BY

D.ASHOK
I.SUSMITHA
M.PAVANI
N.G.N.S VYSHNAVI
N.NAGAPAVANI
P.SRILAKSHMI
S.PRASNNA
 OVER VIEW
 INTRODUCTION
 ADVANTAGES
 DISADVANTAGES
 LIMITATIONS
 PROCESS OVER VIEW
 FORMULATION REQUIRMENTS
 METHOD OF PREPARATION
 SOLVENT CASTING METHOD
 HOT MELT EXTRUSION METHOD
 SEMISOLID CASTINMETHOD
 ROLLING METHOD
 STORAGE AND PACKING
 EVALUATION PARAMETERS
 APPLICATIONS
 TELMISARTAN FLIM
 DRUG PROFILE
 FORMULATION
 MARKETEDODF’S
 CONCLUSION
 INTRODUCTION
•IT IS A SOLID DOSAGE FORM THAT DISINTEGRATE
QUCKILY IN THE ORAL CAVAITY WITH OUT
ADMINISTRATION OF WATER
•THESE AREDISINTEGRATE QUCKILY IN THE MOUTH
•THEY UNDERGO RAPID DISINTEGRATION IN THE MOUTH
•THESE ARE REFERED BY VARIOUS NAMES LIKE QUICK
DISINTEGRATIN,ORALDISINTEGRATIN,RAPIDDISINTEGRATI
NG FLIMS
 ADVANTAGES
1.Availability of larger surface area that leads to rapid disintegrating and dissolution in the
oral cavity
2. No risk of chocking.
3. Convenient dosing and accurate.
4. No need of water to swallow or chew administered anywhere at any time.
5. Small size makes improved patient compliance.
6. Rapid onset of action
7. Ease of handling and transportation.
8. Improve bioavailability for certain therapeutic ingredient and enhanced stability.
9. Taste masking can be achieved.
10. No special formulation setup required for industry.
11. The drug enters the systemic circulation with reduced hepatic first pass effect.
12. Can be loaded lower doses.
13. Minimal side effects.
14. Site specific and local action.
15. Non invasive.
 DISADVATGAES
1.Drugs which irritate the mucosa cannot be administered by
this route.
2. Drug with small dose requirement can only be
administered.
3. Most drugs have bitter taste, and need taste masking.
4. It is hygroscopic in nature so it must be kept in dry place.
5. It also shows the fragile and granule property.
6. They required special packaging for products stability and
safety.
7. High dose cannot be incorporated into the oral film.
8. Drugs which are unstable at buccal pH cannot be
administered
 LIMITATIONS
 Drugs with larger does are difficult to formulate into
ODF e.g. Rifampicin (6Ethambutol (1000mg) etc.
However, research has proven that the concentration
level of activecan be improved upto 50% per dose
weight
 Most bitter drugs should be avoided if used then co-
administered of enzyme inhibition suchas aprotinin,
bestatin, puromicin etc.
PROCESS OVER VIEW
1. WEIGHING
2. MIXING OF SLURRY
3. LAYRING
4. MOTHER ROLL FORMATION
5. SLITTING OF MOTHER ROLLSTO DAUGHTER CELLS
6. PACKING
 FORMULATIONREQUIRMENTS FOR THE
PREPARATION OF ORAL DISINTEGRATING FILMS
1. Drug.
2. Water soluble film forming polymers
3. Plasticizers.
4. Saliva stimulating agent.
5. Sweetening agent.
6. Flavoring agent.
7. Surfactant.
8. Colors and Fillers.
 Methods of preparation
The manufacturing of orally dissolving films is done
byvarious methods such as.
1. Solvent casting method
2. Hot melt extrusion method
3. Semisolid casting method
4. Rolling method
5. Solid dispersion extrusion
 Solvent casting method
•WATER SOLUBLE INGREDIENTS ARE
DISSLOVED IN WATER AND API AND
OTHER AGENTS ARE DISSLOVED IN
SUITABLE SOLVENT TO FORMA CLEAR
VISCOUS SOLUTION
•BOTH THE SOLUTIONS ARE MIXED
•RESULTING SOLUTION IS A CAST OF
FLIM
 Hot melt extrusion method
 The drug is mixed
carriers in solid form
 Extrudres having heaters
melts the mixtures
 Finally the melt is
shaped in films by dies
Semi solid casting method
• Solution of water soluble film
forming polymer is prepared
• Resulting solution is added to a
solution of acid
insolublepolymer
• Appropriate amount of polymer
is added sothat gels mass is
obtained
• Finally thegell mass is casted in
to the films orribbonsusing
heatcontrolled drums the
thickness of the film should be
about 0.15to0.05
 ROLLING METHOD
 SOLUTION OR
SUSPENSIONCONTAINING THE DRUG
IS ROLLED ON CARRIER
 SOLVENT ;WATER OR WATER AND
ALCOHOL
 THE FLIM IS DRIED ON THE ROLLERS
ANDCUT IN TO DESIRED SIZES
 STORAGE AND PACKING
 VARIETY OF PACKING OPTIONS ARE
AVILABLE
 SINGLE PACKING IS MANADATORY
FOR THE FLIM
 AN ALUMINIUM POUCH IS THE MOST
COMMONLY USED
MATERIALS USUALLY FOR PACKING
• FOIL,PAPERF,OR PLASTICPOUCHES
• SINGLE POUCH AND ALUMINIUM POUCH
• BLISTER CARD WITH MULTIPLE UNITS
• BARRIER FILMS
EVLUATION PARAMETERS
 MECHNICAL PROPERTIES
a. DRYNESS
b. THICKNESS
c. TENSILE STRENGTH
d. PERCENTELONGATION
e. YOUNGS MODULE
f. FLODING ENDURANCE
• ORANOLEPTIC TEST
• SWELLING TEST
• SURFACE PH TEST
• CONTACT ANGLE
• TRANSPARENCY
• ASSY
• DIS INTEGRATION TEST
• INVITRO DISSOLOUTION TEST
APPLICATIONS OF THE FAST DISSLOVING FILMS
❖MANAGE THE PAIN
❖ALLERGIES
❖SLEEP DIFFICULTIES
❖CNS DIS ORDERS
❖DELVERING THE VITAMINS ANDPERSONAL CARE PRODUCTS
❖WOUND CARE ETC
TELMISARTAN FILM
 INTRODUCTION OF TELMISARTAN
 THIS IS USED TO TREAT THE HIGH BLODD PRESUURE
 HELPS TO PREVENT THE STROKES ,HEART ATTACKS,AND KIDNEY PROBLEMS
 IT BELONGS TO THE CLASS OF DRUGS CALLED AS ANGIOTENSIN RECIPETOR BLOCKERS

 MECHANISM OF ACTION OF TELMISARTAN

 IT CAN LOWER THE BLOOD PRESSURE BY RELAXING THE BLOOD VESSELS THEN
THE BLOOD CAN FLOW MORE EASILY
DRUG PROFILE
❖MOLECULAR FORMULA-C33H30N4O2
❖MOLECULAR WEIGHT -514.617
❖APPERENCE- AMPHROUS POWEROR CRYSTALINE
❖DOSE-40TO80mg
❖HALF LIFE -24 hours
❖SOLUILITY-SOLUBLE IN STRONG ACIDS AND STRONG
BASES
❖CATEGORY-ANTIHYPERTENSIVE
❖TREATMENT- TO TREAT HYUSEPER TENSION
FORMULATION OF FLIM
 API- TELMISARTAN
 METHOD OF PREPARATION-SOLVENT CASTING METHOD
 WATER SOLUBLE FILM FORMIG POLYMER-HYDROXYL PROPYL
METHY CELLULOSE
 PLASTISIZER-GLYCEROL
 SALIVARY STIMULATING AGENTS-CITRIC ACID
 SWWETNING AGENTS-ASPARTA
 SURFACTNTS-SODIUM LURYL SULPHATE
 COLOURING AGENTS-TITANUM DIOXIDE
MARKETED ODF’S
CONCLUSION
 PHARMACEUTICAL INDUSTRIES HAVE RECOGNISED
THE POTENTIAL FOR DELVERING MEDICINAL
PRODUCTS THROUGH ODF HAVE BEEN LAUNCHED
SEVERAL PRODUCTS
 RECENTLY ODF’S HAVE GAINEDPOPULRITY AS
ADOSAGE FORMS FOR THE MOUTH FRESHNERS
 THEY GAIN THE IMPORTANCE ASTHEY RE IDEAL
DOSAGE FORMS FOR THE YOUNG CHILDERNS AND
GEDIATRIC PATIENTS
 AND MANY INDUSTRIES HAVING PIPELINES FOR THE
CONVERSION OF THEIR EXISTING TABLETS IN TO THE
FILMS