International Journal of PharmTech Research

CODEN (USA): IJPRIF ISSN : 0974-4304

Vol.4, No.4, pp 1712-1720, Oct-Dec 2012

Overview Of Oral Dispersible Tablets

Malay Kumar B Chotaliya*1 , Sumit Chakraborty1
N.R.Vekaria Institute Of Pharmacy, Bilkha Road, Junagadh, Gujarat,India.

*Corres.author: [email protected]

Abstract: The need for delivering drugs to patients efficiently with minimum side effects has prompted
pharmaceutical industries to be engaged in development of new drug delivery systems. Pediatric and
geriatric patients find it difficult to swallow solid dosage forms like tablets. Mouth dissolving tablet that
dissolve or disintegrate rapidly in oral cavity result in solution, is an ultimate remedy for this problem. In
addition they give pleasing mouth feeling. ODT has advantages such as patient compliance, quick onset of
action, improved bioavailability, etc. Therefore, mouth dissolving tablets are attractive alternative to liquid
and conventional tablet dosage forms. In recent past, several manufacturing technologies such as
sublimation technique, spray drying technique… etc. are employed to overcome the limitations of
conventional tablet dosage forms. Once the mouth dissolving tablets are prepared they are required to be
evaluated for various parameters so as to have long term stability and better therapeutic efficacy.
Keywords: Fast Dissolving Tablets, Superdisintegrants, Oral Route.

INTRODUCTION these tablets popular as a dosage form of choice in

the current market. Despite increasing interest in
The oral route of drug administration is
controlled-release drug delivery systems, the most
the most and convenient for patient use. Novel
common tablets are those intended to be
oral drug delivery systems that dissolve or
swallowed whole and to disintegrate and release
disperse quickly in a few seconds after placement
their medicaments rapidly in the gastrointestinal
in the mouth without water can alleviate the
tract (GIT). Conventional method used in
problem of swallowing tablets. The potential for
Preparation of orally disintegrating tablet includes:
improved compliance in patients. The dispersible
Freeze drying , tablet molding , spray drying ,
systems are defined as systems that dissolve or
mass extrusion , sublimation and direct
disintegrate within seconds to a few minutes
compression.1,2,3
placement. In these cases, the bioavailability of
drugs from these formulations might be greater
Advantages4
compared to the conventional oral dosage forms.
1. It bypasses the GI tract and hepatic portal
This creates porous Structure and results in rapid
systems, increase the bioavailability of orally
disintegration. Basic approaches to develop
administered drugs which can otherwise
dispersible tablet include maximizing the porous
undergo hepatic first-pass metabolism.
structure of the tablet matrix, incorporating the
2. Apart from it the drug is protected from
appropriate disintegrating agent and using highly
degradation due to pH and GIT enzymes.
water soluble excipients in the formulation,
3. It improves patient compliance due to the
dispersible tablet can be achieved by various direct
elimination of associated pain with injections;
compression technique.In this way, or dispersible
administration of drugs in unconscious or
tablets provide a rapid onset of action and prevent
incapacitated patients; convenience of
hepatic first-pass metabolism. The benefits, in
administration as compared to injections or
terms of patient compliance, rapid onset of action,
oral medications.
increased bioavailability, and good stability make
Malay Kumar B Chotaliya et al /Int.J.PharmTech Res.2012,4(4) 1713

4. It provides rapid drug delivery from the How it beneficial for patients21
dosage forms.  Ease of administration to patients who refuse
5. A relatively rapid onset of action can be to swallow a tablet, such as pediatric and
achieved as compared to the oral route, and geriatric patients and, psychiatric patients.
formulation can be removed after  Convenience in administration of drug and
discontinuation of therapy. accurate dosing as compared to liquid
6. Drug administration through buccal mucosa is formulations.
easy.  Water is not required for swallowing the
7. Buccal mucosa is less permeable than the dosage from, which is convenient feature for
sublingual area, the buccal mucosa is having patients who are traveling and do not have
rich blood supply, and drugs can be rapidly immediate access to water.
absorbed into the circulation system  Good mouth feels properly of ODTs helps to
underneath the oral mucosa. change the basic view of medication as
8. The large contact area of the oral cavity "bitter pill", particularly for pediatric
contributes to rapid and extensive drug patients.
absorption.  Fast dissolution of medicament and
9. Patient compliance is more. absorption which will leads to rapid, onset of
10. Having rapid onset of action which may leads action.
to an improved bioavailability.  Some drugs are absorbed from the month
11. Patient having difficulty in swallowing tablet pharynx and esophagus as the saliva passes
can easily administer this type of dosage form. down into the stomach, in such cases
12. Useful for pediatric, geriatric and psychiatric bioavailability of drugs is increased.
patients.  It provides advantages of liquid formulations
13. Suitable during traveling where water is may in the form of solid dosage form.
not be available.
 Pregastric absorption can result in improved
14. Gives accurate dosing as compared to liquids.
bioavailability and as a result of reduced
15. Good chemical stability.
dosage, improved clinical performance
16. Free of need of measuring, an essential
through a reduction of unwanted effects.
drawback in liquids.

Pathway of drug release from odt.

Diagram Showing Advantages of ODT 4

Malay Kumar B Chotaliya et al /Int.J.PharmTech Res.2012,4(4) 1714

Criteria of selection of drug ODT9: provides rapid disintegration of tablet after putting
The ideal characteristics of a drug for in vivo in mouth, and release the drug in saliva.
dissolution from an FFDT include Bioavailability of certain drugs may be increased
 No bitter taste due to absorption of drugs in oral cavity and may
 Dose lower than 20mg be due to pregastric absorption of saliva which
 Small to moderate molecular weight contains dispersed drugs which pass down into the
 Good stability in water and saliva stomach. The amount of drug which is subject to
 Partially non ionized at the oral cavities pH undergo first pass metabolism is reduced.
 Ability to diffuse and partition into the
epithelium of the upper GIT (log P>1, or
preferably>2) 1. Superdisintegrants1
 Ability to permeate oral mucosal tissue As ODT require faster disintegration. So,
 Passive diffusion drug absorption pharmacist needs to formulate Disintegrates i.e.
 Bcs-class 2 Superdisintegrants which are effective at low
 Molecular weight below 500 da. concentration and have greater disintegrating
efficiency and they are more effective
MECHANISM OF DRUG RELEASE: intragranularly. But have one drawback that it is
hygroscopic therefore not used with moisture
Overall Mechanism of drug release of ODT:
sensitive drugs.
According to official publication European
And this superdisintegrants act by swelling and
Pharmacopoeia the ODT should be disperses or
due to swelling pressure exerted in the outer
disintegrates in less than three minutes. The
direction or radial direction, it causes tablet to
fundamental approach used in development of
burst or the accelerated absorption of water
ODT is the use of superdisintegrants like sodium
leading to an enormous increase in the volume of
starch glycol ate (Primo gel, Explotab)
granules to promote disintegration.
carboxymelhylcellulose (Croscarmeliose), Poly
vinylpyrrolidone (Polyplasdone) etc. which

Table1. List of superdisintegrants

Example Super- Mechanism Of Action Special Comment
Disintegrants
Crosslinked Crosscarmellose® Swells 4-8 folds in Swelling is in two dimensions.
cellulose Ac-Di-Sol® < 10 seconds. -Direct compression or granulation
Primellose® Swelling and wicking -Starch free
Vivasol® both.
Crosslinked PVP Crosspovidone Swells 7-12 folds Swells in three dimensions and high level
in <30 seconds serve as sustain release matrix

Crosslinked starch Sodium starch Swells 7-12 folds Swells in three dimensions and high level
glycolate in <30 seconds serve as sustain release matrix

Cross linked Alginic acid NF Rapid swelling Promote disintegration in both dry or wet
alginic acid in aqueous medium granulation
or wicking action
Natural Soya Rapid Dissolving Does not contain any starch or sugar. Used
super Disintegrates polysaccharides in nutritional products.
Malay Kumar B Chotaliya et al /Int.J.PharmTech Res.2012,4(4) 1715

Selection of super-disintegrates. Immediately prior to compression or can be added

The ideal superdisintegrant should have22: in to Separate fraction of formulation.
 Poor solubility.
 Poor gel formation. e. By enzymatic reaction5
 Good hydration capacity. These enzymes destroy the binding action of
 Good moulding and flow properties binder and helps In disintegration. Actually due to
 No tendency to form complexes with the swelling, pressure exerted in the outer direction or
drugs. radial direction, it causes tablet to burst or the
 Good mouth feel. accelerated absorption of water leading to an
enormous Increase in the volume of granules to
 It should also be compatible with the other
excipients promote disintegration.
And have desirable tableting properties.
f. Due to disintegrating particle repulsive
forces5 (Secondary to wicking)
The swelling of tablet made through ‘non-
MECHANISM OF ACTION OF
swellable’ Disintegrates.Guyot-Hermann has
DISINTEGRATES
planned particle repulsion Theory based on the
a. Swelling5
General mechanism of action for tablet observation that non-swelling particle also Cause
disintegration of tablets. The electric repulsive
disintegration is Swelling tablets through high
porosity expression poor Disintegration due to forces between particles are the mechanism of
lack of sufficient swelling force. On the other disintegration and Water is required for it.
hand, sufficient swelling force is exerted in the
tablet with low porosity. It is worthwhile to note g. Due to deformation5
that if the packing Fraction is very high; fluid is During the tablet compression, disintegrated
unable to penetrate in the tablet and disintegration particles become deformed and these deformed
is again slows down. particles get into their normal Structure when they
come in contact with aqueous media or water.
Occasionally, the swelling capacity of starch
b. Porosity capillary action (wicking)5
remained Improved when granules where
While we place the drug into appropriate aqueous
extensively deformed during Compression..
medium, the Medium enters into the tablet and
replaces the air absorbed on the particles, which
softness the intermolecular bond and Breakdowns Patented Technologies
the tablet into fine particles. Water uptake by a. Zydis Technology14
Tablet depends upon hydrophilicity of the A Zydis tablet is produced by lyophilizing or
drug/excipient and on tableting environments. For freeze-drying the drug in a matrix usually
these types of disintegrates, Maintenance of consisting of gelatin. The product is very
porous structure and low interfacial tension to lightweight and fragile, and must be dispensed in a
wards aqueous fluid is essential which helps in special blister pack. Patients should be advised not
Disintegration by manufacture a hydrophilic to push the tablets through the foil film, but
system around the Particles. instead peel the film back to release the tablet. The
Zydis product is made to dissolve on the tongue in
c. Heat of wetting (air expansion)5 2 to 3 seconds
When disintegrates through exothermic properties
gets wetted, Localized stress is produced due to b. Orasolv Technology 14
capillary air expansion, this helps in breakdown of in this system active medicament is taste masked.
tablet. It also contains effervescent disintegrating agent.
Tablets are made by direct compression technique
d. Due to release of gases5 at low compression force in order to minimize oral
Carbon dioxide released within tablets dissolution time.
continuously wetting Due to contact between
bicarbonate and carbonate with citric Acid or c. Durasolv technology14
tartaric acid. The tablet disintegrates due to The tablets made by this technology consist of a
generation of pressure inside the tablet. As these drug, fillers and a lubricant. Tablets are prepared
disintegrates are highly Sensitive to small changes by using conventional tableting equipment and
in humidity level and temperature, Strict control of have good rigidity. These can be packed into
environment is required during manufacturing of conventional packaging system like blisters.
the tablets. The effervescent blend is either added
Malay Kumar B Chotaliya et al /Int.J.PharmTech Res.2012,4(4) 1716

d. Wow Tab Technology15 method and followed by compressing into tablets.

It is patented by yamanouchi Wow means (Chang et al., 2000). This technology relays on the
“without water”. Wow tab is an intra buccally use of super disintegrates. Flashtab is a
soluble, compressed tablets consisting of granules combination of wet and dry granulation before
made with saccharine of low and high mould compression. Micro particles of taste-masked API
ability. When low- and high-moldable saccharine are blended with conventional tableting aids and
are used alone tablets obtained do not have desired disintegrate such as pvp or crospovidone (cross-
properties of rapid disintegration and hardness, so linked PVP), cross-linked sodium carboxymethyl
combinations are used. It is used to obtain a tablet cellulose and swelling agents such as starches or
of adequate hardness and fast dissolution rate. The microcrystalline cellulose. Disintegration times are
wow tab formulation is stable to environment due typically less than 1 min.
to its significant hardness than zydis and Orasolv.
Wow tab product is suitable for both conventional Frosta technology53
bottle and blister package. Akina patents this technology. The frosta
technology is based on the compression of highly
e. Oraquick16 plastic granules at low pressure to prepare fast
This technology is patented by K.V melting tablets. The highly plastic granules are
Pharmaceuticals. It utilizes taste masking composed of three components: a plastic
microsphere technology called as micro mask, material,(Maltrin QD M580 and MaltrinM180 are
which provides superior mouth feel, significant maltodextrin and corn syrup solids) a water-
mechanical strength, and quick disintegration/ penetration enhancer (Mannogem EZ Spray) and a
dissolution of product. (Bandari S et al., wet binder (sucrose, polyvinylpyrrolidone and
2008) This process involves preparation of micro hydroxypropyl methylcellulose). Each of the three
particles in the form of matrix that protects drug, components plays an essential role in obtaining
which can be compressed with sufficient tablets with higher strengthened faster
mechanical strength. Low heat of production in disintegration time.
this process makes it appropriate for heat-sensitive
drugs. j.Advantol™ 20053
Advantol™ 200 is a directly compressible
f. Nano Crystal technology14 excipient system offering "Soft-Melt" functionality
Elan’s proprietary NanoCrystal technology and specially formulated for nutraceutical
(NanomeltTM) can improve compound activity applications. SPI Pharma’s Advantol platform uses
and final product characteristics. Decreasing proprietary co-processing technology. Advantol
particle size increases the surface area, which leads requires no special manufacturing equipment or
to an increase in dissolution rate. This can be tooling. Advantol formulations utilize a standard
accomplished predictably and efficiently using rotary tablet press with standard tooling under
NanoCrystal technology. NanoCrystal particles are normal tableting temperature and humidity
small particles of drug substance, typically less conditions to make robust “soft-melt” tablets.
than 1000 nm in diameter, which are produced by
milling the drug substance using a proprietary wet k. Advatab53
milling technique. AdvaTab tablets disintegrate rapidly in less than
30 seconds. These tablets are prepared using
g. Pharmaburst technology14 polymer-coated drug particles that are uniformly
SPI Pharma, New castle, patents this technology. dispersed in an ultra-fine, low-water content,
The Pharmaburst ODT uses a proprietary rapidly disintegrating matrix with superior
disintegrate (Pharmaburst) that is based on organoleptic properties. AdvaTab tablets are
mannitol blended with conventional tableting aids. compressed using a proprietary, patented, external
It utilizes the co processed excipients to develop lubrication system in which the lubricant is applied
ODT, which dissolves within 30-40 s. This only to the tablet surface, resulting in robust
technology involves dry blending of drug, flavor, tablets that are hard and less friable and can be
and lubricant followed by compression into packaged in bottles or blister.
tablets.
 Quicksolv technology16
14
h. Flash Tab This technology is patented by Janssen
Ethypharm, Saint Cloud, France has patented the Pharmaceuticals. It uses two solvents in
Flash tab technology. This technology includes formulating a matrix which disintegrates
granulation of excipients by wet or dry granulation instantaneously. Methodology includes dissolving
Malay Kumar B Chotaliya et al /Int.J.PharmTech Res.2012,4(4) 1717

medium components in water and the solution or passed through liquid nitrogen freezing tunnel to
suspension is frozen. Then dry the matrix by freeze the drug Solution or dispersion. Then the
removing water using an excess of alcohol frozen blister packs are placed in refrigerated
(solvent extraction). Thus the product formed has cabinets to continue the freeze-drying. After
uniform porosity and adequate strength for Freeze-drying the aluminum foil backing is useful
handling. on a blister sealing Machine. Finally the blisters
are packaged and shipped. Advantages of freeze
 Ziplet technology18 drying the major advantage of using this technique
In ziplet technology water insoluble drugs or drugs is that the tablets Produced by this technology
as coated microparticles are used. The addition of have a very low disintegration Time and have
a suitable amount of water-insoluble inorganic great mouth feel due to fast melting effect.
excipients combined with
Disintegrants imparted an excellent physical Disadvantages of freeze drying
conflict to the oral dissolving tablet (ODT) and the This technique is expensive and time consuming;
simultaneously maintained optimal disintegration. fragility makes conventional packaging unsuitable
The use of water-insoluble inorganic excipients for these products and poor stability under stressed
offer better enhancement of disintegration in condition.
comparison to the most commonly used water  Sublimation6
soluble sugars or salts. Tablets primarily of water The slow dissolution of the compressed tablet
soluble components often tend to dissolve rather having even highly water soluble components is
than disintegrate and concentrated viscous solution due to the fact that the low Porosity of the drugs
is formed which reduces the rate of water diffusion reduces water dispersion into the matrix. After
into the tablet core. inert volatile solid ingredients like ammonium
 Oraquick19 Bicarbonate, ammonium carbonate, benzoic acid,
The oraquick fast-dissolving tablet preparation camphor, hexamethylene tetra mine, naphthalene,
utilizes a patented taste masking technology. The phthalic anhydride, urea and urethane were
taste masking method does not develop solvents of additional too along with other tablet excipients
any kind, and consequently leads to faster and and the blend were compressed into a tablet which
additional efficient production. Also, lower heat of is finally subjected to a process of sublimation
manufacture than alternative fast- resulting in exceedingly porosity. These
dissolving/disintegrating technologies makes compressed tablets exhibition Good mechanical
Oraquick suitable for heat-sensitive drugs strength and have high penetrability quickly
Dissolved within 15 seconds in saliva.
Techniques for preparing ODTS7
The various techniques are being utilized or  Mass extrusion7
adopted to Prepare ODTs This technology contains softening the active
• Freeze drying or Lyophilization blend using the Solvent mixture of water soluble
• Sublimation polyethylene glycol, using Methanol and
• Mass extrusion expulsion of softened mass through the extruder or
• Melt Granulation syringe to get a cylinder designed extrude which
• Spray drying finally cut into even segments using heated blade
• Molding to form tablets. This Process can also be used to
• Nanonization coat granules of bitter drugs to mask their taste.
• Direct compression This method used for preparing taste masked
• Cotton candy process Granules. The tablet was prepared with different
• Phase transition process Super disintegrate. E.g. sodium starch glycolate,
 Freeze drying or Lyophilization19 croscarmellose Sodium and crosspovidone etc.
Freeze drying is the technique in which water is
sublimed from the product when it is frozen. This  Melt granulation
technique creates an amorphous porous Melt granulation system is a process through
construction that can dissolve rapidly. A Typical which Pharmaceutical powders are efficiently
process involved in the manufacturing of ODT agglomerated through a melt able binder. The
using this technique. The active drug is dissolved/ benefit of this method associated to a
dispersed in an aqueous solution of a carrier or Conventional granulation is that no water or
polymer. The mixture is dosed through weight and organic solvents is necessary. For there is no
poured in the wells of the preformed Blister drying step, the process is less time consuming and
packages. The trays holding the blister packs are uses less energy than wet granulation. It is a
Malay Kumar B Chotaliya et al /Int.J.PharmTech Res.2012,4(4) 1718

Useful technique to enhance the dissolution rate of  Nanonization20

poorly water–soluble drugs such as griseofulvin In this technology contains reduction in the
41. This methodology to prepare MDT with particle size of Drug to nano size by milling the
sufficient mechanical integrity, involves the use of drug using a patented wet milling Technique. The
a hydrophilic waxy binder (superpolystate, PEG-6- nano-crystals of the drug are stabilized against
Stearate). Superpolystate is a waxy material with a agglomeration by surface absorption on selected
melting point of 33-370C and a HLB value of 9. So Stabilizers which are then incorporated into mouth
it determination not only act as a binder and dissolving Tablets. This system is suitable for
increase the physical resistance of Tablets but will poorly water soluble drugs.
also help the disintegration of the tablets as it Sahu et al., Novel Science International
Melts in the mouth and solubilizes rapidly leaving Journal of Pharmaceutical Science (2012),
no residues8. 1(3):204-211208. Other advantages of this
technology include fast Disintegration/dissolution
 Spray drying7 of nanoparticles leading to better Absorption and
Spray dryers remain widely used in hence higher bioavailability and reduction in Dose,
pharmaceuticals and Biochemical processes. Due cost effective manufacturing process, conventional
to processing solvent is evaporated quickly; spray Packaging due to exceptional durability and wide
drying can produce highly porous, fine powder. range of Doses i.e. 200 mg of drug per unit.
Spray drying can be used to formulate quickly
Disintegrating tablets. This technique is based on a  Direct compression
particulate Support matrix, which is equipped by This process by which tablets are compressed
spray drying an aqueous Composition containing directly from Mixtures of the drug and excipients
support matrix and other components to usage a without any preliminary Treatment. It offers
highly porous and fine powder this is then mixed advantages over the other manufacturing Processes
with active ingredients and compressed into of tablets, such as wet granulation and delivers
tablets. The Tablets made from this technology are high Efficiency. The mixture to be compressed
claimed to disintegrate within 20 seconds. need have Satisfactory flow properties and cohere
under pressure thus making pretreatment as wet
 Molding9 granulation unnecessary. In many cases, the
In this method, molded tablets are prepared by superdisintegrants have a major role in the
using water soluble Ingredients so that the tablets disintegration and dissolution process of mouth
dissolve completely and rapidly. The powder dissolving tablets made by direct compression.
blends is moistened with a hydro alcoholic Solvent The choice of a suitable type and an optimal
and is molded into tablets under pressure Lower amount of disintegrates is vital for ensuring a high
than that used in conventional tablet compression. disintegration rate. The addition of other
The Solvent is then removed by air-drying. They formulation mechanisms such as water soluble
are very less compact than compressed tablets. In excipients or Effervescent agents can further
this process porous Structure is formed and enhance dissolution or disintegration properties 11.
enhances the dissolution rate.
 Cotton candy process12,23
Advantage: It is also known as the “candy floss” method and
As the dispersion matrix is made from water- forms the basis of the technologies such as flash
soluble sugars, molded tablets disintegrate more dose (Fuisz Technology). It utilizes an inimitable
rapidly and offer improved Taste. These properties spinning mechanism to Yield floss like crystalline
are enhanced when tablets with porous Structures structure which mimics cotton candy. ODT is
are produced or when components that are formed using a candy floss or shear form Matrix;
physically modified by the moulding process are the matrix is formed from saccharides or
used. In Comparison to lyophilization process, Polysaccharides processed into amorphous floss
tablets produced by molding technique are easier by a simultaneous action of flash melting and
to adapt to the industrial scale. centrifugal force. The matrix is then cured or
partially recrystallized to provide a compound
Disadvantage: with good flow properties and compressibility.
The molded tablets have poor mechanical strength, The candy floss can then be milled and blended
they may Undergo erosion and breaking during with active ingredients and subsequently
handling. Through Hardening can increase the compressed into MDT. However the high
strength of the tablets but it would be at the cost of processing temperature limits the use of this
their disintegration time. technology.
Malay Kumar B Chotaliya et al /Int.J.PharmTech Res.2012,4(4) 1719

Characteristics: It can accommodate high doses and rapid onset of action had drawn the attention
of drug and offers improved mechanical strength. of many manufactures over a decade. The
introduction of fast dissolving dosage forms has
 Phase transition process solved some of the problems encountered in
It is concluded that a combination of low and high administration of drugs to the pediatric and elderly
melting point sugar alcohols, as well as a phase patient, which constitutes a large proportion of the
transition in the manufacturing process, are world's population. Hence, patient demand and the
important for making MDTs without any special availability of various technologies have increased
apparatus. MDT was produced by Compressing the market share of Fast dissolving tablets, which
powder containing erythritol (melting point: in turn prolongs the patent life of a drug. Keeping
122°C) and xylitol (melting point: 93°, 95°C), and in view of the advantages of the delivery system,
then heating at about 93°C for 15 min. after rapidly disintegrating dosage forms have been
heating, the median pore size of the tablets was successfully commercialized, and because of
increased and tablet hardness was also Increased. increased patient demand, these dosage forms are
The increase of the tablet hardness with heating expected to become more popular. Thus ODT may
and storage did not depend on the crystal state of be developed for most of the available drugs in
the lower melting Point sugar alcohol13. near future.

CONCLUSIONS
The ODTs have potential advantages over
conventional dosage forms, with their improved
patient compliance; convenience, bioavailability

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