a brief review on oro dispersible films

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VIGNAN PHARMACY COLLEGE
(Approved by AICTE, PCI-New Delhi & Affiliated to JNTUK- Kakinada)
Vadlamudi (V), Chebrolu (M), Guntur (Dt.) – 522 213

2.  Introduction
 Applications
 Formulation development
 Evaluation
 Market potential
 FDA approved drugs
 Commercially available marketed products
 Conclusion
 References
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Oro-dispersible 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 paediatric and
geriatric patients who experienced difficulties in swallowing
traditional oral solid-dosage forms.

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A solid dosage form that dissolves or disintegrates quickly in the oral
cavity, resulting in solution or suspension without need for the
administration of water, is known as Oral Fast-dispersing dosage form.
These are also called as:
Orally dissolving films
Flash release wafer
Wafer
Quick dissolving film
Soluble or Buccal film- Preferred by FDA
European Medicines Agency using Oro-Dispersible films
Definition:

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ADHESIVE LAYER
INTERMEDIATE LAYER
BACKING LAYER
Contains API
Or
Adhesion purpose only
Contains API
Drug dissolution
Or
Shielded between layers
Permanent
Or
Dissolvable
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6. • Thin elegant film
• Available in various sizes and shapes
• Less fragile when compared to ODT
• Excellent mucoadhesion
• Dosage accuracy
• Rapid release
• Can be administered without water
• Most acceptable dosage form for
dysphagic patients
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• Thickness ranges from 2-500mm & it’s surface area is 1-20 cm².
• Its low dry tack allows for ease of handling & application.
• Its rapid hydration rate facilitates fast softening & absorption.
• 2mm thickness of film will take 5-10sec to start its disintegration.

8. ADVANTAGES:
1. Improved oral absorption
2. Faster onset of action
3. Minimized first – pass effect
4. Improved bio availability
5. Accurate dosing
6. No special training is required for administration
7. Reduced gastrointestinal irritation
DISADVANTAGES:
1. High dose can't be incorporated
2. Drug unstable in buccal pH can’t be administrated
3. Need special packing has they must be protected from water
4. Drugs with obnoxious odor can not be given
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Topical application:
Feasible in delivery of active agents like analgesics or anti-microbial agents
Gastro retentive dosage systems:
Poorly water soluble and high molecular weight molecules incorporated
into films, dissolution triggered by PH or enzymatic secretions
Diagnostic devices:
Multiple agents can be incorporated in the film for timed release in
diagnostic device

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Comparison between fast dissolving tablets
and films
Fast dissolving Tablets Fast dissolving Films
Lesser dissolution due to less
surface area
Greater dissolution due to large
surface area
Less durable as compared with
oral films
Better durable than oral
disintegrating tablets
Less patient compliance than films More patient compliance
High dose can be incorporated Low dose can only be
incorporated
It has fear of chocking No risk of chocking

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1. Flash release wafers
2. Mucoadhesive melt away wafers
3. Mucoadhesive sustained release wafers
PROPERTIES FLASH RELEASE
WAFERS
MUCO-ADHESIVE
MELT AWAY
WAFERS
MUCO-ADHESIVE
SUSTAINED
WAFERS
Area(cm2) 2-8 2-7 2-4
Thickness(mm) 20-70 50-500 50-250
Structure Single layer system Single or multilayer Multilayer system
Excipients Soluble hydrophilic
polymer
Soluble hydrophilic
polymer
Low/non-soluble
polymer
Drug phase Solid solution Solid solution or
suspended solution
Suspension and/or
solid solution
Dissolution 60 sec Few min Max 8-10 hrs
Application Tongue Gingival or buccal
region
Gingival (other
region in oral cavity)
Classification of Oral
thin films:

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Category Conc(%) Examples
Drug 1-25 NSAIDS, Antiemetic, Anti asthmatic,
Snoring agents, Erectile dysfunction drugs
Hydrophilic
Polymers
40-50 Pullulan, Gelatin, Starch, Sodium alginate,
Pectin, Maltodextrin, HPMC, HPC, PEO,
Kollicoat, PVA, PVP.
Novel film forming polymer: Rosin
Plasticizer 25-35 PEG,PG, PHTHALATE Derivatives
Saliva secreting
agents
2-6 Citric acid, Malic acid, Tartaric acid
Sweetener 2-10 Sucrose, Glucose,Fructose
Aspartame, Sucralose
Flavor 2-5 Peppermint, vanilla,cofee, chocalate,
Strawberry, Lemon

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• 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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SOLVENT CASTING METHOD
1.
• In solvent casting method excipients are dissolved in
water. Then water soluble polymers and in last drug is
added.
2.
• Solutions are stirred with the 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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Finally the melt is shaped in films by the dies
Extruders having heaters melts the mixture
The drug is mixed with carrier in solid form
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HOT – MELT EXTRUSION

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Drug is dissolved in a suitable liquid
solvent
Then solution is incorporated into the melt of
polyethylene glycol, obtainable below 700c
Solid dispersions are shaped into the
films by means of dies.
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SOLID DISPERSION EXTRUSION

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In this method firstly solutions or suspension of
the drug is prepared
Either water or mixture of water and alcohol are
mainly used
Suspension or solution containing drug is
rolled on the carrier
Films are dried on the rollers and cut in to desired
shapes and sizes
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ROLLING METHOD

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MORPHOLOGY STUDY Scanning electron microscope
Visual inspection
THICKNESS Micrometer screw gauge
WEIGHT VARIATION Digital vernier callipers
.
TENSILE STRENGTH
(Load at failure * 100)
FOLDING ENDURANCE A typical folding endurance for a
film is 100 – 150
TRANSPARENCY Transperancy=(logT600)/b=-€c
(Strip thickness * Strip width)

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PERCENTAGE
ELONGATION
(Increase in length of strip /
initial length of strip) * 100
SWELLING PROPERTY (Wt – W0) / W0
SURFACE PH OF FILM PH meter
MOISTURE CONTENT Karl Fischer titration method
or weight variation
(Wt – W0) / W0
PERMEATION STUDIES Franz diffusion cell
DISINTEGRATION TIME Typical disintegration time
for film is 30s
Tests: Slide frame method
Petri dish method
CONTACT ANGLE Goniometer
DISSOLUTION USP Type I or Type II

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Packaging for oral thin films includes foil paper or plastic pouches,
single pouch, aluminum pouch, blister packaging with multiple units
and barrier films.
Barrier films are most commonly used for those drugs which are
extremely moisture sensitive .
The films are manufactured by Rapid film technology developed by
Labtec GmbH describes primary packaging made of a sealing pouch
affords enough space for logos, codes, instructions or other
information.
Barrier films were prepared by a laminating process and packaging
costs are comparable to tablets

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• With the reference to Research and Market : Oral Thin Films Market
,2015-2025:jan 2015
1. As per the market projection study for 2015-2025, owns a good
prospective of growth as a upcoming technology of drug delivery.
2. 10 oral films are in market and another 29 are in the stage of various
clinical and pre clinical trials.
3. Around 10 proprietary technologies like PharmFilm, RapidFilm, Bio-
FX, etc are coming up which has 38% of the market.
4. Thus there is a potential ground of research in this technology.

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Drug Year Company
Versafilm(Rizatriptan) Feb /4 /2014 IntelGenx and RedHill
Biopharma
Suboxone
(Buprinorphine or
Naloxone)
31/08/2010 Reckitt Benckiser
Pharmaceuticals Inc.
Zulpenz January 2010 Pharmfilm technology
Ondansetron 23rd march 2010 APR Applied Pharma
research s.a (“APR”)
and Labtech
GmbH(“Labtech”)
Zelapar October 2005 Valent Pharmaceuticals
Interanational Inc

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Brand Distributor Drug
BenadrylR Allergy quick
dissolve strips
McNeil-PPC Diphenhydramine HCL
Gas –XR thin strips Novartis consumer
health
Simethicone
Risperidon HEXALR
SF Schmelzfilm
Hexal AG Risperidone
SudafedR quick dissolve
strips
McNeil-PPC Phenylephrine HCL
TherafluR Thin strips
long acting cough
Novartis consumer
health
Dextromethorphan HBr
ZulpenzTM Sativa Pharmaceuticals Ondansetron

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Brand Distributor Drug
ChlorasepticR Sore
Throat Relief Strips
Prestige brands Benzocaine
OrajelR Kids Sore
Throat Relief Strips
Church & Dwight Co. Pectin
Snoreez Oral Strips Passion For Life
Healthcare
Peppermint oil,
vitamin E, sodium
hyaluronate, guar gum

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The brief review on oral films concludes with the note that they
are considered as a most promising and important drug delivery
system because of their rapid disintegration include dissolution
properties especially with pediatrics and geriatrics patients.
Even though most of the formulations today are developed as
ODTs, oral films has gained more popularity because of their
easy portability, improved patient compliance and easy of
administration.

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They can be applied by both oral and buccal routes. apart from
being used as medicament films(local anesthetic ,vitamins
supplements and cold allergy remedies).
They can also be used for refreshing the breath.
This technology is growing in fast pace challenging most of the
pharmaceutical companies to develop oral films for a wide range
of active pharmaceutical ingredients.

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REFERENCES
 Arya A, Chandra A, Sharma V, (2010). Fast Dissolving Oral Films: An Innovative Drug.
International Journal of ChemTech Research. 2 (1), 576-583.
 Varma S N, Sharma P K, (2014). Buccal Film: An Advance Technology for Oral Drug
Delivery. Advances in Biological Research. 8 (6),260-267.
 Jain N.K., (2005). Controlled and Novel Drug Delivery. 1st ed. New Delhi: CBS Publishers
and Distributers. pp- 52-56.
 Tarjani et.al,(2014)Evaluation of mouth dissolving films:physical and chemical
methods.Eijppr 4(1):62-65.
 Chonkar ankita D. Et al,(2015) an overview on fast dissolving oral
films.www.asiapharmaonline.org,5(3):129-137.
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Eva maria et al.,(2011), Advances in orodispersible films for drug delivery.informa
health care 8(3):299-316
Alpesh R.Patel et al.,(2010), fast dissolving films as new venture in fast dissolving
dosage forms.International journal of drug development and research , 2(2):232-246
Muhammad irfan et al.,(2015),orally disintegrating films A modern expansion in
drug delivery systems.Saudi pharmaceutical journal
Udhan ravindra radha kisan et ai.,(2012),Mouth dissolving films and their
overview.International research journal of pharmacy,3(9):39-42
Yogyata S. Pathare ew al., (2013), Polymers used for Fast Disintegrating Oral Films:
Review, International Journal Of Pharmaceutical Sciences Review And
Research.,21(1):169-178

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