MDT is fast dissolving tablet in mouth only ,give quick action ,with pleasant test mainly used in journey without use of water.

1. PRESENTED BY:-
HANUMAN K. NAGOLKAR
M.PHARM SEM-II
ROLL NO :- 507
DEPARTMENT OF PHARMACEUTICS
GUIDED BY:-
DR. S.V. SHIROLKAR
DR. D.Y. PATIL INSTITUTE OF PHARMACEUTICAL SCIENCES AND
RESEARCH, PIMPRI, PUNE- 411018
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2.  Definitions
 Properties
 Advantages
 Disadvantages
 Need
 Formulation
 Methodology
 Evaluation
 Patented methodology
 Recent patents of MDTs
 References
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3.  Mouth dissolving tablet (MDT)
It is a tablet that disintegrates and dissolves rapidly in the saliva within a few seconds
without the need of drinking water or chewing.
A mouth dissolving tablet usually dissolves in the oral cavity within 15 s to 3 min.
 Most of the MDTs include certain super disintegrants and taste masking agent.
According to European pharmacopoeia, these MDTs should dissolve/disintegrate in less than
three minutes.
US FDA defined MDTs as “A solid dosage form containing medicinal substances or active
ingredients which disintegrates rapidly within a few seconds when placed up on tounge.
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4. Ideal properties of MDTs
Mouth dissolving tablet should not require water or other liquids 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 and humidity
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5.  No need of water to swallow the tablet.
 Can be easily administered to pediatric, elderly and mentally disabled patients.
 Accurate dosing as compared to liquids.
 Excellent mouths feel property produced by use of flavours and sweetners.
 Convenient to administer during travelling without need of water .
 Fast disintegration of tablets leads to quick dissolution and rapid absorption which
may produce rapid onset of action.
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6.  It is hygroscopic in nature so it must be kept in dry places.
 Packaging of tablet requires special equipments and it is difficult to pack.
 High dose cannot be incorporated into tablet.
 Eating and drinking may become restricted.
 Buccal tablet are moisture sensitive.
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7.  Orally disintegrating dosage forms are particularly suitable for patients find it
inconvenient to swallow traditional tablets and capsules with glass of water.
 Pediatric and geriatric patients
 Patients who are unwilling to take solid preparation due to fear of
choking
 A patient with persistent nausea, who may be in journey, or has little or no access
to water
 Increased bioavailability and faster onset of action are a major claim of these
formulations.
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8.  Superdisintegrants
 Bulking agents
 Emulsifying agents
 Lubricants
 Flavours
 sweetners
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9. Superdisintegrants
 Disintegrants play a major role in the disintegration and dissolution of MDTs.
 Super disintegrants provide quick disintegration due to combined effect of swelling
and water absorption by the formulation.
 Eg.1. Croscarmelose sodium
2. Crospovidone
3. Sodium starch glycolate
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10.  Bulking materials are important in the development of fast dissolving tablets. They
contribute the functions of a diluent, filler and cost reducer.
 Bulking agents improve the texture of the tablets that consequently enhances the
disintegration in the mouth, besides adding volume and reducing the concentration
of the active in the formulation.
 The bulking agents for this dosage form should be more sugar-based such as
mannitol, polydextrose, lactose derivatives such as directly compressible lactose
(DCL) and starch hydrolysate .
 Bulking agents are added in the range of 10% to about 90% by weight of the final
composition
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11.  Emulsifying agents are significant for formulating fast dissolving tablets as they help
in quick disintegration and drug release without the need for chewing, swallowing or
drinking water.
 Also, emulsifying agents stabilize the immiscible blends and increase bioavailability.
 A variety of emulsifying agents for fast dissolving tablet formulations include alkyl
sulfates, propylene glycol esters, lecithin, sucrose esters and others. These can be
added in the range of 0.05% to about 15% by weight of the final formulation.
Lubricants
 Though not essential excipients, these can aid in making the tablets more
palatable after they disintegrate in the mouth.
 Lubricants reduce grittiness and help in the drug transit process from the oral to the
stomach.
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12.  Flavours and taste masking agents make the products more palatable and pleasing
for patients.
 The incorporation of these ingredients assists in overcoming bitterness and
undesirable tastes of some actives.
 Natural as well as synthetic flavours can be used to enhance the organoleptic
characteristic of fast dissolving tablets.
 A wide range of sweeteners including sugar, dextrose and fructose, as well as non-
nutritive sweeteners such as aspartame, sodium saccharin, sugar alcohols and
sucralose are available.
 The addition of sweeteners imparts a pleasant taste as well as bulk to the
formulation.
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13. 1. Freeze drying or lyophilization
2. Cotton candy process
3. Spray drying
4. Nanoionization
5. Direct compression
6. Sublimation
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14.  It is a pharmaceutical process that allows the drying of heat sensitive drugs and
biological under low temperature by the application of vacuum to remove water by
sublimation.
 Drugs are dissolved or dispersed in aqueous solution of a carrier, transferred to
preformed blister packs and subjected to nitrogen flush to freeze out, then placed in
the refrigerator to complete the process.
 Characteristics of lyophilization techniques are, they possess high porosity and
specific surface area, and gets dissolve rapidly in mouth presenting high drug
bioavailability.
 Advantages
 The major advantage of using this technique is that the tablets produced by this
technology have very low disintegration time and have great mouthfeel due to fast
melting effect.
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15.  This process is so named as it utilises a unique spinning mechanism to produce a
floss-like crystalline structure, which mimics cotton candy.
 Cotton candy process involves the formation of Matrix of polysaccharides or
saccharides by the simultaneous action of flash melting and spinning.
 The matrix formed is partially recrystallized to have improved flow properties and
compressibility.
 This candy floss matrix is then milled and blended with active ingredients and
excipients and subsequently compressed to FDTs.
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16.  In this method hydrolyzed and nonhydrolyzed gelatin were used as supporting
matrix.
 Mannitol as bulking agent
 Acidic substances (citric acid) or alkali substance (sodium bicarbonate) further
increase disintegration and dissolution.
 Sodium starch glycolate or crosscarmellose sodium as superdisintegrant.
 Disintegration time < 20 sec
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17.  Nanomelt technology involves reduction in the particle size of drug by proprietary
wet-milling technique.
 Nanocrystals of the drug are stabilized against agglomeration by surface adsorption
on selected stabilizers, which are then incorporated into MDTs.
 Advantages
 For poor water soluble drugs.
 Fast disintegration/dissolution of nanoparticles leads to increased absorption and
bioavailability.
 Reduction in dose.
 cost effective manufacturing process.
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18.  direct compression is the most preferred technique to manufacture the tablets due
to certain advantages:
 The easiest way to manufacture the tablets.
 A limited no. of processing steps are involved.
 Cost effectiveness.
MILLING SIEVING MIXING COMPRESSION
fig. Process of direct compression
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19. Schematic Diagram of Sublimation Technique for Preparation of MDT
 Tablets produce by this method exhibit good mechanical strength and dissolved
within 15 seconds in saliva.
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20.  Analgesics and Anti-inflammatory Agents:
e.g. Indomethacin, Phenylbutazone,etc.
 Anthelmintics
e.g. Albendazole, Mebendazole etc.
 Anti-coagulants:
e.g.Dicoumarol, Nicoumalone etc.
 Anti-bacterial Agents:
e.g. Penicillin, Ciprofloxacin, Clarithromycin, Erythromycin .
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21. Anti-Epileptics:
e.g. Carbamazepine, Clonazepam etc.
Anti-Fungal Agents:
e.g. Amphotericin, Clotrimazole, Econazole Nitrate, Fluconazole Etc.
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22. 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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23.  20 tablets randomly take from lot and weighted individually to check for weight
variation.
Weight variation specification as per IP.
Average weight of
tablet
% Deviation
80 mg or less ± 10
More than 80 mg but less
than 250 mg
± 7.5
250 mg or more ± 5
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24.  Drop a tablet in a beaker containing 50ml of phosphate buffer pH 6.8 & time
required for complete dispersion was determined
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25.  Determined using Roche friabilator .
 Subjected to 100 revolutions (25rpm)
formula :-
Where,
 F- Friability, W0- Weight of the tablets before the test 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.
F = (1- W0 / W) × 100
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26.  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. 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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27. Patented
Technology
Basis of
Technology
Technology
developed by
Company
Active Ingredient
(Brand Names)
Zydis Lyophilization R.P.Scherer,Inc Loratidine (Claritin
Reditab and Dimetapp
Quick Dissolve)
Quicksolv Lyophilization Janssen
pharmaceutics
Risperidone
(Risperdal Mtab)
Lyoc Lyophilization Farmalyoc Phloroglucinol Hydrate
(Spasfon Lyoc)
Orasolv Direct
compression
Cima Labs,Inc. Zolmitriptan
(Zolmig Repimelt),
27

28. S
r.
N
TITLE PATENT
NUMBER
YEAR
1 Orally disintegration tablet (Ticagrelor)
significant proportion of patients with stroke
have difficulty swallowing in the acute phase,
and many have ongoing problems.
WO2017182589 26.10.2017
2 Orally disintegrating tablet containing
(Asenapine) treatment of adults with
schizophrenia and acute treatment of manic or
mixed episodes associated with bipolar I
disorder with or without psychotic features in
adults
US2017014367 25.05.2017
3 Tofacitinib orally disintegrating tablets ,use
in moderate-to-severe forms of rheumatoid
arthritis. It helps to decrease pain,
tenderness, swelling in the joints.
WO2017017542 02.02.2017
28

29.  Ashish Masih, Amar Kumar, Shivam Singh, Ajay Kumar Tiwari. Fast Dissolving
Tablets: A Review. Int J Curr Pharm Res 2017;9(2):8-18.
 Dali Shukla, Subhashis Chakraborty, Sanjay Singh, Brahmeshwar Mishra. Mouth
Dissolving Tablets I: An Overview Of Formulation Technology Sci Pharm. 2009;
77: 309–326
 http:patentscope.wipo.int/search
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