Chauhan VijayKumar et. al.

/ JPBMS, 2011, 5 (08)

Available online at www.jpbms.info

ISSN NO- 2230 - 7885

Review Article

JPBMS
JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL SCIENCES

Mouth Dissolving Tablets: An Overview

Chauhan1, Dr. Rajesh K.S1, Deepak.G.Umalkar1, Lokendra Pal Singh1, Khushbu Shah1, Kuldipsinh Pagi1.
1Department of Pharmaceutics, Parul Institute of Pharmacy, Limda, Vadodara, Gujarat-391760, India.

*VijayKumar

Abstract: Now days formulation research is breaking barriers of conventional methods. Today, active ingredients can
be delivered with a level of convenience, performance and bioavailability never seen in the market place. Fast
disintegrating or Mouth dissolving tablet (MDTs) is one such novel approach to increase consumer acceptance by virtue of
rapid disintegration, self administration without water or chewing. This novel type of delivery system offers convenience
for treatment-resistant population who have difficulty in swallowing unit oral dosage form, namely Tablets and Capsules.
These formulations are particularly beneficial to pediatric and geriatric patients. It is estimated that 50 % of the
population is affected by dysphagia which results in high incidence of non-compliance and ineffective therapy. The aim of
this article is to review the ideal properties, significance, characteristics, limitation, choice of drug candidates, challenges in
formulation, approaches for preparation of MDTs, Patented technologies on MDTs, Suitable drug candidates for MDTs,
Marketed product of MDTs, and Evaluation tests of MDTs.

Key words: Fast disintegrating, Mouth Dissolving Tablet, Dysphagia.

Introduction:
Over the past three decades, Mouth Dissolving tablets
(MDTs) have gained much attention as a preferred
alternative to conventional oral dosage form such as
tablets and capsules and other liquid pharmaceutical
preparation. MDT is a solid dosage form that disintegrates
and dissolves in the mouth without the need of water
within a matter of seconds. Dissolution may take place
either on or under the tongue or in buccal cavity. The US
food and drug administration centre for drug evaluation
and research defines in the orange book MDTs as a solid
dosage form containing medicinal substance which
disintegrate rapidly, usually within a matter of seconds,
when placed upon the tongue. The European
pharmacopoeia defines a similar term, Oro-disperse as a
tablet that can be placed in the mouth where it disperses
rapidly before swallowing. These tablets in contrast with
conventional dosage forms (tablets and capsules) which
takes several minutes to dissolve in mouth, MDTs
disintegrates and dissolves in the mouth in less than 60
seconds and hence pro-duce a rapid action. There are
several synonyms in use of MDTs like orodisperse, orally
disintegrating tablets, quick dissolving tablet, fast melt
tablets, rapid disintegrating tablets and freeze dried
wafers. These tablets releases the medicament in the
mouth for absorption through local oromucosal tissue and
through pre-gastric (Oral cavity, Pharynx, and
oesophagus), gastric (stomach) and post-gastric(small and
large intestine) segments of Gastro Intestinal Tract(GIT).[14]

Ideal Properties: An ideal Mouth dissolving tablet

should:
1. Not require water to swallow, but it should dissolve or
disintegrate in the mouth in matter of seconds,
2. Allow high drug loading,
3. Have acceptable taste masking property,
4. Be portable without fragility concerns,
5. Have a pleasing mouth feel,
6. Leave minimal or no residue in the mouth after oral
administration,
7. Exhibit low sensitivity to environmental conditions as
humidity and temperature,
8. Allows the manufacture of tablet using conventional
processing and packaging equipment at low cost.[5]

Significance of Mouth dissolving tablet:

*Corresponding Author
VijayKumar Chauhan
Parul Institute of Pharmacy, Limda, Vadodara,
Gujarat-391760
Email-vjkumar_007@rediffmail.com

As MDTs are unit solid dosage forms, they provide

good
stability,
accurate
dosing,
easy
manufacturing, small packaging size, and ease of
handling by patients.
No risk of obstruction of dosage form as rapidly
dissolves in saliva.
Administration without water, anywhere and
anytime, hence beneficial for traveling patients
who do not have access to water.
Easy to administer for pediatric, geriatric,
mentally retarded and psychiatric patients.
Rapid disintegration of tablet results in quick
dissolution and rapid absorption which provide
rapid onset of action. Medication as "bitter pill"
has changed by excellent mouth feel property
produced by the use of flavors and sweeteners in
MDTs.
Bioavailability of drugs that are absorbed from
mouth, pharynx, and oesophagus is increased.

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Pre gastric absorption of drugs avoids hepatic

metabolism, which reduces the dose and increase
the bioavailability.
Suitable for delivering relatively low-molecular
weight and highly permeable drugs.
Requires minimum number of ingredients and is
cost effective dosage form.
Solid oral delivery systems do not require sterile
conditions, so less expensive to manufacture.[6]

Characteristics of Mouth dissolving Tablets:

MDDTs, as a novel dosage form, have several
characteristics to distinguish them from the more
traditional dosage forms. Traditional tablet formulations
generally do not require taste masking, because it is
assumed that the dosage form will not dissolve until
passing the oral cavity. Many oral suspensions, syrups, and
chewable tablets simply contain flavors, sugars and other
sweeteners to overcome the bitter taste of the drug. In fast
dissolving/disintegrating tablets include sweeteners and
flavors for taste-masking but many bitter drugs are not
masked by taste masking agent. The primary methods of
taste-masking include adsorption onto or complexation
with carriers and spray coating of drug particles.[7]

Limitation:

The tablets usually have insufficient mechanical

strength. Hence, it requires careful packaging and
handling.
The tablets may leave unpleasant taste and/or
grittiness in mouth if not formulated properly.
They are more susceptible to degradation by
humidity and temperature.
Difficulty in developing extremely high doses
(typically in excess of 500 mg) and extensive taste
masking of bitter tasting actives.[8]

Freeze-drying,
Sublimation,
Molding,
Spray drying,
Mass extrusion

Freeze-Drying:
The tablets prepared by freeze-drying or lyophilization are
very porous in nature and disintegrate or dissolve rapidly
when come in contact with saliva. First of all, the material
is frozen to bring it below its eutectic point. Then drying is
carried out to reduce the bound moisture to the required
volume. Due to lyophilization, bulking agent and
sometimes drug acquire glossy amorphous structure and
thus dissolution is enhanced. However the use of freezedrying is limited due to high cost of equipment and
processing, low mechanical strength, poor stability at
higher temperature and humidity.[11-15]

Sublimation:
This process involves addition of some inert volatile
substances like urea, urethane, naphthalene, camphor,
menthol, ammonium bicarbonate, etc. to other excipients
and the compression of blend into tablet. Removal of
volatile material by sublimation creates pores (Figure 1)
in tablet structure, due to which tablet dissolves when
comes in contact with saliva. Mouth dissolving Tablets
with highly porous structure and good mechanical
strength can be developed by this method. [16-18]
Figure 1: Schematic Diagram of Sublimation Technique for
Preparation of MDT

Choice of drug candidates:

Suitable drug candidate for orally disintegrating tablet
should posses:
No bitter taste.
Good stability in water and saliva.
Dose should be low as possible.
Unsuitable drug candidate for orally disintegrating tablet
should include:
Short half-life and frequent dosing.
Drug having very bitter taste.
Required controlled or sustained release.[9]

Challenges in formulation:
1.
2.
3.
4.
5.
6.
7.
8.

Rapid disintegration of tablet.

Avoid increase in tablet size.
Have sufficient mechanical strength.
Minimum or no residue in mouth.
Protection from moisture.
Good package design.
Compatible with taste masking technology.
Not affected by drug properties.[10]

Approaches for Preparation of MDTs:

Various technologies used in the manufacture of Mouth
dissolving Tablets include:

Molding:
Tablets prepared by this method are solid dispersions. The
drug can exist as discrete particles or micro particles in
the matrix. Molded tablets are less compact than
compressed tablets, with a porous structure that facilitates
rapid disintegration and easy dissolution. Molded tablets
offer improved taste due to water-soluble sugars present
in dispersion matrix. But molded tablets lack good
mechanical strength and can undergo breakage or erosion
during handling and opening of blister packs. However,

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adding sucrose, acacia or polyvinyl pyrrolidone can

increase mechanical strength. [19-21]

Spray Drying:
A highly porous and fine powder is prepared by spray
drying an aqueous composition containing support matrix
and other components. This is then mixed with active
ingredient and compressed into tablet. It provides
immediate dissolution (<20 sec). However this approach
involves high cost and time of production, and also very
poor mechanical strength of tablets.[22-23]

Mass Extrusion:

ingredients is softened using solvent mixture of water

soluble polyethylene glycol, using methanol and then the
softened mass is extruded through the extruder or syringe
to get a cylinder of product, which is finally cut into even
segments with the help of heated blades to get tablets. The
dried cylinder can be used to coat the granules of bitter
tasting drugs and thereby masking their bitter taste. [24]

Patented Technologies of MDTs :

Several technologies are available for preparing Mouth
dissolving tablets. A major focus for future MDT
development will be improving their cost-effectiveness,
when developing more robust and less friable MDTs.

In this technique, a blend of active drug and other

Table 1: Some Patented Technologies for Mouth Dissolving Tablets [25]
NOVELTY

HANDLING / STORAGE OF DOSAGE

FORM

DRUG RELEASE /
BIOAVAILABILITY

ZYDIS (R.P. SCHERER, INC.)

First to market, a unique freeze-dried tablet
with the active drug in a water-soluble matrix,
which is then transformed into blister pockets
and freeze dried to remove water.

Fragility and poor stability during storage Dissolves in 2-10 sec, may allow for
under stressful conditions, Packaged in pre-gastric absorption leading to
blister packs however a secondary enhanced bioavailability.
moisture proof foil punch is often
required as this dosage form is very
moisture sensitive.
ORASOLV (CIMA LABS, INC.)

Unique taste masking, Effervescent disintegrant Soft and fragile tablets, so needed to be Disintegrates in 5-45 sec depending
used, Lightly compressed.
packed in specially designed pick and upon the size of the tablet, No
place package system.
significant
change
in
drug
bioavailability.
DURASOLV (CIMA LABS, INC.)
Similar to Orasolv, but with better mechanical Packaged in blisters or foil or bottles.
strength.

Disintegrates in 5-45 sec, No

significant
change
in
drug
bioavailability.

WOWTAB (YAMANOUCHI PHARMA TECHNOLOGIES, INC.)

Compression molded tablets, Proprietary taste Avoid exposure to moisture or humidity, Disintegrates in 15 sec or less
masking.
packed into bottles and blister packs.
depending upon the size of the
tablet, No significant change in drug
bioavailability.
FLASHDOSE (FUISZ TECHNOLOGIES, LTD.)
Unique spinning mechanism producing floss- Avoid exposure to moisture and humidity, Dissolves within 1 min., Enhanced
like crystalline structure as cotton candy.
Require specialized Packaging.
bioavailability.
FLASHTAB (PROGRAPHARM GROUP)
Compressed dosage
microcrystals.

form,

with

drug

as Only conventional tableting technology is Dissolves within 1 min.

required.

Table 2.Drugs which are incorporated in the Mouth Dissolving Tablets [26]

Categories

Drugs

Analgesics and Anti-inflammatory agents

Piroxicam, Ibuprofen, Ketoprofen, Sulindac, Phenylbutazone, Naproxen,

Indomethacin, Mefenamic acid, azapropazone.

Anti-epileptics

Carbamazepine,Methsuximide,Phenytoin,Primidone,
Phenobarbitone,Valproicacid,Phensuximide,Oxcarbazepine.

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Anti-fungal agents

Clotrimazole,Amphotericin,Griseofulvin,ketoconazole, Miconazole, Nystatin,

Terbinafine, Fluconazole.

Anti-malarial

Chlorquine, Mefloquine, Proguanil, Pyrimethamine

Anti-gout agents

Allopurinol, Probenecid, Sulphinpyrazone

Anti-hypertensive agents

Amlodipine,Dilitazem,Valsartan,Nifedipine,Diazoxide, Prazosin, Terazosin

Antibacterial-agents

Clarithromycin,Ciprofloxacin,Nalidixic acid,Rifampicin, Erythromycin

Anti-neoplastic agents

Chlorambucil,Methotrexate,Cyclosporin,Estramustine, Dacarbazine

Diuretics

Acetazolamide,Amiloride,Chlorthalidone,Chlorthiazide,
Spironnolactone,Frusemide

Anti-parkinsonism agents
Anxiolytic,
Neuroleptics

Sedatives,Hypnotics,

Bromocriptine mesylate, Lysuride Maleate

and

Alprazolam, Chlordiazepoxide, Meprobamate, Lorazepam.

Lipid-regulating agents

Gemfibrozil, Fenofibrate, Clofibrate, Probucol

Opioid analgesics

Methadone,Diamorphine,Pentazocine,Nalbuphine, Morphine

Corticosteroids

Prednisolone, Methylprednisolone,
Prednisone, Dexamethasone.

Oral-Vaccines

Polio,Tetanus,Diphtheria, Hepatitis, Dengue fever, Rubella, Rabies

Local-Anaesthetics

Lidocaine.

Nutritional agents

Vitamin A,Vitamin D,Vitamin K, Vitamin E. Beta-carotene

Stimulants

Amphetamine, Fenfluramine, Dexamphetamine, Pemoline

Sex Hormones

Oestradiol,Testosterone,Methyltestosterone.Ethinyloestadiol,Norgestrel,
Progesterone

Anti-thyroid agents

Carbimazole, Propylthiouracil

Hydrocortisone,

Betamethasone,

Table 3 : MARKETED PRODUCTS OF MDT [27]

Trade Name

Active Drug

Manufacturer

Nimulid-MD

Nimesulide

Panacea Biotech, New Delhi, India

Feldene Fast Melt

Piroxicam

Pfizer Inc., NY, U.S.A

Zyrof Meltab

Rofecoxib

Zydus Cadila, India

Pepcid RPD

Famotidine

Merck and Co., NJ, U.S.A

Romilast

Montelukast

Ranbaxy Labs Ltd., New Delhi, India

Torrox MT

Rofecoxib

Torrent Pharmaceuticals, Ahmedabad, India

Olanex Instab

Olanzapine

Ranbaxy Labs Ltd., New Delhi, India

Zofran ODT

Ondansetron

Glaxo Wellcome, Middlesex, UK

Mosid-MT

Mosapride citrate

Torrent Pharmaceuticals, Ahmedabad, India

Febrectol

Paracetamol

Prographarm, Chateauneuf, France

Maxalt MLT

Rizatriptan

Merck and Co., NJ, U.S.A

Zelapar TM

Selegiline

Amarin Corp., London , UK

Evaluation parameters of Mouth Dissolving

Tablets:
Weight Variation Test:
To study weight variation, 20 tablets of each formulation
were weighed using an electronic balance and test was
performed according to Indian Pharmacopoeia.

Table 4: IP limits for % weight variation tolerance [28]

Average weight of tablet
% deviation
80 mg or less

10

More than 80 mg but less than 250 mg

7.5

250 mg or more

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Crushing Strength:

In-vitro drug release:

It is the force required to break a tablet by compression in

the radial direction. In the present study the crushing
strength of the tablet was measured on the day of
compression, using Monsanto hardness tester. An average
of three observations is reported.[29]

The development of dissolution methods for MDTs is

comparable to the approach taken for conventional
tablets, and is practically identical. Dissolution conditions
for drugs listed in a pharmacopoeia monograph, is a good
place to start with scouting runs for a bioequivalent MDT.
Other media such as 0.1N HCl and buffers (pH - 4.5 and
6.8) should be evaluated for MDT much in the same way as
their ordinary tablet counter parts. The USP 2 Paddle
apparatus is used for this purpose which is the most
suitable and common choice for orally-disintegrating
tablets, with a paddle speed of 50 rpm commonly used.
Typically the dissolution of MDT is very fast when using
USP monograph conditions; hence slower paddle speeds
may be utilized to obtain a profile. The USP 1 Basket
apparatus may have certain applications but sometimes
tablet fragments or disintegrated tablet masses may
become trapped on the inside top of the basket at the
spindle where little or no effective stirring occurs, yielding
irreproducible dissolution profiles. [33]

Friability Testing:
The crushing strength test may not be the best measure of
potential behavior during handling and packaging. The
resistance to surface abrasion may be a more relevant
parameter. The measurement is based on tablet weight
loss, expressed as a percentage, after certain numbers of
revolutions in the Roche Friabilator. A low friability value
represents better tablet strength.
Friability of each batch was measured in the Roche
Friabilator. Ten pre-weighed tablets were rotated at 25
rpm for 4 min. The tablets were then re-weighed and the
percentage of weight loss was calculated.[30]
% Friability = Loss in weight x 100
Initial weight

Simulated Wetting Time:

Wetting time of dosage form is related with the contact
angle. Wetting time of the MDT is an important parameter,
which needs to be assessed to give an insight into the
disintegration properties of the tablet. Lower wetting time
implies a quicker disintegration of the tablet.
A piece of tissue paper folded twice was placed in a
petridish with 10 cm diameter. Ten ml of water
(containing water soluble dye Eosin) was added to the
petridish. A tablet was placed on the surface of the tissue
paper. The time required for complete wetting was
measured as the wetting time. [31]

Stability Study (Temperature Dependent):

The fast dissolving tablets stored under the following
conditions for a period as prescribed by ICH guidelines for
accelerated studies.
i.40 1C
ii.50 1C
iii.37 1C and RH 75% 5%
The tablets were withdrawn after a period of 15 days and
analyzed for physical characterization such as visual
defects, Hardness, Friability, Disintegrations, and
Dissolution etc. The data obtained is fitted into first order
equations to determine the kinetics of degradation.
Accelerated stability data are plotting according Arrhenius
equation to determine the shelf life at 25C.[34]

Figure 2: Simulated Wetting time measurement

Conclusion:

In-vitro disintegration time:

The assessment of the in vitro disintegration profile of
MDT is very important in the evaluation and the
development of such formulations. So far neither the US
Pharmacopoeia nor the European Pharmacopoeia has
defined a specific disintegration test for MDT. Currently, it
is only possible to refer to the tests on dispersible or
effervescent tablets for the evaluation of MDTs
disintegration capacity.
The disintegration test for MDT should mimic
disintegration in mouth with in salivary contents. One
tablet was placed in a beaker/ petridish (10 cm diameter)
containing 10 ml of pH 6.8 phosphate buffer at 37 0.5 C.
The time required for complete dispersion of the tablet
was measured. This method embraces physiological
conditions of the oral cavity, as a screening tool for
developing MDT products.[32]

MDT concept evolved to overcome some of the problems

that existed in conventional solid dosage form i.e. difficulty
in swallowing of tablet in pediatric and geriatric patients
who constitute a large proportion of world's population.
MDT may lead to improve efficacy, bioavailability, rapid
onset of action, better patient compliance due to its quick
absorption from mouth to GIT as the saliva passes. Fast
dissolving tablet acts like solid dosage form when outside
the body and solution when administered. In future MDT
may be most acceptable and prescribed dosage form due
to its quick action (within minute). Their characteristic
advantages such as administration without water,
anywhere, anytime lead to their increased patient
compliance in todays scenario of hectic life. Considering
the many benefits of MDTs, a number of formulations are
prepared in MDT forms by most of the pharmaceutical
companies. Because of increased patient demand,
popularity of these dosage forms will surely expand in
future.

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