content’s

 Definition
 Significance
 Requirements of FDT
 Formulation methodologies
 Patented technologies
 Potential candidates for FDT
 Survey literature
Definition

Fast Dissolving Tablets (FDTs) or “mouth

dissolving tablets” (MDTs) which disintegrates
or dissolves rapidly without water within few
seconds in the mouth.
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”
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,
 Porous tablets,
 Quick melt tablets &
 Rapid melt tablets.
 significance
 It offer all advantages of solid dosage forms
and liquid dosage forms along with special
advantages, includes
 It provide good stability, accurate dosing, easy
manufacturing, small packaging size & easy to
handle.
 No need of water to swallow the dosage form.
 Easy to administer for paediatric, geriatric &
institutionalized patients.
 More rapid drug absorption from the pre-
gastric area which may produce Quick onset of
action.
 Pre-gastric absorption of drug avoids hepatic
metabolism, which reduces the dose and
increase the bioavailability.
 The risk of chocking or suffocation during oral
administration avoided.
 Good mouth feel property of MDDDS helps to
change the basic view of medication as "bitter
pill"
 Patient’s compliance for disabled bedridden
patients and for travelling and busy people,
who do not have ready access to water.
 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
package design.
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 oral
administration.
VI. Exhibit low sensitivity to environment condition
such as humidity and temperature
 Formulation Methodologies
1. Freeze drying or lyophilization
2. Molding
3. Cotton candy process
4. Spray drying
5. Mass extrusion
6. Nanonization
7. Three-dimensional Printing (3DP)
8. Compaction
a) Melt granulation
b) Phase transition process
c) Sublimation
9. Conventional methods
a) Dry granulation
b) Wet granulation
c) Direct compression
 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
Acid sources Carbonate sources
Citric acid, Tartaric acid, Sodium bicarbonate,
Malic acid, Fumaric Sodium carbonate,
acid, Adipic acid, and Potassium bicarbonate,
Succinic acids. and Potassium carbonate.
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
is used.
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
resistance.
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
blister packages.

Film with a thickness of 2 mm have disintegration

time 5 to 10 seconds & dissolving time, is around
30 seconds.
Typical release profile of API is 50% released
within 30 seconds and 95% within 1 minute.
POTENTIAL CANDIDATES FOR FAST
DISSOLVING TABLETS (FDT)

Analgesics and Anti-inflammatory Agents:

• Aloxiprin

• ibuprofen
• ketoprofen

• oxaprozin acid
Anti-bacterial Agents:
• Benethamine penicillin
• ciprofloxacin HCl
• erythromycin
• sulphadoxine
• sulphacetamide
• tetracycline
Anti-coagulants:

•Dicoumarol

•Dipyridamole

•Nicoumalone

•Phenindione
Anti-malarials:

• Chloroquine

• quinine sulphate

• Amodiaquine
Survey literature

Formulation, Evaluation and Optimization of Fast

dissolving tablet containing Tizanidine Hydrochloride

Department of Industrial Pharmacy, Sudhakarrao institute of pharmacy,

Pusad 445 204, M.S.,India.

P.S. Zade, P.S. Kawtikwar*, D.M. Sakarkar