The document discusses mouth dissolving tablets (MDTs). It defines MDTs as solid dosages that disintegrate rapidly within seconds when placed on the tongue without requiring water or chewing. The ideal properties of MDTs are described. The main ingredients used are superdisintegrants that aid rapid disintegration. Several approaches for manufacturing MDTs are outlined, including freeze drying, sublimation, and direct compression. The criteria for drug selection and various patented technologies are also summarized. The document concludes with an overview of preformulation studies, evaluation methods, and examples of marketed MDT products.

1. Presented By Guided By
Nitesh V. Punde Prof. Santosh Kumbhar
T.Y.B.Pharm. M.Pharm .
Dept. :- Pharmaceutics
A REVIEW ON MOUTH DISSOLVING TABLET
SINHGAD TECHNICAL EDUCATION SOCIETIES
SINHGAD INSTITUTE OF PHARMACY
NARHE PUNE-4110417/23/2015

2. CONTENT’S
INTRODUCTION
DEFINITION & IDEAL PROPERTIES
MAIN INGREDIENTS USED IN MDT
CRITERIA FOR DRUG SELECTION
APPROACHES FOR PREPARATION OF MDT
PATENTED TECHNOLOGIES FOR PREPARATION OF MDT
PREFORMULATION STUDIES
EVALUATION OF MDT
MARKETED PRODUCTS OF MDT
REFERENCES
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3. INTRODUCTION
Tablets and capsules are the most popular dosage forms.
But one important drawback of such dosage forms is ‘Dysphagia’ or
difficulty in swallowing.
This is seen to nearly about 35% of the general population.
This disorder is also associated with a number of conditions like :-
1. Parkinsonism
2. Motion sickness
3. Unconsciousness
5. Children
6. Mentally disabled persons
To overcome such problems MDT’s are developed.
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4. Definition
“A solid dosage form containing medicinal substances or
active ingredients which disintegrates rapidly within a few
seconds when placed up on tongue”
Ideal properties of MDT
Mouth Dissolving Tablet should
 Not require water or other liquid to swallow.
 Easily dissolve or disintegrate in saliva within a few seconds.
 Have a pleasing taste.
 Leave negligible or no residue in the mouth when administered.
Be portable and easy to transport.
 Be able to be manufactured in a simple conventional manner within
low cost.
 Be less sensitive to environmental conditions like temperature,
humidity etc.
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5. Superdisintegrants:
Disintegrants play a major role in the disintegration and dissolution of
MDT.
Criteria :-
 Should have rapid disintegration rate when tablet comes in
contact with saliva in mouth.
Produce good mouthfeel to patient.
Should be non toxic.
Should compatible with API.
Mechanism of action of Super disintegrants7/23/2015

6. Mechanism of action of disintegrants
The tablet breaks to primary particles by one or more of the mechanisms listed
below:‐
•By capillary action :- Replaces the air adsorbed on the particles, which weakens
and breaks the tablet into fine particles
•By swelling :- Perhaps the most widely accepted general mechanism of action for
tablet disintegration is swelling which creates pressure leads to disintegration.
•Due to release of gases :- The tablet disintegrates due to generation of pressure
within the tablet. (CO2 RELEASE)
•Due to repulsion :-The electric repulsive forces between particles are the
mechanism of disintegration and water is required for it.
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7. Criteria for Drug Selection
EXAMPLES OF SUPERDISINTEGRANTS
1. NATURAL :- GUMS, MUCILAGE, PLANTAGOOVATA MUCILAGE.
2. SYNTHETIC :- CROSS POVIDONE,CROSS CARMELLOSE,Ac-Di-
Sol.
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8. Approaches for preparation of MDT
Various technologies used in the manufacture of Mouth
Dissolving Tablets include:
1. Freeze‐drying or lyophilization
2. Sublimation
3. Moulding
4. Mass extrusion
5. Direct compression
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9. 1.Freezedrying
First of all, the material is frozen to bring it below its eutectic point.
Then primary drying is carried out to reduce the moisture to around 4%
w/w of dry product.
Finally, secondary drying is done to reduce the bound moisture to the
required volume.
2. Sublimation
This process involves addition of some inert volatile substances like urea,
urethane, naphthalene, camphor,etc..
Removal of volatile material by sublimation creates pores in tablet structure,
due to which tablet dissolves when comes in contact with saliva.
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10. Sublimation Technique for Preparation of MDT
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11. 3. Moulding
Tablets prepared by this method are solid
dispersions.
The drug can exist as discrete particles or micro
particles in the matrix.
It can dissolve totally to form a solid solution or
dissolve partially in the molten carrier and remaining,
if any, stays undissolved and dispersed in the matrix.
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12. 4. Mass extrusion
In this technique, a blend of active drug and other ingredients is softened using
solvent mixture of water soluble polyethylene glycol, using methanol .
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.
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13. 5. Direct compression
The disintegrant addition technology (direct compression) is the most
preferred technique to manufacture the tablets due to certain advantages: -
High doses can be accommodated and final weight of the tablet can exceed
that of other methods.
Easiest way to manufacture the tablets.
Conventional equipment and commonly available excipients
are used.
A limited no. of processing steps are involved.
Cost‐effectiveness.
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14. Patented Technologies for preparation of MDT
1 Zydis technology:
‘Zydis’ is the first mouth dissolving dosage form in the market.
Dissolves in less than 3 seconds.
It is a unique freeze‐dried tablet in which the active drug is incorporated in a
water‐soluble matrix, then transformed into blister pockets and freeze dried to
remove water by sublimation.
Drawbacks
A water insoluble drug can be incorporated only upto 400 mg per tablet or
less .
On the other hand water soluble drug can be incorporated only upto 60 mg
2 Orasolv technology
This technology involves taste masking of active drug.
Effervescent disintegrating agent is also used.
Less force of compaction is used for manufacturing so as to obtain soft and
quickly disintegrating tablets.7/23/2015

15. 3.Durasolv technology
Developed by Ciba, second-generation technology .
This is one of the suitable technologies to prepare products requiring low
amounts of active drug.
 Due to higher force of compaction used, tablets prepared are rigid.
4.Wowtab technology
Yamanauchi pharmaceutical company patented this technology.
‘wow’ means ‘without water’.
The active ingredients may constitute upto 50% w/w of the tablet.
Highly mouldable substance has high compressibility and thus shows slow
dissolution.
The combination of high and low mouldable(lactose,glucose) is used to
produce tablets of adequate hardness.7/23/2015

16. Preformulation Studies
1. Bulk Density
Formula :- ρb = M / V
Where : -
ρb - Bulk density, M- Weight of powder, and
V- Volume of powder.
2. Tapped Density
ρt = M / Vt
Where :
ρt - Tapped density, M- Weight of powder, and
Vt- Minimum volume occupied after tapping.
Formula :-
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17. Simplest way for measurement of flow of powder.
% C.I. = ρt – ρb/ρt x100Formula :-
4. Hausner ratio
Hausner ratio is an indirect index of ease of powder flow.
Lower the value of Housner ratio better is the flow property.
Hausner ratio = ρt/ ρbFormula :-
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18. Flow
property
% C.I. Hosner
ratio
Excellent ≤10 1.00-1.11
Good 11-15 1.12-1.18
Fair 16-20 1.19-1.25
Passable 21-25 1.26-1.34
Poor 26-31 1.35-1.45
Very poor 32-37 1.46-1.59
Very, very
poor
>38 >1.6
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19. ϴ = Tan-1 ( h / r )Formula :-
Where,
ϴ- Angle of repose, h- Hight of the heap, and
r- Radius of the heap.
Flow property Angle of repose (degrees)
Excellent 25-30
Good 31-35
Fair- aid not needed 36-40
Passable- must agitate,
vibrate
41-45
Poor 46-55
Very poor 56-65
Very, very poor >667/23/2015

20. Evaluation of Mouth dissolving tablets
1. Thickness
 Measured using Vernier calipers
2. Hardness
Force required to break a tablet by compression in the radial
direction.
Pfizer hardness testers Monsanto hardness tester
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21. Determined using Roche friability.
Subjected to 100 revolutions (25rpm/minute).
f = (1- W0 / W) × 100Formula :-
Where,
f- Friability, W0- Weight of the tablets before, and
W- Weight of the tablet after the test.
4.Dissolution test
Dissolution study performed using USP II 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.
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22. 5. Stability study
As per ICH Q1A guidelines for accelerated studies.
Tablets stored at 40±1ºC/75% ± 5% RH for 4 weeks.
6. 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.
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23. Marketd products of MDT
Brand name Active
ingredient
Application company
Claritin®
RediTabs®
Loratadine Antihistamine Scherig
corporation
Feldene Melt® Piroxicam NSAIDs Pfizer
Maxalt® -MLT® Rizatritpan
benzoate
Migrane Merck
Pepeid® ODT Femotidene Anti-ulcer Merck
Zyperxa® Olazepine Psychotropic Eli Lilly
Zofran® ODT Olandansetron Antiemetic Galaxo Smith
kline
Resperdal® M-
TabTM
Resperidone Schizophrenia Janssen
ZubrinTM (Pet
drug)
Tepoxelin Canine
NSAIDs
Scherig
corporation
ZelaparTM Selegiline Parkinsons
disease
Elanl Amarin
corporation
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24. 1. Biradar, S. S., Bhagavati, S. T., Kuppasad I. J., Fast Dissolving Drug
Delivery Systems: A Brief Overview, Internet J. Pharmacology, 2006,
4(2).
2. Kuccherkar B.S., Badhan A.C., Mahajan H.S., Mouth dissolving
tablets: A novel drug delivery system, Phrma Times, 2003, 35, 3- 10.
3. Amin, A.F., Shah, T.J., Bhadani, M.N., Patel, M.M., Emerging trends
in orally disintegrating tablets, www.pharminfo.net, 2005.
4. Lailla, J.K., Sharma, A.H., Freeze-drying and its applications, Indian
Drugs, 1993, 31, 503- 513.
5. Seager, H., Drug delivery products and zydis fast dissolving dosage
form, J. Pharm. Phamacol., 1998, 50, 375-382.
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