FROMULATION AND EVALUATION

1. DONE BY ,,,
MUTHUKUMAR.S ABARAJITHA.T
ASSISTANT PROF. 3RD YR B.PHARM
KMCH COLLEGE OF PHARMACY

2. LIST OF CONTENTS ;;:-
 INTRODUCTION
 TEETH AND COMMON PROBLEMS
 CAUSES OF ORAL HEALTH PROBLEMS
 CLASSIFICATION AND EVALUATION OF DENTIFRICES
 FORMULATION OF DENTIFRICES
1] TOOTH PASTES
2] TOOTH POWDERS
3] SOLID BLOCKS
4] LIQUID PREPARATIONS
5] MOUTH WASH
 TOPICAL ANESTHETICS
 TARTAR REDUCING PRODUCT
 MECHANICAL SUPPORT FOR PLAQUE CONTROL
 SAFETY
 DENTAL CARE PRODUCTS
 NEWER APPROACHES

3. INTRODUCTION
 DENTIFRICES:-
 IT IS A PREPARATION FOR CLEANSING AND POLISHING THE TEETH.
 IT MAY CONTAIN A THERAPEUTIC AGENT SUCH AS FLUORIDE , TO INHIBIT
DENTAL CARIES.

4. DENTIFRICES [TOOTH PASTE]
 A PHRMACETICAL COMPOUND USED IN CONJUNCTION WITH THE TOOTHBRUSH
TO CLEAN AND POLISH THE TEETH.
 CONTAINS A MILD ABRASIVE ,A DETERGENT , A FLAVOURING AGENT, A BINDER ,
AND OCCASIONALLY DEODORANTS AND VARIOUS MEDICAMENTS DESIGNED AS
CARIES PREVENTIVES. [E.G ,.. ANTISEPTICS , ETC.,]
 2 TYPES :-
1] SIMPLE CLEASING DENTIFRICES
2] THERAPEUTICS DENTIFRICES
THERAPEUTICS DENTIFRICES MAY CONTAIN
BACTERIOSTATIC, BACTERICIDAL , ENZYME INHIBITION OR ACID NEUTRALIZING
QUALITIES OF THE DRUGS OR CHEMICALS.

5. TEETH AND COMMON PROBLEMS
 BAD BREATH
 TOOTH DECAY
 GUM [ PERIODONTAL ] DISEASE
 ORAL CANCER
 MOUTH SORES
 TOOTH EROSION
 TOOTH SENSITIVITY
 TOOTHACHES AND DENTAL EMERGENCIES
 UNATTRACTIVE SMILE

6. CAUSES FOR ORAL HEALTH PROBLEMS
 PELLICLE:-
 THE PELLICLE IS FORMED ON ALL FRESHLY CLEANED TOOTH SURFACES BY THE
DEPOSITION AND ABSORPTION OF SOME SALIVARY PROTIENS
 IT IS LESS THAN 0.1 MM THICK AND IS INVISIBLE TO THE NAKED EYE.
 PLAQUE:-
 FOLLOWING THE DEPOSITION OF PELLICLE ON A FRESHLY CLEANED TOOTH SURFACE ,
PLAQUE FORMS RAPIDLY.
 PLAQUE IS AN INVISIBLE STICKY FLIM OF BACTERIA , SALIVARY PROTEINS AND POLY
SACCHARIDES THAT ACCUMALATES ON EVERYONE’S TEETH.
 DENTAL CALCULUS [ TARTAR]:-
 DENTAL PLAQUE MAY ITSELF BECOME MINERALIZED AND THIS HARD DEPOSIT IS
CALLED CALCULUS.
 IT ACCUMULATES MAINLY ON THE GINGIVAL MARGIN OPPOSITE TO THE SALIVARY
DUCTS.

7. CLASSIFICATION ON DENTAL PRODUCTS
 DEPENDING UPON DENTAL PROBLEMS :-
 PRODUCTS FOR CARRIES CONTROL
1] SYSTEMIC FLUORIDE
2] TOPICAL FLUORIDE
A] DENTIFRICES
B] GEL
C] RINSES
D] MISCELLANEOUS
 PRODUCTS FOR PLAQUE CONTROL
1] CHEMICAL AGENTS
A] DENTIFRICES
B] MOUTH WASHES
2] MECHANICAL PRODUCTS
A] TOOTH BRUSHES
B] DENTAL FLOSS
C] OTHER AIDS TO PLAQUE REMOVAL
 PRODUCTS FOR TOOTH SURFACE HYPERSITIVITY
 TOPICAL ANESTHETIC
 HALITOSIS

8. EVALUATION OF SOLID DENTAL PRODUCTS
o ABRASIVENESS:-
o VARIOUS TESTS HAVE BEEN DESIGNED AND REPORTED OVER THE YEAR
,MOSTLY ON THE SET OF EXTRACTED TEETH.
o PARTICAL SIZE:-
o THIS CAN BE DETERMINED BY MICROSCOPIC STUDY OF THE PARTICALS
OR BY SIEVING OR OTHER MEANS.
o CLEANSING PROPERTY:-
o THIS IS STUDIED BY MEASURING THE REFLECTANCE CHARACTER OF A
LACQUER COATING ON THE POLYMER FLIM CAUSED BY BRUSHING WITH A
TOOTH CLEANSER .

9.  CONSISTENCY:-
IT IS IMPORTANT THAT THE PRODUCT SHOULD MAINTAIN THE
CONSISTENCY TO ENABLE THE PRODUCT PRESS OUT FROM THE CONTAINER .
VISCOSITY AND RHEOLOGY OF THE POWDER IS ALSO IMPORTANT FOR
THE FLOW PROPERTY OF THE POWDERS.
 pH OF THE PRODUCT:-
pH OF THE DISPERSION OF 10 PERCENT OF THE PRODUCT IN WATER IS
DETERMINED BY pH METER.
 FOAMING CHARACTER:-
THIS TEST IS SPECIALLY FOR FOAM FORMING TOOTH PASTES OR TASTE
POWDER. SPECIFIC AMOUNT OF PRODUCT CAN MIXED WITH SPECIFIC AMOUNT
OF WATER AND TO BE SHAKEN.
 LIMIT TEST FOR ARSENIC AND LEAD:-
THIS IS VERY IMPORTANT AS THESE ARE HIGHLY TOXIC METALS. SPECIPIC
TESTS ARE THERE TO ESTIMATE THESE TWO METALS.

10.  VOLATILE MATTERS AND MOITURE:-
A SPECIFIC AMOUNT OF THE PRODUCT REQUIRED TO BE TAKEN
IN A DISH AND DRYING IS TO BE DONE TILL CONSTANT WEIGHT. LOSS
OF WEIGHT WILL INDICATE PERCENTAGE OF MOISTURE AND VOLATILE
MATTERS.
 EFFECTS OF SPECIAL INGREDIENTS:-
SPECIAL TESTS TO BE DONE FOR THE SPECIAL INCREDIENTS IF
ANY LIKE ANTISEPTIC , ENZYMES ,etc ,. FOR EACH ONE SPECIAL AND
SPECIFIC TESTS ARE TO BE DONE .

11. TOOTH PASTES
 TOOTH PASTES ARE MOST POPULAR VALUABLE AND WIDELY USED
PREPARATIONS FOR CLEANSING THE TEETH.
 IT HAS LARGEST SHARE OF DENTAL CLEANSING AND CARE PREPARATIONS.
 TOOTH PASTES ARE PREFERRED OVER OTHER DENTAL PREPARATIONS
BECAUSE OF FOLLOWING REASONS .
 EASY TO TAKE AND SPREAD ON THE TOOTH BRUSH .
 NO SPILLAGE OR WASTAGE .
 ATTRACTIVE CONSISTENCY .
 PROPER DISTRIBUTION IN MOUTH .
 AVAILABLE IN WIDE VARIETIES .

12. FORMULATION FOR TOOTH PASTES
o THE BINDER , PREWETTED WITH THE HUMENTANT,IT IS DISPERSE IN
LIQUID PORTION CONTAININGTHE SACCHARIN AND PRESERVATIVE AND
ALLOW SWEELING TO FORM A HOMOGENEOUS GEL .
o THE SWELLING MAY BE ACCELERATED BY HEAT AND AGITATION .
o THE SOLID ABRASIVE IS ADDED SLOWLY TO HOMOGENEOUS GEL AND
MIXED IN MIXER UNTIL A PASTE FORMED .
o THE FLAVOUR AND DETERGENT ARE ADDED LAST AND DISTRIBUTED
UNIFORMLY .
o EXCESSIVE AIRATION PARTICULARLY IN THE PRESENCE OF DETERGENT ,
SHOULD BE AVOIDED .
o THE PASTE CAN BE MILLED , DEAIRATED AND TUBED .

13. TOOTH POWERS
 TOOTH POWDERS ARE OLDEST AND SIMPLEST PREPARATIONS .OVER THE
YEARS THEIR MARKET SHARE HAS BEEN REDUCED DUE TO POPULARITY OF
PATES, BUT STILL THEY HAVE A CONSIDERABLE MARKET SHARE .
 THE MAIN PROBLEMS ENCOUNTERED WITH PODWERS ARE-
 FLOATING OF POWDER IN AIR DURING MANUFACTURING .
 FORMATION OF CAKE DURING STORAGE .
 UNEVEN DISTRIBUTION IN MOUTH .

14. COMPOSiTION
 TOOTH POWDER CONTAIN THE INGREDIENTS:-
 ABRASIVES
 SURFACTANTS
 SWEETENING AGENTS
 FLAVOURS
 COLOURS
ABRASIVES ARE USED IN MANUFACTURING OF TOOTH POWDERS
ARE SIMILAR TO THAT OF TOOTH PASTES .THOUGH LIGHTER CALCIUM
CARBONATE IS USED BUT IN TOOTH POWDERS HEAVIER GRADE CALCIUM
CARBONATE IS USED . OTHER INGREDIENTS ARE SIMILAR TO THAT OF TOOTH
PASTES .

15. SOLID BLOCKS
SOLID DENTIFRICEIS LIKE A SOAP PREPARATION.
BASICALLY THEY CONSIST OF TOOTH POWDER SUSPENDED IN A BASE
OF SOAP POWDER ,WATER AND HUMECTANT .
SOLID DENTIFRICES PROVIDE A CONVENIENT AND HANDY FROM OF
CLEANING FOR THE TEETH .
FORMULATION
THE SOAP FIRST DISSOLVED IN A MIXTURE OF GLYCERIN AND
WATER WITH THE AID OF HEAT .
THE POWDER [ABRASIVE] IS THEN UNTIL SOFT MASS FORMED .
MASS IS DRIED ON TRAYS ,CUT INTO BLOCKS.

16. LIQUID DENTAL PREPARATIONS
USED OF LIQUID DENTIFRICES ARE COMPARATIVELY LESS THAN SOLID ONE .
THEY ARE BASICALLY AQUEOUS OR HYDRO ALCOHOLIC SOLUTIONS OF
SURFACTANT WITH ADDITIONAL COMPONENTS LIKE ,
THICKENING AGENT
SWEETENERS
FLAVOURS
THEY DO NOT CONTAIN ANY ABRASIVE AS THEY WILL SEDIMENT.
ACTION OF THIS PREPARATION ON DETAIL IS LESS BUT THE CLEANSING EFFECT
IS MORE .
MANUFACTURING PROCESS IS MAKING SOLUTION OF ALL INGREDIENTS .

17. FORMULATIONS
SODIUM MYRISTATE SULPHATE - 4.0 g
METHYL CELLULOSE - 4.0 g
SACCHARINE SODIUM - 0.1 g
FLAVOURING OIL - 0.3 g
GLYCERIN - 5.0 g
ALCOHOL - 10.0 g
WATER - 85.4 g

18. Mechanical products for plaque control
Tooth brush
Tooth paste
Dental floss
Tongue scraper

19. Tartar[calculus]-reducing products
 the mechanism of action of the calculas reducing chemical is related to the latter’s ability
to inhibit crystal growth and interrupt the transformation of calcium phosphate (found
in food and saliva) into dental calculus .
 This effect may occur as follows :-
 The agents complex on the tooth surface to block receptor sites for calcium phosphate
that precipitates from saliva and chemically absorbs to initiate calculus formation .
 This same receptor site blokage also occurs in the calculus matrix as it begins to form.
 The pyrophosphate complexes combine with free calcium in saliva to inhibit the
attachment at the tooth surface (secondary mechanism) .

20. halitosis
 Local factors ,systemic factor ,or a combination of both can cause halotosis.
 It is estimated that 80 percent of all mouth odours are caused by local factors within
the oral cavity and these odours are most often associated with caries ,gingivitis and
periodontitis .
 Oral malodors occur BECAUSE OF THE ACTION OF VARIOUS MICROORGANISMS
ON PROTEINACEOUS SUBSTANCES SUCH AS EXFOLIATED ORAL EPITHELIUM
,SALIVARY PROTEIN ,FOOD DEBRIS AND BLOOD .
 STUDIES HAVE SHOWN THAT SALIVA FROM INDIVITUALS WHO ARE FREE OF
DENTAL DISEASE PRODUCES MALODOR LESS RAPIDLY THAN SALIVA FROM
PATIENTS WITH DENTAL DISEASE .

21.  IT HAS ALSO BEEN OBSERVED THAT AFTER PROLONGED PERIODS OF
DECREASED SALIVARY FLOW AND ABSTINENCE FROM FOOD AND LIQUID
MALODORS TEND TO BE MORE SEVERE .
 VARIOUS ORAL BACTERIA PRODUCE PRODUCTS THAT ARE DEGRADED TO A
NUMBER OF COMPOUNDS ,FOREMOST OF WHICH ARE SULFIDES AND
MUCOPROTEINS .
 THESE COMPOUNDS HAVE BEEN MOST OFTEN ASSOCIATED WITH ORAL
MALODOR .
 SPECIFICALLY ,IT APPEARS THAT ORAL MALODORS USUALLY RESULTS FROM
THE BACTERIAL –MEDIATED DEGRADATIVE PROCESSES OF METHYL MERCAPTAN
AND HYDROGEN SULFIDE IN ORAL AIR .
 AMMONIA IS ALSO PRODUCED BUT DOES NOT APPEAR TO CONTRIBUTE
SIGNIFICANTLY TO HALITOSIS .
 IT HAS EVEN BEEN SUGGESTED THAT AMMONIA PRODUCTION MAY IMPROVE
THE ODOUR OF MOUTH AIR .

22. SAFETY
o AS WITH ANY OTC DRUG PRODUCT ,PRECAUTIONS NEED TO BE TAKEN TO BE
TAKEN TO PREVENT OVERDOSE .THE FDA REQUIRES LABELLING OF ALL
FLUORIDE DENTIFRICE PRODUCTS INCLUDE A STATEMENT “TO MINIMISE
SWALLOWING USE A PEA SIZE AMOUNT IN CHILDREN UNDER SIX .
o MAKING CHILD PROOF CAPS AVAILABLE ON FLUORIDE PRODUCTS INTENDED
FOR USE BY CHILDREN HAS BEEN RECOMMENDED .
o ANOTHER APPROACH WOULD BE TO PROVIDE METERED DENTIFRICE DELIVERY
SYSTEMS FOR CHILDREN UNDER AGE SIX ,WHICH COULD BE SET TO DISPENSE
THE CORRECT AMOUNT OF FLUORIDE DEPENDING UPON THE BODY WEIGHT
OF THE CHILD .

23. DENTAL CARE PRODUCTS
 EFFERVESCENT POLIDENT DENTURE CLEANSERS
 POLIDENT FRESH CLEANSE DENTURE FORM
 POLIDENT DENTU – GEL DENTURE
 SUPER POLIGRIP DENTURE ADHESIVE CREAM
 SUPER POLIGRIP DENTURE ADHESIVE POWDER
 SUPER POLIGRIP DENTURE ADHESIVE STRIPS

24. NEWER FORMULATIONS OF DENTIFRICE FROM
CHEMICAL ABSTRACTS
 FUNCTIONAL TOOTHPASTE CONTAINING NANO SIZED SILVER.
 HIGH FLUORIDE ION RECOVERY DENTIFRICE COMPOSITIONS .
 APPLICATION OF WATER SOLUBLE CHITOSAN IN TOOTHPASTE AND
MOUTHWASH .
 DENTIFRICE CONTAINING SILICA MICROPARTICLES AS THE SOLE ABRASIVES .
 STABLE SUSPENSIONS OF COMPOSITE MATERIALA FOR USE AS DENTIFRICES
CONTAINING AN ANTIMICROBIAL ORGANIC ACID SALT .