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Abstract:
Oral route is the most preferred route for administration of various drugs because it is regarded as safest, most
convenient and economical route. Recently researcher developed the mouth dissolving tablets with improved patient
compliance and convenience. Upon introduction into the mouth, these tablets dissolve or disintegrate in the mouth
in the absence of additional water for easy administration of active pharmaceutical ingredients. Mouth dissolving
tablets overcome the disadvantages of conventional dosage form especially dysphagia (difficulty in swallowing) in
paediatric and geriatric patients. Mouth dissolving tablets can be formulated by using various technologies like
lyophilization, direct compression, spray drying, molding, nanotization, mass extrusion, sublimation, cotton candy
and phase transition technology along with various patented technologies like zydis,lyoc, flashtab, frosta,
nanocrystal technology, wowtab, durasolv, orasolv advatab and flashdose technology. This review briefly describes
about the various technologies which are used for the formulation of mouth dissolving tablets along with advantages
and limitations of the technology.
Keywords: Mouth dissolving tablets, Patented Technologies, Bioavailability
Corresponding author:
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Dr. R. Santosh Kumar,
GITAM Institute of Pharmacy,
GITAM University,
Rushikonda,
Visakhapatnam-45,
A.P, India.
email:drsantoshrada@gmail.com.
Please cite this article in press as R. Santosh Kumar and Sahithi Mudili., A Review on Technologies Employed In
Formulation of Mouth Dissolving Tablets, Indo Am. J. P. Sci, 2018; 05(02).
finally shows improved bioavailability of the drug. .the formulation which contains maltodextrins as a
Tablets prepared by lyophilization technique shows matrix forming agent was found to effect the integrity
rapid disintegration within 5 seconds due to quick and strength of the tablets, disintegration time and
penetration of saliva into pores when placed on the pore size. Formulation containing showed the
tongue. Figure -1 explains how lyophilization takes stronger tablets. Xanthan gum and
place by using triple point diagram in which water is hydroxyethylecellulose also showed effect on the
removed from the product after it is frozen and strength and disintegration time of the tablet. The
placed under vacuum, allowing ice to change directly formulation which containing hydroxyethylecellulose
from solid to vapor without passing through liquid as a binder showed less disintegration time compared
phase. to xanthan gum.
granules to vacuum and resultant porous granules Taste masking of the drug can be achieved by
were subjected to tableting. The tablets prepared by using spray drying technology.
using this technique showed improved dissolution It is highly economical process.
profile compared to marketed formulation.
Limitations:
The drugs which are sensitive to high
temperature cannot be formulated by using
spray drying technology.
Advantages:
Tablets prepared by this method shows the
fastest disintegration time i.e within 20
seconds
Tablets prepared by this method shows the
porous nature which helps in the fast
disintegration and increased bioavailability of Fig. 5: Mass Extrusion Technique
the drug.
Advantages:
It is simplest and most cost effective tablet
manufacturing technology.
Direct compression technique is most suitable
for the moisture and heat sensitive drugs.
Limitations:
Segregation of API and excipients takes place
because of difference in density.
Low dilution potential which means directly
compressible materials can accommodate only
30-40 % of the poorly compressible active
ingredients Fig. 7: Cotton Candy Technique
8. Compaction:
a) Melt granulation:
In this method mouth dissolving tablets are
prepared by incorporating the drug into the
hydrophilic waxy binder like PEG-6-Stearate.
Hydrophilic waxy binder helps as binding and
disintegrating agent. The tablets prepared by
this method rapidly dissolve in the mouth
without leaving any residue.
Drug example:
Carbamazepine orally disintegrating tablets
have been developed by Perisuuti et al[11] by
Fig. 6: Direct Compression Technique melt granulation technique. In this technique
7. Cotton Candy Process [10]: carbamezepine granules were developed by
Cotton candy process involves the formation of using PEG 4000 as melting binder and lactose
matrix of polysaccharides by simultaneous action of monohydrate as hydrophilic filler and
flash melting and spinning. This candy floss matrix is crosspovidone as disintegrating agent.
then milled and blended with active ingredients and Carbamazepine granules which are prepared
excipients after recrystallization and subsequently by using this technique showed enhanced in
compressed to mouth dissolving tablets. It can vitro drug dissolution rate.
accommodate high doses of drug and offers improved
mechanical strength.figure-7 describes about the b) Phase transition process:
cotton candy process. In this method two types of sugar alcohols are
used in which one is having the high melting
Advantages: point and other one is having the low melting
We can accommodate large doses of drugs by point. The compressed powder going to heat in
using this technique. between these melting points and leads to
increased tablet hardness due to increase of
Advantages:
Mouth dissolving tablets which are produced
by zydis technology shows quick dissolution.
Tablets prepared by this technology acts as a
self-preserving agents because freeze drying
and shows the increased bioavailability of the
drug.
Limitations:
It is very expensive process
Tablets prepared by this technology show the
poor stability at higher temperature and
humidity.
Fig.8: Phase Transition Process
drug. The process of making microspheres has Small doses of the drug can also be formulated
been patented by Fuisz, and is known as into mouth dissolving tablets by using this
ceform and serves as an alternative method of technology.
taste masking. Ceform technology involves
preparation of microspheres of the active drug. 11. Quick-Dis Technology (Lavipharm)[22]
Drug material alone or in combination with Quick-Dis Technology is invented by
other pharmaceutical substances, and Lavipharm laboratories. By using quick-dis
excipients is placed into a rapidly spinning technology can manufacture thin, flexible and
machine. The centrifugal force comes into quick dissolving film. Mouth dissolving film
action, which throws the dry drug blend at when placed on the tongue dissolves rapidly
high speed through small heated openings. on the tongue and helps in the local and
Due to the heat provided by carefully systemic absorption of the drug. Mouth
controlled temperature, drug blend liquefies to dissolving films which are prepared by using
form a sphere, without affecting the drug quick-dis technology shows the quick
stability. The formed microspheres are disintegration time ranges from 5 to 10
compressed into tablet. seconds.
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