This document summarizes a seminar presentation on mouth dissolving films as an effective oral disintegrating drug delivery system. Key points include: Mouth dissolving films were developed as an alternative to tablets and capsules for patients who have difficulty swallowing. The films are thin, elegant, and rapidly disintegrate in the oral cavity upon contact with saliva. Common methods for preparing mouth dissolving films include solvent casting, semi-solid casting, hot extrusion, and solid dispersion extrusion. Films are evaluated based on parameters like thickness, disintegration time, and drug dissolution. Applications include use for pediatric/geriatric patients, topical drug delivery, and as diagnostic devices or for gastroretentive drug delivery.

1. A SEMINAR ON
Under the Guidance of
Mr. S.VENKATESWARA RAO,
M.Pharm, (Ph.D)
Assoc. Professor,
Department of Pharmaceutics
Presented by:
K. Bhanu Sri Chandana
IV B.Pharmacy
Regd No:167N1R0042
MOUTH DISSOLVING FILMS: AN EFFECTIVE ORAL
DISINTEGRATING DRUG DELIVERY SYSTEM
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VIJAYA INSTITUTE OF PHARMACEUTICAL SCIENCES FOR WOMEN
ENIKEPADU,VIJAYAWADA

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CONTENTS
1.INTRODUCTION
2. FORMULATION
3. METHOD OF PREPARATION
4.CHARACTERIZATION OF MDFS
5. APPLICATIONS
6. CONCLUSION
7. REFERENCES

3. 1.INTRODUCTION
Oral drug delivery systems came into existence from late 1970’s as an
alternative to tablets and capsules.
They are mainly used in geriatric, pediatric and dysphasic patients
who have difficulty in swallowing or chewing solid dosage forms.
These systems consists of solid films which disintegrates and dissolves
quickly in the oral cavity.
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 It was developed on the basis of technology of the transdermal patch.
 The delivery system consists of a very thin oral strip, which is simply
placed on the patient’s tongue or any oral mucosal tissue.
 Due to the saliva, film rapidly hydrates and adheres onto the site of
application and shows it’s action.

5. FEATURES OF MDFs
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Thin elegant film
Available in various size and shapes
 Excellent muco-adhesion
 Fast disintegration
 Un obstructive
 Rapid release

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The drug should have pleasant taste.
It should have the ability to permeate oral
mucosal tissue.
It should be partially unionized at the pH of
oral cavity.
The drug with smaller and moderate
molecular weight are preferable.
 It should be stable and soluble in water and saliva.
IDEAL CHARACTERISTICS

7. ADVANTAGES
 Administered without water ,anywhere, any time.
 Films provide rapid disintegrating and dissolution in the
oral cavity
 Mouth dissolving films are flexible and portable in
nature.
 No risk of chocking
 Provide new business opportunity like product
differentiation, promotion.
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High dose cannot be incorporated.
Dose uniformity is a technical challenge
DISADVANTAGES

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S. No. Ingredients Use Example
1. Drug API Salbutamol,
Levocetirizine
2. Film forming polymer For thin film formation Microcrystalline
cellulose, Acacia,
Xanthum
3. Plasticizers To improve flexibility, To
reduce brittleness
Glycerol, Propylene
glycol, Castor oil
4. Sweetening agent To improve sweetness Sorbitol, Mannitol
5. Saliva stimulating
agent
To improve the secretion
of saliva
Citric acid, Ascorbic
acid, Lactic acid
6. Flavoring agent To improve the flavor Caramel, Peppermint
oil
7. Colouring agent To improve elegance TiO2, FD&C approved
colorants
2.FORMULATION

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3.METHOD OF PREPARATION
1. Solvent casting
2. Semi-solid casting
3. Hot Extrusion
4. Solid dispersion extrusion
5. Rolling method

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1. Solvent Casting method:

12. 2. Semi Solid Casting method:
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• This method is used when acid insoluble polymers are included.
Solution of water soluble polymers
Solution of acid insoluble polymer
Plasticizer
Gel mask
Cased into films or ribbons
HEAT ROLLERS
• Thickness – 0.038,
• Ratio of insoluble polymer and film forming polymer is 1:4

13. 3. Hot Extrusion method:
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Drug + Carrier
Extruders
Heaters
Melted mixture
Shaped as films
Dies

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4. Solid Dispersion Extrusion method:
Drug + Liquid Solvent
Dispersed into the melt of Polyethylene Glycol
Shaped into Films
Dies

15. 5. Rolling method:
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Drug suspension
Roller
Film
Dried

16. 4. EVALUATION OF MDF’S
Fast disintegrating oral films are evaluated for the following
parameters:
 Visual inspection
 Thickness measurement
 Measurement of foldin endurance
 pH
 Moisture uptake
 Moisture content
 Disintegration time
 Dissolution time
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17. 5.APPLICATIONS
 Topical applications: The use of dissolvable films may be
feasible in the delivery of active agents such as analgesics
or antimicrobial ingredients for wound care and other
applications
 Oral mucosal delivery via Buccal, sublingual, and
mucosal route by use of OTFs could become a preferential
delivery method for therapies in which rapid absorption is
desired, including those used to manage pain, allergies,
sleep difficulties, and central nervous system disorders
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18.  Diagnostic devices: Dissolvable films may be loaded with
sensitive reagents to allow controlled release when exposed to a
biological fluid or to create isolation barriers for separating
multiple reagents to enable a timed reaction within a diagnostic
device
 Gastro retentive dosage systems: Dissolvable films are being
considered in dosage forms for which water-soluble and
poorly soluble molecules of various molecular weights are
contained in a film format. Dissolution of the films could be
triggered by the pH or enzyme secretions of the
gastrointestinal tract, and could potentially be used to treat
gastrointestinal disorders
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19. STORAGE AND PACKAGING
 A variety of packaging options are available for fast dissolving films. The
rolled film can be die-cut into any shape or size or slit into narrower rolls as
required for the application. Single packaging is mandatory for films, which
are pharmaceutical products; an aluminum pouch is the most commonly
used packaging format.
 Every dose can be taken out individually. For branding purposes and to meet
industry regulations, converters may choose to print information directly
onto the film unit doses before packaging.
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20. MARKETED PRODUCTS OF ORAL STRIPS
Product category Ingredients Indications/Applications
Appetite suppressant Fucusvesiculosus
and guarana extract,
garciniacambogia
These are top selling
natural ingredients
associated with wt loss.
Combogia helps to reduce
the food intake by
suppression
Vitamins and food
supplements
Various vitamins,
minerals and
supplements
It is useful for the
people who do not like
to pop up the tablets or
soluble supplements
Breath freshener strip,
(Antibacterial strip)
Contain mint flavor
and antibacterial
agent,
cetylpyridinium
chloride
It is used as mouth
freshener and to stop
bad breath.
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21. 6.CONCLUSION
The present review shows that mouth dissolving films are one of the novel
approaches in the field of pharmaceutical sciences. The mouth dissolving
film a new dosage forms for all age groups, specifically pediatric, geriatric
patients and patients with swallowing difficulties. Presently, MDFs are widely
available for hypertension, acidity, allergy, pain, etc. reflecting their
importance. Major advantages of such dosage form are their administration
without the use of water fulfilling the need of target population seeking
convenience in drug administration along with bypassing the hepatic
metabolism, consequently, leading to improved therapeutic response.
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22. REFERENCES
 Anderson O, Zweidorff OK, Hjelde T, Rodland EA (1995).
Problems when swallowing tablets. Tidsskr NorLaegeforen.
115: 947-949.
 Arya A, Chandra A (2010). Fast Dissolving Oral Films: An
Innovative Drug Delivery System and Dosage Form.
International Journal of ChemTech Research.2: 2010: 576-583.
 Barnhart SD, Sloboda MS (2007). The future of dissolvable
films. Drug DelTechnol. 7(8):34-37.
 Cilruzo F, Cupone EI (2008). Fast dissolving films made of
maltodextrins.
 European Journal of Pharmaceutics and Bio pharmaceutics. 70:
2008: 895-900.
 Khurana R, Alka A and Khar RK (2000). Development and
Evaluation of Muco adhesive Films of Miconazole Nitrate.
Indian J Pharm Sci 6: 448-452.
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