University of San Agustin

College of Health and Allied Medical Profession

Pharmacy Department

THIN FILMS AS AN EMERGING PLATFORM FOR DRUG DELIVERY

By DECEE DAWN CATAMIN

PHARMACY 2-C
JETH GALLENERO, RPH
UNIVERSITY OF SAN AGUSTIN
GENERAL LUNA STREET, ILOILO CITY
October 15, 2019
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College of Health and Allied Medical Profession
Pharmacy Department

The discovery of the thin film as a platform for drug delivery made a world-breaking
entrance in the pharmaceutical field. This platform of drug delivery is visualized as a thin and
flexible layer of polymer with or without a plasticizer. With this nature, it’s the most efficient drug
release platform compared to the traditional dosage form like tablets and capsules because it
can target sensitive sites that may not be penetrated by the tablet or liquid formulations. Also,
thin films can reduce the dose frequency and enhance the drug efficacy. With this kind of
development, it has pushed many experts to explore and patent substantial works in line with
this kind of product which gives way to the breakthrough of the different types of films.
The creation of thin films as a drug delivery platform is also the solution for people who
have the difficulties in swallowing tablets and capsules. Furthermore, the advantages we can see
in the creation of thin films are limitless. From the most practical to the most scientific way it can
possibly help us; nevertheless, as it gains popularity and acceptance in the pedestal of the
pharmaceutical field, loopholes can now be evidently seen in the way it can be applied to the
manufacturing processes in can undergo.
Thin films have been the talk of every pharmaceutical industry for it embodies the modern
way of providing the most convenient administration of drug through non-invasive routes. These
routes are other ways of taking in a drugs that must be delivered in a specific part of the body.
Ophthalmic films are developed to overcome ocular barriers and avoiding the waste of drug
though lacrimal drainage system. These are used to treat diseases of the anterior segment such
as conjunctivitis, glaucoma, etc. Buccal and Sublingual films are drugs that are permeable with
mucus; hence, it rapidly dissolves with it and administers its effect to its specific target. Having
this kind of characteristics, its way more potent than of the traditional kind of medication. Thin
films are also less to deteriorate and much more convenient to have rather that commercial
tablets that easily disintegrates. In terms of liquid dosage forms, it requires more effort in taking
it wherein you must accurately measure the amount and shaking the bottle before administering
it which may give hassle in times of emergency and may affect the potency of the drug. Experts
in the field of medicine also recommend the use of thin films especially for the pediatric, geriatric,
and psychiatric patients since it is easy to administer to the people who struggle to take in tablets
and capsules and more importantly, prevent the risk of choking and suffocation.
However, even this miracle drug can have its own disadvantages. One of it is its limitation
of the dosage it can have; thus, it can lower the potency level of the drug that the patients is
taking. Being hygroscopic of the thin films is also one of its disadvantages. It must be stored in an
environment where it specifically fits and if not the drug will eventually deteriorate or will lose
its effect as a cure for a disease. Combining it with other drug will also have a conflict in its curing
process for it will hinder each other’s co-administration process which can also lead to an
unknown health adversity of the one taking it. Accuracy of the dosage taken by the patient is a
crucial issue in having thin films as a medication because if the measurement of the drug will not
fit with the need of the patient, it can cause a therapeutic failure, non-reproducible effect and
sometimes toxic effect to the patient.
On the other hand, preparing an oral film formulation requires a long time because it
needs to completely dry at room temperature which subsequently implies that the production
rate of it is slower that traditional medications since it is not ideal to use a hot air oven to speed
up the process for which it will have an alter effect on the drug, maybe on its potency or on the
effect to the patient. With this kind of condition, the preparation of all the thin films requires
more time and effort compared to tablets and capsules which only requires the proportion of the
chemicals for the said drug.
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College of Health and Allied Medical Profession
Pharmacy Department
Despite its convenience as a drug delivery platform, the preparation it undergo seems to
be complicated. It must sustain many conditions before attaining its state of being a useful thin
film. Parameters like flexibility, softness, elasticity, and good physico-chemical stability are only
few of the guidelines in making a thin film. One of the most observable features of thin films is
its size. This physical features speaks about the content and the dosage a thin film has. A specific
thin film of different usage have different range of sizes like buccal films must have an ideal
thickness of 50 to 1000 µm. Vernier caliper, electronic digital micrometer, screw gauge, or
scanning electron microscopy (SEM) are few of the tools being used in this parameter. Having a
variation in weight is not only for the dosage count but also to ensure the drug has an accurate
measure of the content.
Mechanical and physical properties are also important in maintaining the quality of thin
films. One of the properties is the folding endurance which measure the flexibility of the thin film.
This can be measured by folding the thin film repeatedly at 180˚ angle plane until it reaches the
breaking point. The film that breaks at 300 repetitions of folding passes the test of flexibility.
Another test for thin films is the percent elongation and elongation at break. This is a kind of
deformation where it changes the shape of any object according to the applied stress. This test
can also be called as a test of tensile strength. These tests can be measured in two ways: by
texture analyzer or by using the given equation.

a = initial length of the film

a’ = initial length – radius of the probe
b = displacement of the probe
c’ = length of a’ after strain
r = radius of the probe

𝐼𝑛𝑐𝑟𝑒𝑎𝑠𝑒𝑑 𝑙𝑒𝑛𝑔𝑡ℎ 𝑜𝑓 𝑓𝑖𝑙𝑚

%𝐸𝑙𝑜𝑛𝑔𝑎𝑡𝑖𝑜𝑛 = × 100
𝐼𝑛𝑖𝑡𝑖𝑎𝑙 𝑙𝑒𝑛𝑔𝑡ℎ 𝑜𝑓 𝑓𝑖𝑙𝑚

√𝑎′ 2 + 𝑏 2 + 𝑟 2
%𝐸𝑙𝑜𝑛𝑔𝑎𝑡𝑖𝑜𝑛 𝑎𝑡 𝑏𝑟𝑒𝑎𝑘 = ( − 1) × 100
𝑎
On the other hand, Young’s modulus is a test for the resistance to any deformities on the
film can be readily seen by plotting in the strain stress curve where it implies that the greater the
slope, the greater tensile modulus a specific film has. Texture analyzer can also be used in testing
this kind of property of a film. Lastly, tear resistance is one of the most important property that
a film must have because it depicts a film that withstand any rupture. To measure this property,
the film is subjected to a constant rate of deformation. It utilize the stress strain curve wherein,
the area plotted in the curve is directly proportional to the toughness of the film. Therefore,
doesn’t measure the strength of the film but its toughness.
Moisture content of a film is one of the main characteristics that must be considered in
manufacturing it. The amount of moisture present in the film plays a crucial part because it may
affect other aspect of the film like the mechanical strength, adhesive properties, and friability of
the film. The hygroscopic properties of the materials used in making the film can be the reason
of the increase or decrease of the moisture content intended for the film. Karl Fischer titration is
one of the most common method in determining the moisture content of the film. Weighing
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method can also be used where the film is introduced to a tempersture of 100-120˚C until it
attain a constant weight. After that, the result will be calculated using this equation:
𝐼𝑛𝑖𝑡𝑖𝑎𝑙 𝑤𝑒𝑖𝑔ℎ𝑡 − 𝑓𝑖𝑛𝑎𝑙 𝑑𝑟𝑖𝑒𝑑 𝑤𝑒𝑖𝑔ℎ𝑡
𝑀𝑜𝑖𝑠𝑡𝑢𝑟𝑒 𝑐𝑜𝑛𝑡𝑒𝑛𝑡 % = × 100
𝐼𝑛𝑖𝑡𝑖𝑎𝑙 𝑤𝑒𝑖𝑔ℎ𝑡
The swelling property of the film aids it in the process of bioadhesion. It makes the
components of the film hydrophilic. This property also indicates the release profile of the drug
after intake. The test applied to measure this kind of property is polymer hydration. Hydrophilic
polymer has different structure; hence, it may have varying degree of swelling based on its
relative resistance of matrix network structure to water molecule movement. Measuring the
degree of hydration or swelling has a significant role in providing sufficient knowledge on the
mucoadhesive strength. As we presently know, the hydration of polymer causes the relaxation
and interpenetration of the polymeric chains; nonetheless, mucoadhesion property of a polymer
may decrease due to over hydration. Drug release profile of the thin films is related to this and
to all physicochemical properties of the materials used in achieving it. This release profile may
differ according to the route the thin films are intended to be applied because the release of drug
is dependent to the environment where it is subjected to. For example, buccal film is subjected
into biological fluids, like our saliva, the polymer coating it will start to swell and eventually
diffuse the drug.
These qualities of thin films does not only rely on the required amount of dosage intake
the patient needs but also on the route where it must be administered. Some of the patients take
their medication via oral route, especially buccal and sublingual route. These two specific routes
are the ideal way in taking in the films because it provides better mucosa which provides the thin
film to permeate better than with other mucosa. Sublingual route is normally taken when
targeting an acute disorder while buccal route is preferred in treating chronic diseases and it
provides a direct access to the systemic circulation through the internal jugular veins. Using this
route may also pose a risk in the drug delivery in the system because of the unpredicted oral
environment a patient have that may hinder the therapeutic effect of the said film. Some of the
factors that this environment may have that is unfavorable to the film is the Ph level, fluid
volume, enzymes present, and the permeability rate of the mucosa. An ocular route can also be
a way to administer a drug to a patient. For the past few years, ocular medication is always in the
form of suspension and was seen that it does not do any good in alleviating the patient’s
condition or the progress is too slow for a drug that is expensive. This led to the formulation of
thin films that is suitable for ocular route aiming to enhance the ocular bioavailability and
reckoning the ocular drug delivery barriers. Aside from the advantages presented, the creation
of ophthalmic films result to a more visible effect on the patient, reduces side effects, lesser dose
frequency, and better therapeutic results. With this kind of success, there are some hindrances
that impedes the success of this film. The mechanism of the eyes to bling whenever something
enters it washes out the ophthalmic film applied onto it; thus, it results to an uneven drug
diffusion and loss a significant amount of drug. Lastly, transdermal route is one of the routes that
can be taken in administering a drug to a patient. However, many environmental constraints
must be considered before making a drug fit for this route like the material’s molecular size, pH
level, state of the skin hydration, subcutaneous reservoir of the drug and drug metabolism in the
skin flora; hence, there are not much of drugs that is suited in this route.
In manufacturing such special drug delivery platforms needs special components to
formulate such special medication. Polymer is the foundation of building the thin films.
Combining this polymer with each other will create the properties intended for a specific route
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and purpose. Diverse combination of polymers helps to provide properties that varies according
to some parameters. The proportion of each material used in formulating a specific thin film. The
manufacturing process is also an exceptional development in the pharmaceutical field for the
formulation of this drug delivery platform. One best example is solvent casting wherein it is
commonly used in manufacturing the thin film because it is feasible and has a straightforward
manufacturing process and would spend less money in manufacturing. The different steps of this
manufacturing process hones the drug a specific characteristic which contributes to its final
attribute. The first step is the selection of solvent system where the film yields its level of
solubility because this is where the solvent system is chosen according to the drug you want to
have. Preparation of polymeric solution is the second step where the viscosity of the solution is
being tested together with finding the temperature the polymers must be introduced in order to
achieve the certain property. The drying period for the polymer is with the third step. The casted
solution must be dried or be suspended in the hot air oven for a significant amount of time with
a constant temperature of 40 – 50 ˚C. In this step, the moisture content of the thin film is the
main concern. The last step will be the packaging of the prepared film, this is where minor
measurement of the moisture content is happening and the planning of the best container the
film must have to insure and preserve its quality for a long period of time. Another manufacturing
process is the Hot-melt extrusion (HME) where it uses a high temperature to melt the materials
and mold it into the intended outcome. It is also a substitute to the solvent casting when there is
no organic solvent system is required. A practical HME follows an outlined process like this: (1)
feeding of the components to the extruder through a hopper, (2) mixing, grinding, and kneading,
(3) flowing the molten and blended mass to the die, and (4) extruding the mass through the die
and further downstream processing. After measuring the proportion in making the thin film, it is
then subjected to a high temperature to be melted and obtain homogenous matrices.
Printing technologies are new manufacturing processing creating thin films. With this kind
formulation, this could meet the demand of the society for customized medicine. There are two
sub-division in this technology: inkjet printing and flexographic printing technology (FPT). The
inkjet printing belongs to the printing technology which is more versatile, accurate, and relatively
inexpensive to buy and very much applicable in preparing low dose medicines. This is divided into
two types: continuous inkjet printing and drop on demand printing. In the CIP process, the liquid
present is ejected consistently in the orifice and then it breaks down into a stream of drops under
the force of the surface tension. On the other hand, DoD printing process only occurs when a
drop is needed. This drop takes place due to the kinetic energy of drops generated from the
source located in the printhead nearby to each nozzle. The other type of print technology is the
FPT. This is a process by which an active pharmaceutical ingredient is processed into film through
contact printing.
Thin films is just a spectacular piece of the puzzle made to complete what this generation
needs – a convenient source of medication where it has a significant effect in a short period of
time. It also comes in handy for it size does not bulk up into something humongous like our
traditional solid and liquid medication but we are just in the first chapter of this study. Many
underlying studies must be conducted before we introduce this to the world. We cannot risk the
lives of everyone just because we saw how effective it is with just one test. There are also
consequences that the pharmaceutical experts had faced in trying to formulate it. It may seems
to be a rush to conclude that this is the answer to everything but it might what we all need to be
saved from the different epidemic spreading throughout this world.
This article aims to open our minds in the possibility of having the solution in the plague
that killed many people in recent years. It made us all realize that it is not the end of the road of
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those people who are suffering from what they think are ‘incurable diseases’. It showed us the
path we must take in order to lead others to follow us in finding the answer of the questions of
this world. Yet, it doesn’t have an easy way out. The limited knowledge we have about this new
discovery keeps us from moving forward in searching for what we need.
This is not the only answer we have to depend on but this is just a key in opening the door
in discovering more innovations in the pharmaceutical field. Indeed, it would take years for the
experts to perfect this kind of development but what is important is we tried to open a new
source of hope in curing disease that caused million deaths in the whole world. Thin films will be
the greatest medication we can have in our daily lives because of its convenience it can give to
us and the possibility of curing illnesses that has held us captive in the past century. Having some
setbacks is inevitable especially if we are aiming for a bigger success, yet the risk of facing is
worthy of having if we can perfect the development of thin film. If we can only eliminate all the
constraints that is holding us from achievings what we really need and have the quality
specification to circumvent the difficulties associated with the formulation, we can end up
defying what we fear as humans – death. this will not end here, it will be the stepping stones of
those people who wants to know more, for they want to be one with the change they want to
see, the change that eventually turn this world a better place to live.