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P.Venkateshwar Reddy et al / Int. J. of Pharmacy and Analytical Research Vol-3(1) 2014 [22-29]

IJPAR | Volume 3 | Issue 1 | Jan-Mar -2014 ISSN: 2320-2831

Available Online at: www.ijpar.com

[Review article]
Oral Dispersible Tablets - A Review
* P.Venkateshwar Reddy, Swagata Dutta Roy, G.Vasavi, N.Sriram
Department of pharmaceutics,SSRCP, Mahabubnagar, A.P. India.

ABSTRACT
The convenience of administration and improved patients compliance are important in the design of oral drug
delivery s system which remains the preferred route of drug delivery inspite of various disadvantage.one such
problem can be solved in the novel drug delivery system by formulating oral disintegrating tablets which
disintegrates rapidly without water within few seconds in the mouth due to action of super disintegrants in the
formulation. Oral disintegrating tablets are advantageous for pediatric, geriatric mentally ill, nausea patients
who have difficulty in swallowing conventional tablets and capsules. Using various excipients, evaluation tests
marketed formulation and drugs used in the research area.
Keywords: Oral dispersible tablets, super disintegrants, Fast dissolving tablets.

INTRODUCTION TO ORAL regardless of time or place. For example, it can be

DISPERSIBLE TABLETS taken anywhere at any time by anyone who do not
An Oral route of drug administration have wide have easy access to water. It is also easy to dose the
acceptance up 50-60% of total dosage form. Solid aged, bed-ridden patients, or infants who have
dosage forms are popular because of ease of problems swallowing tablets and capsules3.
administration, accurate dosage, self-medication, Recently, many companies have researched and
pain avoidance and most importance patience developed various types of fast-disintegrating
compliance1. dosage form technologies with the potential to
The U.S food and drug administration center for accommodate various physicochemical,
drug evaluation and research (CDER) defines, an pharmacokinetic and pharmacodynamics
ODT as “a solid dosage form containing medicinal characteristics of drugs.
substances, which disintegrates rapidly usually These dosage forms disintegrate within 30 sec with
within a matter of seconds, when placed upon the very less quantity of water. This can be achieved
tongue. by addition of various super disintegrants like
The most desirable formulation for use by the Croscarmellose sodium, Cross povidone, sodium
elderly is one that is easy to swallow and easy to starch glycolate2.
handle. Taking these requirements into These tablets are also called as Orodispersible
consideration, attempts have been made to develop tablets, quick disintegrating tablets, mouth
a rapid dissolving tablet. Since such a tablet can dissolving tablets, fast disintegrating tablets, fast
disintegrate in only a small amount of water in the dissolving tablets, rapid dissolving tablets, porous
oral cavity, it is easy to take for any age patient, tablets and rapimelts3. However, of all the above

* Corresponding author: P.Venkateshwar Reddy.

Email: venkateshwarr3@gmail.com
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terms, United States of pharmacopoeia (USP)  Good mouth feel property helps to change the
approved these dosage forms as ODTs (orally perception of medication as bitter pill
disintegrating tablets). Recently, European particularly in pediatric patient.
Pharmacopoeia has used the term Orodispersible  The risk of chocking or suffocation during oral
tablet for tablets that disperses readily within 3 min administration of conventional formulation due
in mouth before swallowing1. United States of to physical obstruction is avoided, thus
Food and Drug Administration (FDA) defined providing improved safety.
ODT as “A solid dosage form containing medicinal  Beneficial in cases such as motion sickness,
substance or active ingredient which disintegrates sudden episodes of allergic attack or coughing,
rapidly usually within a matter of seconds when where an ultra-rapid onset of action required.
placed upon the tongue.” The disintegration time  An increased bioavailability, particularly in
for ODTs generally ranges from several seconds to cases of insoluble and hydrophobic
about a minute.2  Drugs, due to rapid disintegration and
dissolution of these tablets.
Criteria for Fast dissolving Drug Delivery  Stability for longer duration of time, since the
System drug remains in solid dosage form till it is
The tablets should consumed. So, it combines advantage of solid
 Not require water to swallow, but it should dosage form in terms of stability and liquid
dissolve or disintegrate in the mouth in matter dosage form in terms of bioavailability.
of seconds.
 Be compatible with taste masking. Limitations of Mouth Dissolving Tablets8
 Be portable without fragility concern.  The tablets usually have insufficient
 Have a pleasant mouth feel. mechanical strength. Hence, careful handling
 Leave minimum or no residue in the mouth is required.
after oral administration.  The tablets may leave unpleasant taste and/or
 Exhibit low sensitive to environmental grittiness in mouth if not formulated properly.
condition as temperature and humidity.
Technologies used for manufacturing of
Salient Feature of Fast Dissolving Drug1, FDTs 4
2,3,6,7
In the recent past, several new advanced
Delivery System technologies have been introduced for the
 Ease of Administration to the patient who manufacturing of FDTs with ideal properties like
cannot swallow, such as the elderly, stroke less disintegration time, pleasant mouth feel,
victims, bedridden patients, patient affected by exceptional taste masking and sugar free tablets for
renal failure and patient who refuse to swallow diabetic patients. The technologies used for
such as pediatric, geriatric & psychiatric manufacturing of FDTs broadly classified in two
patients. category one is patented another one is no patented
 No need of water to swallow the dosage form, technologies.
which is highly convenient feature for patients
who are traveling and do not have immediate Lyophilization / Freeze-drying
access to water. Formation of porous product in freeze-drying
 Rapid dissolution and absorption of the drug, process is exploited in formulating FDTs.
which will produce quick onset of action. Lyophilization is a process, which includes the
Some drugs are absorbed from the mouth, removal of solvent from a frozen suspension or
pharynx and esophagus as the saliva passes solution of drug with structure-forming additives.
down into the stomach. In such cases Freeze-drying of drug along with additives imparts
bioavailability of drug is increased. glossy amorphous structure resulting in highly
 Pre-gastric absorption can result in improved porous and lightweight product. The resulting
bioavailability and as a result of reduced tablet has rapid disintegration and dissolution when
dosage; improve clinical performance through placed on the tongue and the freeze-dried unit
a reduction of unwanted effects. dissolves instantly to release the drug. However,
the MDTs formed by Lyophilization have low

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mechanical strength, poor stability at higher hydrophilic- lipophilic balance of 9. It not only acts
temperature, and humidity. as a binder and increases the physical resistance of
tablets, but also helps in the disintegration of
Molding tablets as it melts in the mouth and solubilizes
In this method, molded tablets are prepared by rapidly leaving no residue. Super polystate was
using water-soluble ingredients so that the tablets incorporated in the formulation of MDTs by melt
dissolve completely and rapidly. The powder blend granulation method where granules are formed by
is moistened with a hydro alcoholic solvent and is the molten form of this material 15.
molded into tablets under pressure lower than that
used in conventional tablet compression. The Phase transition process
solvent is then removed by air-drying. Molded Investigated processes for the disintegration of
tablets are very less compact than compressed FDTs by phase transition of sugar alcohols using
tablets. These posses porous structure that increase erythritol (m. pt. 122°C), xylitol (m. pt. 93-95°C),
dissolution. trehalose (97°C), and Mannitol (166°C). Tablets
were produced by compressing a powder
Cotton candy process containing two sugar alcohols with high and low
This process is so named as it utilizes a unique melting points and subsequent heating at a
spinning mechanism to produce floss-like temperature between their melting points. Before
crystalline structure, which mimics cotton candy. heating process, the tablets do not have sufficient
Cotton candy process involves formation of matrix hardness because of low compatibility. The tablet
of polysaccharides or saccharine by simultaneous hardness was increased after heating process, due
action of flash melting and spinning. The matrix to the increase of inter particle bonds or the
formed is partially re-crystallized to have improved bonding surface area in tablets induced by phase
flow properties and compressibility. This candy transition of lower melting point sugar alcohol.
flossmatrix is then milled and blended with active
ingredients and excipients and subsequently Sublimation
compressed to FDTs. The presence of a highly porous structure in the
tablet matrix is the key factor for rapid
Spray drying disintegration of FDTs. Even though the
Spray drying can be used to prepare rapidly conventional tablets contain highly water-soluble
dissolving tablets. This technique is based upon a ingredients, they often fail to disintegrate rapidly
particulate support matrix that is prepared by spray because of low porosity. To improve the porosity,
drying an aqueous composition containing support volatile substances such as camphor can be used in
matrix and other components to form a highly tabletting process, which sublimated from the
porous and fine powder. This is then mixed with formed tablet. Developed FDTs utilizing camphor,
active ingredient and compressed into tablet. Allen a subliming material that is removed from
and Wang have employed spray drying technique compressed tablets prepared using a mixture of
to prepare Orodispersible tablets. Mannitol and camphor. Camphor was sublimated
in vacuum at 80°C for 30 min after preparation of
Mass extrusion tablets.
This technology involves oftening the active blend
using the solvent mixture of water-soluble (i) Direct compression methods
polyethylene glycol and methanol and subsequent This technique is easy way to formulate FDTs
expulsion of softened mass through the extruder or since limited number of processing steps, low
syringe to get acylinder of the product into even manufacturing cost and also accommodate high
segments using heated blade to form tablets. dose the final weight of tablet can easily exceed
that of other production method18,. The
(f)Melt granulation disintegration and dissolution of directly
In this process, FDTs can be prepared by compressed tablets depends on single or combined
incorporating a hydrophilic waxy binder (super effect of disintegrant, water soluble excipients and
polystate) PEG-6-stearate. Superpolystate is a effervescing agents. Disintegrant efficacy is
waxy material with an m. pt. of 33-37°C and a

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strongly affected by tablet size and hardness. Disintegration properties can be

optimized by medium or low tablet size, low promotes wet ability and dispensability of the
hardness and low physical resistance .It is essential system and thereby increase the disintegration and
to choose a suitable and an optimum concentration dissolution20,21,22. The optimum concentration of
of disintegrant to ensure fast disintegration and super disintegrants can be selected according to
high dissolution rates 18,19. The addition of water critical concentration of disintegrant. Below this
soluble excipients or effervescent agent can further concentration the tablet disintegration time is
increase dissolution or disintegration properties. inversely proportional to the concentration of
Super disintegrant provide fast disintegration due superdisintegrants, where as if concentration of
to combine effect of swelling and water absorption. superdisintegrants incorporated in tablet is above
As an effect of swelling of super disintegrant the the critical concentration, the disintegration time
wetted surface of the carrier increase, which remains approximately constant or even increases.

(j)Superdisintegrants addition
A disintegrant is a substance in a tablet formulation Swelling
that enables the tablet to break up into smaller Perhaps the most widely accepted general
fragments upon contact with gastrointestinal fluids. mechanism of action for tablet disintegration is
Superdisintegrants are used at a low level in the swelling. Tablets with high porosity show poor
solid dosage form, typically 1–10%by weight disintegration due to lack of adequate swelling
relative to the total weight of the dosage unit. force. On the other hand, sufficient swelling force
Examples of Superdisintegrants are is exerted in the tablet with low porosity. It is
Crosscarmellose, Crospovidone and sodium starch worthwhile to note that if the packing fraction is
Glycolate, which are a cross linked cellulose, cross- very high, fluid is unable to penetrate in the tablet
linked polymer and a cross linked starch and disintegration is again slows down
respectively. The proper choice of disintegrant and
its consistency of performance are critical to Porosity and capillary action (Wicking)
formulation development of such tablets. Disintegration by capillary action is always the first
Microcrystalline cellulose and low substituted step. When we put the tablet into suitable aqueous
hydroxyl propyl cellulose were used as medium, the medium penetrates into the tablet and
disintegrating agents in the range of 8:2 – 9:1 to replaces the air adsorbed on the particles, which
prepare fast dissolving tablet. Agar powder is used weakens the intermolecular bond and breaks the
as disintegrant for the development of rapidly tablet into fine particles. Water uptake by tablet
disintegration tablets by enhancing the porosity of depends upon hydrophilicity of the drug /excipients
agar by water treatment. Sodium starch Glycolate, and on table ting conditions. For these types of
Crospovidone and Crosscarmellose are some of the disintegrates maintenance of porous structure and
popular superdisintegrants. The list of commonly low interfacial tension towards aqueous fluid is
used Superdisintegrants with their description is necessary which helps in disintegration by creating
shown in Table 1. a hydrophilic network around the drug particles.
The wicking and swelling process of disintegration
Mechanism of Superdisintegrants10 is Due to disintegrating particle/particle
There are four major mechanisms for tablet repulsive forces
disintegration as follows:

WICKING SWELLING
Fig. 1.0: Disintegration by wicking and swelling process

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Another mechanism of disintegrants attempts to swelling capacity of starch was improved when
explain the swelling of tablet made with non granules were extensively deformed during
swellable disintegrants. Guyot-Hermann has compression. This increase in size of the deformed
proposed a particle repulsion theory based on the particles produces a breakup of the tablet. This may
observation that non swelling particle also cause be a mechanism of starch and has only recently
disintegration of tablets. The repulsive forces begun to be studied. Disintegration of tablets by
between particles are the mechanism of deformation and repulsion
disintegration and water is required for it.
Researchers found that repulsion is secondary to Sugar-based Excipients
wicking. Sorbitol, Mannitol, dextrose, xylitol, fructose,
maltose, isomalt and polydextrose have been used
Due to deformation as bulking agents. Because of their high aqueous
During tablet compression, disintegrated particles solubility and sweetness, which impart a pleasing
get deformed and these deformed particles get into mouth feel and good taste masking, nearly all
their normal structure when they come in contact formulations for rapidly dissolving tablets contain
with aqueous media or water. Occasionally, the sugar based materials.

Table 1 List of super disintegrants

Superdisintegrants Example Mechanism of Special comment
action
Crosscarmellose® Cross linked Swells 4-8 folds Swells in two
Ac-Di-Sol® Cellulose in < 10 seconds, dimensions, used for
Nymce ZSX® acts by swelling direct compression
Primellose®Solutab® and or granulation
Vivasol®L-HPC wicking both
Crospovidone Cross linked Swells very little Water insoluble and
Crospovidone M® PVP and returns to spongy in nature so
Kollidon® original size after get porous tablet
Polyplasdone compression
but act by
capillary action
Sodium starch Cross linked Swells 7-12 folds Swells in three
Glycolate Starch in < 30 seconds dimensions and high
Explotab® level serve as sustain
Primo gel release matrix
Alginic acid NF Cross linked Rapid swelling in Promote
Satialgine® alginic acid aqueous medium disintegration
or wicking action in both dry or wet
granulation
Soy polysaccharides Natural Does not contain any
Emcosoy® superdisintegrants starch or sugar, used
in
nutritional products
Calcium silicate Wicking action Highlyporous, 20-40%
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Using acid treated yeast cell wall Durasolv Technology

Natural materials should be useful as Durasolv is the patented technology of CIMA labs.
pharmaceutical additives from the perspective of The tablets made by this technology consist of
resource utilization and safety. Acidified brewers drug, filler and a lubricant. Tablets are prepared by
yeast cell wall (AYC) has been examined with using conventional tabletting equipment and have
respect to novel applications as it can be used as an good rigidity. These can be packaged into
aqueous coating material for tablets and granules. conventional packaging system like blisters.
In accordance with these properties of AYC, AYC Durasolv is an appropriate technology for product
maintains the baggy structure of the original yeast. requiring low amounts of active ingredients.
In water, AYC is dispersed as independent particles
with a surface hydrogel layer. Water is included Orasolv Technology
within the structure unlike other polymers. CIMA labs have developed Orasolv Technology. In
this system
Using hydroxyl waxy binders Active medicament is taste masked. It also contains
This work describes a new approach to prepare fast effervescent disintegrating agent. Tablets are made
dissolving tablets with sufficient mechanical by direct compression technique at low
integrity, involving the use of a hydrophilic waxy compression force in order to minimizeoral
binder (Superpolystate©, PEG-6-stearate). So it dissolution time. Conventional blenders and tablet
will not only act as a binder and increase the machine is used to produce the tablets. The tablets
physical resistance of tablets but will also help the produced are soft and friable.
disintegration of the tablets as it melts in the mouth
and solubilizes rapidly leaving no residues. Flash Dose Technology
Flash dose technology has been patented by fuisz.
Patented Technologies for Fast Dissolving Nurofen meltlet, a new form of ibuprofen as melt
Tablets13, 14.15,16,17. in mouth tablets prepared using flash dose
Zydis Technology technology is the first commercial product
Zydis formulation is a unique freeze dried tablet in launched by Biovail Corporation. Flash dose tablets
which drug is physically entrapped or dissolved consist of self binding shear form matrix termed as
within the matrix of fast dissolving carrier material. “floss”. Shear form matrices are prepared by flash
When Zydis units are put into the mouth, the heat processing.
freeze-dried structure disintegrates instantaneously
and does not require water to aid swallowing. The Wow tab Technology
Zydis matrix is composed of many materials Wow tab technology is patented by Yamanouchi
designed to achieve a number of objectives. To Pharmaceutical Co.WOW means “Without Water”.
impart strength and resilience during handling, In this process, combination of low mouldability
polymers such as gelatin, dextran or alginates are saccharides and high mouldability saccharides is
incorporated. These form a glossy amorphous used to obtain a rapidly melting strong tablet. The
structure, which imparts strength. To obtain active ingredient is mixed with a low mouldability
crystalline, elegance and hardness, saccharides saccharide (e.g. lactose, glucose, and Mannitol) and
such as Mannitol orsorbitol are incorporated. Water granulated with a high mouldability saccharide
is used in the manufacturing process to ensure (e.g. Maltose, oligo saccharides) and compressed
production of porous units to achieve rapid into table.
disintegration while various gums are used to
prevent sedimentation of dispersed drug particles in Flash tab Technology
the manufacturing process. Collapse protectants Prographarm laboratories have patented the Flash
such as glycine prevent the shrinkage of Zydis tab technology. Tablet prepared by this system
units during Freeze-drying process or long-term consists of an active ingredient in the form of micro
storage. Zydis products are packed in blister packs crystals.
to protect the formulation from moisture in the
environment.

Table 2 List of commercially available Orodispersible/FDT tablets

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Trade Name Active Drug Manufacturer

Felden fast melt Piroxicam Pfizer Inc., NY, USA
Claritin redi Tab Loratidine Schering plough Corp., USA
Maxalt MLT Rizatriptan Merck and Co., NJ, USA
Zyprexia Olanzapine Eli lilly, Indianapolis, USA
Pepcid RPD Famotidine Merck and Co., NJ, USA
Zofran ODT Ondansetron Glaxo Wellcome, Middlesex,
UK
Zoming-ZMT Zolmitriptan AstraZeneca, Wilmington,
USA
Zeplar TM Selegilline Amarin Corp., London, UK
Tempra Quiclets Acetaminophen Bristol Myers Squibb, NY,
USA
Febrectol Paracetamol Prographarm, Chateauneuf,
France
Nimulid MDT Nimesulide Panacea Biotech, New Delhi ,
India
Torrox MT Rofecoxib Torrent pharmaceuticals , India
Olanex instab Olanzapine Ranbaxy lab. Ltd. New-Delhi,
India
Romilast Montelukast Ranbaxy lab. Ltd. New-Delhi,
India
Benadryl Fast melt Diphenhydramine Warner Lambert, NY, USA
and
pseudoephedrine

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