ORODISPERSIBLE FILMS

1. DOCTRAL FOUNDATION SEMINAR PRESENTATION
ORO-DISPERSIBLE FILMS
SCHOLAR NAME : Priya Thakur
ROLLNO. 2250941034
DEPARTMENT OF PHARMACEUTICS
CHITKARA COLLEGE OF PHARMACY
CHITKARA UNIVERSITY, PUNJAB
1
SUPERVISOR NAME: DR. Pallavi Bassi
ASSOCIATE PROF.
DEPARTMENT OF PHARMACEUTICS
CHITKARA COLLEGE OF PHARMACY
CHITKARA UNIVERSITY, PUNJAB

2. 2
Introduction
Special Features
Advantages
Disadvantages
Formulation Consideration
Manufacturing Methods
Evaluation Test
Application
Literature Review
Marketed Formulations
Market & Future Perspective
References
Contents

3. Introduction
Oral dispersible films were first introduced in late 1970s based on the
technology of transdermal patches to overcome swallowing difficulties
exhibited by tablets & capsules.
ODFs are polymeric films intended to deliver therapeutic moieties either locally
or systemically in the oral cavity or through gastrointestinal absorption.
An alternative approach to conventional dosage forms.
ODFs are considered to be convenient to swallow, self administrable and fast
dissolving dosage forms which makes it a versatile platform for drug delivery.
Oro dispersible films is an ultra thin film that employs a hydrophilic polymer
that rapidly hydrates or adheres when placed on the tongue or in the buccal
cavity.
These films disintegrate or dissolve within seconds to release the active agent
without drinking and chewing.

4. Large surface area available in the film dosage form allows rapid wetting by
saliva then quickly disintegrates and dissolve and absorbed directly and can
enter the systemic circulation and increase the bioavailability.
ODF consists of single or multiple layers of polymers that form a thin film of
individual sizes which can be loaded or incorporated with active
pharmaceutical ingredients (API) depending on the underlying manufacturing
process.
ODFs have shown the capabilities to improve onset of drug action, prompt
drugs to enter the circulatory system directly by oromucosal and/or
sublingual absorption.
Reduced dose frequency and enhanced drug efficacy.
Introduction

5. SPECIAL FEATURES
Oro dispersible
films
Rapid release
Can
be administered
without water
various size and
shapes
Thin & elegant
films
Better
mucoadhesion
adaptable for
dysphagic patient

6. Advantages
Advantages
Reduced GIT
irritation
Availability of
larger surface area
that leads to rapid
disintegration and
dissolution in the
oral cavity
Improved patient
compliance
Minimized first
pass effect
Offers
administration of
drugs with a high
risk of disruption in
the gastrointestinal
tract
Accurate dosing

7. Advantages
Advantages
consumed at any time or
place as per the convenience of
the individual
Oro dispersible films are
more flexible, compliant and
can be easily handled, storage
and transported.
desirable for patients
suffering from motion sickness,
dysphagia, repeated emesis,
hypertension, paralysis and
mental disorder.
Accuracy in the administered
dose is assured
As the first pass effect is avoided
so a dose of a drug can be
reduced which leads to reduction
in side effects associated to
molecule
Pediatric, geriatric and
psychiatric patients can easily
administer oro dispersible films

8. Disadvantages
High dose cant
be incorporated
Challenges in
achieving
content
uniformity
The drugs
which cause
irritation to
mucosa cannot
be administered.
Most drugs
have bitter taste
and need taste
Masking.
ODFs are
fragile and must
be protected
from water so it
needs special
packaging.
Drug unstable
in buccal pH
can’t be
administered
Disadvantages

9. ODFs
Hydrophilic (Water
soluble) polymer
40-50%
Sweeting agents
3-6%
Super disintegrant
0-8%
Drug(API) 5-30%
Surfactants
q.s.
Saliva stimulating
agents
2-6%
Plasticizer
0-20%
Flavours, colour,
fillers
q.s.
Formulation consideration

10. Formulation components
Components Function Examples
Polymer
Used as a carrier for drug and
provides mechanical strength to the
film; robustness of the film mainly
depends on the type of polymer and
the amount in the formulation
Different grades of hydroxypropyl
methyl cellulose, polyvinyl
pyrrolidine, sodium alginate, sodium,
carboxy methyl cellulose,
pullunan, polyethylene Glycol.
Plasticizer
Imparts tensile strength; percent
elongation is improved by adding
plasticizer to the formulation;
concentration of plasticizer usually
ranges from 0% to 20% w/w
Glycerol, diethyl phthalate,
polyethylene glycols, triethyl citrate,
tributyl citrate, phosphate esters,
esters of oleate and stearate.
Saliva
stimulating
agent
Will increase the production rate of
saliva, which aids in the faster
disintegration of the fast-
disintegrating strip formulation;
stimulates the saliva, thus indirectly
improving the quick disintegration
and dissolution of the film
Citric acid, malic acid, lactic
acid, ascorbic acid, and
tartaric acid

11. Formulation components
Components Function Examples
Surfactants
Surfactants play a vital role as
dispersing, wetting, and solubilizing
agents, thus enabling ,films to
disintegrate within seconds to
minutes and releasing the drug
quickly
Sodium lauryl sulphate
benzalkonium chloride,
polyoxyethylene sorbitan fatty acid
ester (tweens), polaxamer 407.
Sweetening
agent
Used to mask the bitter taste of the
drugs and to make them palatable to
the consumer
Mannitol, sodium saccharin,
aspartame, thaumatin I & II,
neotame, alitame, and glycerin
Flavoring
agent
To mask the bitter or nauseating
taste of the incorporated drug and
enhance the acceptance of the
formulation; amount of flavor in the
formulation depends upon its nature
and strength
Mints and sour flavor such as
vanilla, licorice, Sucralose, lemon
oil, ginger, coffee, and peppermint
oil
Coloring agent and water-soluble
dyes
Provides color to improve the patient
acceptance and identification
Titanium dioxide natural colors and
custom pantone- matched colors

12. Solvent casting
method
I.Semisolid
casting method
Printing
Technologies
I.Solid
dispersion
extrusion method
I.Rolling
method
I.Hot melt
extrusion
method
Conventional Techniques
Manufacturing Methods
Innovative Techniques

13. Solvent Casting Method
Excipients are dissolved in water. Then hydrophilic polymer and in last
drug is added.
Stirred with the help of magnetic stirrer to form a homogeneous
mixture.
Finally casted in to the petri plate & dried.

14. Semi-solid Casting Methods
First solution of water soluble polymers is prepared
This solution is added to the solution of acid insoluble polymer
Plasticizer is added to obtain a gel mass
Gel mass is casted in to thin films or ribbons using heat
controlled drums
The thickness of the film is about 0.038cm
Acid insoluble polymer & film forming polymer are used in the
ratio of 1:4

15. Hot- Melt Extrusion method
Drug is mixed with carrier in solid form
Extruders having heater melt the mixture.
Melted mixture is shaped in to film by dyes

16. Solid Dispersion Extrusion
Drug is dissolved in a suitable liquid solvent
Then solution is incorporated in to melt of polymer
Then solid dispersion are shaped in to films by means of dyes

17. Rolling Method
First solution or suspension of drug is prepared
Solvent used are water or alcohol
Suspension or solution containing drug is rolled in to the carrier
Films are dried on the rollers & cutted in to desired shapes &
sizes

18. Evaluation Test
S.NO Name of the test How to carry out
1. Morphological study Scanning electron microscopy
Visual inspection
2. Thickness Micrometer screw gauze
3. Weight variation Digital vernier caliper
4. Tensile strength Load at failure * 100
(strip thickness* Strip width
5. Folding Endurance Folding endurance for a film is
150-300
6. Transparency Transparency= logT600/b=-€c
7. Percentage Elongation (increase in length of strip/initial
length of strip*100

19. Evaluation Test
S.NO Name of the test How to carry Out
8 Swelling Property Final weight-initial weight/initial
weight*100
9 Surface PH of Film PH Meter
10 Moisture Content Karl Fischer Titration Method or
Weight Variation
11 Permeation Studies Franz Diffusion Cell
12 Disintegration Time Typical disintegration time for
Films is 30 Seconds.
Test:
13 Content Uniformity the relative standard deviation %
is not more than 6%

20. Applications
The use of films may be feasible in delivery of active
agents like analgesics and anti-microbials ingredients for
wound care and other topical preparation.
Topical
application
The drug can be released by dissolving the film via
triggering by p H or enzyme secretion in gastrointestinal
tract helping in treating GI disorders.
Gastro-
retentive dosage
form
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.
Diagnostic
devices

21. Literature Review
S. No. Reference Year Formulation
1 Bhavya Shree T
et al
2023 formulation and evaluation of oro-
dispersible films containing diltiazem
hydrochloride
2 Muruganantham S
et al
2021 Nanoparticle-Loaded Oral Fast-
Dissolving Film
3 Pezik E et al 2021 Development and characterization of
pullulan-based orally disintegrating films
4 Mukund AP et al 2019 A Future of Modern Drug Delivery
System
5 Kaur Prabhjot et al 2018 Oral dissolving film: present and future
aspects
6 Niyaz USH et al 2018 An innovative drug delivery system
7 Joshua JM et al 2016 Fast dissolving oral thin films

22. S.
No.
Reference Year Formulation
8 Mehboob HBM et
al
2016 Oral Films A Comprehensive Review
9 Sharma D et al 2015 Fast dissolving oral films technology
10 Naik TS et al 2014 Evaluation of mouth dissolving films
11 Chauhan BS et al 2013 An Approach Based on Advantages over
Conventional System
12 Kathpalia H et al 2013 An Introduction to Fast Dissolving Oral
Thin Film Drug Delivery Systems
13 Prasanna P et al 2013 Mouth dissolving films
14 Saini P et al 2012 Fast disintegrating oral films
15 Hoffmann EM et
al
2011 Advances in orodispersible films for drug
delivery
16 Malke S et al 2009 Oral films: Patient compliant dosage form
for pediatrics

23. Marketed Formulations
API Proprietary Name Category Strength(mg)

24. Market & Future perspective
• ODFs have shown great promise as a novel alternative to
conventional dosage forms, not only due to easy administration
but also for cost effectiveness in manufacturing as well as
convenience in transportation, easy storage & handling.
• Versatile platform for drug delivery: With the possibility of
incorporating various drug compounds, including chemical
drugs, vaccines, probiotics & herbal extracts.
• With the reference to Transparency Market Research: Oral thin
film market:
 Growth in investment in R&D of ODFs and rise in demand of ODF
drug delivery systems are driving their market size.
 Market size value in 2021: US$ 2.9 Bn
 Market Forecast value in 2031: > 7.1 Bn
• Thus there is a potential ground of research in this technology.

25. References
1.Bhavya Shree T, Baby Lynthong, Krishnananda Kamath K, Shabaraya A.R. formulation and
evaluation of oro-dispersible films containing diltiazem hydrochloride. European Journal of
Biomedical and Pharmaceutical Sciences. Vol 10, Issue 3, 2023.
2.Muruganantham S, Kandasamy R , Alagarsamy S. Nanoparticle-Loaded Oral Fast-
Dissolving Film: New Realistic Approach of Prospective Generation in Drug Delivery – A
Review. Critical ReviewsTM in Therapeutic Drug Carrier Systems, 38(1):1–35 (2021)
3.Pezik E, Gulsun T, Sahin, S, Vural, I. Development and characterization of pullulan-
based orally disintegrating films containing amlodipine besylate. Eur. J. Pharm. Sci.2021
4.Mukund AP, Patel MP. Orodispersible Films - A Future of Modern Drug Delivery System.
International Journal of Pharmacy and Biological Sciences-IJPBSTM (2019) 9 (3): 795-810
5.Kaur Prabhjot, Garg Rajeev. Oral dissolving film: present and future aspects. Journal of
Drug Delivery & Therapeutics. 2018; 8(6):373-377
6.Niyaz USH, Elango K. Oral fast dissolving films: An innovative drug delivery
system. World Journal of Pharmacy and Pharmaceutical Sciences. 2018;7:881–907.
7.Joshua JM, Hari R, Jyothish FK and Surendran SA. Fast dissolving oral thin films: An
effective dosage form for quick release, International journal of pharmaceutical science
review and research, 38(1), 2016, 282-289.
8.Mehboob HBM, Riaz T, Jamshaid M, Bashir I and Zulfiqar S, Oral Films A Comprehensive
Review” International current pharmaceutical journal, 5(12),2016, 111-117.

26. 9.Sharma D, Kaur D, Verma S, Singh D, Singh M, Singh G, Garg R. Fast
dissolving oral films technology: A recent trend for an innovative oral drug
delivery system. Int. J. Drug Deliv. 2015;7:60–75.
10.Naik TS, Khal A and Kanekar H, Evaluation of mouth dissolving films:
Physical and chemical methods, International journal of pharmaceutical and
phytopharmacological research 4(1), 2014, 62-65.
11.Chauhan BS, Chauhan LS, Chatterjee A, Niraj, Pandey S, Baghel US. An
Approach Based on Advantages over Conventional System. Journal of
Biomedical and Pharmaceutical Research 2 (1) 2013, 41-51
12.Kathpalia H, Gupte A. An Introduction to Fast Dissolving Oral Thin Film
Drug Delivery Systems: A Review. Current Drug Delivery. 2013;10:667–684.
13.Prasanna P, Ghodake, Kailas M, Karande, Osmani RA, Mouth dissolving
films: innovative vehicle for oral drug delivery, International journal of pharma
research& review, 2(10), 2013, 41-47.
14.Saini P, Kumar A, Sharma P, Visht S. Fast disintegrating oral films: A recent
trend of drug delivery. Int J Drug Dev Res. 2012;4:80–94.
15.Hoffmann EM, Breitenbach A, Breitkreutz J, Advances in orodispersible films
for drug delivery, Expert opinion on drug delivery, 8 (2011) 299-316.
16.Malke S, Shidhaye S, Desai J, Kadam V. Oral films: Patient compliant dosage
form for pediatrics. The Internet Journal of Pediatrics and
Neonatology. 2009;11:1–7.