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Culture Documents
CONTENTS
Advantages over conventional tablet dosage forms
Challenges in formulation and development
Materials required
Mechanism of drug release
Formulation techniques
Conventional methods
Patented technologies
Marketed products
Evaluation tests
Future developments
Conclusion
References
INTRODUCTION
Definitions of ODTs:
According to US FDA:
Ease of administration for patients who are mentally ill, disabled and
un co-operative.
Challenges in the product design, formulation and
manufacture of ODTs.
Palatability
Mechanical strength
Amount of drug
Size of tablet
Hygroscopicity
Aqueous solubility
Short half-life
Cost of the tablet
PALATABILITY
releasing the active ingredients which come in contact with the taste
buds;
very low compression force, which makes the tablets friable and/or
brittle,
reported that the easiest size of tablet to swallow is 7-8 mm. While
the
Therefore, the tablet size that is both easy to take and easy to handle
is
difficult to achieve
HYGROSCOPICITY
Several orally disintegrating dosage forms are hygroscopic and cannot
humidity. Hence, they need protection from humidity which calls for
formation of a glassy solid that may collapse upon drying because loss
of
Excipients
THE IDEAL CHARACTERISTICS OF DRUG
For disintegration and dissolution in oral cavity i.e., the pre-gastric
absorption from an ODT include,
1. No bitter taste
2. Dose lower than 20mg
3. Small to moderate molecular weight
4. Good solubility in water and saliva
5. Partially nonionized at the oral cavity’s pH.
6. Ability to diffuse and partition into the epithelium of upper GIT.
7. Ability to permeate oral mucosal tissue.
EXCIPIENTS
FILLER SUPERDISINTEGRANTS
FLAVOURING AGENTS
Eg: Menthol, Vanilla, Liquorice, Citrus fruits flavour, Anise oil, Clove
oil, Pippermint oil, Eucalyptus oil.
SWEETENERS
Eg: Natural- Mannitol, Lactose, Sucrose, Dextrose
Artificial- Saccharin, Aspartame, Cyclamate
MECHANISMS OF DRUG RELEASE
The drug releases from the FDT due to the action of super
disintegrants and generally by swelling of the porous matrix.
MECHANISM OF SUPERDISINTEGRANTS
Due to deformation
Tablet moulding
Direct compression
Spray drying
Sublimation
Mass extrusion
rapidly.
high specific surface area, which dissolves rapidly and show improved
The dried cylinder can also be used to coat granules of bitter tasting
drugs
centrifugal force.
good flow properties and compressibility. The candy floss can then be
milled
Orasolv Technology
Durasolv Technology
Oraquick Technology
Quick-Dis Technology
Nanocrystal Technology
ZYDIS TECHNOLOGY
A Zydis tablet is produced by lyophilizing or freeze-drying the drug in
a
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.
ORASOLV TECHNOLOGY
lubricant.
blisters.
compressed.
drugs.
Tapped density = W / Vf
Moisture content
Some of the Marketed ODTs in India
Name of product Active Ingredient
The test can be carried out by keeping ten tablets along with calcium
chloride in a desiccator maintained at 37 °C for 24 hrs to ensure
complete drying of the tablets.
The tablets are then weighed and exposed to 75% RH, at room
temperature for 2 weeks. The required humidity can be achieved by
keeping saturated sodium chloride solution in the dessicator for 24
hrs.
The USP 1 (basket) apparatus may have certain application for such
tablets but is used less, frequently due to specific physical properties
of tablets.
Improved efficacy
ODTs may be suitable for oral delivery of drugs such as proteins and
peptide based therapeutics that has limited bioavailability when
administered by conventional tablets.