Mouth Dissolving Film Mayur R. Khinvasara SSDJ College of Pharmacy, Chandwad.

1. Presented by
Mr. MAYUR R. KHINVASARA
(M. Pharm. Sem. II)
Roll No. A-11
Department of Pharmaceutics
S. S. D. J. COLLEGEOF PHARMACY,CHANDWAD
MOUTH DISSOLVING FILM :
INNOVATIVE DRUG DELIVERY SYSTEM
BDDS
Guided by
Dr. SANJAY B. PATIL
( M. Pharm., Ph.D.)

2. CONTENTS
♪ INTRODUCTION
♪ ANATOMY AND PHYSIOLOGY OF ORAL CAVITY
♪ ADVANTAGES
♪ DISADVANTAGES
♪ ROLE OF SALIVA
♪ TRANSPORT OF MATERIAL ACROSS THE ORAL MUCOSA
♪ FORMULATION
♪ METHODS OF PREPARATION
♪ EVALUATION
♪ REFERENCES
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3. INTRODUCTION
• A drug can be administered via many different routes to produce a
systemic pharmacologic effect.
• The most common method of drug administration is via the Peroral
route, in which the drug is swallowed and enters the systemic
circulation primarily through the membranes of the small intestine.
• Although this type of drug administration is commonly termed oral.
Peroral is a better term because oral administration more accurately
describes drug absorption from the mouth itself.
• In general, mucosal DDS drugs penetrate the mucous membrane by
simple diffusion and are carried in the blood, which richly supplies
the salivary glands and their ducts, into the systemic circulation via
the jugular vein.
• Mucosal drug delivery has lately become an important route of drug
administration.
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4. • Mouth dissolving film drug-delivery systems were first developed in
the late 1970s as based on the technology of the transdermal patch.
• An alternative to tablets, capsules, and syrups for pediatric and
geriatric patients who experienced difficulties in swallowing
traditional oral solid-dosage forms.
• This delivery system consists of a thin film, which is simply placed on
the patient’s tongue or mucosal tissue, instantly wet by saliva; the
film rapidly dissolves.
• Then it rapidly disintegrates and dissolves to release the medication
for oral mucosal absorption.
• Mouth dissolving film is prepared using hydrophilic polymer that
rapidly dissolves on the tongue or buccal cavity.
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5. ANATOMY AND PHYSIOLOGY OF ORAL CAVITY
 The different anatomical
regions of the oral cavity and
mucosal tissues.
 The various target sites for
drug delivery may include-
 The inner surfaces of the
upper and lower lips.
 Gums (gingiva),
 Hard and soft palate,
 Floor of the mouth
(sublingual),
 Tongue and buccal
mucosal tissue (cheek).
Fig. The anatomic regions of the oral cavity.
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6. • Oral cavity offers a unique environment for delivering the drugs.
• The oral mucosal tissue consists of a keratinized epithelium in the
masticatory region consisting of the gums (gingivae), palatal mucosa,
and inner sides of the lips.
• The sublingual (floor of mouth) and the buccal mucosa are
nonkeratinized.
• The keratinized areas of the hard palate and gingival tissue resist shear
forces and abrasion caused by food materials.
• The masticatory regions have an underlying Submucosa in the hard
palate. Submucosa is absent in the gingiva.
• Submucosa contains mucus salivary glands, greater palatine nerves,
and blood vessels.
• It serves to anchor the buccal mucosa to the periosteum of the
maxillae and palatine bones.
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7. ADVANTAGES
• No need of water to swallow or chew
• Available in various size and shapes.
• Hydrate and dissolves in the buccal cavity within a fraction of seconds.
• Fast disintegration or dissolution.
• Polymer used should be non toxic and non irritant.
• Taste masking.
• Enhanced stability.
• Small size for improved patient compliance.
• Ease of handling and transportation.
• No risk of chocking.
• Rapid onset of action.
• To avoid first-pass metabolism.
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8. o It is hygroscopic in nature so it must be kept in dry places.
o Packaging of films requires special equipment's and it is difficult to
pack.
o High dose cannot be incorporated into the oral film.
o Eating and drinking may become restricted.
o Mouth dissolving film are moisture sensitive.
DISADVANTAGE
S
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ROLE OF SALIVA
1. Continuous mineralization / demineralization of the tooth enamel.
2. Protective fluid for all tissues of the oral cavity.
3. To hydrate oral mucosal dosage forms.

9. TRANSPORT OF MATERIAL ACROSS THE ORAL MUCOSA
 The majority of drugs move across epithelial membranes, including the oral
epithelia, by passive mechanisms which governed primarily by the law of
diffusion.
Diffusion layer Mucosal membrane
 In the case of simple diffusion, two
potencial routes of material transports
across the epithelium are-
1. Transcellular pathways
2. Paracellular pathways.
 In Transcellular routes involves transport
into and across cells.
 In Paracellular routes involves the passages
of molecules through intercellular space
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10. FORMULATIONS
S. No. INGREDIENTS AMOUNT (w/w)
1. Drug 1-30%
2. Film forming polymer 40-50%
3. Plasticizer 0-20%
4. Saliva stimulating agent 2-6%
5. Sweetening agent 3-6%
6. Flavoring agent q.s.
7. Surfactant q.s.
8. Colors, Filler q.s.
10

11. DRUG (ACTIVE PHARMACEUTICAL
INGREDIENT)
• Different type of API can be successfully incorporated in the Mouth dissolving
film.
• Micronized API can improve the texture of the film and also dissolution and
uniformity of the oral fast dissolving film.
• Taste of bitter drug need to be masked for that cyclodextrins or resins can be
used; they prevent the direct contact of API with the saliva.
• The dug should have high solubility and high permeability (BCS class I).
• The drug should have low dose
• It includes-
• Cough/Cold Remedies (antitussive, Expectorants)- Ambroxol HCL.
• CVS Agent- Valsartan, Verapamil.
• Antihistamines- Levocetrizine HCL,
• Antiasthamatics- Salbutamol sulphate, Montelukast sodium.
• Nausea- Domperidone, 11

12. FILM FORMING POLYMER
• Polymers play an important role in the film formation.
• Hydrophilic polymers are used in the preparation.
• Now a day’s both natural and synthetic polymers are used in the oral cavity.
• Natural polymers are safe, effective and devoid of side effect so more
preferred than synthetic polymers.
• Ideal properties-
 It should be inexpensive and readily available
 It should have good wetting and spreadibility property.
Natural polymer Synthetic polymer
Pullulan Hydroxypropylmethyl cellulose (HPMC)
Starch Polyvinyl pyrrolidone (PVP)
Pectin Kollicoat
Sodium alginate Hydroxypropyl cellulose
Maltodextrin Carboxy methyl cellulose (CMC)
Lycoat NG 73 Poly ethylene oxide
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13. PLASTICIZERS
• Plasticizers are the important excipient of the oral film.
• The selection of film forming polymers, is one of the most important
and critical parameter for the successful development of film
formulation.
• It improves the flexibility and a mechanical property of the film like
tensile strength and elongation and reduces the brittleness of the
strip.
• Plasticizer significantly improves the strip properties by reducing the
glass transition temperature of the polymer.
• A plasticizer should be selected so that it must be compatible with the
drug.
• Plasticizer can improve the flow and enhances the strength of
polymer.
• Different plasticizers used in the preparation of the oral films are
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14. SALIVA STIMULATING AGENT
Ω These are used to increase the secretion of saliva so that the oral film
disintegrate and dissolve faster in the oral cavity.
Ω The acids which are used in the preparation of food are generally used as
saliva stimulators.
Ω Citric acid, malic acid, lactic acid, ascorbic acid, tartaric acid are the saliva
stimulating agent.
† Sweeteners are used for the taste masking of bitter drugs so that drugs are
palatable.
† Natural as well as artificial sweeteners are used in the preparation of oral film.
† Natural sweeteners used are xylose, ribose, glucose, sucrose, maltose,
steviosides, dextrose, fructose, liq. Glucose.
† Fructose is sweeter than sorbitol and mannitol and thus widely used as a
sweetner.
† Artificial sweetners used in oral films are sodium or calcium saccharine salts.
† Sucralose have more than 200-600 times sweet.
† Neotame & Altitame have more than 2000- 8000 times sweetening power as
compared to sucrose.
SWEETENING AGENT
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15. FLAVORING AGENT
• Flavouring agent are those ingredients which impart flavour to any of the
formulation.
• Any US-FDA approved flavour can be added to the formulation according to
the choice of the individuals of different age groups.
• The flavours liking changes with the age as geriatric population like
menthol, mint or orange flavour while young generation like fruit,
raspberry, strawberry flavour.
• Flavouring agent should be compatible with the drug and other excipients.
• Flavouring agent can be extracted from different part of the plant like
leaves, flower, fruit, bark, and seeds.
SURFACTAN
T Surfactant are used as a solubilizing or wetting or dispersing agent so that
the film gets dissolve within seconds and release the active agent
instantly.
 One of the most important surfactant is poloxamer 407 that is used as
solubilizing, wetting and dispersing agent.
 Some of the commonly used surfactants are sodium lauryl sulphate,15

16. METHOD OF PREPARATION
• Mouth dissolving film can be prepared by five methods:
1. Solvent casting method
2. Semisolid casting method
3. Hot melt extrusion
4. Solid dispersion technique.
5. Rolling method
• Generally Solvent casting method is most preferred for the
manufacture of mouth dissolving film.
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17. SOLVENT CASTING METHOD
1.
• In solvent casting method excipients are dissolved in
water. Then water soluble polymers and in last drug is
added.
2.
• Solution are stirred with help of magnetic stirrer for 5
mins. to form a homogenous solution
3.
• Finally casted in to the Petri plate and dried at 40°C
temp in hot air oven.
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18. SEMISOLID CASTING METHOD
1. In semisolid casting method firstly a solution of water soluble film
forming polymer is prepared.
2. The resulting solution is added to a solution of acid insoluble
polymer (e.g. cellulose acetate phthalate, cellulose acetate
butyrate), which was prepared in ammonium or sodium hydroxide.
3. Then appropriate amount of plasticizer is added so that a gel mass
is obtained.
4. Finally the gel mass is casted in to the films or ribbons using heat
controlled drums.
5. The thickness of the film is about 0.015-0.05 inches. The ratio of the
acid insoluble polymer to film forming polymer should be 1:4.
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19. HOT MELT EXTRUSION
1. The drug is mixed with carriers in solid form.
2. Then the extruder having heaters melts the mixture.
Finally the melt is shaped in to films by the dies. There are certain
benefits of hot melt extrusion.
• Fewer operation units
• Better content uniformity
• An anhydrous process
1) A solution or suspension containing drug is rolled on a carrier.
2) The solvent is mainly water and mixture of water and alcohol.
3) The film is dried on the rollers and cutted in to desired shapes and sizes.
4) Other ingredients including active agent are dissolved in small portion of
aqueous solvent using high shear processor.
5) Water soluble hydrocolloids dissolved in water to form homogenous
viscous solution.
ROLLING METHOD
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20. SOLID DISPERSION TECHNIQUE.
1. The term solid dispersions refer to the dispersion of one or
more active ingredients in an inert carrier in a Solid state in the
presence of amorphous hydrophilic polymers.
2. Drug is dissolved in a suitable liquid solvent
3. Incorporated solution into the melt of polyethylene glycol,
below 70°C
4. Solid dispersions are shaped into the films by means of dies.
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21. EVALUATION OF FILM
1. Mechanical properties
A. Thickness
B. Dryness/tack test
C. Tensile strength
D. Percent elongation
E. Young’s modulus
F. Folding endurance
2. Organoleptic test
3. Swelling test
4. Surface pH test
5. Contact angle
6. Transparency
7. Assay/ content uniformity
8. Disintegration test
9. In-vitro dissolution test 21

22. MECHANICAL PROPERTIES
1. Thickness
• The thickness of film is measured by micrometer screw gauge or calibrated
digital Vernier Callipers.
• The thickness of film should be in range 5-200 μm. The thickness should be
evaluated at five different locations (four corners and one at centre) and it
is essential to ascertain uniformity in the thickness of film as this is directly
related to accuracy of dose distribution in the film.
2. Tensile Strength
The maximum stress applied to a point at which the strip breaks is called
as tensile strength. Was calculated by equation-
Load at break
Strip break × Strip Width
3. Folding Endurance
Folding endurance is measured by Manual repeated folding of film at
same place till it broke. The number of time the film is folded without
breaking is known as the folding endurance value.
Tensile strength =
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23. 4. Young’s Modulus
 The measure of stiffness of the strip is young’s modulus.
 It is measured by using houns field universal testing machine.
 It is represented by equation-
slope × 100
strip thickness ×cross-head speed
5. Percent Elongation
When stress is applied, a film sample stretches and this is referred to
as strain. Strain is basically the deformation of film divided by original
dimension of the sample. Generally elongation of film increases as the
plasticizer content increases.
Percent elongation= L*100/L0
L = Increase in length of film
L0 = Initial length of film
Young modulus =
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24. SWELLLING TEST
1) Film swelling studies is conducted using simulated saliva solution.
2) Each film sample is weighed and placed in a preweighed stainless steel
wire mesh.
3) The mesh containing film sample is submerged into 15ml medium in a
plastic container.
4) Increase in the weight of the film was determined at preset time interval
until a constant weight was observed.
• The degree of swelling was calculated by
• W= Wt-Wo/Wo
• Where,
• Wt- is weight of film at time t,
• Wo is weight of film at time zero.
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25. IN VITRO DISSOLUTION TIME
• The in vitro dissolution study is carried out in simulated saliva
solution pH 6.4 phosphate buffer using USP paddle apparatus at
37±0.5°C.
• Samples are withdrawn at regular time interval and analyzed by
UV-Visible spectrophotometer.
ASSAY/DRUG CONTENT AND CONTENT
UNIFORMITY
 Drug content is determined by any standard assay method which is
described for the particular API in any standard pharmacopoeia. Limit
of content uniformity is 85-115%
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26. TRANSPARENCY
 The measurement of the oral film transparency can be determined by
using a simple UV spectrophotometer.
 Cut the film sample into rectangles and placed on the internal side of the
spectrophotometer cell.
 Now determine the transmittance of the film at 600 nm.
 The transparency of film was calculated as follows-
Transparency = (logT600)/b = C
Where,
T600 = Transmittance
b = Film thickness
C = Concentration
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27. IN VITRO DISINTEGRATION TEST
 Disintegration time is the time when an oral film starts breaking when
brought in contact with water or saliva.
 For a fast dissolving film, the time of disintegration should be in range of 5-
30s.
 United State Pharmacopoeia (USP) disintegration apparatus can be used to
study disintegration time.
 In another method, the disintegration time can be visually determined by
determined by dipping the film in 25 ml water in a beaker.
 The beaker should be shaken gently and the time was noted when the film
starts to breaks or disintegrates.
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28. SURFACE PH TEST
• The surface pH of Mouth dissolving film can cause side effects to the oral
mucosa, so it is necessary to evaluate the surface pH of film.
• The surface pH of film should be 7 or close to neutral.
• For this purpose, a combined pH electrode can be used with the help of
water, Mouth dissolving film was made slightly wet and the pH was
measured by bringing electrode in contact with surface of oral film.
• This study should be done on at least six films of each formulation and
their mean ± SD can be calculated.
• In another method to determine the surface pH, the films are placed on
the 1.5%w/v agar gel and then the pH paper are placed on the film, change
in color of pH paper gives surface pH of the film.
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29. MARKETED FORMULATIONS
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30. REFERENCES
1. Arya A, Chandra A, Sharma V, (2010). Fast Dissolving Oral Films: An
Innovative Drug. International Journal of ChemTech Research. 2 (1),
576-583.
2. Varma S N, Sharma P K, (2014). Buccal Film: An Advance Technology
for Oral Drug Delivery. Advances in Biological Research. 8 (6),260-
267.
3. Jain N.K., (2005). Controlled and Novel Drug Delivery. 1st ed. New
Delhi: CBS Publishers and Distributers. pp- 52-56.
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31. 5. Nair A.B, Kumria R, (2013). In Vitro Techniques of Buccal Films.
Journal of Controlled Release. 166, 10-21.
6. Dixit R.P, Puthli S.P, (2009). Oral Strip Technology: Overview and
Future Potential. Journal of Controlled Release. 139,94-107.
7. Thakur N., Bansal M, Sharma N, (2013). Overview “A Novel
Approach of Fast Dissolving. Advances in Biological Research. 7 (2),
50-58.
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