International Journal of Pharmacy Teaching & Practices 2013, Vol.4, Issue 2, 655-661.

Fast Dissolving Films: A Novel Approach to Oral Drug Delivery

Pandya Ketul*, K.R.Patel, M.R.Patel, N.M.Patel

Department of pharmaceutics, Shri B.M.Shah College of Pharmaceutical Education and Research,

Modasa

Introduction
Review Article In the late 1970s as an alternative to conventional
dosage forms for pediatric and geriatric patients
Please cite this paper as: Pandya Ketul*, K.R.Patel, M.R.Patel, who experience difficulties in swallowing
N.M.Patel. Fast Dissolving Films: A Novel Approach to Oral Drug traditional oral solid dosage forms formulate the fast
Delivery. IJPTP, 2013, 4(2), 655-661.
dissolving tablets by using superdisintigrant/s and
Corresponding Author: hydrophilic ingredients which has the higher
bioavailability, quick action and most patient
Dr. Pandya Ketul compliance. Many FDTs are prepared by using the
Department of pharmaceutics, Shri B.M.Shah College of expensive lyophillisation process and sometimes
Pharmaceutical Education and Research, Modasa difficult to carry, store and handle (fragility and
Email: onlineketul20@gmail.com
friability).also fear of chocking with fast dissolving
Telephone: +91 9898014867 1
tablet .
To eliminate the drawbacks of fast dissolving
tablet a fast dissolving film can be placed. Fast
Abstract dissolving films are very similar to ultra-thin strip
of postage stamp in their shape, size and
In the recent years, many of the pharmaceutical groups are thickness. Fast dissolving films are formulated
focusing their research on rapid dissolving technology. This using polymers, active pharmaceutical
technology evolved over the past few years from the ingredients (API), plasticizers, saliva stimulating
confection and oral care markets in the form of breath strips agents, sweeteners, flavors, preservatives and
and became a novel and widely accepted form by consumers, colors. Fast dissolving film is simply placed on the
so OFDFs are gaining the interest of large number of patient’s tongue or any oral mucosal tissue, instantly
pharmaceutical industries. The main advantage of this wet by saliva the film rapidly hydrates and adheres
technology is the administration to pediatric and geriatric onto the site of application. It then rapidly
patient population where the difficulty of swallowing larger disintegrates and dissolves to release the medication
oral dosage forms is eliminated. This fast dissolving drug for oromucosal absorption or with formula
delivery system (FDDS) is suited for the drugs which undergo modifications, will maintain the quick-dissolving
high first pass metabolism and is used for improving aspects allow for gastrointestinal absorption to be
bioavailability with reducing dosing frequency to mouth achieved when swallowed.
plasma peak levels, which in turn minimize adverse/side Technology Catalysts forecasts the market for drug
effects and also make it cost effective. Orally fast dissolving products in oral thin film formulations to be valued
film is the type of drug delivery system which when placed in at $500million in 2007 and could reach $2 billion.
the oral cavity, disintegrate or dissolve within few seconds More importantly, prescriptions of fast dissolving
without the intake of water. OFDFs are very similar to postage films have been now approved in US, EU and Japan
stamp in their shape, size and thickness. The present review which are the three major regions. These approved
provides an account of various formulation considerations, Rx films, have potential to dominate over other oral
method of preparation and quality control of the OFDFs. dosage forms of the same drugs. It seems that the
value of the overall oral thin film market will grow
Keywords: Fast dissolving Films, Buccal film, Improved significantly.
Patient Compliance, Pediatric Patients, Geriatric Patients.
Special features of Fast Dissolving Films
• Thin elegant film
• Available in various size and shapes
• Unconstructive
• Fast disintegration
• Rapid release

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• Have an acceptable taste.
• Give a pleasing mouth feel.
• Should not leave residue in mouth.
4,5,6
Advantages
• Accessibility of larger surface area that leads to quickly
disintegrate and dissolution in the oral cavity within seconds.
• Fast Dissolving Film is flexible so they are not as fragile and
need not any kind of special package for protection during Tablet 1: Composition of Film Active
8
transportation and storage as compared to FDT. Pharmaceutical agents
• No need of water has led to better satisfactoriness amongst
the dysphasic patients. Sr. Category Percentage
• No fear of chocking as compared to FDT. No amount%
• The large surface area available in the film dosage form
1 Drug (API) 1-30%
allows rapid wet by saliva then quickly disintegrates and
dissolve and absorbed directly and can enter the systemic 2 Polymer 40-50%
circulation without undergoing first-pass hepatic metabolism
3 Plasticizer 0-20%
and on increase the bioavailability
• The dosage form can be consumed at any place and any 4 Surfactant(Solub q.s
time as per convenience of the individual ility Enhancer)
5 Saliva 2-6%
Disadvantages stimulating
• Dose uniformity is a technical challenge agent
• Hygroscopic in nature 6 Sweetening 3-6%
• High doses cannot be incorporated agent
• Require special packaging for products stability and safety 7 Flavoring agent 0-10%

8 Coloring agent q.s

9 Stabilizing agent 0-5%

or Thickening
agent

The ideal characteristics of a drug to be selected

Figure 1: Fast Dissolving Film • The drug should have pleasant taste.
• The drug to be incorporated should have low dose
Composition of the system less than 30mg.
Fast dissolving film is a thin film with an area of 2-8 cm
2 • The drugs with smaller and moderate molecular
containing an active ingredient. The immediate dissolution, in weight are preferable.
water or saliva is reached through a special matrix from water- • The drug has stability and solubility in water as
soluble polymers. Drugs can be incorporated up to a single well as in saliva.
dose of 30mg. Formulation considerations have been reported • It should be partially unionized at the pH of oral
as important factors affecting mechanical properties of the cavity.
films. The excipients used in formulation of fast dissolving • It should have the ability to permeate oral
films are also discussed in detail. From the regulatory mucosal tissue
perspectives, all excipients used in the formulation should be
9,10
generally regarded as safe(i.e.GRASlisted)and should be Water soluble polymers
7
approved for use in oral pharmaceutical dosage forms . Water-soluble polymers are used as film formers.
The use of film forming polymers in dissolvable films
Active pharmaceutical substance can be from any class of has attracted considerable attention in medical and
pharmaceutically active substances that can be administered nutraceutical application. The water-soluble
orally or through the buccal mucosa. Like antiulcers, polymers achieve rapid disintegration, good mouth
antiasthmatics, antitussive, antihistaminic, antiepileptic, feel and mechanical properties to the films. The
expectorants, antianginal etc. For the effective formulation, disintegration rate of the polymers is decreased by
dose of drug should be in mgs (less than 20 mg/day). Some of increasing the molecular weight of polymer film
the examples of suitable drug molecule that can be bases. Some of the water soluble polymers used as
incorporated in the FDF. film former are HPMC E-3 and K-3, Methyl cellulose
A-3, A-6 and A-15, Pullulan,
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carboxmethylcellulosecekol 30, Polyvinylpyrollidone PVP K-90, than 200 ‐300 time sweetness.
Pectin, Gelatin, Sodium Alginate, Hdroxypropylcellulose,
14
Polyvinyl alcohol, Maltodextrins and Flavoring agents
EUDRAGITRD10.Polymerized rosin is a novel film forming Flavoring agents can be selected from the synthetic
polymer. flavor oils, oleo resins, extract derived from various
parts of the plants like leaves, fruits and flowers.
Plasticizers Flavors can be used alone or in the combination.
Formulation considerations (plasticizer, etc.) have been Any flavor can be added such as essential oils or
reported as important factors affecting mechanical properties water soluble extracts of menthol, intense mints
of films. The mechanical properties such as tensile strength such as peppermint, sweetmint, spearmint,
and elongation tothe films have also been improved by the wintergreen, cinnamon, clove, sour fruit flavor such
addition of plasticizers. Variation in their concentration may as lemon , orange or sweet confectionary flavors
affect these properties. The commonly used plasticizers such as vanillin, chocolate ,or fruit essence like
areglycerol, di-butylpthallate, and polyethylene glycolsetc. apple , raspberry, cherry, pineapple. The amount of
flavor needed to mask the taste depends on the
11
Saliva stimulating agent flavor type and its strength
The purpose of using saliva stimulating agents is to increase
the rate of production of saliva that would aid in the faster Colour
disintegration of the rapid dissolving film formulations. A full range of colors is available, including FD&C
Generally acids which are used in the preparation of food can colors, EU Colours, Natural Colours and custom
be utilized as salivary stimulants. E.g.Citric acid, malic acid, Pantone matched colours.Some saliva stimulating
lactic acid, ascorbic acid and tartaric acid. These agents are agents may also be added toenhance the
used alone or in combination between 2 to 6% w/w of disintegration and to get rapid release.Some of
weight of the film. these agents are citric acid, tartaric acid, malicacid,
ascorbic acid and succinic acid.
Surfactants
Surfactants are used as solublising or wetting or dispersing Methods of manufacture of fast dissolving films
agent so that the film is getting dissolved within seconds and One (or a combination) of the following processes
release active agent immediately. Some of the commonly used may be used to manufacture the oral films:
are sodium lauryl sulfate, benzalkonium chloride, bezthonium • Solvent casting
chloride, tweens etc. One of the most important surfactant is • Hot-melt extrusion
polaxamer 407 that is used as solubilizing, wetting and • Semisolid casting
dispersing agent. • Solid dispersion extrusion
12,13
• Rolling.
Sweetening agents
Sweeteners have become the important part of Solvent Casting
15

pharmaceutical products intended to be disintegrated or Fast dissolving buccal films are preferably
dissolved in the oral cavity. The classical source of formulated using the solvent casting method,
sweetener is sucrose, dextrose, fructose, glucose, liquid whereby the water soluble ingredients are
glucose and isomaltose. The sweetness of fructose is dissolved to form a clear viscous solution and the
perceived rapidly in the mouth as compared to sucrose and drug along with other excipients is dissolved in
dextrose. Fructose is sweeter than sorbitol and mannitol and suitable solvent then both the solutions are mixed
thus used widely as a sweetener. Polyhydric alcohols such and stirred and finally casted in to the Petri plate
as sorbitol, mannitol, and isomalt can be used in and dried.
combination as they additionally provide good mouth‐feel
and cooling sensation. Polyhydric alcohols are less
carcinogenic and do not have bitter after taste which is a
vital aspect in formulating oral preparations. The artificial
sweeteners have gained more popularity in pharmaceutical
preparations. Saccharin, cyclamate and aspartame are the
first generation of the artificial sweeteners followed by
acesulfame‐K, sucralose, alitame and neotame which fall
under the second generation artificial sweeteners.
Acesulfame‐K and sucralose have more than 200 and 600
time sweetness. Neotame and alitame have more than
2000 and 8000 time sweetening power as compared to Figure 1: Solvent casting
sucrose. Rebiana which is a herbal sweetener, derived from
plant Stevia rebaudiana (South American plant) has more

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16
Hotmelt extrusion active drug substance and different excipients
Hot metal extrusion is commonly used to prepare granules, plays an important part of the formulation stage
sustained release tablets, transdermal and transmucosal drug during the development of solid dosage form.
delivery systems. Melt extrusion was used as a Fourier Transformer Infra Red Spectrum (FTIR),
manufacturing tool in the pharmaceutical industry as early as Differential scanning calorimeter (DSC), thin layer
1971. chromatography and X Ray Diffraction (X-RD) can be
used to assess possible drug excipient interaction.
DSC allows the fast evaluation of possible
incompatibilities, because it shows changes in
appearance, shift of melting endotherms and
exotherms, and variation in the corresponding
enthalipies of the reaction.

Thickness
Thickness test can be carried out using an
electronic micrometer. The thickness of the film
sample should be measured at five locations (center
and four corners), and the mean thickness is
Figure2: Hot melt extrusion calculated. Samples with air bubbles, nicks or
tears and having mean thickness variation of
17
Semisolid casting greater than 5% are excluded from analysis.
Solution of water soluble film forming polymer is prepared.
Resulting solution is added to a solution of acid insoluble Folding endurance
polymer (e.g. cellulose acetate phthalate, cellulose acetate To determine folding endurance, a strip of film is
butyrate). Appropriate amount of plasticizer is added so that cut and repeatedly folded at the same place till it
gels mass is obtained. Finally the gel mass is casted in to the broke. The number of times the film could be
films or ribbons using heat controlled drums. The thickness of folded at the same place without breaking gives
the film should be about 0.015-0.05 inches. The ratio of the the value of folding endurance.
acid insoluble polymer to film forming polymer should be 1:4
Swelling index
Solid dispersion extrusion The studies for swelling index of the film are
The term solid dispersions refer to the dispersion of one or conducted in stimulated salivary fluid. The film
more active ingredients in an inert carrier in a solid state in sample is weighed and placed in a pre weighed
the presence of amorphous hydrophilic polymers. Drug is stainless steel wire sieve. The mesh containing the
dissolved in a suitable liquid solvent. Then solution is film is submerged into 50 ml of stimulated salivary
incorporated into the melt of polyethylene glycol, obtainable medium contained in a mortar. Increase in weight
◦ of the film is determined at each interval until a
below 70 C Finally the solid dispersions are shaped into the constant weight is observed. The degree of swelling
films by means of dies. is calculated using the formula:
18
SI = wt – wo /wo
Rolling method
In this method the film is prepared by preparation of a
Where SI is the swelling index,
pre-mix, addition of an active and subsequent formation of
wt is the weight of the film at time “t”,
a film. Prepare pre-mix with film forming polymer, polar
wo is the weight of film at t = 0
solvent and other additives except a drug Add pre mix to
st
master batch feed tank. Fed it via a 1 metering pump and Tensile strength
st nd The tensile strength (psi) is the property of the film
control valve to either or both of the 1 and 2 mixer. Add
required amount of drug to the desired mixer.Blend the drug that requires a load to cause load deformation
with master batch pre mix to give a uniform matrix. Then a failure of film. Evaluated this mechanical property
specific amount of uniform matrix is then fed to the pan by using Testing Instrument. Film strips in special
nd dimension and free from air bubbles or physical
through 2 metering pumps. The film is finally formed on imperfections were held between two clamps
the substrate and carried away via the support roller. The wet positioned at a distance of 3 cm. During
film is then dried using controlled bottom drying. measurement, the strips were pulled by the top
19,20,21,22,23
clamp at a rate of 100 mm/min; the force and
Characterization of fast dissolving films elongation were measured when the film broke.
Drug-excipients interaction studies Results from film samples, which broke at and not
Assessment of possible incompatibilities between an between the clamps, were not included in the

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calculations. Measurements were run in triplicate for each pharmaceutical products; an aluminum pouch is the
film. Tensile strength is also defined as the maximum stress most commonly used packaging format. APR- Labtec
applied to a point at which the film specimen breaks and has developed the Rapid card, a proprietary and
can be computed from the applied load at rupture as a mean patented packaging system, which is specially
of three measurements and cross- sectional area of fractured designed for the Rapid films. The rapid card has
film from the following equation . same size as a credit card and holds three raid films
on each side. Every dose can be taken out
2 individually.
Tensile strength (N/mm ) = breaking force (N)
The material selected must have the following
2
cross sectional area of sample (mm ) characteristics
• They must protect the preparation from
Percent elongation: environmental conditions.
The percent elongation is measured when the film snaps • They must be FDA approved.
as sufficient force applied so as to exceed the elastic limit. • They must meet applicable tamper-resistant
Percentage elongation can be obtained by following equation: requirement
• They must be non-toxic.
% Elongation =Increase in length at breaking point(mm) ×100 • They must not be reactive with the product.
original length(mm)
• They must not impart to the product tastes or
Palatability test:
odors
Palatability study is conducted on the basis of taste, after
bitterness and physical appearance. All the batches are rated
Foil, paper or plastic pouches: The flexible pouch is
A, B and C grades as per the criteria. When the formulation
a packaging concept capable of providing not only
scores at least one A grade, formulation is considered as
a package that is temper- resistance, but also by
average. When the formulation scores two A grade then it
the proper selection of material, a package with
would be considered as good and the one with all three A
a high degree of environmental protection. A
grade it would be the very good formulation.
flexible pouch is usually formed during the
Grades: A= very good, B= good, C=poor.
product filling operation by either vertical or
horizontal forming, filling, or sealing equipment.
Disintegration test:
The pouches can be single pouches or aluminum
Disintegrating time is defined as the time (second) at which a
pouches.
film breaks when brought into the contact with water or
saliva. The disintegration time is the time when a film starts to
Single pouch and Aluminum pouch: Soluble film
break or disintegrate. Thickness and mass play a role in
drug delivery pouch is a peelable pouch for “quick
determining the dissolvable films physical properties.
dissolve” soluble films with high barrier properties.
Disintegration test is done by Disintegration apparatus.
The pouch is transparent for product display. Using
a 2 structure combination allows for one side to
Dissolution test:
be clear and the other to use a cost-effective foil
Dissolution is defined as the amount of drug substance that
lamination. The foil lamination has essentially zero
goes into the solution per unit time under standardized
transmission of both gas and moisture. The
conditions of liquid/solid interface, temperature and solvent
package provides a flexible thin film alternative for
concentration. In vitro release studies are carried out in
nutriceutical and pharmaceutical applications. The
modified USP XXIII apparatus (paddle over disk).
single dose pouch provides both product and
dosage protection. Aluminum pouch is the most
Stability study:
commonly used pouch.
Stability study of fast dissolving films is carried out for all
the batches according to ICH guidelines. After
predetermined time intervals, the films are evaluated for
the drug content, disintegration time and physical
appearance
24
Packaging of fast dissolving film
In the pharmaceutical industry it is vital that the package
selected adequately preserve the integrity of the product.
Expensive packaging, specific processing, and special care are
required during manufacturing and storage to protect the
dosage of other fast dissolving dosage forms. A variety of Figure 3: Blister card
packaging options are available for fast dissolving films.
Single packaging is mandatory for films, which are Blister card with multiple units: The blister

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 International Journal of Pharmacy Teaching & Practices 2013, Vol.4, Issue 2, 655-661.
container consists of two components: the blister, which is both patient compliance (especially pediatric and
the formed cavity that holds the product, and the lid stock, geriatric) as well as industrial acceptability. They
which is the material that seals to the blister. The blister combine the greater stability of a solid dosage form
package is formed by heat –softening a sheet of and the good applicability of a liquid. Oral films
thermoplastic resin and vaccum-drawing the softened sheet can replace the over-the counter drug , generic and
of plastic into a contoured mold. After cooling the sheet is brand name from market due to lower cost and
released from the mold and proceeds to the filling station of consumer preference. This technology is a good tool
the packaging machine. The semi –rigid blister previously for product life cycle management for increasing the
formed is filled with the product and lidded with the heat patent life of existing products.
sealable backing material. The film selection should be based
upon the degree of protection required. Generally the lid References
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