IRSHAD AHMED QURESHI

-T.Y.B.Pharm
 Definition

“ODTs are solid dosage forms containing

medicinal substances which disintegrate
rapidly, usually in a matter of seconds, when
placed on the tongue”.
• Products of ODT technologies entered the
market in the 1980s
• The first ODT form of a drug to get approval
from the U.S. FDA was a Zydis ODT
formulation of Claritin (loratadine) in
December 1996.
 Need for ODTs

“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.
Advantages of ODT’s

1) Good for patients with swallowing difficulties.

2) Good for paediatric compliance
3) Convenient to administer during travelling or
working without need of water
4) The pre-gastric drug absorption avoids the first-
pass metabolism
 Formulation of ODT’s

 Active ingredient
 Disintegrating agents
 Binders
 Sweeteners
 Flavourants
 Glidants, lubricants, anti-adherents.
 Formulation of ODT’s
Disintegrating agents:
 Starch and modified starches (e.g. – Primogel,
Carboxy methyl Starches, Pregelatinized, Starch
USP, Starch 1500 )
 Cross-linked polyvinylpyrrolidone (eg.
Povidone).
 Modified celluloses such as cross-linked sodium
carboxymethylcellulose (eg. Ac-Di-Sol)
 Alginic acid and sodium alginate
 Microcrystalline cellulose e.g. - Avicel DG,
Avicel PH-101.
 Formulation of ODT’s
Binders –
MCC (Microcrystalline cellulose)
SMCC (Silicified microcrystalline cellulose )
SMCC1 SMCC2 SMCC3
Starch paste , Natural Gums, Liquid Glucose , etc. )
Flavors: -
a bitter product - mint, cherry or anise may be used
a salty product - peach, apricot or liquorice may be
used
a sour product - raspberry or liquorice may be used
an excessively sweet product - vanilla may be used
 Formulation methodology
 Freeze Drying
A process in which water is sublimated from the product after freezing. Lyophilization
is a pharmaceutical technology which allows drying of heat sensitive drugs and
biological at low temperature under conditions that allow removal of water by
sublimation.
Lyophilization results in preparations, which are highly porous, with a very high
specific surface area, which dissolve rapidly and show improved absorption and
bioavailability.

 Moulding
In this method, molded tablets are prepared by using water-soluble ingredients so that
the tablets dissolve completely and rapidly.
The powder blend is moistened with a hydro-alcoholic solvent and is molded into
tablets under pressure lower than that used in conventional tablet compression.
The solvent is then removed by air-drying. Molded tablets are very less compact than
compressed tablets. These possess porous structure that enhances dissolution.
 Formulation methodology
• Sublimation
The slow dissolution of the compressed tablet containing even
highly water-soluble ingredients is due to the low porosity of the
tablets. Inert solid ingredients that volatilize readily (e.g.  urea, 
ammonium  carbonate,  ammonium  bicarbonate, camphor etc.)
were added to the other tablet ingredients and the mixture is
compressed into tablets.
The volatile materials were then removed via sublimation, which
generates porous structures.
Additionally, several solvents (e.g. cyclohexane, benzene) can be
also used as pore forming agents.
• Direct Compression
All the excipients along with the active are weighed, sieved and
compressed to form tablets.
 Patented Technologies For Fast
Dissolving Tablets
Zydis Technology
A Zydis tablet is produced by lyophilizing or freeze-drying the drug in a
matrix usually consisting of gelatin.

The product is very lightweight and fragile, and must be dispensed in a

special blister pack.

Patients should be advised not to push the tablets through the foil film,
but instead peel the film back to release the tablet.
The Zydis product is made to dissolve on the tongue
in 2 to 3 seconds.

Feldene Melt (Piroxicam 20 mg )

Claritin Reditab (Loratidine 10 mg )

 Cont….
 Durasolv Technology
The tablets made by this technology consist of a drug, fillers and a lubricant.
Tablets are prepared by using conventional tableting equipment and have good
rigidity.
These can be packed into conventional packaging system like blisters.
Durasolv is an appropriate technology for products requiring low amounts of
active ingredients.
Parcopa® (levodopa and carbidopa)
NuLev® (hyoscyamine)

 Orasolv Technology
In this system active medicament is taste masked.
It also contains effervescent disintegrating agent.
Tablets are made by direct compression technique at low compression force in
order to minimize oral dissolution time.
Conventional blenders and tablet machine is used to produce the tablets.
The tablets produced are soft and friable and packaged in specially designed pick
and place system.
FazaClo® (clozapine)
Orapred ODT®** (prednisolone sodium phosphate)
 Cont…
 Flash Dose Technology
- Nurofen meltlet, a new form of ibuprofen as melt-in-mouth tablets,
prepared using flash dose technology is the first commercial product
launched by Biovail Corporation.
- Flash dose tablets consists of self binding shearform matrix termed as
"floss". Shear form matrices are prepared by flash heat processing.

 Wowtab Technology
- WOW means "Without Water ".
- In this process, combination of low mouldability saccharides and high
mouldability saccharides is used to obtain a rapidly melting strong tablet.
- The active ingredient is mixed with a low mouldability saccharide and
granulated with a high mouldability saccharide and compressed into
tablet.
 Drugs Formulated Into ODT’s
 Analgesics and Anti-inflammatory Agents:
e.g. Azapropazone, Meclofenamic Acid,
Indomethacin, Phenylbutazone, etc.
 Anthelmintics
e.g. Albendazole, Mebendazole, Dichlorophen,
etc.
 Anti-coagulants:
e.g.Dicoumarol, Nicoumalone, Phenindione, etc.
 Drugs Formulated Into ODT’s
 Anti-bacterial Agents:
e.g. Penicillin, Ciprofloxacin, Clarithromycin, Clofazimine,
Cloxacillin, Demeclocycline, Doxycycline, Erythromycin,
Ethionamide,
 Anti-Epileptics:
e.g. Carbamazepine, Clonazepam, Ethotoin, Methoin, etc.
 Anti-Fungal Agents:
e.g. Amphotericin, Clotrimazole, Econazole Nitrate,
Fluconazole, Fiucytosine, Griseofulvin, Itraconazole,
Ketoconazole, Miconazole, Natamycin, Nystatin. Etc.
Marketed Fast Dissolving Tablets in
India
Name of the Product Active Ingredients

Imodium Lingual Imodium

Pepcid RPD famotidine

Zyprexa Zydis olanzapine

Zofran ODT ondansetron 

Remeron Soltab mirtazepine 

Claritin Reditab micronized loratadine

Feldene Melt piroxicam

Maxalt-MLT rizatriptan
 Conclusion

 Orally disintegrating tablets have better patient

acceptance and compliance and may offer
improved biopharmaceutical properties, improved
efficacy, and better safety compared with
conventional oral dosage forms.
 ODTs are more widely available as OTC
products for the treatment of allergies, cold, and
flu symptoms.
 References -
 FDA, CDER data standards manual (C-DRG-
00201Version008),www.fda.gov/Drugs/DevelopmentApprov
alProcess/FormsSubmissionRequirements/ElectronicSubmis
sions/DataStandardsManualmonographs/ucm071666.htm,
accessed Aug. 20, 2009.
 Orally Fast Disintegrating Tablets: Developments,
Technologies,Taste-Masking and Clinical Studies Yourong Fu,
Shicheng Yang, Seong Hoon Jeong, Susumu Kimura,& Kinam
Park Purdue University, Departments of Pharmaceutics and
Biomedical Engineering,West Lafayette, Indiana, USA.
 http://www.pharmainfo.net/reviews/new-generation-tablet-
fast-dissolving-tablet.
THANK YOU….