ejbps, 2016, Volume 3, Issue 3, 550-559. Review Article SJIF Impact Factor 3.

881

European Journal ISSN 2349-8870

Mundke et al. Europeanof Biomedical
Journal of Biomedical and Pharmaceutical Sciences
Volume: 3
AND Pharmaceutical sciences Issue: 3
550-559
http://www.ejbps.com Year: 2016

COMPREHENSIVE REVIEW ON ORALLY DISINTEGRATING DOSAGE FORMS

Sameer S. Mundke*, Asish Dev and Ganesh Deshmukh

Oriental College of Pharmacy, Sanpada, Navi Mumbai, 400705.

*Author for Correspondence: Sameer S. Mundke

Oriental College of Pharmacy, Sanpada, Navi Mumbai, 400705.

Article Received on 17/01/2016 Article Revised on 08/02/2016 Article Accepted on 29/02/2016

ABSTRACT
The Mouth Dissolving Drug Delivery Systems was an advancement that came into existence in the early 1970s
and combats over the use of the conventional tablets, syrups, capsules which are the other oral drug delivery
systems. Orally disintegrating dosage forms can address the pharmaceutical needs of the paediatric and geriatric
patient group having difficulties in swallowing the conventional solid oral dosage forms. Orally disintegrating
dosage forms also have the advantage of self medication, pain avoidance hence better patient compliance. Taste
masking of bitter drugs is an important parameter. Orally disintegrating dosage forms may have an added
advantage of bypassing first pass metabolism.

KEYWORDS: ODT, MDT, Oro dispersible, Dysphasia, Patient compliance.1

INTRODUCTION Minimal or no residue remains in mouth after

Oral drug delivery is the more advisable route for drug
administration among all the routes used for drug
delivery. Various types of dosage forms are prepared for
administration of drug via oral route. Solid dosage
forms are popular because of ease of administration,
self medication, accurate dosage, pain avoidance and
most importantly the patient compliance.[1] Buccal
dosage forms are most commonly used dosage forms. [2]
Most common dosage form is a tablet which can be
defined as a unit of a solid dosage form made by
compaction of medicaments. There are many types of
tablets for the delayed rate or controlled rate of drug
release. In this formulation the main drawback is
dysphagia i.e having difficulty in swalloving. Dysphagia
occurs in children due to undeveloped muscular and
nervous system, geriatric patients suffering from
parkinsons disease, bedridden &mentally ill patients. [3]
To overcome these problems mouth dissolved tablets are
the best choice of formulation. These tablet contents get
disintegrated or dissolved in buccal cavity avoiding
water consumption. This is a newer dosage form that
gets dissolved in saliva in very few seconds. these tablets
are also known as melt in mouth tablet (MMT), Fast
melting tablet(FMT), Fast dissolving tablet(FDT), Orally
Disintegreted tablet(ODT), Rapidly Disintegreted
tablet(RDT).[7]
administration.[3]
Rapid drug therapy intervention. [7]
Good mouth feel property helps to change the
perception of medication.[2]
Administration of drug is possible to paediatric,
geriatric & psychiatric patients.[6]
Achieve increased bioavailability/rapid absorption
through pre gastric absorption.[6]
Convenient for administration and patient compliant
for disabled, for busy people and travellers, who do
not always have access to water and bedridden
patients.[5]
The risk of chocking during oral administration of
conventional formulations due to physical
obstruction is avoided, thus providing batter
safety.[7]
Beneficial in cases such as suede episodes of allergic
attack or coughing, motion sickness where a rapid
onset of action required.[5]
An increased bioavailability, specifically in cases of
insoluble and hydrophobic drugs, due to quick
disintegration and dissolution of these tablets. [3]
Suitable for sustained/controlled release actives. [10]
In condition of pain their Fast disintegration also
impose a placebo effect before the medicines effect
actually begins and patient get relief quickly. [3]

Advantages of Mouth Dissolving Tablets Limitations of Mouth Dissolving Tablets:

ODTs offer all the advantages of liquid dosage The tablets usually not have sufficient mechanical
forms and solid dosage forms and.[4] strength. Hence, careful handling is required.[5]

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FDT requires special packaging for safety of stable
product and properly stabilization. [11]
The tablets may leave unpleasant taste in mouth if
not formulated properly.[3]
Drugs with relatively larger doses are difficult to
formulate into MDT.[3]
Patients who frequently take anti cholinergic
medications & patients with Sjgren's syndrome or
dryness of the mouth due to lesser saliva production
may not be good for these tablet formulations.[3]
The mechanical strength of the fast dissolving
tablets is not so much then the traditional tablets.
Many products are very light weight requiring them
to be individually packaged. Patients were advised
not to push these tablets through the foil film, but
the peel the film back to release the fast-dissolving
tablet.[12]
Desired Criteria for MDDS
Mouth Dissolving Tablets should
Not require water to swallow, but it should
disintegrate or dissolve in the mouth in matter of
seconds.[6]
Effective taste masking methods should be adopted
for bitter taste drugs[4]
Be portable without fragility concern. [4]
Have a pleasing mouth feel.[2]
Leave minimal or no residue in the mouth after oral
administration.[3]
Exhibits low sensitivity to environmental conditions
as temperature and humidity.[2]
Be able to be manufactured in a simple conventional
manner within low cost.[13]
Selection of Excipients
Excipients balance is the properties of the active
ingredients in fast-melting tablets. This demands a
trough understanding of the chemistry of excipients to
prevent interaction with the actives. These inactive food-
grade ingredients, when integrate in the formulation,
impart the desired organoleptic properties and product
efficacy.[1]
1] BulkAgents
Bulk agents are significant in the formulation of rapid-
dissolving tablets. The material contributes functions of a
filler, diluent and cost reducer. Bulk agents improve the
textural characteristics that inturn enhance the
disintegration in the mouth, besides adding bulk also
decreases the concentration of the active in the
composition.[20] The recommended bulking agents for
this delivery system should be sugar-based such as
mannitol, polydextrose,starch hydrolystate , DCL (direct
compressible lactose) and lactitol for higher aqueous
solubility and good sensory perception. Mannitol in
particular has good sensory perception and high aqueous
solubility. Bulking agents are added in the range of 10
percent to about 90 percent by weight of the final
composition.[7] The sugar based excipients which are
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commonly used are especially bulking agents (like
dextrose,fructose, mannitol, maltose,starch hydrolysate ,
sorbitol, polydextrose and xylitol) which display high
aqueous solubility and sweetness, and hence give taste
masking property. Mizumito et.al, classified sugar-based
excipients on the basis of dissolution rate and molding
Type 1 saccharides (mannitol and lactose) exhibit low
mouldability but high dissolution rate.Type 2 saccharides
(maltose )exhibit high mouldability but low dissolution
rate.[21]
2] Emulsifying agents
These are important excipients for formulating rapid-
melting tablets. They aid in rapid disintegration and drug
release without drinking water, chewing and swallowing.
In addition, incorporating emulsifying agents is useful in
enhancing bioavailability and stabilizing the immiscible
blends. A wide range of emulsifiers is recommended for
fast-dissolving tablet formulation, including alkyl
sulfates, lecithin, propyleneglycol esters, sucrose esters
and others. These agents can be incorporated in the range
of 0.05 % to about 15 percent by weight of the final
composition.[20,21]
3] Lubricants
Lubricants are not that much essential excipients, can
further assist in making these tablets more palatable after
they disintegrate in the mouth. Lubricants abolish
grittiness and assist in the drug transport mechanism
from the mouth down into the stomach.[9]
4] Flavours and Sweeteners
Taste-masking agents and flavours make the products
more palatable and pleasing for patients. The addition of
these ingredients aids in overcoming disagreeable tastes
and bitterness of some active ingredients. Both natural
and synthetic flavours can be used to enhance the
organoleptic characteristics of fast-melting tablets.
[5]Formulators can choose from a wide range of
sweeteners including sugar, fructose and dextrose, as
well as non-nutritive sweeteners such as aspartame,
sodium saccharin, sugar alcohols and sucralose.[9]
5] Superdisintegrants[14-19]
Gernally In many orally disintegrating tablet
technologies based on direct compression, the addition of
super disintegrants principally affects the rate of
dissolution and rate of disintegration. The presence of
other formulation ingredients such as effervescent agents
and water-soluble excipients further hastens the process
of disintegration. This technique contains micro granules
and coated crystals along with the disintegrants. In this
technology, two types of granules are used; first one is a
disintegrating agent, which has a high swelling force,
and second one is a swelling agent, which has a low
swelling force.
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 Mundke et al. European Journal of Biomedical and Pharmaceutical Sciences

List of superdisintegrants[14-19]
Superdisintegrants
Crosscarmellose Ac-Di-
Sol Nymce ZSX
PrimelloseSolutab
VivasolL-HPC
Crospovidone Crospovidone
M Kollidon
Polyplasdone
Sodium starch glycolate
Explotab Primogel
Alginic acid NF Satialgine
Soy polysaccharides
Emcosoy
Calcium silicate
Example Mechanism of action Special comment
Swells 4-8 folds in < 10 Swells in two dimensions. -Direct
Crosslinked
seconds -Swelling and compression or granulation -Starch
Cellulose
wicking both free
Swells very little and returns
Crosslinked to original size after -Water insoluble and spongy in
PVP compression but act by nature so get porous tablet
capillary action
-Swells in three dimensions and
Crosslinked Swells 7-12 folds in < 30
high level serve as sustain release
Starch seconds
matrix
Rapid swelling in aqueous -Promote disintegration in both dry
Crosslinked alginic acid
medium or wicking action or wet granulation
-Does not contain any starch or
Natural super Disintegrant
sugar. Used in nutritional products
Wicking action Highly porous, 2040%

NEWER MANUFACTURING METHODS c. No vacuum lyophilization:This method involves

1. Freeze Drying
A method in which water is sublimated from the product
after freezing is called freeze drying. Lyophilization is a
pharmaceutical technology which allows drying of
biological and heat sensitive drugs at low temperature
under conditions that allow removal of water by
sublimation. That results in preparations, which are
highly porous, with a very high specific surface area,
which dissolve rapidly and show enhanced in absorption
and bioavailability.[1] The entire freeze drying process is
done at non elevated temperature to abolish adverse
thermal effects that may affect drug stability. The major
disadvantages of lyophilization method are that it is time
consuming and costly ; fragility makes conventional
packaging incompatible for these products and poor
stability under stressed conditions and their restricted
ability to accommodate adequate concentration of
drugs[22-26]
2. Tablet Molding
Tablets prepared by this process are solid dispersions.
Physical form of drug in the tablets depends on whether
and to what level it dissolves in the wetted mass. The
drug can exist as discrete particles or micro particles in
the matrix. It can dissolve completely to form a solid
solution or dissolve partially in the molten carrier and
remaining, if any, stays not dissolved and dispersed in
the matrix. Disintegration time, drug dissolution rate and
mouth feel will depend on the type of dispersion.
Different moulding techniques can be used to prepare
mouthdissolving tablets.[27,28]
a. Compression moulding
The powder mixture before wetted with a solvent like
ethanol/water is compressed into mould plates to form a
wetted mass.
evaporation of solvent from a drug solution or
suspension at a standard pressure[30]
3. Direct Compression
In the direct compression, disintegrant addition
technology is the most preferred technique to
manufacture the tablets due to certain advantages:
a. High doses can be accommodated and final weight of
the tablet can exceed that of other methods.
b. Easiest way to manufacture the tablets.
c. Conventional equipment and commonly available
excipients are use
d. A limited no. of processing steps are involved.
e. Costeffectiveness.[31,19]
Tablet hardness and size strongly affect the disintegrant
efficacy. Hard and large tablets have more disintegration
time than normally required. Very soft and small tablets
have low mechanical strength. So, an optimum kind and
concentration of disintegrant should be chosen to achieve
fast disintegration and high dissolution rates. Above the
critical concentration level, disintegration time remains
roughly around constant or even increases. [32]
4. Spray Drying
Spray drying can produce fine and highly porous
powders that dissolve rapidly. The formulations are
incorporated by non hydrolysed and hydrolysed gelatins
as supporting agents, mannitol as bulking agent, sodium
starch glycolate or croscarmellose sodium as
disintegrant.[33] By adding acidic material (e.g.citric acid)
and/ or alkali material to enhance dissolution and
disintegration. Tablet compressed from the spray dried
powder disintegrated within 20 seconds when plunge in
an aqueous medium.[1]

b. Heat moulding
A molten matrix in which drug is dispersed or dissolved
can be directly moulded into Mouth dissolving tablets[29]

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 Mundke et al.
Figure 1: Flowchart for coating liquid and solid
particles using spray-dry process[5]
5. Sublimation
This method involves addition of some inert volatile
substances like urea, urethane, naphthalene, camphor, etc
to other excipients and the compression of blend into
tablet and Removal of volatile material[6] By sublimation
creates pores in tablet structure ,by which tablet dissolves
when comes in contact with saliva. Additionally several
solvents like benzene, cyclohexane etc can also be used
as pore forming agents. Mouth dissolving tablets with
highly porous structure and superior mechanical strength
have been developed by this method.[26,34]
Fig.: Schematic Diagram of Sublimation Technique
for Preparation of MDT[6]
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European Journal of Biomedical and Pharmaceutical Sciences
6. Mass-Extrusion
This process involves softening of the active blend using
the solvent mixture of water soluble methanol and
polyethylene glycol. This softened mass is extruded
through the extruder or syringe and a cylindrical shaped
extrude is obtained which are cut into even segments
using heated blade to form tablets. Granules of bitter
drugs can be coated using this method to mask their
taste.[6]
Patented technology
i) Zydis Technology
Zydis is a excellent technology for manufacture of rapid
dissolving or disintegrating tablets. When tablets made
by this technology placed on the tongue, dissolve in less
than 3 seconds. Zydis tablet is made by lyophilization or
freeze drying technique is highly porous in nature. The
drag is physically trapped in a water soluble matrix
usually consisting of gelatin. [39] In addition, it utilizes
microencapsulation with specialized polymers or
complexation with ion-exchange resins to mask the bitter
tasting drug.[5]
A major claim of Zydis product is increased
bioavailability compared to conventional tablets as it
predominately absorbs buccal, pharyngeal and gastric
regions which avoids hepatic fast pass metabolism. [39]
ii.) Wowtab Technology
This technology is patented by Yamanouchi
Pharmaceutical Co. The WOW in Wowtab signifies the
tablet is to be given With Out Water. [4] The Wowtab
rapid - disintegrating or dissolving tablet formulation has
been on the Japanese market for a number of years It is
recently been introduced into the U.S.The Wowtab
technology makes use of sugar and sugar-like (e.g.,
mannitol) excipients.[5] WOWTAB technology employs
a combination of low and high moldability saccharides to
produce rapid dissolving tablets using conventional
granulation and tableting techniques.A saccharide having
low moldability was granulated with a saccharide having
excessive moldability as a binder. The low-moldability
saccharides were used a as the main component. The
tablets show as adequeate hardness and fast
disintegration and dissolution when put in the mouth [39]
iii.) OraSolv Technology
OraSolv Technology had developed by CIMA labs. In
this system active medicament is taste masked. It also
contains effervescent disintegrating agent. The Tablets
are made by direct compression technique at low
compression force in order to minimize oral dissolution
time.[2]The limitation associated is that the tablets
produced are soft and friable. An advantage that with the
low degree of compaction of OraSolv is that the particle
coating used for taste masking is not compromised by
fracture during processing.[5]
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 Mundke et al. European Journal of Biomedical and Pharmaceutical Sciences
iv.) Durasolv Technology
DuraSolv has much excessive mechanical strength than
its predecess or due to the use of higher compaction
pressures during tabletting. The main ingredients in this
formulation are filler and lubricant. [3] DuraSolv is so
durable that it can be packaged in either vials or
traditional blister packaging . The particle size of the
filler is preferably between about 20 and 65m. This
method can produce tablets by using the direct
compression method, conventional tableting processes
and conventional package equipment. Thus, the
production cost is significantly reduced.[5]
v.) Flash Dose Technology
Flash dose technology had patented by Fuisz
Technologies Ltd. Nurofen meltlet, a new form of
ibuprofen as melt in mouth tablets prepared using this
technology is the first commercial product launched by
Biovail Corporation.[40] Flash dose tablets having self-
binding shear form matrix termed asfloss. Shear form
matrices are prepared by flash heat processing. [5]
vi.) Flashtab Technology
Prographarm laboratories has been patented the Flashtab
technology. Flashtab technology produces tablets by
compression of granular excipients. Flashtab
technology uses almost the same excipients as do
conventional compressed tablets. Excipients used in
Flashtab technology comprise two groups of
components: disintegrating agents, such as insoluble
reticulated poly vinyl pyrollidone or carboxy methyl
cellulose ; and swelling agents, such as starch, modified
starch, carboxy methylated starch,carboxy methyl
cellulose, microcrystalline cellulose and possibly directly
compressible sugars.[39]The micro-granules of the active
ingredient are added to granulated mixture of excipient
sprepared by dry or wet granulation, and compressed into
tablets. All the processing make a use of the
conventional tablet technology, and the tablets produced
are accounted to have superior mechanical strength and
disintegration time is less than 60 seconds.[35]
vii.) Oraquick Technology
The OraQuick rapid-dissolving/disintegrating tablet
formulation employs a patented taste masking
technology. The taste masking process does not make
use of any solvents and hence leads to faster and more
efficient production.[3] KV Pharmaceutical claims its
microsphere technology which is known as Micro Mask,
has better taste masking property.. OraQuick is
appropriate for heat-sensitive drugs since utilizes
Category of drugs promising to be incorporated in MDTs[2]
Aloxiprin, Auranofin, Azapropazone, Etodolac, Fenbufen, Flurbiprofen,
Analgesics and Anti -
Indomethacin, Ketoprofen, Mefenamic acid, Nabumetone, Naproxen,
inflammatory Agents
oxaprozin, Phenylbutazone, Piroxicam, Sulindac.
Anti-coagulants Dicoumarol, dipyridamole, nicoumalone, phenindione
Anti-arrhythmic Agents Amiodarone HCl, Disopyramide, flecainide acetate, quinidine sulphate
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minimum heat for the production than the competing fast
dissolving technologies.[5]
viii.) Quick Dis Technology
Lavipharm Laboratories Inc. (Lavipharm) has been
invented an ideal intraoral fast-dissolving drug delivery
system, which satisfies the unmet needs of the market
and The novel intraoral drug delivery system,
trademarked Quick-Dis, is Lavipharms proprietary
patented technology[35] and is a thin, flexible, and
quick-dissolving film. The film is placed on the floor or
the top of the tongue. It is retained at the site of
application and rapidly releases the active agent for local
and/or systemic absorption.[5]
ix.) Ziplets/Advatab
This technology has been patented by Passano con
Barnago, Italy. It employs water-insoluble ingredient
merged with one or more effective disintegrants to
produce mouth dissolve tablets with improved
mechanical strength and optimal disintegration time at
low compression force.[5]
x.) Lyoc
Lyoc technology has been patented by PHARMALYCO.
Lyoc utilizes a freeze drying process but it differs from
Zydis in that the product is frozen on freeze dryer
shelves. In order to prevent homogeneity by
sedimentation during this process, these formulations
also require a maximum proportion of undissolved inert
filler such as mannitol, to increase the viscosity of the in
process suspension. The exsesive proportion of filler
used reduces the potential porosity of the dried dosage
form and therefore results in denser tablets with
disintegration rates that are comparable with the loosely
compressed fast melt formulations.[36]
xi.) Pharmabrust Technology
Pharma burst technology is being patented by SPI
pharma. The tablet manufactured by this process
involves a dry blend of a drug, lubricant and flavors then
followed by compression into tablets which then dissolve
within 30-40 seconds.[5]
iii.)Nanocrystal Technology
This has been patented by Elan, King of Prussia.
Nanocrystal technology includes lyophilization of
colloidal dispersions of drug substance and the water-
soluble ingredients filled in to blister pockets. This
method avoids manufacturing process such as blending ,
granulation, and tableting, which is more advantageous
for highly potent and hazardous.[36]
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 Mundke et al. European Journal of Biomedical and Pharmaceutical Sciences

Benethamine penicillin, cinoxacin, ciprofloxacin HCl, clarithromycin,

Anti-bacterial Agents clofazimine, cloxacillin, demeclocycline, doxycycline, erythromycin,
ethionamide, imipenem
Albendazole, bephenium hydroxynaphthoate, cambendazole, ivermectin,
Anthelmintics
mebendazole
Amoxapine, ciclazindol, maprotiline HCl, mianserin HCl, nortriptyline HCl,
Anti-depressants
trazodone HCl, trimipramine maleate.
Amlodipine, carvedilol, benidipine, darodipine, dilitazem HCl, diazoxide,
Anti-hypertensive Agents felodipine, guanabenz acetate, indoramin, isradipine, minoxidil, nicardipine
HCl.
Acetohexamide, chlorpropamide, glibenclamide, gliclazide, glipizide,
Anti-diabetics
tolazamide, tolbutamide.
Local Anaesthetics Lidocaine Amphotericin, butoconazole nitrate, clotrimazole, econazole nitrate,
Anti-fungal Agents fluconazole, flucytosine, griseofulvin, itraconazole, ketoconazole, miconazole
Beclamide, carbamazepine, clonazepam, ethotoin, methoin, methsuximide,
Anti-epileptics methylphenobarbitone, oxcarbazepine, parame thadione, phenacemide,
phenobarbitone
Anti-gout Agents Allopurinol, probenecid, sulphinpyrazone.
Anti-parkinsonian Agents Bromocriptine mesylate, lysuride maleate
Amodiaquine, chloroquine, chlorproguanil HCl, halofantrine HCl,mefloquine
Anti-malarials
HCl, proguanil HCl, pyrimethamine, quinine sulphate.
Atropine, benzhexol HCl, biperiden, ethopropazine HCl, hyoscine butyl
Anti-muscarinic Agents bromide, hyoscyamine, mepenzolate bromide, orphenadrine, xyphencylcimine
HCl, tropicamide
Aminoglutethimide, amsacrine, azathioprine, busulphan, chlorambucil,
Anti-neoplastic agent and
cyclosporin, dacarbazine, estramustine, etoposide, lomustine, melphalan,
Immunosuppressants
mercaptopurine, methotrexate, mitomycin, mitotane.
Cardiac Inotropic Agents Amrinone, digitoxin, digoxin, enoximone, lanatoside C, medigoxin.
Alprazolam, amylobarbitone, barbitone, bentazepam, bromazepam,
Anxiolytic,Sedatives, bromperidol, brotizolam, butobarbitone, carbromal, chlordiazepoxide,
Hypnotics& Neuroleptics chlormethiazole, chlorpromazine, clobazam, clotiazepam, clozapine,
diazepam, droperidol, ethinamate.
Acebutolol, alprenolol, atenolol, labetalol, metoprolol, nadolol, oxprenolol,
-Blockers
pindolol,propranolol.
Nitrates and other Anti Amyl nitrate, glyceryl trinitrate, isosorbide dinitrate, isosorbidemononitrate,
anginal Agents pentaerythritol tetranitrate.

Evaluation Test Far Fast Dissolving Tablet
Tablets from all the formulation were subjected to
following quality control test.
1. General Appearance
The general appearance of a tablet is its visual identity
and overallelegance is essential for consumer
acceptance. Include in are tablets size, shape, colour,
presence or absence of an odour, taste, surface texture,
physical flaws and consistency and legibility of any
identifying marking.[1]
2. Size and Shape
The size and shape of the tablet could be dimensionally
described, monitored and controlled.[1]
3. Pre-compression Parameters
Evaluation of blend for the following parameters to be
carried out before compression of MDTs
i) Untapped Bulk Density: 10 g powder place into 100
ml measuring cylinder. Volume occupied by the powder
weight is noted without disturbing the cylinder and bulk
density is calculated by the following equation:
Untapped Bulk Density = Mass of bulk drug /Volume of
bulk drug[3]
ii) Tapped Bulk Density: 10 g powder place into 100 ml
measuring cylinder. The cylinder is then subject to a
fixed number of taps (~100 times) until the powder bed
volume goes to the minimum level. Record the final
volume and calculate the tap density by following
equation:
Tapped Bulk Density = Mass of bulk drug/ Volume of
bulk drug on tapping[3]
iii) Compressibility:[1]
It is an important measure obtained from bulk density
and is
Defined as,
C=. Pb-Pu/Pb x100
Where Pb=tapped density of powder
Pu=bulked density of powder

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 Mundke et al. European Journal of Biomedical and Pharmaceutical Sciences
If the particle bed is more compressible the blend will
beless flowable and flowing materials.
Table 3: Relationship between % compressibility and
flowability
% Compressibility Flow ability
5 12 Excellent
12 16 Good
18 21 Fair Passable
23 35 Poor
33 38 Very Poor
< 40 Very Poor
iv) Hausner Ratio:[3]
Hausner of the drug is found out using the following
formula:
Hausner Ratio = Bulk Density / Tapped Density
Table 2: Angle of Repose as an Indication of Powder Flow
Sr. No. Angle of Repose ()
1 < 20
2 20 30
3 30 34
4 > 34
4. Hardness
A significant strength of MDT is difficultto achieve due
to the specialized processes and ingredients used in the
manufacturing. The limit of hardness for the MDT is
usually kept in alower range to facilitate rapid
disintegration in the mouth. The hardness of the tablet
can be measured using conventional hardness test.[4,9]
Limits for the weight variation of tablets
Average weight of tablet % deviation
Average weight of tablet
80mg or less
More than 80 mg but lessthan 250 mg
250mg or more
6. Tablet thickness
Tablet thickness is an important parameter in
reproducing appearance and also in counting by using
filling. Some filling equipment utilizes the same or
uniform thickness of the tablets as a counting
mechanism. Ten tablets are taken and thickness is
measured by micrometer.[1]
7. Friability:[1]
It is measured of mechanical strength of tablets. Roche
fribalator was used to determine the friability by
following procedure. A pre weighed tablet was placed in
the fribalator. Fribalator consist of a plastic-chamber that
revolves at 25rpm, dropping those tablets at a distance of
6 inches with each single revolution. The tablets were
rotated in the friabalator for at least 4 minutes. At the end
of test tablets were dusied and reweighed, the loss in the
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v) Angle of repose:[1]
The frictional force of a powder can be measured by the
angle of repose. It is defined as, the maximum angle
possible between the piles surface of the powder & the
horizontal plane. If more powder is added to the pile, It
slides down the sides of the pile until the friction of the
particles producing a surface angle, which is in
equilibrium with the force of gravitation.
The angle of repose was determined by the funnel
methodsuggested by Newman. Angle of repose is
determined by the Formula
Tan= h/r
Therefore = Tan-12h/r
Where = Angle of repose
h = height of the cone
r= Radius of the cone base
Angle of Repose less than 30 shows the free flowing of
the material.
Type of Flow Properties
Excellent
Good
Passable
Very Poor
5.Weight variation[1]
Select20 tablets randomly from the lot and weigh
individually to checkfor weight variation. Weight
variation specification as per I.P. is shown as follows
% deviation
10
7.5
5
weight of tablet is the Measure of friability and is
expressed in percentage as
%Friability =( loss in weight / Initial weight )x 100
8. Tensile Strength
The tablet tensile strength is the force or pressure
required to break a tablet by compressing it in the radial
direction and is measured using a tablet hardness tester.
For computing the hardness of the tablets, the plunger of
the hardness tester drive down at a speed of 20 mm/min.
Tensile strength for crushing (T) is calculated using
equation:
Eq. I. T= 2F / dt
Where F = crushing load, and d and t denote the diameter
and thickness of the tablet, respectively .Though, this is a
mostly used and accepted method for hardness testing, it
is not applicable to very delicate tablets prepared by
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 Mundke et al. European Journal of Biomedical and Pharmaceutical Sciences
lyophilization technique .Flash dose tablets prepared by
cotton candy process are also poor candidates for this
test[37]. This test is the best suited for tablets prepared
by direct compression and moulding methods. However,
the tensile strength of these tablets is always kept low or
minimum which needs to be compromised to keep the
disintegration time as minimum as possible. [5]
9. Disintegration Test
Six tablets were taken for the disintegration test using
distilled water at 370c 20c was used as disintegration
media and the time in second taken for entire
disintegration of the tablet with no palpable mass
remaining in the apparatus was measured in seconds. [3]
10. Dissolution Test
The dissolution rate of the drag from the primary
particles of the tablets is the important factor in drug
absorption and for a lot of formulations is the rate -
limiting step. Therefore, a dissolution time is more
indicative of the availability of a drag from a tablet than
the disintegration test. Dissolution test for mouth
dissolving tablets is same as that of conventional tablets.
Test must be carried out as prescribed in the monograph.
Medias such as 0.1N HC1 and buffers (pH 4.5 to 6.8)
may be used for the evaluation.[41]
11. Wetting Time and Water Absorption Ratio
It is related with the contact angle. Wetting time of the
ODT is another important parameter, which needs to be
evaluated to give a look into the disintegration properties
of the tablet. The wetting time of the tablets can be
evaluated using a simple procedure[38] Five circular
tissue papers of 10 cm diameter were placed in a
petridish with a 10-cm diameter.10 milliliters of water-
soluble dye (eosin) solution is added to petridish. A
tablet is carefully kept on the surface of the tissue paper
and the time required for water to reach upper surface of
the tablet is taken as the wetting time. To measure the
water absorption ratio the weight of the tablet before
keeping in the petridish is noted down (W b) and the
wetted tablet was taken and reweighed (W a). The water
absorption ratio, R can be then determined according to
the equation:[4]
R = 100 (W a - W b)/W b
12. Moisture Uptake Studies
Moisture uptake studies for orally disintegreted tablet
should be conducted to assess the stability of the
formulation. Ten tablets from each formulation were put
in a desiccators over calcium chloride at 37C for 24 h.
The tablets were then weighed and exposed to 75
percentage relative humidity, at room temperature for
2weeks. Required humidity was achieved by keeping
saturated NaCl solution to the bottom of the desiccators
for 3 days. One tablet as control (without
superdisintegrant) was kept to determine the moisture
uptake due to other excipients. Tablets were weighed and
the percentage increase in weight was recorded.[4]
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13. Stability study
Stability study of mouth dissolving tablets is done
according to ICH guidelines for accelerated studies after
suitable packaging at following conditions:
1) 40 1C
2) 50 1C
3) 37 1C and RH 75% 5%
Tablets are withdrawn at specified time period and
analysed for various parameters like visual defects,
hardness, friability, disintegration, dissolution etc. [39]
CONCLUSION
The technologies described in this article explain how
recent advances in formulation development and
processing technologies meet the efforts to achieve more
convenient and sophisticated drug delivery system (Oral
Disintegrating/Mouth Dissolving Tablets).Mouth
dissolve tablets are formulated for those patients who are
geriatric, paediatric, bedridden etc. MDT offers
advantages of ease of dosing and convenience of dosing
in the absence of water or fluid. The clinical studies also
showed that Oral Disintegrating tablets can improve
patient compliance, provide a rapid onset of action, and
increase bioavailability. An extension of exclusivity of
market, which can be provided by a fast-
dissolving/disintegrating dosage form, leads to increase
revenue and also targeting under-treated and underserved
patient populations. Furthermore, development of such
system which correlates well with all desired specific
characteristics for effective delivery would nevertheless
be an appropriate futuristic endeavour. The future trends
in innovations of drug delivery systems will continue to
bring together different formulation aspects and
technological disciplines to create novel technologies.
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