Volume 2
Issue 2
Article 3
Drug Delivery System Using a Buccal Film
Zainab Thabit Salih
Pharmacy College, Baghdad University, Baghdad, Iraq, zainab.saleh@copharm.uobaghdad.edu.iq
Asia Al-Mahmood
Pharmacy College, Baghdad University, Baghdad, Iraq
Sumayah Al-Mahmood
Pharmacy College, Baghdad University, Baghdad, Iraq
Follow this and additional works at: https://majms.alkafeel.edu.iq/journal
Recommended Citation
Salih, Zainab Thabit; Al-Mahmood, Asia; and Al-Mahmood, Sumayah (2023) "Drug Delivery System Using a Buccal
Film," Maaen Journal for Medical Sciences: Vol. 2 : Iss. 2 , Article 3.
Available at: https://doi.org/10.55810/2789-9136.1021
This Review is brought to you for free and open access by Maaen Journal for Medical Sciences. It has been accepted for
inclusion in Maaen Journal for Medical Sciences by an authorized editor of Maaen Journal for Medical Sciences. For more
information, please contact majms@alkafeel.edu.iq.
REVIEW
Drug Delivery System Using a Buccal Film
Zainab T. Salih a,*, Asia Al-Mahmood b, Sumayah Al-Mahmood b
a
b
Pharmacy College, Baghdad University, Baghdad, Iraq
Dentistry College, Al-Iraqia University, Baghdad, Iraq
Abstract
The pharmaceutical industry has recently adopted a revolutionary strategy concerning the dosage form's composition
and delivery methods, it is necessary to generate unique dosage forms in order to increase patient compliance, safety,
and effectiveness. Enzymes are responsible for both the first-pass digestion and subsequent degradation of common oral
dosage forms, although mucoadhesive films can prevent this issue, so, the creation of the buccal film is just one of the
cutting-edge technologies that serve as an alternative to the conventional oral solid dosage form particularly for young
children and elderly patients who have trouble swallowing. The buccal film is easier to use, visually appealing, and
more suitable than alternative buccal drug administration since it is non-irritating, simple to use, quickly absorbed,
elegant, and biodegradable (1). The buccal mucosa offers a direct pathway into the bloodstream while eliminating an
acidic environment. The most popular method for producing a buccal film is called film casting for delivering proteins
and personal care items. This article provides a thorough analysis of the buccal film's advantages, drawbacks, evaluation
criteria, and formulation.
Keywords: Buccal film, Solvent casting, Mucoadhesive polymers, Buccal mucosa
1. Introduction
I
n recent years, mucoadhesive systems for drug
delivery have attracted a lot of attention in the
delivery of pharmaceuticals. The study of mucosal
drug delivery has increased due to recent developments in drug delivery, and oral, buccal, ocular,
nasal, and pulmonary routes are some examples of
this type of route. Systems for delivering drugs that
adhere to mucous membranes are known as
mucoadhesive drug delivery systems, they become
adhesive on hydration, therefore, have significant
value for both regional and systemic delivery of
drugs since they. It can be used to continuously
supply the body with drugs for longer [1].
Buccal films are an unconventional and creative
method of administering drugs to reach the blood
instead of any swallowing [2], easy to use and
painless, and patients report no feeling of a foreign
body as shown in Fig. 1. As a result, they could
provide significant benefits over oral tablets and
suppositories in the fields of pediatrics and geriatrics. In addition, less API can be utilized in comparison to the mentioned dosage forms [3,4].
Buccal drug delivery, the drug may reach the
blood more quickly from the buccal mucosa, leading
to higher drug availability, attributable to the
mucoadhesive properties of non-invasive drug
administration, in addition to that avoiding the
liver's first-pass action. In buccal medication
administration, due to the fact that the drug and
gastric acid have no contact, the stomach is shielded
against the drug as well as the opposite is true [5],
additionally, the smallish stature and lower film
thickness result in an improve in the patient care
compared to tablets and lozenges [6]. In the pharmaceutical industry, films as dosage forms have
become more significant as unique,” patientfriendly " amiable, and practical products. and this
less friable dosage forms than most manufactured
tablets that dissolve in the mouth, which typically
need to be packaged specifically. Additionally, due
Received 2 May 2023; revised 13 June 2023; accepted 19 June 2023.
Available online 16 August 2023
* Corresponding author.
E-mail address: zainab.saleh@copharm.uobaghdad.edu.iq (Z.T. Salih).
https://doi.org/10.55810/2789-9136.1021
2789-9136/© 2023 University of AlKafeel. This is an open access article under the CC-BY-NC license (http://creativecommons.org/licenses/by-nc/4.0/).
MA'AEN JOURNAL FOR MEDICAL SCIENCES 2023;2:54e61
Fig. 1. Buccal Film.
to its attachment to the buccal tissue, it can be used
to show confined or systemic action [7].
1.1. Buccal films' benefits
Buccal films have a number of advantages
compared to oral tablets, swallowed tablets, and oral
liquids [8e10].
1. Rapid disintegration and dissolution due to the
larger surface area provided by buccal films and
promote systemic absorption.
2. Lack of chewing, swallowing, and choking
prevention.
3. Bypasses the hepatic first-pass metabolism,
result in an increase of bioavailability.
4. Drugs are protected from the gastric environment and enzymes of the gastrointestinal tract.
5. Rapid onset of action.
6. Precise dose in comparison with liquid dosage
formulations.
7. Prolong the time at which the drug is spent at
the absorption site.
8. Simple administration for those younger or
elderly, intellectually challenged, physically
impaired, or uncooperative patients.
9. Acceptable oral sensation
10. The simplicity of handling, storage, and
shipping.
1.2. Disadvantages of buccal drug delivery [11,12]
The following are some drawbacks of buccal
medication delivery system.
1. Very little medication at the surface of the
absorbing membrane since saliva continuously
55
generates in the mouth cavity, resulting in diluting
drugs there.
2. Possibility to be swallowed
3. The candidate list of drugs for the buccal route
may be restricted by irritation, taste, allergy, and
unfavorable discoloration or tooth erosion.
4. Eating and drinking may be restricted
5. Limited amount of loaded drug
6. Less stable than tablets and capsules
7. More expensive compared to conventional oral
dosage form
9. Variable drug absorption
10. Affected by mouth wounds and ulcers
11. Hard to mask undesirable test
12. Can be used only for small MW highly lipophilic
drugs
13. May cause mouth irritations
14. Thickness of film is critical
15. Absorption is affected by saliva volume
16. Manufacture is not suitable for heat sensitive
materials
17. Permitted for medications that are absorbed
through passive diffusion only.
2. The buccal mucosa
The lip, tongue, cheek, delicate palate, solid palate, and mouth floor make up the oral cavity. Three
layers make up the oral mucosal layer: the epithelium which is the outer layer, the middle layer
which is the basement, and the inner layer which is
made of connective tissues as shown in Fig. 2. The
oral cavity has an epithelial thickness of 0.5 mm
thickness epithelium [13].
Drug delivery can fall into one of three types inside the oral cavity.
1. Sublingual Route
2. Buccal Route
3. Local Route
3. Buccal absorption
The passive diffusion of non-ionized species,
which is mainly affected by the difference in the
concentration, through the epithelium's intercellular
spaces results in drug absorption in the buccal
cavity. There are two main routes for drug transport
through the buccal mucosa: transcellular and paracellular pathways. The main pathway for large
molecules to pass through stratified epithelium is
the intercellular spaces, where there is a barrier to
penetration due to the intercellular substance's alterations in the surface layers. It is widely accepted
56
MA'AEN JOURNAL FOR MEDICAL SCIENCES 2023;2:54e61
Fig. 2. Structure of oral mucosa [14].
that the lipid matrix of the extracellular space plays
a significant role in the barrier function of the paracellular route, especially when the substances, like
peptides, are hydrophilic and have a large molecular weight [15].
The lipid solubility and molecular weight of the
diffusant have an impact on the buccal mucosa's
capacity for absorption. It has been discovered that
some medications absorb more readily via the
buccal mucosa when the carrier pH is lowered and
less readily when the carrier pH is raised [16].
4. Aspects of buccal films' formulation
Buccal films generally consist of a number of ingredients like polymer, plasticizer, drug, sweetener,
and necessary additives. Recently, mucoadhesive
films using polymers have been vastly used.
4.1. Active pharmaceutical ingredient
The buccal film can typically incorporate active
medicinal components ranging from 5% w/w to
thirty% w/w of total weight of polymer. Dose of
drug in mgs (less than 20 mg/day) is required for
effective formulation [8]. The water-soluble drugs
can be found in the buccal film in a dissolved condition or as a solid solution, hydrophobic medications are evenly distributed throughout the film or
complexation with different cyclodextrins can increase the drug's solubility. According to the
necessary drug release pattern, API can be mixed as
milled, nanocrystalline, micronized, or in the form
of particles. The film texture will be enhanced by the
usage of micronized API, as well as for improved
dissolving and homogeneity [9]. It is possible to use
every kind of medicinally active substance that can
be ingested orally and administered through buccal
mucosa such as drugs used for ulcer and antiallergic
drugs [18].
4.2. Water soluble polymers
Polymers that are water-soluble considered as a
film former and its use in medical and nutraceutical
applications has drawn significant attention since it
gives the films quick disintegration, a pleasant
mouthfeel, and strong mechanical qualities. Higher
molecular weight polymers have led to a slower rate
of polymeric disintegration. Methyl cellulose A-3,
A-6, and methyl cellulose A-15 are a few of the
water-soluble polymers utilized as film formers,
along with K-3 Pullulan [19,20].
4.3. Plasticizers
The use of plasticizers in the creation of a buccal
medication delivery system is absolutely essential
since they aid by enhancing the buccal film's mechanical qualities, including its tensile strength and
elongation, while also offering other benefits
including a decrease in the film's brittleness and
increased flexibility as well as a higher degree of the
polymer's flow characteristic and a lower glass
transition temperature [21]. Glycerin, sorbitol,
MA'AEN JOURNAL FOR MEDICAL SCIENCES 2023;2:54e61
propylene, and polyethylene glycol are a few examples of plasticizers, as are tri-acetin, dibutyl
phthalate, tri-ethylcitrate, acetyl tri-ethyl-citrate,
and various citrate esters. The amount of plasticizer
to be used can be 20% or less of the total dried
polymer's weight [21]. The choice of plasticizers is
influenced by polymer type, solvent solubility, and
compatibility. Plasticizers used in excess or with the
wrong materials can result in film that peels, splits,
and cracks [22].
4.4. Mucoadhesive polymers
Muco-adhesion was thought to be mainly generated by the polymer hydrating and expansion caused
by the diffusion of water and the resulting dehydration of mucin and expansion ought to boost the
flexibility of the polymeric molecule and interchain
penetration, strengthening the mucoadhesive
strength. The features of polymer to be utilized for
buccal formulation depend on extent of spreading
capacity and capacity to create various kinds of
molecule and molecule bonds at distinct stages of
water absorption [23]. Various mucoadhesive polymers have been researched recently for extending
dose form or active retention in specified locations of
the oral mucosa. Acrylic acid polyethylene glycol
(PEG) and monomethyl ether copolymer, are the
polymers that usually find their way in the formulation of buccal dosage forms, in addition to that
varieties of cellulose, such as sodium carboxymethyl
cellulose (NaCMC), are among other frequently used
polymers. Chitosan is a natural polymer that is
positively charged, biocompatible, and biodegradable. Because of its electrostatic interaction with
mucin's negatively charged O-linked oligosaccharide
chain, chitosan has been widely used as a mucoadhesive polymer. Chitosan's limited solubility at the
physiological pH of the buccal mucosa and compatibility concerns with anionic medicines and excipients are what restrict its widespread use. Many
chitosan derivatives are now being researched to
improve chitosan's solubility and permeability at
various pH levels without any precipitation caused
by drug-polymer complexation [23].
57
a few of the chemicals that might increase penetration. Additionally, polymers with the muc-oadhesion property, bile salts, azone, and presently
chitosan, its derivatives, and have the potential to
increase penetration. Chitosan is viewed as a
possible penetration enhancer for hydrophilic
macromolecular medicines that are absorbed
transmucosally [24].
4.6. Saliva stimulating agent
Fast-dissolving film preparations dissolve quickly
because more saliva is produced when using them.
As a result, these dosage forms may include saliva
enhancers such as citric acid and tartaric acid [25].
4.7. Cooling agent
Using monomethyl succinate as cooling agents
contributes to the enhancement of the mouthfeel
and flavor intensity of the film. In addition to agents
including WS3 is a menthol derivative,it is virtually
nonvolatile, odorless, and tasteless in contrast to
menthol and considered as one of the most popular
cooling agents on the market, WS23, and Utracoll II
can be utilized [7].
4.8. Sweetening agents
Sweeteners are essential in pharmaceutical products wanted to dissolve or disintegrate in the mouth.
Traditional sweetener sources include sucrose,
dextrose, glucose, liquid glucose, and fructose. For
the purpose of developing oral medications, polyhydric alcohol like mannitol is important because,
they are free of a bitter aftertaste and have a lesser
risk of causing cancer [26]. For people with diabetes,
the use of naturally occurring sugars is limited in
these formulas. Artificial sweeteners, such as
aspartame and saccharin, are consequently most
frequently employed in food products and pharmaceutical items [27].
4.5. Penetration enhancers
4.9. Surface active agents
Improving drug penetration through buccal mucosa was achieved by using penetration enhancers.
The use of water is one of the straightforward
penetration enhancers examples, their effects
should be reversible and not irritating. Surfactants
(like Tween), fatty acids (like oleic acid), terpenes
(like eucalyptus), and solvents (like ethanol) are just
Surfactants are used as wetting, dispersing, and
solubilizing agents to melt the film quickly and
release the active ingredient. Furthermore, surfactants make drugs that are not soluble more soluble
in rapidly dissolving buccal films, examples include
polaxamer407, sodium lauryl sulfate, benzalkonium
chloride, tweens, and spans [8,21].
58
MA'AEN JOURNAL FOR MEDICAL SCIENCES 2023;2:54e61
4.10. Agents for stabilizing and thickening
The solution or dispersion used for preparing the
film for casting has better consistency and viscosity
by the addition of stabilizing and thickening agents
before casting. Cellulose derivatives and carrageenan are some examples of naturally occurring
stabilizers and thickeners in a 5% w/w concentration
[28].
4.11. Buccal film production techniques
The manufacturing procedures used to create
buccal films are solvent casting, hot melt extrusion,
and direct milling [17].
4.11.1. Solvent casting method [29,30]
The solvent-extraction process is mainly utilized
for preparing the oral film. According to this
method, the required amount of polymer is dissolved in distilled water. A small amount of the
active medicinal ingredient is then added to this
solution, then, plasticizer is added and thoroughly
combined with the solution. After applying the
mixture on a Petri dish, it dried out at 40 C in the
oven with hot air. Once it has dried, it should be
removed with a blade from the Petri dish and place
it in a desiccator for 24 h. It should be cut and
shaped as needed. Ivabradine hydrochloride buccal
film formulation and evaluation for the treatment of
stable angina pectoris according to study done according to Lodhi M et al., positive results were obtained by combining the basic polymers K15M and
K100M of HPMC and carbopol 940. Additionally,
the medication content of each formulation was
assessed and confirmed to be consistent. Utilizing
phosphate buffer pH 6.6, an in vitro release study
was conducted on all formulations and a drug
release
from
films
in
the
range
of
90.36% ± 0.854e98.37% ± 0.589 was obtained at the
end of 6 h [31].
4.11.2. Hot melt extrusion method [32]
The solvent casting method can be replaced by
hot melt extrusion (HME). In the HME procedure,
the unprocessed components are transported
through rotating screws at a high temperature
through a die to produce a product with a uniform
structure, including dietary supplements, pharmaceutically active ingredients, polymers, and plasticizers. There are four steps in the hot-melt extrusion
process. Mixing, chopping, and kneading bioactive
substances and the formulation ingredients before
feeding them through a hopper to the extruder. The
molten material is transferred to the rotating screw,
then it is extruded through the die to form the
desired shape [33]. Central composite design was
used to prepare domperidone film using hot melt
extrusion method and controlled release films are
intended for buccal administration [34].
4.12. Parameters for evaluating buccal film
4.12.1. The Film's weight [35]
Using an adjusted weighing balance, the buccal
film is weighed; the weight of each one has been
determined individually.
4.12.2. Film thickness [36]
This test is carried out with a calibrated micrometer screw gauge to measure the uniformity of
how thick the film is since it has a substantial impact
on the film's dosing precision and maintains the
production process's predictability. A mean value is
calculated after five analyses of the film's thickness.
4.12.3. pH of the Film's surface [37]
After the films have interacted with 1 ml of
distilled water for 2 h at 25 C, the pH can be
measured by placing the electrode on the film's
surface and letting it equilibrate for 1 min.
4.12.4. Folding endurance [30]
The film is continuously folded in the same spot
till it breaks to assess how long it can withstand
folding. The number of folds a film can endure in a
specific area before rupturing is known as its folding
tolerance.
4.12.5. Tensile strength [30]
A film's tensile strength is the amount of force
needed to cause deformation failure. In between
two clamps that are spaced apart by a certain
amount, film strips of a particular size are held.
"Tensile strength (N/mm2) ¼ breaking force (N) /
cross sectional area of sample".
4.12.6. In-vitro disintegration time [38]
A Petri plate filled with two milliliters of distilled
water measures the in vitro disintegration time by
rotating it each 10 s while visually observing how
long it takes to disintegrate. This time is then
recorded as the period during which the film
disintegrates.
4.12.7. Homogeneity of the drug content [37]
Homogeneity determination was assessed by
taking 5 films that had been previously weighed,
and dissolved in 100 ml of isotonic phosphate
MA'AEN JOURNAL FOR MEDICAL SCIENCES 2023;2:54e61
59
buffer, pH 6.8, then allowing the mixture to stand
for 2 h using a magnetic stirrer, then, the resulting
liquid was filtered employing Whatman filter paper,
and after the correct dilution, the medication was
assessed using a spectrophotometer.
medication was released. The following formula was
used to determine the flux value:
4.12.8. Test for percent moisture loss [39]
The percentage of moisture loss was determined
by putting two films measuring 2 2 cm2 with
anhydrous calcium chloride in a desiccator for three
days. After removing and weighing the film sheets,
an equation was employed to calculate the percentage of moisture lost.
4.12.12. Ex-vivo muco-adhesion time [26]
The buccal film is put to the fresh buccal mucosa
of sheep or rabbit, which is tied to a glass slide, to
measure the muco-adhesion time using fingertips
and a drop of phosphate buffer pH 6.8 to moisten
the buccal film, then, the buccal mucosa is covered
for 30 s. The glass slide is kept at 37 C ± 1 C in a
beaker containing phosphate buffer with a pH of 6.8.
After 2 min, a 50-rpm stirring speed is introduced,
and film adherence for 24 h to mimic the buccal
cavity environment. Along with the film's time
collapsing, a timer records how long it takes for
shape and color changes to become apparent.
"Percentage Moisture Loss ¼ [(Initial weight e Final
weight) / Initial weight] X 100%"
4.12.9. Percentage moisture uptake [39]
Films were dried out in a desiccator for 24 h at
25 C with a saturated potassium chloride solution
and 84% relative humidity level. The short films
were taken off after a full day and weighed. The
percentage of moisture uptake can be determined
by employing the formula below.
"Percentage moisture uptake ¼ [(Final weight e
Initial weight) / Initial weight] X 100%"
4.12.10. Swelling index [40]
Each buccal film was individually weighed (W1)
and put in a petri plate containing phosphate buffer
pH 6.8. Buccal films were dried with filter paper to
separate the excess surface water and reweigh it
(W2).
Swelling index (S1) was calculated using the
formula:
"SI](W2 e W1) / W1";
where; SI ¼ Swelling index, W2 ¼ Final weight.
W1 ¼ Initial weigh.
4.12.11. In-vitro drug release [37]
Two chambers Franz diffusion cell was utilized,
one of which contains a buffer solution with a pH of
6.8 and the other of which has 10 mg of the medicine
as a donor. Between these sections, a dialysis
membrane (Mol. Wt. 12,000e14000Da) that had
previously been soaked for 2 h in receptor media
was used to create a barrier. The flowing water bath
kept the temperature at 37 C throughout the entire
procedure. For up to 8 h, 0.5 ml of the sample was
taken out of the receptor compartment and replaced
with a new buffer at predetermined intervals. The
appropriate dilution was done, and spectroscopic
analysis was carried out to find how much
Flux ¼ Amount of drug released (mg)/Time
(hr) Area (cm2)
4.12.13. Ex-vivo permeation studies [31]
The adapted Franz diffusion cell comprised of two
sections: a donor chamber and a receptor chamber,
each having a 25 ml capacity, was implemented to
carry out permeation investigations. In order to
control the environment of the test at 37 C, a water
jacket comprised of 23 ml of pH 6.6 phosphate
buffer was inserted within the compartment that
holds the receptors. The dissected buccal epithelium
was installed between the two chambers, and a
Teflon-coated magnetic bead was used to suspend
the complete assembly on a magnetic stirrer. After
the buccal film was set aside to stabilize, 1 ml of the
sample was taken out at regular intervals and
properly diluted for spectrophotometric analysis.
4.12.14. Stability studies [41]
Stability tests are carried out for the purpose of
examining any changes that may occur while storing
any formulation. All of the formulations were stored
in stability chambers for three months in triplicate at
40e42 C and 75 C þ 5% RH. Stability experiments
were analyzed for folding durability, drug content,
and in vitro drug release.
5. Conclusion
The current review has determined that buccal
film is the most attractive and appealing dosage
form due to its unique characteristic properties
compared to other innovative buccal drug delivery
systems, it skips first-pass metabolism and also increases the bioavailability of the active component.
Buccal drug administration is an interesting alternative for the non-invasive delivery of potent
60
MA'AEN JOURNAL FOR MEDICAL SCIENCES 2023;2:54e61
peptide and maybe protein therapeutic molecules as
well as a potential field for systemic delivery of
medications that are ineffective when taken orally.
However, a key element for a bright future in the
field of buccal medication delivery is the requirement for safe and efficient buccal permeation and
absorption enhancement. Research on buccal film is
expected to continue with the goal of systematically
delivering medications that are ineffective when
taken orally.
Conflict of interest
There is no conflict of interest.
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