Bali Medical Journal (Bali Med J) 2015, Volume 4, Number 1: 17-20
P-ISSN.2089-1180, E-ISSN.2302-2914

ORODISPERSIBLE TABLET:
A Patient Friendly Dosage Form (a Review)
Rameesa C. K., Drisya M. K.
Karuna College of Pharmacy, Pattambi, Kerala-India.

Background: The most common and preferred route of drug administration is through the oral route.
Orodispersible tablets are gaining importance among novel oral drug delivery system as they have
improved patient compliance and have some additional advantages compared to other formulation.
They are also solid unit dosage forms, which disintegrate in the mouth within a minute in the presence
of saliva due to superdisintegrants in the formulation. Thus this type of drug delivery helps a proper
per oral administration in pediatric and geriatric population where swallowing is a matter of trouble.
Various scientists have prepared orodispersible tablets by following various methods. However, the
most common method is the direct compression method. Other special methods are Freeze
Drying,Tablet Molding, Sublimation, Spray Drying, Mass extrusion, Phase transition process, etc.
Since these tablets dissolve directly in the mouth, so, their taste is also an important factor. Various
approaches have been taken in order to mask the bitter taste of the drug. A number of scientists have
explored several drugs in this field. Like all other solid dosage forms, they are also evaluated in the
field of hardness, friability, wetting time, moisture uptake, disintegration test and dissolution test.
Key words: Disintegration; Manufacturing process; Orodispersible tablets; Superdisintegrants.
INTRODUCTION
Now a day’s, there has been an enhanced
demand for more patient-friendly and compliant
dosage forms. As a result, the demand for
developing new technologies has been increasing
annually. For most therapeutic agents used to
produce systemic effects, the oral route still
represents the preferred way of administration,
owing to its several advantages and high patient
compliance compared to many other routes. Tablet
is the most popular among all dosage forms
existing today because of its convenience of self
administration.1
Advances in novel drug delivery (NDDS) aim
to enhance safety and efficacy of drug molecule by
formulating a convenient dosage form for ease of
administration and to achieve better patient
compliance. Dysphagia is the common problem
encountered in all age groups in concern to
conventional solid dosage forms like tablets and
capsules. Especially, many elderly persons face
difficulties in administering conventional oral
dosage forms because of hand tremors and
dysphagia. Swallowing problem is common in
children because of their underdeveloped muscular
and nervous systems. In some cases such as motion
Rameesa C K,
Karuna College of Pharmacy,
Pattambi, Kerala, India.
Email: rameesa@gmail.com

sickness, sudden episodes of allergic attack or
coughing, and an unavailability of water,
swallowing conventional tablets may be difficult.
To fulfill these medical needs, formulators have
devoted considerable efforts for developing a novel
type of dosage form for oral administration known
as orodispersible tablet (ODT).2 This is an
innovative technology where the dosage form
containing active pharmaceutical ingredients
disintegrates rapidly in saliva usually in a matter of
seconds without the need for water, providing
optimal convenience to the patient and are thus
quite suitable for children, elderly and mentally
disabled patients.3
Orodispersible tablets are also called as orally
disintegrating tablets, quick disintegrating tablets,
mouth dissolving tablets, fast disintegrating tablets,
fast dissolving tablets, rapid dissolving tablets,
porous tablets, and rapimelts.2 Recently, European
pharmacopoeia has used the term orodispersible
tablets. This may be defined as uncoated tablets
intended to be placed in the mouth where they
disperse readily within 3 min before swallowing.
United States Pharmacopoeia has also approved
these dosage forms as orodispersible tablets. Thus,
orodispersible tablets are solid unit dosage forms
like conventional tablets, but are composed of super
disintegrants, which help them to dissolve the
tablets within a minute in the mouth in the presence
of saliva without any difficulty of swallowing4. It
offers several advantages with respect to its
stability, administration without water, accurate

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Bali Medical Journal (Bali Med J) 2015, Volume 4, Number 1: 17-20
P-ISSN.2089-1180, E-ISSN.2302-2914

dosing, easy manufacturing, small packaging size,
and handling.Its ease of administration in the
population especially for pediatric, geriatric, or any
mentally retarded persons makes it a very popular
dosage form. Due to the presence of super
disintegrants, it gets dissolved quickly, resulting in
rapid absorption of drug which in turn provides
rapid onset of action.Since the absorption is taking
place directly from the mouth, so, bioavailability of
the drug increases. Drugs present in orodispersible
tablets are also not suffering from first pass
metabolism. This type of drug delivery is becoming
popular day by day due to numerous advantages.5
Advantage of ODTs
It can be easily administered to pediatric,
elderly and mentally disabled patients, accurate
dosing as compared to liquids, Dissolution and
absorption of drug is fast, offering rapid onset of
action, bioavailability of drugs is increased as some
drugs are absorbed from mouth, pharynx and
esophagus through saliva, advantageous over liquid
medication in terms of administration as well as
transportation, cost effective, high drug loading is
possible, have acceptable taste and pleasant mouth
feeling, no residue in the mouth after oral
administration, free of risk of suffocation due to
physical obstruction when swallowed, thus offering
improved safety, avoid first pass metabolism.3
Disadvantages of Fast Dissolving Tablets
Hygroscopic in nature, low amount of drug
can be incorporated in each dose, some time it
possesses mouth feeling, highly fragile sometimes,
ODT requires special packaging for properly
stabilization & safety of stable product, eating and
drinking may become restricted.6
Need to Formulate ODTs
The need for non ‐ invasive drug delivery
systems continues due to patient’s poor acceptance
and compliance with existing delivery regimes,
limited market size for drug companies and drug
uses coupled with high cost of disease
management. ODT is one such dosage form which
is useful for Geriatric patients mainly suffering
from conditions like hand tremors and dysphagia.7
Challenges in Formulating ODTs
Mechanical strength and disintegration time
ODTs are formulated to obtain disintegration
time usually less than a minute. While doing so,
maintaining a good mechanical strength is a prime
challenge. Many ODTs are fragile and there are
many chances that such fragile tablet will break
during packing, transport or handling by the
patients.8
Taste masking

Many drugs are bitter in taste. A tablet of
bitter drug dissolving/ disintegration in mouth will
seriously affect patient compliance and acceptance
for the dosage form. So effective taste masking of
the bitter drugs must be done so that the taste of the
drug is not felt in the oral cavity.4
Mouth feel
ODTs should not disintegrate into larger
particles in the oral cavity. The particles generated
after disintegration of the ODTs should be as small
as possible. ODTs should leave minimal or no
residue in mouth after oral administration.
Moreover addition of flavours and cooling agents
like menthol improve the mouth feel.9
Sensitivity to environmental conditions
ODTs generally should exhibit low sensitivity
to environment conditions such as humidity and
temperature as most of the materials used in ODTs
are meant to dissolve in minimum quantity of
water.6
Cost
The technology used for ODTs should be
acceptable in terms of cost of the final product. 10
Evaluation of ODTs
Tablet thickness
Tablet thickness is an important characteristic
in reproducing appearance and also in counting by
using filling equipment.Some filling equipment
utilizes the uniform thickness of the tablets as a
counting mechanism. Thickness was recorded using
vernier caliper.11
Weight variation
A number of 20 tablets were selected
randomly from the lot and weighed individually to
check for weight variation.1
Friability
Friability Attempts for decreasing the
disintegration time increase the friability of ODTs
than the conventional tablets. Dosage forms like
Zydis are very fragile. Friability is a measure of
mechanical strength of the tablet. If a tablet has
more friability it may not remain intact during
packaging,transport or handling. Roche friabilator
is used to determine the friability by following
procedure. Pre weighed tablets are placed in the
friabilator. Friabilator consist of a plastic chamber
that revolves at 25 rpm, dropping those tablets at a
distance of 6 inches with each revolution. The
tablets are rotated in the friabilator for at least 4
minutes.4 At the end of test tablets are dusted and
reweighed; the loss in the weight of tablet is the
measure of friability and is expressed in percentage
as:

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Bali Medical Journal (Bali Med J) 2015, Volume 4, Number 1: 17-20
P-ISSN.2089-1180, E-ISSN.2302-2914

% Friability = 1 ‐ (loss in weight / Initial weight) x
100
Hardness (crushing strength)
Tablet hardness is measured with hardness
testers like Monsanto. A tablet is placed in the
hardness tester and load required to crush the tablet
is measured. The hardness of ODTs is generally
kept lower than conventional tablets as increased
hardness delays the disintegration of the tablet. The
force is measured in kg and the hardness of about
3-5 kg/cm2 is considered to be satisfactory for
uncoated tablets4.
Water absorption ratio
A small piece of tissue paper folded twice is
placed in a small petridish containing 6 ml of water.
Put a tablet on the paper and the time required for
complete wetting is measured. The wetted tablet is
then reweighed. Water absorption ratio, R is
determined by using following formula:
R= 100 x Wa-Wb / Wb
Where, Wb is the weight of tablet before water
absorption and Wa is the weight of tablet after
water absorption.
Uniformity of dispersion
Keep the Two tablets in 100ml water and stir
gently for 2 minutes. The dispersion is passed
through 22 meshes. The tablets will consider
passing the test if no residue remained on the
screen.8

and 2 cm diameter and mesh size of #10 is placed
above a beaker containing 900 ml of simulated
saliva. The basket is so positioned in the liquid that
it contains only 6 ml of the liquid. The assembly is
supported with a heater to maintain temperature at
37°C and a magnetic stirrer. DT is noted at 25 rpm.
One of the simplest methods is to take 6ml of
simulated saliva in a measuring cylinder and place
the tablet in it. The liquid is neither shaken nor
stirred and DT is noted.8
In vivo disintegration time
In vivo disintegration time is determined using
a panel of healthy human volunteers.The DT noted
by the volunteers by placing the tablet in mouth.12
Taste/ Mouth sensation
Mouth-feel is critical, and patients should
receive a product that feels pleasant. One tablet
from each batch is tested for the sensation by
placing the tablet on the tongue. The healthy human
volunteers are used for evaluation of mouth feel.
Taste evaluation is done by a panel of 5 members
using time intensity method. Sample equivalent to
40 mg i.e. dose of drug is put in mouth for 10
seconds and record taste instantly and then after 10
seconds, 1, 2, 4 and 6 minutes. Volunteer’s opinion
for the taste is rated by giving different score values
i.e. 0 = good, 1 = tasteless, 2 = slightly bitter,3 =
bitter, 4 = awful.13

Wetting time
Five circular tissue papers of 10 cm diameter
are placed in a petridish with a 10 cm diameter. Ten
millimeters of water containing Eosin, a watersoluble dye, is added to petridish. A tablet is
carefully placed on the surface of the tissue paper.
The time required for water to reach upper surface
of the tablet is noted as a wetting time.1

Dissolution test
The dissolution method for oral disintegrating
tablets is the same as that of conventional tablets.
USP 2 paddle apparatus is most suitable and
common choice for dissolution test of oral
disintegrating tablets, where the paddle speed is 50
rpm is used. The USP 1 (basket) apparatus may
have certain application for such tablets but is used
less frequently due to specific physical properties of
tablets.

Disintegration time
According to the European pharmacopoeia the
fast disintegrating or ODTs should disintegrate
within 3 minutes without leaving any residue on the
screen. However it is difficult to assess the
disintegration rate even in small amounts of water.
Further the conventional test employs a volume of
900 ml of distilled water compared to the volume of
saliva in humans, which is limited to a few ml.
Thus the disintegration rate obtained from
conventional test does not appear to reflect the
actual disintegration rate in human mouth. To
overcome these problems, several new methods
have been proposed.9 One of these methods uses a
Charge Couple Device (CCD) camera or texture
analyzer to evaluate the disintegration time of
tablets. In another method, a modified DT
apparatus is used. Here a wire basket of 3cm height

Future Prospects
These dosage forms may be suitable for the
oral delivery of drugs such as protein and peptidebased therapeutics that has limited bioavailability
when administered by conventional tablets. These
products usually degrade rapidly in the stomach.
Should next generation drugs are predominantly
protein or peptide based, tablets may no longer be
the dominant format for dosing such moieties.
Injections generally are not favored for use by
patients unless facilitated by sophisticated autoinjectors13. Inhalation is one good alternative
system to deliver these drugs, but the increased
research into biopharmaceuticals so far has
generated predominantly chemical entities with low
molecular weights.
The developments of enhanced oral protein
delivery technology by ODTs which may release

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Bali Medical Journal (Bali Med J) 2015, Volume 4, Number 1: 17-20
P-ISSN.2089-1180, E-ISSN.2302-2914

these drugs in the oral cavity are very promising for
the delivery of high molecular weight protein and
peptide.14
CONCLUSION
Orodispersible
tablets
have
potential
advantages over conventional solid dosage form.
This drug delivery is one of the great inventions of
all the novel drug-delivery systems. They have
better patient acceptance and compliance and may
offer improved biopharmaceutical properties,
improved efficacy, rapid onset of action and better
safety compared with conventional oral dosage
forms. Prescription ODT products initially were
developed to overcome the difficulty in swallowing
conventional tablets among pediatric, geriatric, and
psychiatric patients with dysphagia. Today, ODTs
are more widely available as OTC products for the
treatment of allergies, cold, and flu symptoms. The
target population has expanded to those who want
convenient dosing anywhere, anytime, without
water.The potential for such dosage forms is
promising because of the availability of new
technologies combined with strong market
acceptance and patient demand. By paying close
attention
to
advances
in
technologies,
pharmaceutical companies can take advantage of
ODTs for product line extensions or for first to
market products. With continued development of
new pharmaceutical excipients, one can expect the
emergence of more novel technologies for ODTs in
the days to come.
Conflicts of interests: Nil
REFERENCES
1. Patel Poojan, Tanwar YS, Jaimin Modi, Amit
Patel.Journal of pharmaceutical science and
bioscientific research: 2013; 2271-3681
2. Tanmoy ghosh, Amitava ghosh and Devi
prasada. Review on new generation
orodispersible tablets and its future prospective:
2011: 3, Issue 1.
3. Panchal Dhavalkumar M, Tiwari Ajaykumar,
Srivastava Priyam. A review on orodispersible
tablets – A novel formulation for oral drug
delivery system and its future prospective: indo
american journal of pharmaceutical research
2013.

4. Yourong Fu, Shicheng Yang, Seong Hoon
Jeong, Susumu Kimura,&Kinam park. Orally
fast disintegrating tablets:developments,
technologies,Taste-Masking and Clinical
Studies Critical Reviews in Therapeutic Drug
Carrier Systems, 2004:21(6):433–475
5. Tarique Khan, Sayyed Nazim,Siraj Shaikh,
Afsar Shaikh,Ashish Khairnar, Aejaz Ahmed.
An approach for rapid disintegrating tablet: a
review: 2011;3(3): 170 – 183
6. Debjit Bhowmik, Chiranjib.B, Krishnakanth,
Pankaj, R.Margret Chandira. Fast Dissolving
Tablet: An Overview.Journal of Chemical and
Pharmaceutical Research, 2009, 1(1): 163-177.
7. Pooja Arora, Vandana Arora Sethi.
orodispersible tablets: A comprehensive review:
IJRDPL.2013; 2(2): 270-284
8. Amit Kumar Nayak,Kaushik Manna. Current
developments in orally disintegrating tablet
technology; Pharm Educ Res . 2011; 2(1): 2134.
9. Velmurugan S, Sundar Vinushitha. Oral
Disintegrating Tablets: An Overview;
International Journal of Chemical and
Pharmaceutical Sciences 2010, Dec., Vol.1 (2);
1-12.
10. Saikh Mahammed Athar Alli. Orally
disintegrating drug delivery systems: A
technical note on technologies and issues; ISSN
2249 – 1112
11. Jaysukh J Hirani, Dhaval A Rathod, Kantilal R
Vadalia. Orally Disintegrating Tablets: A
Review.Tropical Journal of Pharmaceutical
Research, April 2009; 8 (2): 161-172
12. Deshpande K.B. Orodispersible tablets: An
overview of formulation and technology vol 2/
issue1/jan-mar 2011
13. Malay Kumar B Chotaliya, Sumit
Chakraborty.Overview Of Oral Dispersible
Tablets. International Journal of PharmTech
Research. 2012; 4(4):1712-1720.
14. Sunil K Jain, Aditya Nath Pandey, Akhlesh K.
Jain. A review on mouth dissolving tablets
prepared by solid dispersion technique
pharmagene; 2013;Vol:1 ,Issue:2 .

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