Fast Dissolving Tablets (FDTs) or “mouth dissolving
tablets” (MDTs) which disintegrates or dissolves
rapidly without water within few seconds in the
4. According to European pharmacopoeia, these MDTs
should dissolve/disintegrate in less than three minutes.
US FDA defined ODTs as “A solid dosage form
containing medicinal substances or active ingredients
which disintegrates rapidly within a few seconds when
placed up on tongue”
5. Mouth dissolving tablets are also called as
Orodispersible tablets (ODTs),
Fast disintegrating tablets,
Orally disintegrating tablets,
Quick disintegrating tablets,
Fast dissolving tablets,
Rapid dissolving tablets,
Quick melt tablets &
Rapid melt tablets.
It offer all advantages of solid dosage forms
and liquid dosage forms along with special
It provide good stability, accurate dosing, easy
manufacturing, small packaging size & easy to
No need of water to swallow the dosage form.
Easy to administer for paediatric, geriatric &
More rapid drug absorption from the pregastric area which may produce Quick onset of
7. Pre-gastric absorption of drug avoids hepatic
metabolism, which reduces the dose and
increase the bioavailability.
The risk of chocking or suffocation during oral
Good mouth feel property of MDDDS helps to
change the basic view of medication as "bitter
Patient’s compliance for disabled bedridden
patients and for travelling and busy people, who
do not have ready access to water.
8. Requirements of ODTs
An ideal FDT should
I. Dissolve / disintegrate in the mouth in matter
of seconds without water.
II. Have sufficient mechanical strength and good
III. Not affected by drug properties.
IV. Effective taste masking technologies should be
adopted for bitter taste drugs.
V. Leave minimal or no residue in mouth after
VI. Exhibit low sensitivity to environment
condition such as humidity and temperature.
9. Formulation Methodologies
Freeze drying or lyophilization
Cotton candy process
Three-dimensional Printing (3DP)
Phase transition process
11. 1. Freeze drying or lyophilization
This process includes the removal of solvent from a
frozen suspension or solution of drug with
Freeze-drying of drug along with additives imparts
glossy amorphous structure resulting in highly
porous and lightweight product.
MDTs formed by lyophilization have
low mechanical strength,
poor stability at higher temperature, and
12. 2. Molding
Molded tablets are prepared by using water-soluble
The powder blend is
Molded into tablets under pressure lower than that
used in conventional tablet compression.
Solvent is then removed by air-drying.
Molded tablets are very less compact than
13. 3. Cotton candy process
This process involves formation of matrix of
polysaccharides or saccharides by simultaneous
action of flash melting and spinning.
Formed matrix is partially re-crystallized to have
improved flow properties and compressibility.
This candy floss matrix is then milled.
Blended with active ingredients and excipients and
subsequently compressed to FDTs.
14. 4. Spray drying
In this method hydrolyzed and nonhydrolyzed
gelatin were used as supporting matrix.
Mannitol as bulking agent
Sodium starch glycolate or crosscarmellose sodium
Acidic substances (citric acid) or alkali substance
disintegration and dissolution.
15. This technology produces highly porous and fine
powders as processing solvent is evaporated during
Disintegration time < 20 sec
16. 5. Mass extrusion
Involves softening the active blend using the
solvent mixture of water-soluble polyethylene
glycol and methanol.
Subsequent expulsion of softened mass through the
extruder or syringe.
To get a cylinder of the product into even
segments using heated blade to form tablets.
17. 6. Nanonization
Nanomelt technology involves reduction in the
particle size of drug by proprietary wet-milling
Nanocrystals of the drug are stabilized against
agglomeration by surface adsorption on selected
stabilizers, which are then incorporated into MDTs.
For poor water soluble drugs.
nanoparticles . .. leads to increased absorption and
Reduction in dose.
18. 7. Three-dimensional Printing (3DP)
It is a rapid prototyping (RP) technology.
Prototyping involves constructing specific layers
that uses powder processing and liquid binding
Loose powders in it was fabricated using 3DP
Based on computer-aided design models
TAG tablets seemed due to the rapid water
penetration into the tablet resulting from the large
19. 8. Compaction
a) Melt granulation
Powders are efficiently agglomerated by a melt able
Advantages:- No water or organic solvents is
For this, purpose high shear mixers are utilized.
Product temperature is raised above the melting
point of binder by a heating jacket or by the heat of
friction generated by impeller blades.
21. b) Phase transition process
In this compress powder containing erythritol
(melting point: 122 °C) and xylitol (melting point:
93 - 95 °C), and then heating at about 93 °C for 15
After heating, the median pore size and tablet
hardness was increased.
Heating process enhances the bonding among
particles leads to sufficient hardness of tablets.
22. c) Sublimation
When inert volatile solid ingredients like
ammonium bicarbonate, ammonium carbonate,
benzoic acid, camphor, hexamethylene tetramine,
naphthalene, phthalicanhydride, urea and urethane
were added to other tablet excipients.
Blend was compressed in to a table & finally
subjected to sublimation resulting in highly porous
Tablets produce by this method exhibit
good mechanical strengthhigh,
porosity (approximately 30%),
dissolved within 15 seconds in saliva.
23. Figure:- Steps Involved in sublimation
24. 9. Conventional methods
a) Direct compression
Easiest way to manufacture tablets.
Conventional equipment, commonly available
excipients and a limited number of processing steps
are involved in direct compression.
Also high doses can be accommodated and final
weight of tablet can easily exceed that of other
Tablet disintegration time can be optimized by
concentrating the disintegrants.
25. Below critical concentration, tablet disintegration
time is inversely proportional to disintegrants
disintegration time remains approximately constant
or even increases.
The major drawback of effervescent excipients is
their hygroscopicity (i.e., the ability to absorb
Another approach is the use of sugar‐based
excipients (e.g., dextrose, fructose, isomalt,
maltitok, maltose, mannitol, sorbitol, starch
hydrolyse, polydextrose, and xylitol).
26. Which are having high aqueous solubility and
It impart taste masking and a pleasing mouthfeel.
carboxymethyl cellulose sodium, cross linked
polyvinyl pyrrolidone and partially substituted
hydroxypropyl cellulose, though water insoluble,
absorb water and swell due to capillary action and
act as effective disintegrants.
27. b) Wet granulation
Acid component of the effervescent couple
presented in the tablet with lower than 5%, quick
disintegration times could be achieved.
In the patent, the formulation includes polyalcohols
(e.g., mannitol, xylitol, sorbitol, maltitol, erythritol,
1–30% of an edible acid & an active ingredient as
the dry mixture wet granulated with an aqueous
solution of a water-soluble or water-dispersible
polymer (e.g., poly(ethylene glycols), carrageenan,
28. which consisted of 1–10% of the final weight of
the granule in a fluid bed.
Granules with high porosity and low apparent
density disintegration times ranging from 3 to 30
seconds in the saliva were obtained.
29. c) Dry granulation
Low-density alkali earth metal salts or watersoluble carbohydrates were precompacted, and the
resulting granules were compressed into tablets.
Powdered material with a density of 0.2–0.55
g/mL was precompacted to increase the density to
0.4–0.75 g/mL by applying a force ranging from 1
to 9 kN/cm.
The resulting granules were compressed into
30. Patented Technologies
1. OraSolv technology
OraSolv technology (Cima Labs) produces tablets
by low compression pressure
It uses an effervescent disintegration pair that
releases gas upon contact with water.
Widely used effervescent disintegration pairs
Citric acid, Tartaric acid, Sodium bicarbonate,
Malic acid, Fumaric
acid, Adipic acid, and
and Potassium carbonate.
31. The carbon dioxide evolved from the reaction may
provide some “fizzing” sensation, which is a
positive organoleptic sensation.
20–25% of total weight of tablet effervescent agent
OraSolv tablets - soft and fragile nature.
PakSolv - Special packaging system
“Dome-shaped” blister package
Prevents the vertical movement of the tablet
within the depressions.
Protect the tablets from breaking during transport
and storage also offers light, moisture, and child
32. 2. DuraSolv Technology
Developed by Ciba, second-generation technology.
To Produce stronger tablets for packaging in
blisters or bottles.
Tablets have low friability, about 2% or less when
tested according to the USP.
Hardness of the tablets - at least about 15–20 N.
Disintegration time is less than 60 seconds.
By Direct compression method tablets produce.
conventional tableting methodologies & conventional package equipment are used.
33. Key ingredients Non-direct compression filler and lubricant.
Non-direct compression filler particle size 20-65 μm.
e.g. dextrose, mannitol, sorbitol, lactose, &
advantage - quick dissolution and avoid gritty or
60–95% amount of the total tablet weight is used.
Direct compressible fillers –
at least 85% of the particles are over 100 μm size.
Have some of the gritty or sandy texture.
34. Higher amounts (1–2.5%) of hydrophobic
lubricants, such as magnesium stearate, can be
lubricant blending times can also be increased to
10–25 minutes or longer.
0.2–1% lubricant in conventional tablets.
Relatively modest compressive force is needed to
compress the formulation.
35. 3. WOWTAB Technology
Patented by "Yamanouchi Pharmaceutical Co. "
WOW means "Without Water ".
In this process, API is mixed with a low
mouldability saccharide and granulated with a high
mouldability saccharide and compressed into
There is no single saccharide that can make tablets
having both high strength and fast disintegration
36. Low moldability saccharides
e.g. lactose, mannitol, glucose, sucrose, and
Tablets with hardness 0-2 kg, when 150 mg of
such a saccharide is compressed under pressure of
10–50 kg/cm2 using a die 8 mm in diameter.
e.g. maltose, oligosaccharides, maltitol, & sorbitol.
Produce tablets with hardness above 2 kg when
prepared under identical conditions.
The typical high- moldability saccharides are
37. 4. Flashtab Technology
Drug micro granules may be prepared by using the
conventional techniques like coacervation, micro
encapsulation, and extrusion spheronisation.
Excipients mixtureis prepared by either dry or wet
Excipients used - two groups of components:
1] Disintegrating agents- carboxymethylcellulose
or insoluble reticulated polyvinylpyrrolidone; and
39. 5. AdvaTab Technology
Patented by Kyowa Hakko Kogyo
Lubrication is dispensed onto each tablet by using
10–30 times less hydrophobic lubricant employed
& 30–0% stronger than conventional tablets.
Handle high drug loading and coated drug
Traditional tablets produced using an internal
lubrication system, which disperses lubricant on
the inside and the surface of the tablets, decrease
tablet mechanical strength.
40. 6. Dispersible Tablet Technology
Lek in Yugoslavia was issued patents for
dispersible tablets of dihydroergotoxine and
Dihydroergotoxine is poorly water soluble in free
Improved dissolution rate of dihydroergotoxine
methanesulphonate was observed with dispersible
tablets containing 0.8– 10%, preferably about 4%
by weight, of an organic acids.
41. Cimetidine formulated with one of disintegrating
agent. It provides rapid swelling and/or good
wetting capability to the tablets and thereby a quick
e.g. starch or modified starches, microcrystalline
cellulose, alginic acid, cross-linked sodium
carboxymethyl cellulose, and cyclodextrin
Combination of two or more disintegrating agents
produced better disintegration results.
42. 7. Pharmaburst Technology
Process involves a dry blend of a drug, flavor, and
lubricant that are compressed into tablets on a
standard tablet press with stock tooling.
uses off- the-shelf coprocessed excipients,
depending on the type of active and loading (up to
700mg), dissolves within 30–40 seconds.
Manufacture process can be carried out under
normal temperature and humanity conditions.
The tablets can be packaged in blister packs or
43. 8. OraQuick technology
It utilizes a patented taste masking technology.
KV Pharmaceutical claims its microsphere
technology, known as MicroMask.
Taste masking process does not utilize solvents of
any kind, it leads to faster and more efficient
Lower heat of production than alternative fast‐
dissolving/disintegrating technologies makes
OraQuick appropriate for heat‐sensitive drugs.
Matrix that surrounds and protects the drug
powder in microencapsulated particles is more
44. Tablets can be compressed to achieve significant
mechanical strength without disrupting taste
KV Pharmaceutical has products in development
such as analgesics, scheduled drugs, cough and
cold, psychotropics, and anti‐infectives
45. 9. Quick –Dis technology
Lavipharm Laboratories Inc. (Lavipharm) invented
this ideal intraoral FDDS.
Thin, flexible, and quick‐dissolving film.
Quick‐Dis™ provided in various packaging
configurations, unit‐dose pouches to multiple‐dose
Film with a thickness of 2 mm have disintegration
time 5 to 10 seconds & dissolving time, is around
Typical release profile of API is 50% released
within 30 seconds and 95% within 1 minute.
46. 10. Zydis technology
Zydis is a unique freeze dried oral solid dosage
Dissolves in less than 3 seconds.
Drug is physically trapped in a water soluble
matrix, and then freeze dried.
Thirteen products are currently available based on
In worldwide market, zydis formulations
available for oxazepam, lorazepam, loperamide,
47. Matrix contain excipients like
1] Polymers (e.g., gelatine, alginates, and dextrin)
to provide strength and rigidity to tablets;
2] Polysaccharides (e.g.,mannitol and sorbitol)
to impart crystallinity and hardness to the matrix
and to improve palatability;
3] Collapse protectants (e.g, glycin)
to prevent the product from shrinking in its
packaging during manufacturing or storage;
4] Flocculating agents (e.g, xanthan gum and
to provide uniform dispersion of drug particles;
5] Preservatives(e.g., parabens)
to prevent microbial growth;
48. 6] Permeation enhancers (e.g., sodium lauryl
to improve transmucosal permeability;
7] pH adjusters (e.g, citric acid)
to optimize chemical stability;
8] Flavours and sweeteners
to improve patient compliance and
9] water to ensure formation of porous units.
In US, zydis products availableClaritin Reditab, Dimetapp Quick Dissolve,
Feldene Melt, Maxalt-MLT, Pepcid RPD, Zofran
FDT, and Zyprexa Zydis.
49. 11. Frosta technology
Patented by Akina.
It utilizes core concept of formulating plastic
granules and compressing at low pressure to
produce strong tablets with high porosity.
Process involves mixing the porous plastic
material with water penetration enhancer and
granulated with binder.
Used for - aspirin, loratidine, caffeine, and folic
acid, vitamins and dietary supplements.
50. Superdisintegrants employed in ODT
disintegrants available grades
Swells 4-8 folds in
< 10 seconds.
Crosspovidon M® Swells very little
and returns to
original size after
compression but act
by capillary action.
Swells in two
spongy in nature
so get porous
Swells 7-12 folds in
< 30 seconds.
Swells in three
and high level
serve as sustain
Rapid swelling in
aqueous medium or
in both dry or wet
Does not contain
any starch or
Sugar. Used in
52. Marketed product of MDTs
Resperdal® MTab TM
53. Preformulation Studies
1. Bulk Density
ρb - Bulk density, M- Weight of powder, and
V- Volume of powder.
2. Tapped Density
ρt = M / Vt
ρt - Tapped density, M- Weight of powder, and
Vt- Minimum volume occupied after tapping.
54. 3. Compressibility Index
Simplest way for measurement of flow of powder.
% C.I. = ρt – ρb/ρt x100
4. Hausner ratio
Hausner ratio is an indirect index of ease of
Lower the value of Housner ratio better is the flow
Hausner ratio = ρt/ ρb
55. Flow property
56. 5. Porosity
ε = ( 1 - ρapp / ρtrue) X 100
ε- Porosity, ρapp- Apparent density, and
ρtrue- True density.
V = Vb - Vp
V- Voide volume, Vb- Bulk volume, and
Vp- Tapped volume.
57. 7. Angle of repose
ϴ = Tan-1 ( h / r )
ϴ- Angle of repose, h- Hight of the heap, and
r- Radius of the heap.
Fair- aid not needed
Angle of repose (degrees)
Passable- must agitate,
Very, very poor
58. Evaluation of Mouth dissolving
Measured using Vernier calipers.
Force required to break a tablet by compression in
the radial direction.
Pfizer hardness testers
Monsanto hardness tester.
59. 3. Uniformity of weight
20 tablets randomly take from lot and weighted
individually to check for weight variation.
Weight variation specification as per IP
Average weight of tablet
80 mg or less
More than 80 mg but less than
250 mg or more
60. 4. In-vitro dispersion time test
Drop a tablet in a beaker containing 50ml of
sorrenson’s buffer pH 6.8 & time required for
complete dispersion was determined.
61. 5. Friability test
Determined using Roche friability.
Subjected to 100 revolutions (25rpm/minute).
f = (1- W0 / W) × 100
f- Friability, W0- Weight of the tablets before, and
W- Weight of the tablet after the test.
6. In vivo Disintegration time
Time required for complete disintegration of tablets
in oral cavity determined by administering tablets
to 10 healthy volunteers.
62. 7. Wetting time
Tablet is placed on a piece of tissue paper folded
twice and kept in a Petri dish (ID = 6.5 cm)
containing 6 ml of water, and the time for complete
wetting is measured.
8. Water absorption ratio
This test performed as like wetting time
R = 10 ( Wa /Wb)
R- Water absorption ratio, Wb- Weight of tablet
before water absorption, & Wa- weight of tablet
after water absorption.
63. 9. Dissolution test
Dissolution study performed using USP
apparatus (paddal speed 50rpm).
USP monographs dissolutions conditions should
be followed in addition 0.1N HCl, pH 4.5 & 6.8
buffers should be evaluated.
10. Stability study
As per ICH Q1A guidelines for accelerated
Tablets stored at 40±1ºC/75% ± 5% RH for 4
64. Afterword withdraw & analyse for physical
characterization (visual defects, hardness,
friability, disintegration, dissolution etc.) drug
65. Promising Drugs to be incorporated In FDT
Analgesics and Anti-inflammatory Agents
Anti-Neoplastic Agents And Immunosuppressants
Anti Protozoal Agents
66. Gastro-Intestinal Agents
Histamine H,-Receptor Antagonists
Lipid Regulating Agents
Neuro -Muscular Agents
Nitrates And Other Anti-Anginal Agents
Proteins, Peptides And Recombinant Drugs
Anxiolytic, Sedatives, Hypnotics And Neuroleptics
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