is used in high
concentrations ( up to 30%).
 BASIC REQUIREMENTS OF DENTIFRICE

5. Its consistency should be optimum so that it can

be easily squeezed out of the tube to spread on
the brush but should not sink into it.
6. It should give a polishing effect on the enamel.
It should exert minimum tooth abrasion with
maximum cleansing efficacy.
7. It should be non-toxic, should not sensitize the
buccal membrane.
 WHY TOOTHPASTE IS PREFERABLE
OVER TOOTH POWDER OR GEL?
Tooth powder, though cheap, contains high amount of abrasive
materials, which may impart dullness to tooth enamel, may
cause scratching of teeth.
Gel contains high amount of soluble materials. Though abrasive
reaction is not too much, it may sink through brush & may not
be distributed properly in the mouth remaining in a particular
area.
On the other hand, Toothpaste contains high solid content which
does not sink in brush. For toothpaste:
1. It is easy to take measured quantity & spread it on the
toothbrush.
2. There is low spoilage & wastage.
3. It has attractive consistency & is properly distributed in all
portions of the mouth.
 The Two Most Common Harmful
Bacteria
Streptococcus mutans is the bacteria you've probably
heard the most about. It lives in your mouth and feeds
on the sugars and starches that you eat. That alone
wouldn't be so bad, but as a by-product of its ravenous
appetite, it produces enamel-eroding acids, which
make streptococcus mutans the main cause of tooth
decay in humans.
 The Two Most Common Harmful
Bacteria (Cont..)
Porphyromonas gingivalis is usually not present in a
healthy mouth, but when it does appear, it has been
strongly linked to periodontitis.
Periodontitis is a serious and progressive disease
that effects the tissues and the alveolar bone that
support the teeth.
It is not a disease to be taken lightly. It can cause
significant dental pain, and can eventually lead to
tooth loss.
 COMMONLY USED FORMULATION
AIDS
ABRASIVES: Abrasives are solid dentifrice cleaning agents.
FUNCTIONS: Removal of food debris & residual stains from the
teeth.
PROPERTIES:
1.They should be compatible with other ingredients.
2.They Should be non-toxic.
3.They should be free from earthy taste.
4.They should provide maximum cleansing with minimum abrasion.
COMMONLY USED ABRASIVES: Calcium carbonate, dicalcium
phosphate dihydrate, calcium phosphate anhydrous, hydrated
alumina, silica & silicates.
AMOUNTS USED: 15-50% in tooth paste, in tooth powder 90-95%
may be used. High percentage is used to maintain the consistency of
tooth paste.
a) CALCIUM CARBONATE: Chalk or calcium carbonate
is available in a number of grades varying in crystalline
form, particle size & surface area. The two common
crystalline forms are:
1.Aragonite
2.Calcite
particle size in range of 2-20 micron is normally used.

PROBLEMS:
1.All chalks gives an alkaline reaction to tooth pastes. It may
also cause corrosion of aluminium tubes. To prevent this
sodium silicate may be added.
2.Chalk sometimes causes scratching on enamel surface. To
overcome this, small proportion of chalk with a larger
proportion of one of the less abrasive phosphates are used.
3.Up to the mark shining is not obtained with calcium
carbonate. So combinations of phosphates are used.
b) DICALCIUM PHOSPHATE DIHYDRATE:
BENEFITS:
1. pH value is maintained within 6-8. For ideal toothpaste pH should be
slightly alkaline as acidic pH will promote tooth decay.
2. It is better than calcium carbonate with minimum abrasion & maximum
cleansing.
3. It has better taste than CaCO3.
PROBLEM: It is present in metastable form, which converts to anhydrous
form. So consistency may be changed. Therefore Calcium phosphate
anhydrous is used.
c) CALCIUM PHOSPHATE ANHYDROUS: It has better abrasive
property & stability profile than dicalcium phosphate dihydrate & used
in small amount.
d) TRI CALCIUM PHOSPHATE & CALCIUM PYROPHOSPHATE:
Solubility is less than other phosphates stated above. Fluoride based tooth
paste is most compatible with these two forms.
2. SURFACTANT: (1-2% ) Tooth cleaning is essentially a
detergent process. So all tooth pastes incorporate a SAA.

FUNCTIONS:
1.Clean the teeth by forming emulsion.
2. Produce large amount of foam.
3.Remove solid particles by suspending action. The
cleansing action is obtained by lowering the surface
tension.

COMMONLY USED SURFACTANTS: Sodium lauryl

sulfate, Sodium lauryl sarcosinate, Mono glyceride
sulphate, Mono glyceride sulfonate etc. Sodium lauryl
sarcosinate has anti enzyme properties.

At conc 0.03% it inhibits hexokinase enzyme of bacteria & at

conc 0.025% inhibits bacterial flora of human saliva.
3.HUMECTANTS: (10-15%) Humectants are used in
the tooth paste to retain the moisture, when the paste
is exposed to air thus preventing the paste from
hardening. It also gives some degree of plasticity to
the paste.

COMMONLY USED HUMECTANTS: Glycerol

(50%), Sorbitol (70%), Propylene glycol etc.

4.BINDERS or GELLING AGENTS:(1-2.5%) They

are used to increase the viscosity. They also modifies
the dispersibility & consistency. Gel contains high
amount of it.

COMMONLY USED BINDERS: CMC, CMC-Na,

MC, HEC, Carbopol. Acacia & agar is avoided.
5.SALIVA STIMULATING AGENTS (5-7%): They are
used to enhance saliva secretion which helps in the foam
formation.
COMMONLY USED AGENTS: Mannitol, Sorbitol etc.

6. SWEETENING AGENT: (0.1-0.5%) It is used to mask the

unpleasant taste of Abrasives & Polishing agents. They are
also used to stimulate saliva secretion.
COMMONLY USED AGENTS: Saccharine-Na (0.1-0.2%),
Sorbitol, Mannitol, Glycerol etc.

7. POLISHING AGENT (5%) It is used to obtain sufficient

sheen in the enamel.
COMMONLY USED AGENTS: MgO, MgCO3, ZnO,
Ultrafine grade of precipitated CaCO3
8. FLAVORING AGENTS: It leaves a pleasant,
clean & refreshing feeling in the mouth after use. It
also gives distinctive taste to the product.
COMMONLY Spearmint, peppermint, clove,
cinnamon, menthol, eucalyptus etc are used.
(CLOVE is a good dental analgesic)

9. PRESERVATIVES (0.1-0.5%): To prevent the

growth of microorganisms. (As the pH of tooth paste
is slightly alkaline, it may act as a suitable medium
for the growth of microbes. So preservatives are
used)

COMMONLY USED AGENTS: Methyl Paraben &

Propyl Paraben, sodium benzoate
10. PROPHYLACTIC AGENT: (0.9-1 ppm)
1. Anti caries agent (Fluorides)
2. Antibiotics (Erythromycin, Penicillin)
3.Anti histamines (Promethazine HCl,
Chlorpheniramine maleate)
4.Anti haemorrhagics: (Vit K, Thrombin)
5.Local anesthetics(Procaine, benzocaine, lidocaine)
6.Vitamins: (Vit C in gum infection)

11. Stain remover: Those who consume alcohol or

nicotine develop stain.(Abrasive material, Pumice
stone etc)
 AN EXAMPLE OF STANDARD
TOOTHPASTE FORMULATION
INGREDIENTS AMOUNT (%) JUSTIFICATION
Calcium phosphate anhydrous 15-50% Abrasive

Glycerol & sorbitol(70%) 10-30% Humectant, viscosity

modifier.
Carboxy methyl cellulose 1-1.25% Binder
Mannitol or Sorbitol 5-7% Saliva stimulating agent
MgO & ZnO <5% Polishing agent
Sodium or Stannous fluoride 1 ppm Prophylactic agent
Methyl paraben + propyl paraben 1-.5% Preservative
Sodium lauryl sulfate 1-2% Surfactant
Saccharine sodium 0.1-0.2% Sweetener
menthol 1-1.5% Flavor, Antiseptic, Local
anesthetic
Color Q.S For aesthetic value
Water Q.S Vehicle
Manufacturing
&
ESSENTIAL QUALITIES OF
TOOTH PASTE
• CONSISTENCY: Consistency should be
optimum & should be free from gritty particle,
• pH: slightly alkaline
• TASTE: Mild sweet taste.
• FOAMING: Adequate
• REACTION with container & cap should be
minimum
• STABILITY: up to 2 years
• ABRASIVE & CLEANING ACTION:
Adequate
 MANUFACTURING OF TOOTH PASTE
1) DISPERSION OF THE ABRASIVE IN THE
BINDER:
The binder is pre wetted with the humectant, then it is
dispersed in the liquid portion containing aqueous phase
& preservative & allowed to swell to form a
homogenous gel.
The swelling may be accelerated by heat & agitation.
The homogenous gel is pumped into a suitable mixer &
the solid abrasive is added slowly with agitation until
uniform paste is formed.
The flavor & surfactant are added last & distributed
uniformly. Then it is kept for 24-72 hours, de-aerated &
tubed.
2) HYDRATION OF GELLING AGENT or BINDER

In this method, the binder is premixed with solid

abrasives & introduced simultaneously with an aqueous
solution of the humectant, preservative & sweetening
agent into suitable mixer.
After mixing to a homogenous paste, the flavor &
detergent are added, the mixing is completed & the
resulting paste is finished as described in the 1st method.
If color is to be added, it should be mixed with sorbitol
or glycerol. It should not be added directly to the base as
they may cause the air pocket formation, which may
increase volume.
 EVALUATION OF TOOTH PASTE
(QUALITY CONTROL)
1. CONSISTENCY: It should be of such consistency that a
single thumb pressure is enough to eject the paste out of the
tube. Again it should not sink in the brush. The consistency
is maintained by proper selection of binding agents,
humectants etc.
2. PARTICLE SIZE DISTRIBUTION: Micronized particle
is used for abrasiveness & ultrafine grade is used for
polishing effect. They should be free from gritty particle.
Paste is taken on watch glass & checked by eye or finger
for the presence of gritty particle.
3. pH: The pH should be slightly alkaline(7-8). To measure
the pH of the tooth paste, 20% solution of the paste is made
& the pH is checked. If the pH is too acidic or too alkaline,
it should be adjusted
 EVALUATION OF TOOTH PASTE
(QUALITY CONTROL)
4. FOAM FORMING CAPACITY: There are two purpose
for foaming.
a. To produce foam for cleaning purpose.
b. Psychological acceptance of the consumer.
10 gm tooth paste is taken in a measuring cylinder & 70 ml
water is added, shaken well & the volume of foam is
measured. Foam forming capacity should be adequate.
5. POLISHING EFFECT: Polishing effect is evaluated by
observing the light reflection after brushing a model teeth.
6. CLEANSING PROPERTY: It is determined by the
abrasiveness & luster of the ingredients, amount of
abrasive, type & quality of foaming & polishing agents.
This cleansing action must be achieved in short time & at
body temperature.
 EVALUATION OF TOOTH PASTE
(QUALITY CONTROL)
7. TASTE: The taste is an important factor for consumer
acceptability. Taste should be sweet & palatable. It should
not be bitter, pungent, irritating to the oral mucosa. Taste
is governed by sweeteners & flavoring agent. It is
observed by touching the preparation with tongue.
8. APPEARANCE: The final appearance is very important
for consumer acceptability & is governed by color, texture,
package, product stability etc.
9. MEDICAMENT: The concentration of medicament
should be measured. If fluoride is to be used in the tooth
paste.
10. MICROBIOLOGICAL ASSAY: The slight alkalinity
can favor the growth of micro organisms. Sterile nutrient
agar medium is taken & paste is added to it. Then it is
poured into a petridish & incubated. Colony formation will
indicate the presence of micro organisms.
 MANUFACTURING PROBLEM
1.DURING MANUFACTURING
A) PRESENCE OF COARSE PARTICLE: If the particle size
of chalk powder is larger, then paste of desired consistency can not be
obtained. So, small sized particle should be used.
REMEDY: Pass the paste through miller.
b) AIR ENTRAPMENT: Due to high speed rotation in
highly viscous product, air may entrap within the paste &
produce air pocket. This causes oxidation of constituents &
increases the volume.
REMEDY:
1.Before tubing the final paste is kept for 24-72 hours
2. Low speed rotation is used.
3.vacuum is applied in air tight container containing the paste.
 MANUFACTURING PROBLEM
C) CONTAMINATION: Tooth paste becomes contaminated
if the ingredients are contaminated. The chance of
contamination is maximum during filling.
REMEDY:
1. Ingredients & working area must be free from
contamination
2. Containers & mixers must be cleaned properly.
3. Aseptic filling should be performed
D) HARD & VISCOUS PASTE: Due to more solid portion,
the paste becomes hard & viscous & can not come out from
the tube.
REMEDY: Small amount of water, with humectant (glycerine)
is added & mixed again.
 MANUFACTURING PROBLEM
E) COLOR CHANGE or NON UNFORM: Colouring agent
may be distributed non uniformly within the paste.
REMEDY: Color must be added in dissolved form & given
slowly in vehicle.
2. AFTER MANUFACTURING:
A) BURNING SENSATION: This may be due to high flavor
content, pH etc.
REMEDY: Adjust flavoring agent & pH.
B) LESS FOAMING PROPERTY: From consumer’s point of
view it is essential. Less foaming property is not accepted by
the consumers.
REMEDY: Adjust surfactant conc. Adjust amount of saliva
secreting agent.
 MANUFACTURING PROBLEM

C) LESS SALIVA SECRETING PROPERTY: To remove

this problem increased amount of saliva secreting agent is
used.
D) LESS PLEASANT TASTE: Sweetening & flavoring
agents should be used.
TOOTH POWDER: Tooth powders are the original,
simplest & cheapest form of dentifrice. Mainly abrasive
material is used ( about 90-95%). No water is used, more
corrosive than paste, less appealing to consumer.

TOOTH GEL: Binder & surfactant conc is high. All

component should be water soluble. Solid conc is low.
MOUTH WASH:
Mouthwash is a medicated solution used to cleanse or
treat diseases of the oral mucosa, reduce halitosis (bad
breath), add fluoride to teeth for control or prevention of
dental caries.
In dental practice they are also employed as a part of post
operative treatment & during the course of certain
operative procedures, when such use adds to comfort or
oral hygiene of the patient.
Some mouth washes have a topical anesthetic effect on
oral mucosa & are useful for relieving pain associated with
Denture sore spots, herpetic infection, aphthous ulcer.
In patients with painful lesions, these mouth washes
should be used prior to eating to improve comfort.
 SOME MATERIALS USED AS MOUTH WASH

BASE: Mouth wash is based on aqueous alcoholic

solution of flavoring agents. Water : alcohol ratio=40:60,
50:50, 60:40. High amount of alcohol is used because it
acts as anti septic, co-solvent & it has pleasant smell &
taste.
ASTRINGENTS: They are also used in less than 1%
(e.g. alum)
Other ingredients used in mouthwash include
Chlorohexidine, NaCl, Povidone iodine. Hydrogen per-
oxide. 5.Cetyl pyridinium chloride…etc. They act as
ANTISEPTICS & used in 2-4% conc.
Thank You!