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Abstract
Recently, fast dissolving films are gaining interest as an alternative of fast dissolving tablets. The films are designed to
dissolve upon contact with a wet surface, such as the tongue, within a few seconds, meaning the consumer can take the
product without need for additional liquid. This convenience provides both a marketing advantage and increased patient
compliance. As the drug is directly absorbed into systemic circulation, degradation in gastrointestinal tract and first pass effect
can be avoided. These points make this formulation most popular and acceptable among pediatric and geriatric patients and
patients with fear of choking. Overthecounter films for pain management and motion sickness are commercialized in the
US markets. Many companies are utilizing transdermal drug delivery technology to develop thin film formats. In the present
review, recent advancements regarding fast dissolving buccal film formulation and their evaluation parameters are compiled.
Key words: Fast dissolving films, oral mucosa, permeability, solvent casting, solvent casting and disintegration
SPECIAL FEATURES OF FAST DISSOLVING Packaging of films requires special equipments and it is
FILMS[8] difficult to pack.
the standard composition of fast dissolving strip along with the APPROACHES USED FOR THE FORMULATION OF
various ingredients used in the formulation of fast dissolving strips. FAST DISSOLVING FILMS[18]
approximately 3-4min so that mass should be properly melted. also having the ability to incorporate active pharmaceutical
The extrudate(T = 650C) obtained is then pressed into a ingredients. The XGel film systems can be made to encapsulate
cylindrical calendar in order to obtain a film. There are certain any oral dosage form and can be soluble in either cold or hot
benefits of hot melt extrusion: Fewer operation units, minimum water. XGel film is comprised of a range of different water
product wastage, possibility to scale up, an anhydrous process, soluble polymers, specifically optimized for the intended use.
absence of organic solvents, include shorter temperature and
shorter residence time of the drug carrier mix, and better content Soluleaves
uniformity.[19] This technology is used to produce a range of oral delivery
films that can incorporate active ingredients, colors, and flavors.
Semisolid casting Soluleaves films can be designed to dissolve rapidly on contact
This method is mostly preferred when film ingredient involves with saliva, quickly releasing the active ingredients, and flavors.
acid insoluble polymer. In this firstly, the water soluble polymers This quality makes edible films an excellent delivery method for
are dissolved in water. The obtained solution is added to the acid a large range of products requiring fast release in the mouth. For
insoluble polymer solution which is separately formed. Both the pharmaceutical uses, this method of administration is especially
solutions are mixed properly. After mixing the two solutions, useful for pediatric or elderly patients who may have difficulty
appropriate amount of plasticizer is added to the obtained final swallowing traditional tablets or capsules. The delivery system can
solution so that gels mass can be obtained. At last, the gel mass be used for the cough/cold, gastrointestinal, and pain therapeutic
is casted onto the films or ribbons using heat controlled drums. areas as well as delivering nutritional products. Soluleaves
The thickness of the film should be about 0.015-0.05. The ratio films can also be designed to adhere to mucous membranes and
of the acid insoluble polymer to film forming polymer should be to release the active ingredient slowly over15min.
1:4. Examples of acid insoluble polymers are cellulose acetate
phthalate and cellulose acetate butyrate. Wafertab
Wafertab is a drug deliver y system that incorporates
Solid dispersion extrusion pharmaceutical actives into an ingestible filmstrip. The system
Method involves the solid dispersion of drug incorporated in provides rapid dissolution and release of actives when the strip
melted polymer solution so that drug can be loaded. The drug comes into contact with saliva in the mouth. The Wafertab
is dissolved in suitable liquid solvent and obtained solution is filmstrip can be flavored for additionally improved taste masking.
added to the melt of suitable polymer, obtainable below 70C The active ingredient is precisely dosed and integrated into
without removing the liquid solvent to obtain the solid dispersion. the body of a premanufactured XGel film, thus preventing
Finally the obtained solid dispersions are shaped into films by exposure to unnecessary heat and moisture and potentially
means of dyes. enhancing product stability. The Wafertab system lends itself
to many possibilities for innovative product design, enabling
Rolling method multiple films with different actives to be bonded together.
In rolling method, both the drug solution and film forming Wafertab can be prepared in a variety of shapes and sizes and
polymer solution are mixed thoroughly and the resultant solution is an ideal method for delivery of medicines, which require fast
or suspension is subjected to the roller. The solution or suspension release or for use by patients who have difficulty in swallowing.
should have specific rheological consideration. The film is dried
on rollers and cut into desired shapes and sizes. Foamburst
It is a special variant of the Soluleaves technology where an
Patented approaches[20] inert gas is passed into the film during production. This results
XGel in a film with a honeycombed structure, which dissolves rapidly
XGel film provides unique product benefits for healthcare giving a novel mouth sensation. Foamburst has attracted
and pharmaceutical products: It is nonanimal derived, approved interest from food and confectionary manufacturers as a means
on religious grounds, and is suitable for vegetarians; the film is of carrying and releasing flavors.
genetically modified organism(GMO) free and continuous
production processing provides an economic and competitive Micap
manufacturing platform. XGel film can be taste masked, Micap plc signed an option agreement in 2004 to combine its
colored, layered, and capable of being enteric properties whilst expertise in microencapsulation technology with the Bio Progress
water soluble films. The developments will be aimed at providing Hard and brittle strips demonstrate a high tensile strength and
new delivery mechanisms for the $1.4billion global market for Youngs modulus with small elongation.
smoking cessation products(SCPs).
Folding endurance
Folding endurance gives the brittleness of a film. The method
EVALUATION PARAMETERS followed to determine endurance value is that the film
specimen(2 2 cm2) are repeatedly folded at the same place
Thickness
until it breaks or a visible crack is observed. The number of times
The thickness of film is measured by micrometer screw gauge or
the film is folded without breaking or without any visible crack
calibrated digital Vernier Calipers. The thickness of film should
is the calculated folding endurance value.[26]
be in range 5-200 m.[21] The thickness should be evaluated at
five different locations(four corners and one at centre) and it is
In vitro disintegration test
essential to ascertain uniformity in the thickness of film as this
Disintegration time is the time when an oral film starts breaking
is directly related to accuracy of dose distribution in the film.
when brought in contact with water or saliva. For a fast dissolving
film, the time of disintegration should be in range of 5-30 s.
Dryness/tack test
United State Pharmacopoeia(USP) disintegration apparatus
In all there have been eight stages identified for film drying and
can be used to study disintegration time.[27] In another method,
these are set-to-touch, dust-free, tack-free(surface dry), dry-to
the disintegration time can be visually determined by dipping the
touch, dry-hard, dry-through(dry-to-handle), dry-to-recoat, and
film in 25ml water in a beaker. The beaker should be shaken
dry print-free. Tack is the tenacity with which the strip adheres to
gently and the time was noted when the film starts to breaks or
an accessory(a piece of paper) that has been pressed into contact
disintegrates.[28]
with strip. Instruments are also available for this study.[22]
In vitro dissolution studies
Tensile strength
Dissolution is defined as the amount of drug substance that goes
Tensile strength is the maximum stress applied to a point at which
into the solution per unit time under standardized conditions of
the strip specimen breaks. It is calculated by the applied load at
liquid/solid interface, temperature, and solvent concentration.
rupture divided by the cross-sectional area of strip as given in
the equation below: The standard basket or paddle apparatus described in any of
the pharmacopoeia can be used for dissolution testing. The
Tensile strength=Load at failure100/Strip thicknessStrip selection of dissolution medium will essentially depend as per
width the sink conditions and highest dose of API. The temperature
of dissolution medium should be maintained at 37 0.5C
Percent elongation and rpm at 50. When the paddle apparatus is employed, it has
When stress is applied on a film(2 2 cm2) sample it gets a disadvantage that oral films have a tendency to float over
stretched, this is referred to strain. Strain is basically the the dissolution medium. Mashru etal.,[29] used stainless steel
deformation of strip before it gets broken due to stress. It is wire mesh with sieve opening of approximately 700 m used
measured by using hounsfield universal testing machine.[23] to dip salbutamol fast dissolving film inside the dissolution
Generally elongation of strip increases as the plasticizer content medium.[30,31]
increases. It is calculated by the formula:
Drug content uniformity
% Elongation=Increase in length of strip100/Initial length This is determined by any standard assay method described
of strip for the particular API in any of the standard pharmacopoeia.
Content uniformity is determined by estimating the API content
Tear resistance in individual strip. Limit of content uniformity is 85-115%.[32]
Tear resistance is the resistance which a film offers when some
load or force is applied on the film specimen. The load mainly Organoleptic test
applied is of very low rate 51mm/min. The unit of tear resistance The desired organoleptic properties a fast dissolving formulation
is Newton or poundsforce. In other words it is the maximum should have are color, flavor, and taste. As the formulation
force required to tear the specimen.[24] will disintegrate in the oral cavity so it should provide
acceptable organoleptic palatable characteristics. Color
Youngs modulus makes a formulation acceptable among the patients and
Youngs modulus or elastic modulus is the measure of stiffness of moreover oral films should have attractive color as they are
strip.[25] It is represented as the ratio of applied stress over strain administered to children. Hence, color of formulation should
in the region of elastic deformation as follows: be uniform and attractive. Color can be evaluated by visual
inspection. The other organoleptic property is the odor. The
Youngs modulus=Slope100/Strip thicknessCross head flavor used in the formulation should provide good odor to
speed the formulation. The odor of the polymer, drug, and any
other excipient should be masked with use of flavoring agent. Permeation studies
Taste is also an important factor which has to be evaluated. Even though permeability of oral mucosa is 41000times greater
To evaluate the taste, special human taste panels are used. than that of skin, permeation studies should be carried out. To
Experiments using electronic tongue measurements have also study the permeability, modified Franz diffusion cell can be
been reported to distinguish between sweetness levels in taste used along with porcine buccal mucosa. The Franz diffusion
masking formulation.[33] Electronic tongue technique works cell consists of a donor and a receptor compartment. In between
on the principle of potentiometric titration method. In this the two compartments, mucosa is mounted and the size of the
liquid samples can be analyzed directly, whereas solid samples mucosa should be of the same size as that of the head of receptor
need to be dissolved in a suitable solvent before analyzing. In compartment. The receptor compartment is filled with buffer
this method, reference electrode and sensors are dipped in a and maintained at 370.2C and to maintain thermodynamics
beaker containing a test solution for 120 s and a potentiometric a magnetic bead stirring at a speed of 50rpm is used. Afilm
difference between each sensor and a reference electrode is specimen moistened with a few drops of simulated saliva should
measured and recorded by the Etongue software.[34,35] be kept in contact with mucosal surface. The donor compartment
should consist of 1ml simulated saliva fluid of pH6.8. At
Surface pH test particular interval, samples are withdrawn and replaced by
The surface pH of fast dissolving strip can cause side effects to same amount of fresh medium. By suitable analytical method,
the oral mucosa, so it is necessary to evaluate the surface pH of percentage of drug permeated can be determined.[40]
film. The surface pH of film should be 7 or close to neutral. For
this purpose, a combined pH electrode can be used. With the help Percentage moisture loss
of water, OS was made slightly wet and the pH was measured To determine percentage moisture loss films of area 22 cm2 are cut
by bringing electrode in contact with surface of oral film. This and weighed accurately on an electronic balance. After weighing, the
study should be done on at least six films of each formulation films were kept in desiccators containing fused anhydrous calcium
and their meanSD can be calculated.[36] In another method to chloride. The films should be kept for 72h in the desiccator. After
determine the surface pH, the films are placed on the 1.5%w/v 72h, they are taken out and again weighed and the percentage
agar gel and then the pH paper are placed on the film, change moisture loss of films was measured by using the formula:
in color of pH paper gives surface pH of the film.
Percent moisture loss =(Initial weightFinal weight)/Initial
Contact angle weight100
Contact angle measurement predicts the wetting behavior,
disintegration time, and dissolution of oral film. These The percentage moisture loss studies are done to determine
measurements are performed with help of goniometer(AB physical stability and integrity of the film.[41]
Lorentzen and Wettre, Germany) and the measurements should
be done at room temperature. The water used to determine Determination of % yield of buccal patches[42]
contact angle should be double distilled water.[37] A drop of double Percentage yield of buccal patches can be calculated by the
distilled water is placed on the surface of dry film. Images of following formula:
water droplet are recorded within 10 s of deposition by means of
digital camera. Digital pictures can be analyzed by imageJ 1.28v % yield=Mass of the buccal patches obtained/Total weight of
software(NIH, USA) for angle determination. drug and polymer100
and holds three films on each side. Every dose can be taken out The example of such case would be a comparative bioequivalence
individually.[44] between an orally disintegrating tablet(ODT) formulation and
orally dissolving film(ODF) product. However, developed oral film
product may exhibit different pharmacokinetic profile compared
APPLICATIONS OF OTF IN DRUG DELIVERY to the existing marketed product. The ODF is categorized as new
SYSTEMS dosage form and the section 505(b)(2) approval process needs to
be followed. In this case a new clinical study would be required.
Oral mucosal delivery via sublingual, buccal, and mucosal The advantage of new clinical study is that it would award 3years
routes by use of oral thin film could become preferential of marketing exclusivity to the product. In Europe, marketing
deliver y method for therapies requiring rapid drug authorization approval is essential as per the European Medicine
absorption, including those used to manage pain, allergies, Evaluation Agency guidelines. Either of the two modes, that is,
sleep, and central nervous system disorders.[45] decentralization procedure or mutual recognition process can be
Topical applications: The use of dissolvable films may be adopted. The Ministry of Health, Labor and Welfare is responsible
feasible in delivery of active agents such as analgesic or for product approval in Japan.[46] Many of the regulatory agencies
antimicrobial agents in the wound care and other applications. lay special emphasis on the taste and palatability aspects, especially
Gastrorententive delivery system: Dissolvable films are if the product is intended to target the pediatric population. Oral
being considered in the dosage form for which water soluble mucosa irritation testing is carried out in both animal models and
and poorly soluble molecules of various molecular weight humans. In case of animal studies, the most appropriate model is
are contained in film formate. Dissolution of film could hamster cheek pouch, it is a reliable model for predicting irritation
be triggered by pH or enzyme secretion of gastrointestinal criteria prior to testing in humans. In clinical trials, the clinical
tract(GIT) and could potentially be used for treatment of endpoint is significant. Primary and secondary outcome measures
gastrointestinal disorder. are to be noted. The objective is to demonstrate the superiority and
Diagnostic devices: Dissolvable films may be loaded with advantage of newly developed OS as against the existing traditional
sensitive reagent to allow controlled release when exposed to conventional dosage forms. The ICH has laid guidance on product
a biological fluid or to create isolation barriers for separating development. According to the ICH Q8 guideline on pharmaceutical
multiple reagents to enable a timed reaction within a development, companies may choose either an empirical approach
diagnostic device. or a more systematic approach towards product development.
This document is an integral part of regulatory document for
Clinical and regulatory aspects USA, EU, and Japan. Clinical study protocol should define a
In the US Food and Drug Administration(US FDA), if the product clear objective; different problems should be tackled in separate
is bioequivalent to that of the existing oral product the drug, an welldefined studies. The planned study should have sufficient
Abbreviated New Drug Application(ANDA) route is followed. resolution power to pick up critical adverse health effect(including
There is no clinical studies associated on this generic approval supporting rationale). Calculation of the study size(s) is dependent
processes(section 505(j) of the Food, Drug, and Cosmetic Act). on type of study(e.g.,effects on soft tissues and/or on hard tissues).
Specification of all endpoints should be determined. Description over conventional dosage form and can also be used in cases of
of usage pattern(s)(single/multiple application) is to be included. dysphagia, Parkinsons disease, mucositis, or vomiting.
Followup during a relevant period after treatment(e.g.,single
application with followup periods of 1, 3, 6, and 12months;
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