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Universal Journal of Pharmaceutical Research FAST DISSOLVING DRUG

DELIVERY SYSTEMS: FORMULATION, PREPARATION TECHNIQUES AND
EVALUATION

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Universal Journal of Pharmaceutical Research
An International Peer Reviewed Journal
Open access to Pharmaceutical research
©2018, publisher and licensee UJPR, This is an open access article which permits unrestricted non commercial
use, provided the original work is properly cited
Volume 3, Issue 4, 2018

REVIEW ARTICLE

FAST DISSOLVING DRUG DELIVERY SYSTEMS: FORMULATION,

PREPARATION TECHNIQUES AND EVALUATION
Satbir Singh*1, Tarun Virmani1, Reshu Virmani1, Pankaj Kumar2, Geeta Mahlawat1
1
School of Pharmaceutical Science, MVN University, Palwal, (Haryana), 121105, India
2
Advanced Institute of Pharmacy, Palwal, (Haryana), 121105, India

ABSTRACT
The Fast Dissolving Drug Delivery Systems sets a new benchmark was an expansion that came into existence in the early 1980’s
and combat over the use of the different dosage form like tablets, suspension, syrups, capsules which are the other oral drug
delivery systems. Fast Dissolving Drug Delivery System (FDTS) has a major advantage over the conventional dosage forms since
the drug gets rapidly disintegrated and dissolves in the saliva without the use of water .In spite of the downside lack of immediate
onset of action; these oral dosage forms have valuable purposes such as self medication, increased patient compliance, ease of
manufacturing and lack of pain. Hence Fast Disintegrating Tablets (FDTS) technology has been gaining importance now-a-days
with wide variety of drugs serving many purposes. Fast Disintegrating Tablets (FDTS) has ever increased their demand in the last
decade since they disintegrate in saliva in less than a minute that improved compliance in pediatrics and geriatric patients, who
have difficulty in swallowing tablets or liquids. As fast dissolving tablet provide instantaneous disintegration after putting it on
tongue, thereby rapid drug absorption and instantaneous bioavailability, whereas Fast dissolving oral films are used as practical
alternative to FDTS. These films have a potential to deliver the drug systemically through intragastric, sublingual or buccal route
of administration and also has been used for local action.
In present review article different aspects of fast dissolving tablets and films like method of preparations, latest technologies,
evaluation parameters are discussed. This study will be useful for the researchers for their lab work.
Keywords
Fast Dissolving drug delivery systems, dysphagia, fast disintegrating tablet, pediatric, geriatric, bioavailability.

Article Info: Received 8 July 2018; Revised 1 September; Accepted 7 September, Available online 15 September 2018
Cite this article-
Satbir Singh, Tarun Virmani, Reshu Virmani, Pankaj Kumar, Geeta Mahlawat. Fast dissolving drug
delivery systems: formulation, preparation techniques and evaluation. Universal Journal of Pharmaceutical
Research. 2018; 3(4): 60-69.
DOI: https://doi.org/10.22270/ujpr.v3i4.185
Address for Correspondence:
Satbir Singh, School of Pharmaceutical Science, MVN University, Palwal, Haryana, 121105, India.
Phone: +91-8816973242, E-mail: satbirpharma89@gmail.com.

INTRODUCTION Dysphagia includes difficulty starting a swallow

(called oropharyngeal dysphagia) and the sensation of
At present scenario formulation research is modified in
food being stuck in the neck or chest (called
such a way that the active ingredients can be delivered
esophageal dysphagia)3.
to the target site with a level of convenience,
Tablet is the most popular and common dosage form.
performance and improved bioavailability1. As the cost
However some limitations are associated with it like,
for developing a generic molecule is too expensive, the
large size of dosage forms, and in some cases as of
research is being done on the new dosage forms for
uncooperative, pediatric and dysphagia patients, it may
having better patient compliance as compared to the
create some problems. Moreover traveling patients
different dosage forms of which the oral route serves to
suffering from motion sickness and diarrhea don’t have
make a provenance. The oral route of administration is
easy access to water for oral drug administration.
always considered to be the most preferred route
To overcome these problems, a new modified form of
because of its various advantages like ease of
tablets is developed, which is known as fast dissolving
administration, pain avoidance, versatility and most
tablet or mouth dissolving tablet4. Fast-dissolving
important patient compliance2.
tablets (FDTS) disintegrate and/or dissolve
Dysphagia and Fast-dissolving tablets-Dysphagia is
instantaneously in the saliva without the use of water.
the term used to describe difficulty swallowing.
FDTS are best alternative for all of these patients. The

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Singh et al. Universal Journal of Pharmaceutical Research

Center for Drug Evaluation and Research (CDER), US CHALLENGES FOR DEVELOPMENT OF FDTS
FDA defined Oral Disintegrating Tablets (ODT) as a 1. Taste masking
solid dosage form containing medicinal substances, Undesirable taste is one of the important formulation
which disintegrates rapidly, usually within a matter of problems that are encountered with many drugs. Bitter
seconds, when placed upon the tongue5. drugs in the form of FDTS can’t be accepted by the
The disintegration time of such tablets is very short patients. Administration of bitter drugs orally with
because of their highly porous structure and the high acceptable level of palatability is the aim of all
solubility of the sugar alcohol or saccharide present as manufacturers. As most drugs are unpalatable, rapid
the diluents. disintegrating drug delivery systems usually contain
Drug gets released after rapidly disintegration rapidly; the medicament in a taste- masked form. Delivery
drugs are absorbed from the mouth, pharynx and systems disintegrate or dissolve in patient’s oral cavity,
esophagus as the saliva passes down into the stomach6. thus releasing the active ingredients which come in
Most fast dissolving drug delivery system films consist contact with the taste buds; hence, taste-masking of the
of different substances to mask the bitter taste of active drugs becomes critical to patient compliance.
ingredient. This masked active ingredient is than Taste-masking technologies are being used for bitter-
swallowed by the patient’s saliva along with the tasting drugs like the macrolide antibiotics, non-
soluble and insoluble excipients. These are also called steroidal anti-inflammatory drugs, and penicillins.
as melt-in-mouth tablets, repimelts or porous tablets. However taste masking of water-soluble bitter drugs,
Advantages of FDTS with a high dose, is difficult to achieve by using
1. No need of water and chewing. sweeteners alone11.
2. Better taste masking properties. 2. Hygroscopicity
3. Beneficial in cases such as motion sickness, It is the capacity of a product (e.g. cargo, packaging
sudden episodes of allergic attack or coughing. material) to react to the moisture content of the air by
4. Ease of administration to patients who cannot absorbing or releasing water vapor. Hygroscopicity is,
swallow like the bed-ridden, stroke victims and of course, an important characteristic of a powder. It
patients who refuse to swallow like geriatrics, can be shown, roughly, for a fairly soluble compound
pediatrics and psychiatrics. that the hygroscopicity is related to its solubility. FDTS
5. Stability can be improved7. should have low sensitivity to humidity. This problem
6. Acceptable taste and pleasant mouth feeling. can be especially challenging because many highly
7. Dissolution and absorption of drug is fast, water soluble excipients are used in formulation.
offering rapid onset of action. Highly water-soluble excipients are susceptible to
8. Bioavailability of drugs is increased by avoiding moisture; some will even deliquesce at high humidity.
first pass metabolism. A good package design or other strategy should be
9. High drug loading can be possible. followed to protect FDTS from atmospheric
10. No specific packaging is required. It can be conditions12.
packaged in push through blisters. 3. Mouth feel
11. Minimum risk of suffocation in airways due to The particles generated after disintegration of the
physical obstruction, when ODTs are swallowed, FDTS should be as small as possible in oral cavity for
thus they provide improved safety and the good feeling. Moreover addition of flavors and
compliance with their administrations8. cooling agents like menthol improve the mouth feel13.
Disadvantages of FDTS 4. Aqueous solubility
1. These tablets usually have insufficient mechanical Water-soluble drugs pose various formulate ion
strength. Hence, careful handling is required. challenges because they form eutectic
2. Fast dissolving tablets requires special kind of mixtures, which result in freezing-point depression and
packaging for proper stabilization and safety of the format ion of a glassy solid that may collapse upon
stable product9. drying because of loss of supporting structure during
3. Drugs with relatively larger doses are difficult to the sublimate ion process. Such collapse sometimes
formulate into MDT e.g. antibiotics like can be prevented by using various matrix-forming
amoxicillin with adult dose tablet containing excipients such as mannitol than can induce
about 500 mg of the drug. crystallinity and hence, impart rigidity to the
4. Tablets may leave unpleasant taste and/or amorphous composite14.
grittiness in mouth if not formulated properly. 5. Amount of drug
5. Patients with Sjogren’s syndrome or dryness of For lyophilized dosage forms, the drug dose must be
the mouth due to decreased saliva production may lower than 400 mg for insoluble drugs and less than 60
not be good candidates for these tablet mg for soluble drugs. This parameter is particularly
formulations10. challenging when formulating a fast-dissolving oral
6. They are more susceptible to degradation by films or wafers. The application of technologies used
humidity and temperature. Fast dissolving tablets for FDTS is limited by the amount of drug that can be
are hygroscopic in nature so must be keep in dry incorporated into each unit dose15.
place. 6. Mechanical strength and disintegration time
7. Drugs with short half-life and frequent dosing and FDTS are formulated to obtain disintegration time
those whom require controlled or sustained usually less than a minute. FDTS dissolves or
release are unsuitable candidates of FDTS. disintegrates quickly in the oral cavity upon the contact

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Singh et al. Universal Journal of Pharmaceutical Research

with saliva, resulting in solution or suspension of the croscarmellose sodium as disintegrating and an acidic
administered medicine. It is obvious that increasing the material (e.g. citric acid) and/ or alkali material (e.g.
mechanical strength will delay the disintegration time. sodium bicarbonate) to improve disintegration and
So a good compromise between these two parameters dissolution. This formulation technique gives porous
is always essential. While doing so, maintaining a good powder and disintegration time < 20 sec17.
mechanical strength is a prime challenge16. 4. Sublimation
7. Cost The key to rapid disintegration for mouth dissolving
The technology used for FDTS should be economical. tablets is the presence of a porous structure in the tablet
Special technologies used may increase the cost of matrix. Conventional compressed tablets that contain
final products. highly water-soluble ingredients often fall to dissolve
rapidly because of low porosity of the matrix.
TECHNOLOGIES FOR PREPARATION OF Highly volatile ingredients like ammonium
FDTS bicarbonate, ammonium carbonate, benzoic acid,
A. Non-patented Technologies menthol, camphor, naphthalene, urea, urethane or
1. Direct Compression phthalic anhydride could be compressed along with
Direct compression is the easiest way to manufacture other excipients into a tablet. The volatile material is
tablets. Direct compression is viewed as the technique then removed by sublimation leaving behind a highly
of choice for the manufacture of tablets containing porous matrix. Tablets manufactured by this technique
thermolabile and moisture-sensitive drugs The great are reported to usually disintegrate in 10- 20 sec. and
advantage of direct compression is the low exhibit sufficient mechanical strength16.
manufacturing cost. It uses conventional equipment, 5. Lyophilization or freeze drying
commonly available excipients, and a limited number A process in which water is sublimated from the
process steps. Single or combined action of product after freezing is called freeze drying. Freeze
disintegrants, water soluble excipients and effervescent dried forms offer more rapid dissolution than other
agents depends on the disintegration and solubilization available solid products. The tablets are very porous in
of directly compressed tablets. Breakage of tablet nature and dissolve quickly when come in contact with
edges during handling and tablet crack during the salivary the lyophilization technique. The active drug is
opening of blister alveolus, all result from insufficient dispersed in an aqueous solution of a carrier which is a
physical resistance protection17. polymer15. First the trays having sample are freeze in
2. Tablet Moulding blister packs by passed through liquid nitrogen freezing
Tablets prepared by this method are solid dispersions. tunnel to freeze the drug solution or dispersion. First of
Molded tablets are less compact than compressed all, the material is frozen to bring it below its eutectic
tablets, with a porous structure that facilitates rapid point. This primary drying is done to decrease the
disintegration and easy dissolution. Molded tablets moisture to about 4% w/w of dry product. By repeating
offer improved taste due to water-soluble sugars secondary drying which reduce the bound moisture to
present in dispersion matrix. Moulding technique is of the required volume of the drug product. However the
two types18. use of freeze-drying is restricted due to high cost of
a. Solvent method equipment and processing. The freeze- drying
In this technique damping the powder blend is done by technique has demonstrated improved absorption and
an alcoholic solvent and then compressing at low increase in bioavailability. A major limitation of the
pressure in molded plates to form a wet mass. After air final dosage form comprises lack of physical resistance
drying tablets prepared by this technique are less in standard blister packs21.
compact than compressed tablets and posses a porous 6. Melt Granulation
structure that accelerates the dissolution19. Melt granulation technique is a process by which
b. The heat process pharmaceutical powders are efficiently agglomerated
It involves preparation of a suspension that contains a by a meltable binder. It is a technique useful to enhance
drug, agar and sugar and pouring the suspension in the the dissolution rate of poorly water-soluble drugs, such
blister packaging wells, solidifying the agar at the room as griseofulvin. There is no need of drying that is main
temperature to form a jelly and drying at 30ºC under benefit of the melt granulation technique benefit is
vacuum. The mechanical strength of molded tablets is compared to a conventional granulation is that no water
to be notified and hence binding agents are mixed to or organic solvents is required. Since there is no drying
give strength. Taste masking is an additional trouble in step, the process is less time consuming and requires
this technology. The taste masked drug particles were less energy than wet granulation22.
prepared by spray congealing a molten mixture of 7. Mass extrusion
hydrogenated cottonseed oil, sodium carbonate, In mass extrusion technique solvent mixture of water-
lecithin, polyethylene glycol and an active ingredient soluble polyethylene glycol and methanol are used for
into a lactose based tablet triturate form20. softening the blend of drug and consequent removal of
3. Spray Drying softened mass through the extruder or syringe to get a
For producing porous and fine powders that dissolve cylinder of the product into even segments using
rapidly spray drying technique is used. The heated blade to form tablet. The dried cylinder can also
formulations are included by hydrolyzed and non be used to coat granules for bitter drugs and thereby
hydrolyzed gelatins as supporting agents, mannitol as achieving taste masking22,25.
bulking agent, sodium starch glycolate or

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8. Cotton candy process/ candy floss process In this technology, the matrix compositions are
In this technology, the matrix is formed from dissolved in the solvent (usually water), and then this
saccharides or polysaccharides processed into an solution is frozen3,7. The first solvent will remain in
amorphous floss through a shear foam process. This the solid form, and then the frozen solution contacts the
technique makes use of a unique spinning mechanism second solvent which is usually, ethanol, menthol, or
to produce floss-like crystalline structure, which mimic acetone. Thus, the first solvent is removed after a few
cotton candy that’s why this is called Cotton candy hours of contacting the second solvent to result in a
process involves the formation of matrix of usable matrix. The final product disintegrates almost
polysaccharides or saccharides by simultaneous action instantly27.
of flash melting and spinning23. 6. Ziplets/Advatab
B. Patented Technologies This technology is patented by Passano con Barnago,
1. Lyoc Italy. In this technique water-insoluble ingredient are
Lyoc technology is patented by Pharmalyco. Lyoc merged with one or more effective disintegrants to
utilizes a freeze drying process but it differs from Zydis produce ODT with improved mechanical strength and
in that the product is frozen on the freeze dryer shelves. optimal disintegration time at low compression force28.
In order to prevent homogeneity by sedimentation 7. Nanocrystal technology
during this process, these formulations also require a This is patented by Elan, King of Prussia. In this
large proportion of undissolved inert filler such as technique, crystal colloidal dispersions of the drug
mannitol, to increase the viscosity of the in process substances are combined with water soluble
suspension. The high proportion of filler used reduces ingredients, followed by filling into blister and
the potential porosity of the dried dosage form and lyophillization. This technique avoids manufacturing
hence results in denser tablets with disintegration rates processes such as granulation, blending, and tableting,
that are comparable with the loosely compressed fast which is more advantageous for highly potent and
melt formulations24. hazardous29.
2. Wow tab Technology 8. OraSolv technology
Wowtab technology is patented by Yamanouchi OraSolv was Cima's first fast-dissolving/disintegrating
Pharmaceutical Co. The WOW in Wowtab signifies the dosage form. This includes the use of effervescent
tablet is to be given “With Out Water”. It consist of disintegrating agents which is compressed with low
combination of low- moldability saccharides like pressure to produce the fast dissolving tablets. Tablets
lactose, mannitol, glucose, sucrose, and xylitol and are made by direct compression technique at low
high-moldability saccharides like maltose, sorbitol, and compression force in order to minimize oral dissolution
oligosaccharides in order to produce fast dissolving time. The evolution of carbon dioxide from the tablet
tablets using conventional granulation and tableting produces a fizzing sensation, which is a positive
techniques4,6,9. organoleptic property. The limitation associated is that
3. Flash dose technology the tablets produced are soft and friable9.
Flash dose technology has been patented by Fuisz 9. Pharmabrust technology
Technologies Ltd. It uses a unique spinning mechanism Pharmaburst technology is being patented by SPI
so as to produce a floss-like crystalline structure, much pharma. By this methodology tablets have sufficient
like cotton candy. The Flash dose tablets consist of strength and can be packed in blister packs and bottles.
self–binding shear form matrix termed as “floss. This The tablet manufactured by this process involves a dry
crystalline sugar can then incorporate the drug and be blend of a drug, flavors, and lubricant then followed by
compressed into a tablet. The final product which is compression into tablets which then dissolve within 30-
being produced has a very high surface area for 40 seconds5.
dissolution. It disperses and dissolves quickly once 10. Zydis technology
placed on the tongue25. Scherer has patented the Zydis technology. In this the
4. DuraSolv technology drug is produced by freeze drying or lyophilizing the
DuraSolv R technology was developed by Ciba to drug in gelatin matrix. The product thus produced is
provide stronger tablets for packaging in blisters or very light weight and packed in blister packs. Patients
bottles. DuraSolv is so durable that it can be packaged should be advised not to push the tablets through the
in either traditional blister packaging or vials. The key foil film, but instead peel the film back to release the
ingredients in this formulation are filler and lubricant. tablet. This technique mask the bitter taste of drug by
The tablets have low friability (about 2%) .The means of microencapsulation using specialized
disintegration time is less than 60 seconds. This polymers and resins. This technique is quite expensive.
method can produce tablets by using the direct Zydis formulation should be used within six month
compression method, conventional tableting after opening. This technology claims for increased
methodologies and conventional package equipment. bioavailability as compared to other conventional
Thus, the production cost is significantly reduced26. tablets. The main advantage of this technology is
5. Quicksolv technology convenience and disadvantage is that the freeze drying
Quicksolv technology is patented by Janssen process is quite expensive manufacturing process30.
Pharmaceutica, Beese, Belgium. This method claimed 11. Quick-dis technology
to prevent or to reduce the incidence of cracking during This technology is a proprietary patented technology of
the final preparation, having uniform porosity and also Lavipharm Laboratories. It is a thin, flexible, and quick
the adequate strength for handling. dissolving film. The film is placed on the top or the

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floor of the tongue. It is retained at the site of 24 hrs. The tablets are reweighed and the percentage
application and rapidly releases the active agent for increase in weight is recorded35.
local and/or systemic absorption. 5. Tablet Porosity
12. Flash tab technology The mercury penetration porosimeter can be used to
Prographarm laboratories has patented the Flashtab measure the tablet porosity which is a relative
technology. This technology engages in the preparation assessment of the degree of water penetration in the
of rapidly disintegrating tablet which consists of an formulation, responsible for its fast disintegration9,16.
active ingredient in the form of microcrystals. To 6. Wetting Time and Water Absorption Ratio
prepare drug microgranules all the processing utilized This study is carried out by using a piece of double
conventional tabletting technology like coacervation, folded tissue paper placed in a petridish containing 6
extrusion-spheronization, simple pan coating methods ml of water. One tablet was placed on this paper and
and microencapsulation. Disintegration time of these the time for complete wetting of tablet was noted as
tablets is less than one minute31. wetting time. The wetted tablet was then weighed and
13. Frosta technology the water absorption ratio, R, was determined
This technology is patented by Akina. Plastic granules according to equation.
are prepared and compressed at low pressure to R = 100 (Wa−Wb)/Wb
produce strong tablets with high porosity. The process Where Wb and Wa are the weights of tablet before and
involves mixing the porous plastic material with water after water absorption respectively. Where R is water
penetration enhancer followed by granulating with absorption ratio28.
binder. The tablets obtained have excellent hardness 7. In-vivo disintegration time
and rapid disintegration time ranging from 15 to 30 sec The time for disintegration of Orally Disintegrating
depending on size of tablet32. tablets is less than one minute and in actual it is just 5
to 30 seconds time duration for the disintegration25,26.
EVALUATION OF FAST DISSOLVING TABLET 8. Dissolution Test
1. Weight variation The development of dissolution methods for Orally
20 tablets were selected randomly from the lot and Dissolving Tablets and conventional tablet are similar.
weighted individually to check for weight variation. Dissolution conditions for drugs listed in a
Deviation of ±10% is allowed for tablet of less than or pharmacopoeia monograph, is a good place to start
equal to 80mg, ±7.5% deviation is allowed for tablet in with scouting runs for a bioequivalent orally dissolving
between 80 to 250 mg. For a tablet of more than 250 tablets. Other media such as 0.1N HCl and buffers (pH
mg, ±5% deviation is allowed 33. - 4.5 and 6.8) should be evaluated for orally dissolving
2. Tensile Strength tablets much in the similar way as conventional tablets.
Tensile strength is the measure of force required to USP dissolution apparatus 1 and 2 can be used for this
break a tablet by compressing it in the radial direction study. USP 1 Basket apparatus may have certain
and is measured using a tablet hardness tester. The applications, but sometimes, tablet fragments or
plunger of the hardness tester is driven down at a speed disintegrated tablet masses may become trapped on the
of 20 mm/min for measuring the hardness of the inside top of the basket at the spindle where little or no
tablets34. effective stirring occurs, yielding irreproducible
3. Friability dissolution profiles. USP 2 Paddle apparatus, which is
The friability test for a tablet is carried out and the limit the most suitable and common choice for ODTs, with a
is not more than 1% using tablet friability apparatus, paddle speed of 50 rpm commonly used. Typically, the
carried out at 25 rpm for 4 min (100 rotations). Big dissolution of tablets is very fast when using USP
challenge for a formulator is that how to achieve monograph conditions; hence, slower paddle speeds
friability within this limit for FDT product keeping may be utilized to obtain a profile. The USP 2 Paddle
hardness at its lowest possible level in order to achieve apparatus at 50 to 100 rpm is suitable for dissolution
a minimum possible disintegration time. This test is testing of taste-masked drug as well36, 37.
again not applicable for lyophilized and flash dose
tablets, but is always recommended for tablets prepared FAST DISSOLVING ORAL FILMS
by direct compression and moulding techniques11,15. Fast dissolving oral films (FDOFs) are the most highly
4. Moisture Uptake Study developed form of oral solid dosage form due to more
Mouth Dissolving Tablets have high concentration of flexibility and comfort. It improves the efficacy of
hydrophilic excipients with the minimum possible drugs by dissolving within 60 seconds in oral cavity
hardness which together contributes to their increased after the contact with saliva without chewing and no
susceptibility to moisture uptake hence special need of water for administration38. It gives rapid
attention is required during the storage and packaging absorption and instant bioavailability of drugs due to
of these dosage forms. The test can be carried out by high blood flow and permeability. FDOFs are useful in
keeping ten tablets along with calcium chloride in a patients such as pediatric, geriatrics, bedridden, emetic
desiccator maintained at 37 °C for 24 hrs to ensure patients, diarrhea, sudden episode of allergic attacks, or
complete drying of the tablets. The tablets are then coughing for those who have an active life style. Fast
weighed and exposed to 75% RH, at room temperature dissolving oral films are based on the technology of the
for 2 weeks. For achieving the required humidity keep transdermal patch. Sometimes taste masking agents are
saturated sodium chloride solution in the dessicator for also added to mask the taste of the active ingredient34.
Fast dissolving oral films have advantages like:

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1. Thin film is more stable, durable and quick variety of shapes and sizes and is an ideal method for
dissolving than other conventional dosage forms. deliverying medicines which require fast release and
2. Improved dosage accuracy as compared to liquid also for use by patients who have difficulty
formulations. swallowing40.
3. No need of water with improved patient 2. XGEL
compliance. Does not interfere with normal XGel film Technology developed by BioProgress was
function like talking, drinking etc11. causing a revolution in
4. Accessibility of larger surface area that leads to the product offerings and manufacturing methods. It is
quickly disintegrate and dissolution in the oral nonanimal-derived, approved on religious grounds and
cavity within seconds. is suitable for vegetarians. These film can be taste
5. No first-pass hepatic metabolism thus improved masked, coloured, layered, and capable of being enteric
bioavailability25. properties whilst also having the ability to incorporate
6. Ease of handling and transportability. active pharmaceutical ingredients. The XGEL™ film
7. Pleasant mouth feel systems can be made to encapsulate any oral dosage
form, and can be soluble in either cold or hot water 41.
FORMULATION METHODOLOGY FOR FAST 3. Foamburst
DISSOLVING FILMS In this technology gas is blown into the film during
1. Solvent casting method production, resulting in a
In solvent casting method water soluble polymers are film with a honeycombed structure. The voids in the
dissolved in water and the drug along with other film may be gas-filled, empty
excipients is dissolved in suitable solvent then both the or filled with other materials to produce specific taste-
solutions are mixed and stirred and finally casted in to burst characteristics or to
the Petri plate dried and cut in to uniform dimensions38. deliver active drugs. The light honeycombed structure
2. Semisolid casting results in capsules that dissolve rapidly, causing a melt-
In semisolid casting method firstly a solution of water- in-the mouth sensation. This technology has attracted
soluble film forming polymer is prepared. The interest from food and confectionary manufacturers as
resulting solution is added to a solution of acid a means of carrying and releasing flavours42.
insoluble polymer (e.g. cellulose acetate phthalate, 4. Soluleaves
cellulose acetate butyrate), which was prepared in This technology is used to produce a range of oral
ammonium or sodium hydroxide. Then appropriate delivery films that can incorporate active
amount of plasticizer is added so that a gel mass is ingredients, colours and flavours. In this technology
obtained. Finally the gel mass is casted in to the films the film is produced in order to release the active
or ribbons using heat controlled drums. The thickness ingredients on coming in contact with saliva. This
of the film is about 0.015-0.05 inches. The ratio of the method is especially useful for pediatric and geriatric
acid insoluble poly merto film forming polymer should patients who may have difficulty swallowing
be 1:439. conventional tablets. These are designed in such a way
3. Hot melt extrusion that they adhere to mucous membrane in order to
In hot melt extrusion method firstly the drug is mixed release the drug slowly in 15mins43.
with carriers in solid form. Then the extruder having
heaters melts the mixture. Finally the melt is shaped in EVALUATION PARAMETERS
to films by the dies. 1. Thickness
4. Solid dispersion extrusion The thickness of the patch is measured using digital
In this method immiscible components are extrude with Vernier Calliper with a least count of 0.01 mm at
drug and then solid dispersions are prepared. Finally different spots of the film. The thickness was measured
the solid dispersions are shaped in to films by means of at three different spots of the patch and average was
dies taken and SD was calculated44.
5. Rolling method 2. Weight variation
In rolling method a solution or suspension containing A particlular centimeter square of the film is cutted at
drug is rolled on a carrier. The solvent is mainly water different places from the casted film. The weight of
and mixture of water and alcohol. The film is dried on each film is taken and weight variation is calculated22.
the rollers and cut in to desired shapes and sizes16,17. 3. Folding endurance
Folding endurance is determined by repeated folding of
TECHNOLOGIES FOR FAST DISSOLVING the film at the same place till the strip breaks. The
FILMS number of times the film is folded without breaking is
1. WaferTab computed as the folding endurance value25.
WaferTab is a drug delivery system which incorporates 4. Tensile strength
pharmaceutical actives into an ingestible film strip. It Tensile strength is the maximum stress applied to a
provides rapid dissolution and release of active point at which the film specimen breaks45. It is
pharmaceutical ingrdient when the strip comes into calculated by the applied load at rupture divided by the
contact with saliva in the mouth. The WaferTab film cross-sectional area of the film as given below:
strip can also be flavoured for additionally improved Tensile strength = Load at failure × 100/ Film thickness
taste-masking. The active ingredient is integrated into × film width
the body of a fused. The film can be prepared in a

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Singh et al. Universal Journal of Pharmaceutical Research

5. Percent elongation leads to target underserved and undertreated patient

A film sample stretches when stress is applied and it is populations. Their unbeatable advantages such as
referred to as strain. Strain is basically the deformation administration without water, anywhere, anytime lead
of film divided by original dimension of the sample. to their suitability to geriatric and pediatric patients.
Elongation of film increases as the plasticizer content Rapid onset, good stability and increased
increases. bioavailability lead to its current growth in the market
𝐿 which is extended day by day. Now a day’s new
% Elongation = 𝑋100 techniques are patented for the preparation of fast
𝐿𝑜
Where, L = Increase in length of film,Lo = Initial dissolving films and tablets day by day which is
length of film. beneficiary for the pediatrics and geriatrics patient.
6. Surface pH
The film to be tested was placed in a petri dish and is ACKNOWLEDGEMENT
moistened with 0.5ml of distilled water and kept for Author express sincere thanks to Mr. Tarun Virmani,
30sec. The pH is noted after bringing the electrode of Assistant Professor, MVN University for guiding and
the pH meter in contact with the surface of the supporting the authors during the work.
formulation and allowing equlibriation for 1min35.
7. Uniformity of drug content CONFLICT OF INTEREST
This parameter is determined by dissolving one film of “No conflict of interest associated with this work”.
dimension 2x2cm by homogenization in 100 ml of
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Table 1: Various ingredients of FDTS

S. N. Types of ingredients %
1. Active pharmaceutical agent 1-25%
2. Water soluble film forming polymer 40-50%
3. Plasticizer 0-20
4. Sweetening agent 3-6%
5. Saliva stimulating agent 2-6%
6. Colors and Flavors 0-10%

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Singh et al. Universal Journal of Pharmaceutical Research

Table 2: Composition of fast dissolving oral film

S. N. Ingredients Quantity
Active pharmaceutical
1. 1-25%
agent
2. Film forming polymer 40-50%
3. Plasticizer 0-20%
Saliva stimulating
4. 2-6%
agent
5. Sweetening agent 3-6%
6. Flavoring agent 10%
7. Colouring agent 1%

Table 3: Comparison between Fast Dissolving, Tablets and Films

Criteria Fast Dissolving Tablets Fast Dissolving Films
Form It is a tablet It is a film
Thickness thickness 0.015-.05 inches Same size as of conventional tablet
Dissolution Greater dissolution due to larger
Less dissolution due to less surface area
surface area
Durability Better durable than oral disintegrating
Less durable as compared with oral films
tablets
Patient
Less patient compliance than films More patient compliance
compliance
Dose size Large dose can be incorporated Small dose can only be incorporated
Chocking Fear of chocking is present No risk of chocking

Table 4: Commercially available fast dissolving tablets

Brand name Active ingredient Company
Diphenhydramine
Benadryl Fastmelt® Pfizer
Citrate
Childrens Dimetapp® Wyeth consumer
Loratadine
ND Healthcare
Claritin® RediTabs® Loratadine Scherig corporation
Domray MD Domperidone Ray remedies
Dolib MD Rofecoxib Panacea
Excedrin®QuickTabs Acetaminophen Bristol-Myers Squibb
Felden FM Piroxicam Pfizer
Gaster D Famotidine Yamanouchi
Imodium Istant Melts Loperamide HCL Janssen
Klonopin® wafer Clonazepam Roche
Kozicold Nimesulide Kaizen Drugs
Lonazep MD Olnazepine Sun Pharma
Maxalt –MLT Rizatritpan benzoate Merck
Mosid MT Mosapride Torrent Pharma
Nasea OD Ramosetoron HCl Yamanouchi
Nimulid MD Nimesulide Panacea
Olanex Instab Olanzapine Ranbaxy Labs Ltd
Ondem MD Ondensetron Alkem Pharma
Pepcid RPD Famotidine Merck Pharma
Cisapride
Propulsid®Quicksolv ® Janssen
Monohydrate
Remeron® Soltab® Mirtazapine Organon Inc.
Resperdal®MTabTM Resperidone Janssen
Rofixx MD Rofecoxib Cipla Ltd.
Romilast Montelucast Ranbaxy
Tempra Quicksolv Acetaminophen Bristol-Mters squibb

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 Singh et al. Universal Journal of Pharmaceutical Research

Cont.
Torrox MT Rofecoxib Torrent
Triaminic® Various
Novartis consumer Health
Softchews® combination
Valus Valdecoxib Galen Mark
Vomidon MD Domperidone Olcare Lab
ZelaparTM Selegiline Elanl Amarin corporation
Zofer MD Ondansetron Sun Pharma
Zofex-25 MD Rofecoxib Zota pharma
Zontacet MD Cetrizine Zosta Pharma India
ZubrinTM (Pet
Canine Tepoxelin Scherig corporation
drug)
Zyperxa® Olazepine Eli Lilly

Table 5: Examples of commercially available fast dissolving oral films

Brand name Active ingredient Company
Benadryl Diphenhydramine HCl Pfizer
Chloraseptic Benzocaine: Menthol Prestige
Donepzil Donepzil HCL Labtec GmbH
Eclipse3 Sugarfree mints Wringley’s
Gas-X Simethicone Novartis
Listerine Cool mint Pfizer
Little Colds Pectin Prestige brands
Ondansetron Ondensteron Labtec GmbH
Orazel Menthol/Pectin Del
Sudafed PE Phenylephrine HCl Pfizer
Suppress Dextromethorphan InnoZen
Theraflu Dextromethorphan HBr Novartis
Triaminic Diphenhydramine HCl Novartis

ISSN: 2456-8058 69 CODEN (USA): UJPRA3

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