Professional Documents
Culture Documents
By
V.SRUJANA
M.Pharm ( 1st SEM )
DEPARTMENT OF PHARMACEUTICS
CONTENTS
Introduction
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;
Separating the different substances eliciting the same taste (sour, bitter,
sweet).
In order to allow ODTs to disintegrate in the oral cavity, they are made of
either very porous and soft-molded matrices or compressed into tablets with
very low compression force, which makes the tablets friable and/or brittle,
difficult to handle, and often requiring specialized peel-off blister packing that
The degree of ease when taking a tablet depends on its size. It has been
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
humidity. Hence, they need protection from humidity which calls for
formation of a glassy solid that may collapse upon drying because loss of
like Mannitol which induces crystallinity and hence impart rigidity to the
amorphous composite.
SHORT HALF-LIFE
maximum amount of dose takes place in the pre-gastric region, these have
Drug
Excipients
THE IDEAL CHARACTERISTICS OF DRUG
3. No bitter taste
4. Dose lower than 20mg
5. Small to moderate molecular weight
6. Good solubility in water and saliva
7. Partially nonionized at the oral cavity’s pH.
8. Ability to diffuse and partition into the epithelium of upper GIT.
9. Ability to permeate oral mucosal tissue.
EXCIPIENTS
FILLER SUPERDISINTEGRANTS
COLOURS
Eg: Carotene, chlorophyll, brilliant blue, Indigotene, Erythrosine
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
a. Deformation b. Repulsion
WICKING AND SWELLING
a. Wicking b. Swelling
FORMULATION TECHNIQUES
COVENTIONAL TECHNIQUES
Tablet moulding
Direct compression
Spray drying
Sublimation
Mass extrusion
Molded tablets are prepared by using water soluble ingredients so that the
molded into tablets under pressure lower than that used in Conventional
Spray drying can produce highly porous and fine powders that dissolve
rapidly.
high specific surface area, which dissolves rapidly and show improved
This technology involves softening the active blend using the solvent
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
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
lubricant.
blisters.
In this technique, saccharides of both low and high mouldability are used
to
compressed.
drugs.
Tapped density = W / Vf
Moisture content
Some of the Marketed ODTs in India
Wb and Wa are the weights of tablet before and after water absorption
HARDNESS TEST
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.
This test are carried out by using any one of the following method
The dissolution method for oral disintegrating tablets is the same as that of
conventional tablets.
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.
Because drugs delivered in ODTs may be absorbed in the pre gastric sites
of highly permeable buccal and mucosal tissues of the oral cavity, they
may be suitable for delivering relatively low-molecular weight and highly
permeable drugs.
CONCLUSION