Mouth Dissolving Tablets: An Insight into Challenges and Future Prospects of Technologies in Pharmaceutical Industries

Abstract

Despite advancements in science and technology and newer innovations in drug delivery, the oral route is still the most popular route for administering the drugs. The tremendous measures are adopted to make it as cost-effective, non-invasive, and self-administrative process for improving patient compliance. It has found acceptance from people of all ages, especially children and old age, as there is difficulty in swallowing the tablet. The longing efforts have made to improve the flavor and taste of orally managed tablets that prompted the advancement of numerous medicines with improved acceptance and palatability. Mouth dissolving tablets (MDTs) have become progressively prominent in recent decades, and this field has turned into a quickly developing territory in the pharmaceutical industries. One of the promising characteristics of MDTs is the quick disintegration in the mouth when mixed with saliva and provides a pleasant and sweet taste for disagreeable medicines. This article surveys the past utilizations and newer techniques adopted by descriptors for taste concealing. It projects the most recent improvements and strategies taken for diminishing the sharpness for oral pharmaceuticals. It further highlights the problems faced by paediatrics and geriatrics patients in the swallowing of tablets and also adopted for the disintegration of the tablet in the mouth to enhance patient compliance and acceptability through ease of administration at an affordable cost. The incorporation of superdisintegrants employed for the development of the MDTs and other formulation aspects promotes the use of MDTs in pharmaceutical industries from a research point of view.

Full text

Research J. Pharm. and Tech. 15(11): November 2022
5068
ISSN 0974-3618 (Print) www.rjptonline.org
0974-360X (Online)
RESEARCH ARTICLE
Mouth Dissolving Tablets: An Insight into Challenges and Future Prospects
of Technologies in Pharmaceutical Industries
Jitendra Gupta
Institute of Pharmaceutical Research, GLA University, Chaumuha, Mathura-281406, Uttar Pradesh, India.
*Corresponding Author E-mail: smartjitu79@gmail.com, jitendra.gupta@gla.ac.in
ABSTRACT:
Despite advancements in science and technology and newer innovations in drug delivery, the oral route is still
the most popular route for administering the drugs. The tremendous measures are adopted to make it as cost-
effective, non-invasive, and self-administrative process for improving patient compliance. It has found
acceptance from people of all ages, especially children and old age, as there is difficulty in swallowing the tablet.
The longing efforts have made to improve the flavor and taste of orally managed tablets that prompted the
advancement of numerous medicines with improved acceptance and palatability. Mouth dissolving tablets
(MDTs) have become progressively prominent in recent decades, and this field has turned into a quickly
developing territory in the pharmaceutical industries. One of the promising characteristics of MDTs is the quick
disintegration in the mouth when mixed with saliva and provides a pleasant and sweet taste for disagreeable
medicines. This article surveys the past utilizations and newer techniques adopted by descriptors for taste
concealing. It projects the most recent improvements and strategies taken for diminishing the sharpness for oral
pharmaceuticals. It further highlights the problems faced by paediatrics and geriatrics patients in the swallowing
of tablets and also adopted for the disintegration of the tablet in the mouth to enhance patient compliance and
acceptability through ease of administration at an affordable cost. The incorporation of superdisintegrants
employed for the development of the MDTs and other formulation aspects promotes the use of MDTs in
pharmaceutical industries from a research point of view.
KEYWORDS: Geriatrics, Mouth Dissolving Tablet (MDT), Paediatrics, Patient Compliance,
Superdisintegrants, Taste Concealing.
INTRODUCTION:
The Mouth dissolving tablets are innovative smart drug
delivery systems that dissolve, disperse, and disintegrate
in the buccal mucosa. It is a highly acceptable and
potential candidate for drug delivery for geriatric,
paediatric, and critically ill patients facing difficulty in
swallowing ordinary tablets, thus promotes better patient
compliance. The orodispersible tablets are suitable for
drug candidates showing high first-pass metabolism to
provide a rapid onset of action. The active ingredient
disperses in the presence of saliva after swelling of
Mouth dissolving tablets (MDTs) and gets absorbed in
the systemic circulation1.
Received on 12.08.2021 Modified on 18.10.2021
Accepted on 30.12.2021 © RJPT All right reserved
Research J. Pharm. and Tech 2022; 15(11):5068-5077.
DOI: 10.52711/0974-360X.2022.00852
For overcoming these primary threads, scientists and
analysts have built newer creative medication for
patients that are popularly known as orodispersible
tablets or (MDTs). These are altogether newer
medications that found its acceptance in the patient's
household due to the benefits of disintegrations in the
mouth and dissolving in saliva without the use of water.
The advantages of using the MDTs have provided better
patient acceptability. As indicated by the European
Pharmacopoeia, MDTs disintegrates within 30s or less
in the presence of saliva. These strategies frequently
utilized to make successful MDTs candidates for
bedridden, old, child, and patients who have difficulty
swallowing of tablets. The advancement of MDT helps
in the improvement of patient behavior through speedy
recovery, enhanced bioavailability, and spacious
steadiness, thus making MDTs popular candidate for
providing promising results of pharmaceutical
importance2-5.

Research J. Pharm. and Tech. 15(11): November 2022
5069
MDTs marketed as orodispersible tablets, fast-
dissolving tablets, and fast-disintegrating tablets.
Nevertheless, most of the characteristics of MDTs are
beneficial and highly acceptable by severely ill patients.
According to United State Food and Drug
Administration (USFDA), the orodispersible tablets
characterized as a strong measurement structure
containing restorative substances or dynamic fixings
which deteriorates quickly inside mouth within a couple
of moments when placed on the tongue6,7.
Ideal Properties of MDTs
MDTs should8-11.
• Quickly disintegrates within a fraction of seconds in
mouth.
• Ease of self-administration.
• Do not require water for swallowing tablets.
• Better patient compliance and acceptability.
• Pleasant mouth feels.
• Harder and less fragile.
• Ease of fabrication with minimum cost and efforts.
• Versatile and simple to transport.
• Compatible with moisture, temperature, and pH.
• Ease of availability enhancing stocking of tablets in
the large amount.
Rationale of MDTs:
• Simplicity in administration for those individuals
who can't ingest the conventional tablets like the
paediatrics, geriatrics and psychiatric patients,
depressive patients, heart patients and patients confined
to bed12,13.
• The quicker effect of medication by ingestion of the
pre-gastric region, such as mouth area, pharynx, and
esophagus, provides fast onset of action13,14.
• Devoid of usage with water while using MDTs15.
• Disintegration and dissolution at a faster rate,
promote better patient compliance.
• Accurate dosing when contrasted with fluids16.
• The risk of asphyxiation during oral medication is far
away, improving the patient's wellness.
• The advantageous technique for traveling, poor and
occupied, is individuals, where drinking water facilities
are not available.
• It also masked the disagreeable, bitter, and nauseous
effect of medicines by imparting sweeteners, flavors,
and sugars to enhance palatability and acceptability for
paediatric patients.
• Ease of self-dosing for isolated patients17,18.
Challenges to Develop MDTs5,6,8
• Effectively taste concealing of nauseous and bitter
drugs.
• Formulate with insignificant exertion.
• No undesirable side effects.
• Provide acceptable compact structure and moisture
shield.
• Avoid an increase in tablet size.
• Sensitivity to biological condition.
Salient Features of MDTs9,10
• Do not require water to ingest tablets, which is a
significantly favorable element for persons who are on
road trips and forget to carry drinking water.
• Elicit the quick onset of action due to the rapid
penetration of saliva.
• Excellent oral acceptability of MDTs is important for
ingesting an unpleasant pill, particularly in geriatric
patients.
• The convenience of association and accurate dosing
when compared with liquids due to the ease of
transportation.
• Less prone to spoil and break.
Limitations for MDTs11,12
• Patients on anticholinergic prescriptions are not ideal
candidates for orodispersible tablets. Individuals like
Sjogren's who have issues in less saliva production are
poor candidates for oral delivery of MDTs.
• Difficulty to formulate a tablet of ciprofloxacin
weighing 500mg with excess friability.
Mechanisms of Superdisintegrants:
Four significant mechanisms are explained of MDTs for
disintegration in the mouth (Figure 1)11,12,19-22.
By Molecular Breaking Down Technique (Particle
Repulsive Force)
This technique developed an "un-swellable" MDTs. The
scientist Guyot-Hermann proposed the speculation of
molecule repugnance determined by the perception
stating that the non-expanding particles cause the
crumbling of tablets with the help of detestable electric
controls. This process requires water for crumbing
tablets into smaller fragments, shown in (Figure 1a).
Permeability and Capillary Behavior (Wicking)
This method stages and based on the principle of falling
apart of tablets through capillary action. The tablets
placed with a reasonable amount of fluid, cause
penetration into the drug substance, and replace the
adsorbed air present in it. Due to intermolecular
interactions, the drug substances destroyed depending on
excipient hydrophilicity and tablet conditions. This
process demands to keep the permeable structure and
low interface tension towards the watery liquid, which
separates simply by shaping a hydrophilic portion of
medicated substances in pieces, showed in (Figure 1b).

Research J. Pharm. and Tech. 15(11): November 2022
5070
Figure 1. Various mechanisms of superdisintegants of MDT
Bloating (Swelling)
Extensively used bloating causes deterioration of tablets
due to the swelling process. The breaking of tablets into
fragments depends upon the property of swelling and
porosity of coated polymer, depicted in (Figure 1c).
Structural Deformation
At the time of tablets' compaction, the undissolved
substances get distorted, and change to a particular
structure comes in contact with the water. From time to
time, starch swellability improved the granulation and
governed through the structural deformation process.
This process causes isolation of the tablet into smaller
fragments, shown in (Figure 1d).
TECHNOLOGIES EMPLOYED FOR THE
MANUFACTURING OF MDTs :
The technologies employed for the production of MDT
classified into two categories. The first is patented, and
the other non-patented technologies. Further, the
technology utilized for the creation of MDT are broadly
grouped in two classes, firstly licensed, and the second
non-licensed technologies (21,22).
(I) Non-Patented Technology
The non-patented technologies are shown in (Figure 2).
(A) Mass Extrusion
This technique utilizes an aqueous mix of solvents like
methanol and polyethylene glycol. After that, it removes
the unexpected amount by employing an extruder or a
syringe to circle that holds the chamber into
proportionate pieces by warming to form tablets23.
(B) Cotton Candy Process:
(a) Floss Processing
The string framing machine utilizes the moment's
warmth and quick stream procedures to create a
framework from the transported material. This machine
uses the arrangement of "cotton sweets," which
comprises a turning head and warming components.
During the procedure, heat initiates the barrier material's
interior stream condition that helps in producing floss
material.
(b) Floss Blend
FLASHDOSE® is a mouth dissolving drug delivery
system (MDDDS), delivered applying Shearform™
development met up with Ceform TI™ advancement to
conceal the flavor of the prescribed tablets. The cross-
section called "dental floss" contains a blend of
excipients, both its self by having medicine and is ready
for employing shear forming development. Irrespective
of various polysaccharides, polydextrose, and
polymaltose (dextrins) showed a temperature of 30-40%
less than sucrose. With this switch, artificially unreliable
drugs combined using this technique. Incredibly porous
nature of the material gives a beguiling tendency in the
mouth because of the quick crumbling of sugar with
salivation.
The dental floss mix contained eighty percent sucrose in
blend in with a dextrose/mannitol and one percent
surfactant. The surfactant provides dental floss the
crystallization booster needed. This methodology
maintains the dissipation of medicine inside the
structure, thus restricting the advancement from the
mix24.

Research J. Pharm. and Tech. 15(11): November 2022
5071
(C) Fast Dissolving Films:
Another manufacturing method of MDTs through a non-
watery arrangement that contains water-miscible film
former such as carboxymethylcellulose, hydroxypropyl
methylcellulose, hydroxyethylcellulose, hydroxypropyl
cellulose, polyvinylpyrrolidone, polyvinyl and sodium
alginate. In this process the medication and other
dissolvable flavors are covered with a structural layer,
which dissipates and forms gum adsorbate or covered
medication microparticles that incorporated into the
film25. On placing the tablet in the mouth, the film melts
or breaks up rapidly, discharging the medication in the
form of suspension26.
(D) Direct Compression:
Immediate pressure is the least bothersome and most
useful technique for producing tablets. MDT readily
developed using this methodology on account of the
openness of better ingredients, specifically sugar-based
components and other superdisintegrants.
(E) Superdisintegrants:
The pace of separating a tablet is usually affected by the
development of superdisintegrant and therefore breaking
down. Various fixings, such as water-dissolvable
ingredients are essential administrators that enhance the
disintegration process27,28.
(F) Sugar-based Ingredients:
Starch hydrolysate, mannitol, maltitol, lactitol, maltose,
fructose, sorbitol, dextrose, xylitol, and polydextrose are
sugar-based excipients used for taste concealing. These
excipients show large water dissolvability and sweet
taste, and possess a good flavor, covering properties and
provide an excellent long-lasting oral experience. The
sugar-based ingredients into two sorts subject one is the
speed of improvement, and the other is falling apart. The
Type 1 saccharides (lactose and mannitol) show low
adaptability due to increased wear and tear rate. Type 2
saccharides (maltose and maltitol) show high
vulnerability and low breaking down cost.
(G) Spray Drying
This method involved both non-hydrolyzed and
hydrolyzed gelatin as a lattice reinforcement. It also
contains sodium starch glycolate, cross carmellose (as a
superdisintegrant) mannitol as filler. The citrus
concentration and sodium bicarbonate stimulated the
disintegration and broke down of MDTs. A penetrable
powder was gained by spray-drying the above
suspension and added into drug substances. The drug
substances made through this procedure disintegrates
within 20 seconds in the presence of water.
(H) Freeze-drying/Lyophilization:
This process involved solidifying the watery substance
into ice mass, thereby showing improved disintegration
properties because of the presence of a gleaming
formless structure formed during the breaking of
medication. This method depends on the relative
insolubility of drug substances in water and fluid
solidness in suspensions. The fundamental issues related
to water-dissolvable medications are the development of
a eutectic blend due to the decreased solidification point
and the arrangement of a vitreous substantial after
solidify, which may fall during sublimation. The
expansion of mannitol or precious stone framing
materials actuates crystallinity and offers an unbending
nature of the undefined material. The benefit of utilizing
the stop drying procedure is that pharmaceutical
substances prepared in a non-raised temperature along
these lines dispensing with antagonistic agents done
efficiently. The use of hardware and costly handling
methods limits the utilization of this procedure29,30.
(I) Melt Granulation:
MDTs made using hydrophilic waxy material of PEG-6-
stearate at 91.4-98.6°F. It is not just going about as
lamina and manufactures the physical obstacle of
tablets; however, it also disintegrates tablets because it
melts in the mouth and sets apart quickly, leaving no
residue. Superpolystate is considered as a binder and
provides physical resistance for MDT and helps in
disintegration in mouth31.
(J) Molding:
There are two sorts of trim systems, for instance,
dissolvable procedure and warm methodology. The
dissolvable technique involved the wetting of powder
mixture using a water-alcohol and then smashing at low
weight in molded plates to gain wet mass (pressure
shaping). Air drying happens to bare the dissolvable.
Thus, tablets conveyed are less small than pressed
tablets and also have a porous structure that animates
breaking down. In the hot-trim methodology, a
suspension of drug, sugar, and agar (e.g., Lactose or
Mannitol) is ready. A suspension filled trouble
squeezing wells, and after the agar sets at space,
temperature to shape a jam and dried in 86°F below
vacuum. The essential issue related to the shape of
tablets is usually their mechanical quality, which got
with confining managers. A sprinkle solidifying the
fluid mix of sodium carbonate, hydrogenated cottonseed
oil, polyethylene glycol, lecithin, and the sturdy fixing
as a lactose-based pass on the tablet used to form
particles of the secured flavor of the prescription.
Differentiated as well as the quit drying technique,
tablets made by frivolity are simpler to scale for current
scale creation32.

Research J. Pharm. and Tech. 15(11): November 2022
5072
(K) Sublimation:
A closeness of an unusual porous nature in the tablet
strategy is a primary aspect of the speedy disintegrating
of MDTs. Although ordinary tablets consist of a
considerable amount of water dissolvable fixing that is
not separated easily due to low porosity. To enhance the
porosity of MDTs camphor and mannitol are added and
sublimated in a vacuum at 176°F for 30 minutes for
setting up the tablets33.
(II) Patented Technology:
The patented technologies showed in (Figure 3).
(A) Ceform Technology
This innovation includes the arrangement of dynamic
medication microspheres. The medication's components
are placed alone or blended with other pharmaceutical
substances and ingredients using a quick turning
machine. A radial power is enacted, which launches the
dry medication blend at rapid speed through warm
smaller gaps. Due to warmness, the medication blend
consolidates to frame a ball, the microspheres
subsequently shaped are packed into tablets. Since both
the medication and excipients handled at the same time,
this makes a remarkable microenvironment wherein
materials joined into the microspheres that can change
enhance solvency and security.
(B) Nanocrystal Technology:
Elan, Ruler of Prussia, licensed it. Nanocrystal
advancement includes lyophilization of colloidal
scatterings of the medicinal material and H2O-
dissolvable parts packed in annoy packets. This tactic
avoids the amassing program, for instance, granulation,
mixing, and tableting, i.e., progressively significant for
healthy and harmful medicines. Since the creation and
occurrences are irrelevant, this system is advantageous
for a constrained amount of the prescription34.
(C) Shearform Technology:
The "Floss" shear grid placed in this innovation. The
primitive material arranged with the sugar's bearer
exposed to heat treatment. In this process, sugar exposed
to diffusive power and temperature, angle, that makes
the mass temperature of sugar increase, consequently
causing an interior stream condition empowering it's
fragmentary; regional development comparative with the
mass. The streaming mass goes out through the pivoting
head, which usually tosses the floss. The string created
is shapeless. Hence, by different tactics, it is additionally
hacked and recrystallized to guarantee a consistent
stream for increased mixing. The recrystallized
framework, powerful medication, and various excipients
combined and compressed into tablets.
(D) Flash Dose Technology:
Fuisz realizes this technology. This system uses a
mixture of Shear form and Ceform headways to cover
the prescription's disagreeable flavor. This system is
dependent on sugar, called 'dental floss,' and uses a
mixture of excipients (crystalline sugars) or blends
within medicines. Meltlet Nurofen, another kind of
Ibuprofen, as a dissolving tablet processed and launched
by Biovail Corporation.
(E) Wowtab Technology:
The Yamanouchi pharmaceutical association offers
ensured development by using "Shocking" connotes
without water. The dynamic fixings may create two
halves of the excess weight of the tablet. In this
approach, saccharides with high and low permeability
used to build the granules. Due to significantly weak
strategies, the substance has large compressibility, and
along these lines shows moderate damage. The blend of
high and low permeability used to make tablets of
considerable hardness. The powerful fixings mixed with
saccharides and less flexibly were granulated with
saccharides with high malleability, and after that pressed
into a tablet35.
(F) Flashtab Technology:
This technique is the patented work of Ethypharm
France. This development includes granulation of
ingredients by damp or dry granulation process and
compressed into tablets. The disintegrants used, e.g.,
polyvinylpyrrolidone, carboxymethyl cellulose,
carboxymethylated starch, microcrystalline cellulose,
modified starch, and starch. These tablets have
acceptable physical restriction having disintegration
time, usually less than 1 min34.
(G) Durasolv Technology:
It is likewise a licensed CIMA research center
innovation that produces second era MDT. Tablets
arranged to utilize this innovation contain drugs, fillers,
glidants, and organized by ordinary gadgets. Durasolv
systems have higher mechanical quality than attributed
to the utilization of higher compaction weight. It is one
of the proper innovations for an item requiring limited
quantities of dynamic fixings36.
(H) Orasolv Technology:
CIMA Labs develop this technology by using bubbly
disintegrating compacted tablets under low stress to
convey MDT. The addition of carbon dioxide from
tablets triggers a slant of a bubble, which is a positive
organoleptic property. The commonplace centralization
of bubbly mix used is usually 20-25% of the tablet
excess weight37,38. Because the tablets set up with low
compressive quality have sensitive and delicate
character. This kind of technology was Paksolv utilized

Research J. Pharm. and Tech. 15(11): November 2022
5073
this technology one of a kind product packaging to
shield tablets coming from breakage during limit and
shipping39.
(I) Zydus Technology:
This advancement includes physical entrapment of the
medicine in a mix section made out of polymer and
saccharide. The polymers used in this technology are
efficiently hydrolyzed gelatin, hydrolyzed dextran,
dextrin, alginates, polyvinyl alcoholic beverages, acacia,
polyvinyl pyrrolidine. A framework incorporates
dissolving or dissipating fixings organized and filled in
to annoy cavities that placed in a circumstance of
liquefied nitrogen. The set dissolvable is emptied or
sublimated to outline porous wafers40-42.
The perfect drug contender for Zydus would be
misleading, unfaltering, and insoluble in water and
should have a tiny particle size (under 50 microns).
Water-dissolvable drugs can shape into eutectic mixes
and don't set correctly, so they converted to 60mg
mass43.
International and National Products of MDTs :
The various national and international products of
MDTs with drug available in the market, are shown in
(Figure 4)7,10,48,49.
Figure 2. Non-patented techniques of MDTs. Figure 3. Patented techniques of MDTs.
Figure 4. National and International products of MDTs with active pharmaceutical ingredient.

Research J. Pharm. and Tech. 15(11): November 2022
5074
Regulatory Aspects of MDTS:
FDA and ICH Guidelines:
U.S. Food and Drug Administration (USFDA) covers
three major points subjected to the guidelines of MDT.
• The in-vitro disintegration time of MDT is
approximately 30s or less.
• The weight of the tablet should not more than
500mg.
• The tablet should disintegrate within seconds after
swallowing.
• The other factors are also very crucial for MDTs.
Besides the size of the tablet and disintegration rate, the
patient acceptability and palatability for taste, texture
and mouthfeel, dosing frequency, and patient motivation
are notable45.
The ICH Guidelines for accelerated stability studies are
as follows and performed at 40±1ºC, 50±1ºC, and
37±1ºC with a relative humidity of 75±5%. After 15
days of analysis, withdraw the tablets and subjected to
various quality control parameters. The hardness,
friability, water permeation, visual inspection, average
weight, dissolution, and disintegration tests should
comply with the standard and followed the first-order
kinetics1,46,47.
PREFORMULATION STUDIES OF MDTs :
The pre-formulation study relates to the drove
pharmaceutical and analytic assessments and supporting
the undertakings to develop portions of MDTs as health
professional prescribed substance. Preformulation gives
the fundamental data that is essential to create an
appropriate status for toxicological profiles. It provides
the information with expected to show the possibility of
the drug material and gives structure work to promote
mixing with pharmaceutical excipients as an
evaluation48,49.
Angle of Repose (θ)
The fixed funnel method employed for determining the
flow behavior of sieve powder. The funnel height
adjusted so that the powder sample after passing through
the funnel forms a heap. The cone diameter is measured,
and the angle of repose was determined using the
following formula and results were interpreted on the
basis of (Table 1)46,48-50.
[θ = tan-1 (h) / (r)]
Table 1. Nature of flow behavior based on the angle of repose.
Nature of Flow
Angele of Repose (º)
Very poor
Greater than 34º
Acceptable
30º to 34º
Good
20º to 30º
Excellent
Less than 25º
Bulk Density (δb)
Determined the apparent bulk density by pouring the
powder sample in a graduated cylinder for measuring
the weight and volume of the sample. The following
formula used for calculation of bulk density46,48-50.
[δb = PM / PV] Where, PM- Mass of powder, PV-
Volume of powder.
Tapped Density (δt)
The specific amount of drug or powder blend was added
in the graduated cylinder and subjected to tapping
numerous times. The tapping continued till the powder
blend occupies constant volume. The volume occupied
by powder was examined and recorded the difference
before and after tapping, calculated it using the
following formula in (g/ml)46,48-50.
[δt = PM / TV] Where, PM- Mass of powder, PV-
Tapped volume
Percent Compressibility/ Carr's index (C.I.)
It demonstrates powder flow characteristics and
determined using the following formula and are shown
in (Table 2)46,50.
C.I. = [(δt – δb) / δt x 100]
Table 2. Relationship between flowability and percent
compressibility index
Flow ability
Percent Compressibility index
Very very poor
Less than 40
Very poor
33 to 38
Poor
23 to 35
Fair acceptable
18 to 21
Good
12 to 16
Excellent
5 to 12
Evaluation of MDTs:
Weight Variation
The twenty tablets randomly selected and weighed
separately to check the weight variations according to
the I.P. and U.S.P. acceptance criteria46,50,51.
Friability (F) Test:
Roche friabilator used to calculate the weight loss (%).
To access tablets, withstand extremes for temperature,
pressure, and storage conditions performed the tests. The
randomly selected 20 tablets from each batch and
subjected to testing at 25rpm in Roche friabilator for 4
min. It calculated using the following formula as per
U.S.P. Standards46,50,52.
{F = [(Wi-Wf)/ Wi] x 100} Where, Wi- Initial weight,
Wf- Final weight

Research J. Pharm. and Tech. 15(11): November 2022
5075
Hardness:
It used to measure tablet strength. The tablet was
pressed with the anvils of the Monsanto tablet hardness
tester to determine the force needed to break the tablets
into pieces in terms of kg/cm2 (U.S.P. Standards)46,50.
Tablet Thickness:
Randomly select the tablets from each batch and
measured their thickness by using an automated helical
micrometre46,50,53-55.
Crushing Strength:
It is a crucial parameter in the arrangement of tablets for
deterioration in the oral cavity. In this assessment, tablet
crush quality evaluated using Pfizer hardness analyzer as
per U.S.P. Standards46,50.
Mechanical Strength (T):
This test performed to determine the mechanical shocks
encountered by tablets during storage, packaging, and
transportation. The friability and crushing strength are
two essential parameters for mechanical strength
determination. The mechanical strength calculated using
the following formula (U.S.P. Standards)46,50.
[T = 2F / π d t] Where, F- Crushing load, t- Tablet
thickness, d- Tablet diameter.
Wetting Time:
The wetting time is related to the tablet's structure and
the hydrophilicity in the excipient. The tablets placed on
the surface of five wetted tissue papers present in Petri
plates containing 3ml (0.2% w/v) solution and note
down time required to develop blue color on tissue
surface as per U.S.P. standards50,56-60.
Water Absorption Ratio (R):
The small perti-plate containing 6ml water, and placed
twice folded tissue paper placed over it. The tablet
placed on wetted paper and time required for complete
wetting of the tablet was measured and calculated the
water absorption ratio using the following formula.
[R = (Wa - Wb / Wb) x 100]
Where, Wa- Tablet weight after water absorption, Wb -
Tablet weight before water absorption46,50.
Moisture Uptake:
The previously weighed tablets kept in the desiccators
have calcium chloride for 2-3 days at 37±1°C1 at
75±5% R.H. After 72hrs, tablets reweighed and
determined the moisture uptake by calculating the
increase in tablets' weight47.
In-vitro Disintegration Time:
The disintegration of tablets into smaller fragments
evaluated as per Indian Pharmacopeia. The tablets added
in each cylinder that suspended in pH 6.8, 37±2°C
temperature to note down the disintegration time50,61-65.
In-vitro Dissolution Test:
The tablet placed in phosphate buffer at pH 6.8,
37±0.5°C using U.S.P. (Paddle apparatus) type II at 50
rpm (revolution per minute). Aliquot samples of 5ml
withdrawn at specific time intervals of 2min. The
amount of drug dissolved in the medium determined
with a suitable analytical method after appropriate
dilution54,66-72.
CONCLUSION:
The shortcomings of conventional tablets, lead to
potential inclinations of MDTs for improved structures,
enhanced likeness with patients, ease of self-
administration, increased bioavailability, and rapid onset
of the action provided helping hands to pharmaceutical
industries. MDTs course of action procured using a bit
of these advanced modern techniques showing
satisfactory mechanical quality, brisk
crumbling/breaking down in the buccal cavity in the
absence of water.
MDTs promote progressive stretch that has applied in
paediatrics who have lost their teeth at a very young age
and old patients who have misplaced their teeth forever,
where swallowing is a significant challenge. MDTs
render promising approaches and tactics for enhancing
patient compliance at affordable costs through
superdisintegrants. The primary crucial measures
adopted by descriptors for the development and
screening of newer oral medication for needy patients in
a cost-effective manner provide a helpful hand to
research-oriented pharmaceutical industries for
expanding the life span of severely ill bedridden
patients.
CONFLICT OF INTEREST:
The author declared no conflict of interest.
ABBREVIATIONS:
MDT: Mouth dissolving tablets; P.E.G.: Polyethylene
glycol; B.D.: Bulk Density; T.D.: Tapped Density; CI:
Carr's index, I.P. Indian Pharmacopoeia. U.S.P
ACKNOWLEDGMENT:
Thankful to the management of G.L.A. University and
Ms. Ashima Ahuja Institute of Pharmaceutical Research,
for helping and support during the paper's writing.

Research J. Pharm. and Tech. 15(11): November 2022
5076
REFERENCES:
1. Gupta K and Singhvi I. Formulation, characterization and
optimization of mouth dissolving tablets of diacerein: β-
cyclodextrin solid dispersion. Asian Journal of Pharmaceutical
Research and Development. 2015; 3(5): 1-16.
2. Cheng R, Guo X, Burusid B. and Couch R. A review of fast
dissolving tablets. Pharmaceutical Technology. 2000; June: 52-58.
3. Bi Y, Sunada H, Yonezawa Y, Dayo K, Otsuka A. and Iida K.
Preparation and evaluation of compressed tablet rapidly
disintegrating in oral cavity. Chemical and Pharmaceutical
Bulletin. 1996; 44(11): 2121-2127.
4. Quick dissolving tablets. http:/www.biospace.com. (Accessed on
Feb 6, 2020).
5. Kuccherkar BS, Badhan AC. and Mahajan HS. Mouth dissolving
tablets: A novel drug delivery system. Pharm Times. 2003; 35: 3-
10.
6. Fu Y, Yang S, Jeong SH, Kimura S. and Park K. Orally fast
disintegrating tablets: Developments, technologies, taste-masking
and clinical studies. Critical Reviews in Therapeutic Drug Carrier
Systems. 2004; 21(6): 433-476.
7. Bandari S, Mittapalli RJ, Gannu R. and Rao YM. Orodispersible
tablets: An overview. Asian Journal of Pharmaceutics. 2008; 2(1):
1-11.
8. Indurwade NH, Rajyaguru TH. and Nakhat PD. Novel approach:
Fast dissolving tablets. Indian Drugs. 2002; 39(8): 405‐41.
9. Bradoo R, Shahani S, Poojary S, Deewan B. and Sudarshan S.
Fast Dissolving Drug Delivery Systems. JAMA India. 2011;
4(10): 27-31.
10. Masih A, Kumar A, Singh S. and Tiwari AK. Fast dissolving
tablets: A review. International Journal of Current Pharmaceutical
Research. 2017; 9(2): 8-18.
11. Gohel M, Patel M, Amin A, Agrawal R. and Dave R, Bariya N.
Formulation design and optimization of mouth dissolve tablets of
nimesulide using vacuum drying technique. AAPS PharmSci
Tech. 2004; 5(3):10-15.
12. Wilson CG, Washington N, Peach J, Murray GR. and Kennerley
J. The behavior of a fast dissolving dosage form (Expidet)
followed by γ-scintigraphy. International Journal of
Pharmaceutics. 1987; 40(1-2): 119-123.
13. Fix JA. Advances in quick-dissolving tablets technology
employing Wowtab. Paper Presented at: IIR Conference on Drug
Delivery Systems, Oct.; Washington DC, USA, 1998.
14. Virely P. and Yarwood R. Zydis - A novel, fast dissolving dosage
form. Manufacturing Chemist. 1990; 61: 36–37.
15. Reddy LH, Ghosh B. and Rajneesh. Fast dissolving drug delivery
system: A review of literature. Indian Journal of Pharmaceutical
Sciences. 2002; 64(4): 331‐336.
16. Habib W, Khankari R. and Hontz J. Fast‐dissolving drug delivery
systems. Critical Reviews in Therapeutic Drug Carrier Systems.
2002; 17(1): 61‐72.
17. Nand P, Vashist N, Anand A. and Drabu S. Mouth dissolving
tablets- A novel drug delivery system. International Journal of
Applied Biology and Pharmaceutical Technology. 2010; 1(3): 20.
18. Behnke K, Sogaard J, Martin S, Bauml J, Ravindran AV, Agren
H. and Vester-Blokland ED. Mirtazapine orally disintegrating
tablet versus sertraline: A prospective onset of action study.
Journal of Clinical Psychopharmacology. 2003; 23(4): 358-364.
19. Kumar S. and Garg SK. Fast dissolving tablets (FDTS): Current
status, new market opportunities, recent advances in
manufacturing technologies and future prospects. International
Journal of Pharmacy and Pharmaceutical Sciences. 2014; 6(7): 22-
35.
20. Shrivastava P. and Sethi V. A review article on:
Superdisintegrants. International Journal of Drug Research and
Technology. 2013; 3(4): 76-87.
21. Gauri S. and Kumar G. Fast dissolving drug delivery and its
technologies. The Pharma Innovation. 2012; 1(2): 34-39.
22. Badgujar BP. and Mundada AS. The technologies used for
developing orally disintegrating tablets: A review. Acta
Pharmaceutica. 2011; 61(2): 117–139.
23. Bhaskaran S. and Narmada GV. Rapid dissolving tablet: A novel
dosage form. Indian Pharmacist. 2002; 1(6): 9-12.
24. Saroha K, Mathur P, Verma S, Syan N. and Kumar A. Mouth
dissolving tablets: An overview on future compaction in oral
formulation technologies. Der Pharmacia Sinica. 2010; 1(1): 179-
187.
25. Bess WS, Kulkarni N, Ambike SH. and Ramsay MP. Fast
dissolving orally consumable solid film containing a taste masking
agent and pharmaceutically active agent at weight ratio of 1:3 to
3:1. US Patent 7067116, Jun 27, 2006.
26. Hughes Medical Corporation. Fast Dissolving Films.
http://www.hughes-medical.com/products/fast-dissolving-
film.htm (Accessed on March 26, 2020)
27. Bagul U, Gujar K, Patel N, Aphale S. and Dhat S. Formulation
and evaluation of sublimed fast melt tablets of levocetirizine
dihydrochloride. International Journal of Pharmaceutical Sciences.
2010; 2(2): 76-80.
28. Kalia A, Khurana S. and Bedi N. Formulation and evaluation of
mouth dissolving tablets of oxcarbazepine. International Journal
of Pharmacy and Pharmaceutical Sciences. 2009; 1(1): 12-23.
29. Rishi RK. A review on fast dissolving tablets techniques. Pharma
Review. 2004; 2: 32.
30. Kuchekar SB, Badhan CA. and Mahajan SH. Mouth dissolving
tablets: A novel drug delivery system. Pharma Times. 2003; 35: 7-
9.
31. Abdelbary G, Prinderre P, Eouani C, Joachim J, Reynier JP. and
Piccerelle P. The preparation of orally disintegrating tablets using
a hydrophilic waxy binder. International Journal of Pharmaceutics.
2004; 278(2): 423-433.
32. Siddiqui MN, Garg G. and Sharma PK. Fast dissolving tablets:
Preparation, characterization and evaluation: An overview.
International Journal of Pharmaceutical Sciences Review and
Research. 2010; 4(2): 87-96.
33. Koizumi K, Watanabe Y, Morita K, Utoguchi N. and Matsumoto
M. New method of preparing high-porosity rapidly saliva soluble
compressed tablets using mannitol with camphor: A subliming
material. International Journal of Pharmaceutics. 1997; 152(1):
127-131.
34. Kaushik D, Dureja H. and Saini TR. Orally disintegrating tablets:
An overview of meltin mouth tablet technologies and techniques.
Tablets and Capsules. 2004; 2(4): 30-36.
35. Sreenivas SA, Dandagi PM, Gadad AP, Godbloe AM, Hiremath
SP. and Mastiholimath VS. Orodispersible tablets: New-fangled
drug delivery systems-A review. Indian Journal of Pharmaceutical
Education and Research. 2005; 39(4): 177-181.
36. Kumar D, Sharma I. and Sharma V. A comprehensive review on
fast dissolving tablet technology. Journal of Applied
Pharmaceutical Science. 2011; 1(5): 50-58.
37. Wehling F. and Schuehle S. Base coated acid particles and
effervescent formulation incorporating same. US Patent 5, 503,
846; April 2, 1996.
38. Wehling F, Schuehle S. and Madamala N. Effervescent dosage
form with microparticles. US Patent 5,178,878; Jan 12, 1993.
39. Amborn J. and Tiger V. Apparatus for handling and packaging
friable tablets. US Patent 6, 311,462, 2001.
40. Seager H. Drug-delivery products and the Zydis fast-dissolving
dosage form. Journal of Pharmacy and Pharmacology. 1998;
50(4): 375-382.
41. Gregory GK. and Ho DS. Pharmaceutical dosage form packages.
US Patent 4, 305, 502; Dec 15, 1981.
42. Yarwood R, Kearnery P. and Thompson A. Process for preparing
solid pharmaceutical dosage form. US Patent 5,738,875; April 14,
1998.
43. Manivannan R. Oral disintegrating tablets: A future compaction.
Drug Invention Today. 2009; 1(1): 61-65.
44. Velmurugan S. and Vinushitha S. Oral Disintegrating tablets: An
overview. International Journal of Chemistry and Pharmaceutical
Sciences. 2010; 1(2): 1-12.

Research J. Pharm. and Tech. 15(11): November 2022
5077
45. Patel ZK, Patel RR, Patel KR. and Patel MR. A review:
Formulation of fast dissolving tablet. PharmaTutor. 2014; 2(3):
30-46.
46. Nagar P, Singh K, Chauhan I, Verma M, Yasir M, Khan A, et al.
Orally disintegrating tablets: Formulation, preparation techniques
and evaluation. Journal of Applied Pharmaceutical Science. 2011;
1(04): 35-45.
47. Comoglu T. and Dilek-Ozyilmaz E. Orally disintegrating tablets
and orally disintegrating mini tablets-novel dosage forms for
pediatric use. Pharmaceutical Development and Technology.
2019; 24(7): 902–914.
48. Rasheed HS, Arief M, Gajavalli SR, Vani PS, Rao KS, Kumar
SLVVSNKS, et al. A Comparison of different superdisintegrants
in designing of fast dissolving tablets of salbutamol sulphate.
Research Journal of Pharmaceutical, Biological and Chemical
Sciences. 2011; 2(2): 155-163.
49. Ratnaparkhi MP, Mohanta GP. and Upadhyay L. Review on: Fast
dissolving tablet. Journal of Pharmacy Research. 2009; 2(1): 5-12.
50. Savale SK. Pharmaceutical solid dosage forms: in process quality
control tests. Asian Journal of Phytomedicine and Clinical
Research. 2018; 6(1): 44-54.
51. Patil BS, Kulkarni U, Bhavik P, Soodam SR. and Korwar PG.
Formulation and evaluation of mouth dissolving tablets of
nimesulide by new coprocessed technique. Research Journal of
Pharmaceutical, Biological and Chemical Sciences. 2010; 1(4):
587-92.
52. Singh SK, Mishra DN, Jassal R. and Soni P. Fast disintegrating
combination tablets of omeprazole and domperidone. Asian
Journal of Pharmaceutical and Clinical Research. 2009; 2(3): 1-9.
53. Prajapati BG. and Patel SN. Formulation, evaluation and
optimization of orally disintegrating tablet of cinnarizine. e-
Journal of Science & Technology. 2010; 5(5): 9-21.
54. Kuchekar BS, Mahajan S. and Bandhan AC. Mouth dissolve
tablets of sumatriptan. Indian drugs. 2004; 41(10): 592-98.
55. Lalla JK. and Mamania HM. Fast dissolving rofecoxib tablets.
Indian Journal of Pharmaceutical Sciences. 2004; 59(4): 23-26.
56. Mohanachandran PS, Krishnamohan PR, Saju F, Bini KB, Babu
B. and Shalina KK. Formulation and evaluation of mouth
dispersible tablets of amlodipine besylate. International Journal of
Applied Pharmaceutics. 2010; 2(3): 1-6.
57. Bhagat BV, Hapse SA, Jadhav AP, Gawand RB. Mouth
dissolving tablet: A formulation approach. Research Journal of
Pharmacy and Technology. 2017; 10(1): 355-361. Doi.
10.5958/0974-360X.2017.00072.5
58. Bhagwat A, Kakade SM, Naval CV, Tilker M, Walture RM,
SAdichwal SA, et al. Formulation and evaluation of mouth
dissolving tablets of domperidone. Research Journal of Pharmacy
and Technology. 2010: 3(3): 821-824.
59. Sravanthi N, Alekhya I and Reddy V. Formulation and evaluation
of mouth dissolving tablets of clozapine by direct compression
method. Research Journal of Pharmacy and Technology. 2017;
10(8): 2543-2550.
60. Nandare DS, Mandlik SK, Khiste SK and Mohite YD.
Formulation and optimization of mouth dissolving tablets of
olanzapine by using 32 factorial design. Research Journal of
Pharmacy and Technology. 2011; 4(8): 1265-1268.
61. Ahad HA, Kumar CS, Reddy KK, Kumar A, Sekhar C, Sushma
K, Sairam T. and Sivaji S. A novel technique in formulation and
evaluation of mouth dissolving nimesulide tablets. Journal of
Advanced Pharmaceutical Research. 2010; 1(2): 101-107.
62. Dholakiya RB, Akbari BV, Shiyani BG, Patel GF, Ramani GK
and Vekariya NR. The effect of various superdisintegrating agents
on mouth dissolving tablet of ranitidine HCl. Research Journal of
Pharmacy and Technology. 2010; 3(1): 175-178.
63. Bhanja S, Deepthi KL, Sudhakar M and Panigrahi BB. Design,
optimisation and in-vitro evaluation of mouth dissolving tablets of
venlafaxine hydrochloride. Research Journal of Pharmacy and
Technology. 2014; 7(5): 502-512.
64. Venkatalakshmi R, Sasikala C and Silambarasan SP. Formulation
and evaluation of loperamide hydrochloride mouth dissolving
tablet by using super disintegrants. Research Journal of Pharmacy
and Technology. 2010; 3(2): 530-534.
65. Venkatalakshmi R, Ho NJ, Sheshala R and Chinnappan S.
Formulation and characterization of mouth dissolving tablets of
dexamethasone using synthetic superdisintegrants. Research
Journal of Pharmacy and Technology. 2018; 11(4): 1429-1435.)
66. Degwy MAAEAAE, Tayel S, Nabarawi MAE. and Rehem RTAE.
The effect of using two NSAIDs with different solubility on freeze
drying technology. Current Trends in Biotechnology and
Pharmacy. 2013; 7(4): 890-903.
67. Sreeja V, Prajapati J, Thakkar V, Gandhi T. and Darji VK. Effect
of excipients on disintegration, viability and activity of fast
disintegrating tablets containing probiotic and starter cultures.
Current Trends in Biotechnology and Pharmacy. 2016; 10(2):
108-117.
68. Balusu H. and Veerareddy PR. Formulation and evaluation of fast
disintegrating zolmitriptan sublingual tablets. Current Trends in
Biotechnology and Pharmacy. 2012; 6(1): 84-98.
69. Gupta J, Mohan G, Prabakaran L and Gupta R. Effects of
formulation and process variables on aceclofenac loaded ethyl
cellulose microspheres. International Journal of Drug
Development & Research. 2013; 6(1): 293-302.
70. Akhter MH, Gupta J, Faisal MS and Mohiuddin M. A
Comprehensive review on buccal drug delivery systems.
International Journal of Pharmaceutical Research and
Development. 2012; 3(11): 59-77.
71. Swamivelmanickam M, Venkatesan P and Sangeetha G.
Preparation and evaluation of mouth dissolving tablets of
loratadine by direct compression method. Research Journal of
Pharmacy and Technology. 2020; 13(6): 2629-2633.
72. Deshmukh KR, Pandey A, Pandey A, Patel V, Verma S,
Dewangan P, et al. Deshmukh G. Design and development of
loratadine containing mouth dissolving tablets. Research Journal
of Pharmacy and Technology. 2011; 4(11): 1676-1681.