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NAME: SABA ERUM

YEAR OF STUDY: FINAL PROF
DEPARTMENT: PHARMACY
UNIVERSITY: UNIVERSITY OF SINDH JAMSHORO
TOPIC OF ASSIGNMENT: ORAL DISINTEGRATING TABLET
EMAIL ADDRESS: perwashaerum@gmail.com

Table of Contents
SUMMARY: .................................................................................................................................................... 2
INTRODUCTION: ........................................................................................................................................ 2
IMPORTANCE OF ODTs: ........................................................................................................................... 3
ADVANTAGES: ...................................................................................................................................... 3
LIMITATIONS: ........................................................................................................................................ 3
CHALLENGES IN THE FORMULATION OF ODTS: ........................................................................................ 4
MOST COMMON EXCIPIENTS USED IN ODTS FORMULATIONS: ............................................................... 4
TECHNOLOGIES USED FOR ODTS FORMULATIONS:.................................................................................. 4
FREEZE DRYING/ LYOPHILIZATION: ....................................................................................................... 5
MOLDING: ............................................................................................................................................. 5
SUBLIMATION: ...................................................................................................................................... 5
SPRAY DRYING:...................................................................................................................................... 5
MASS EXTRUSION: ................................................................................................................................ 6
DIRECT COMPRESSION:......................................................................................................................... 6
ORAL FILMS/WAFERS: ........................................................................................................................... 6
NANOCRYSTAL TECHNOLOGY: .............................................................................................................. 6
COTTON CANDY METHOD: ................................................................................................................... 6
PHASE TRANSITION METHOD: .............................................................................................................. 6
EVALUATION OF FAST DISSOLVING TABLETS:........................................................................................... 6
PRECOMPRESSION CHARACTERIZATION OF TABLETS: ......................................................................... 7
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POSTCOMPRESSION CHARACTERIZATION OF TABLETS: ....................................................................... 7

CONCLUSION:............................................................................................................................................ 7
REFERENCES: ................................................................................................................................................. 7

TITLE OF ARTICLES:
1. Oral disintegrating tablets: A review
2. Predicting oral disintegrating tablet formulations by neural network
techniques.
3. The technologies used for developing orally disintegrating tablets: A review
4. Oral Disintegrating Tablets: Background and Review on Recent
Advancements
5. Evaluation of preparation methods for orally disintegrating tablets
6. Oral disintegrating tablets: A future compaction

NOTE: The references of the above mentioned articles are at the end of
reference heading. I am also attaching my above mentioned articles in PDF form
with the email too.

SUMMARY:
INTRODUCTION:
Oral disintegrating tablet is a unit dosage form is also known as fast or rapid dissolving tablets,
quick melts, fast disintegrating and orodispersible systems, porous tablets, mouth dissolving
tablets and rapimelts, which disintegrates within a 3 minutes or 3 seconds in buccal cavity
without using any liquid. It is one of the convenient dosages which includes in the aims of the
recent advances in novel drug delivery system (NDDS) to enhance the efficacy, safety of drug
molecules and compliance for the geriatric, paediatric populations. The mechanism of its
disintegrating or dissolving will help in the dysphasia conditions and in those conditions where
it is difficult to swallow or chewing any tablets or capsules. When the ODT (oral disintegrating
tablets) are put on the tongue, it will disintegrate rapidly and absorbed into bloodstream from
the oral cavity without the need of any fluid. These form of dosage forms have advantages over
the other conventional forms of drugs because it bypass hepatic metabolism which means it
become more available in systematic circulation and lead to the higher bioavailability and
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therapeutic efficacy. The ODT formulation defined by the Food and Drug Administration (FDA)
as “a solid dosage form containing medicinal substances which disintegrates rapidly, usually
within a matter of seconds when placed upon the tongue”.

The excipients used in ODT technology are mostly hydrophilic in nature and it may be selected
on the basis of drug's physicochemical properties like hydrophilicity or hydrophobicity. If the
active pharmaceutical ingredient is hydrophobic in nature, then dosage form is known as
disintegrating tablet whereas, if it is hydrophilic, then the dosage form is known as fast
dissolving tablet.

IMPORTANCE OF ODTs: Following are few importances of oral disintegrating

tablets.

ADVANTAGES: It includes;
 No need of water to dissolve/ disintegrate/ swallowing purposes.
 Allows high drug loading.
 No chewing or any mechanical forces needed.
 Better taste by masking the bitter taste of drug.
 Improved stability.
 Suitable for controlled/sustained release actives.
 Ability to provide advantages of liquid medication in the form of solid preparation.
 Adaptable and amenable to existing processing and packaging machinery.
 Cost- effective.
 No risk of suffocation due to physical obstruction when swallowed, thus offering
improved safety.
 ODTs are suitable for sustained and controlled release actives.
 Unit packaging.
 Can be easily administered to paediatric, elderly and mentally disabled patients.
 No residue in the oral cavity after administration.
 As it bypass the hepatic metabolism, it will absorb more in systematic circulation.

LIMITATIONS:
 The tablets usually have inadequate mechanical strength because have a porous and
soft molded matrix which makes difficult to handle.
 The tablets with bitterr actives are difficult to formulate so, properly masking
techniques.
 Drugs which have large doses, can cause problems to formulate them into ODTs.
 Patients who simultaneously take anticholinergic drugs are not suitable candidates for
ODTs.
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 ODTs are sensitive towards humidity and temperature.

 Drugs with a shorter half-life and frequent dosing are unsuitable.
 Mostly are hygroscopic in nature so, it required specialized packaging.
 Decreasing the amount of saliva which can occur as a result of taking drug formulations
like some antidepressants, can directly affect the bioavailability of the ODT formulations
in a negative way.

CHALLENGES IN THE FORMULATION OF ODTS:

 To achieve proper mechanical strength is difficult which is directly related to
disintegration time of ODTs.
 It is challenge to achieve such as dosages forms which dissolve rapidly in buccal cavity.
 Selection of polymer and its quantity/ concentration for the coating of drug particles is a
complicated task since the thickening of drug particle coating or pH dependent solubility
of coated polymers.
 It is a big challenge to achieve a better taste for bitter active drugs.
 To achieve better patients compliance, it is estimated that no residue should persist in
the mouth after its disintegrations.
 To achieve such a ODTs which are less sensitive towards the humidity and temperature.
 It is challenges to adopt such as technologies for the development of ODTs which is cost
effective too.

MOST COMMON EXCIPIENTS USED IN ODTS

FORMULATIONS:
Excipients with types and range of its use (% in weight) are in following tables:

Types of excipients Examples W / W (%)

Binders Polyvinyl alcohol, hydroxyl propyl etc. 5-10
Antistatic agents Sodium lauryl sulfate, polyoxyethylene stearates etc. 0-10
Diluents Magnesium carbonate, calcium sulphate etc. 0-85
Superdisintegrants Sodium starch, glycolate, carboxy methyl cellulose. 1-15

TECHNOLOGIES USED FOR ODTS FORMULATIONS:

The various technologies adopted to prepare ODTs are:

1. Freeze drying / Lyophilization

2. Molding
3. Sublimation
4. Spray drying
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5. Mass extrusion
6. Direct compression
7. Oral films/wafers
8. Nanocrystal Technology
9. Cotton Candy Method
10. Phase Transition Method

FREEZE DRYING/ LYOPHILIZATION:

It is one of the first generation techniques of preparing ODT, in which water sublimes from the
product after freezing. It involves the removal of water from the frozen drug solution or a
suspension containing structure-forming excipients under the low temperature and desired
pressure (−55°C and 0.44 mbar) by the application of vacuum to remove water by sublimation.
Active ingredients are dissolved in an aqueous solution, transferred to preformed blisters and
subjected to flush to freeze out with nitrogen, then placed in a refrigerator to complete the
process. The final product (tablet) formed from this method is highly porous that allow, rapid
dissolution.

MOLDING:
The mixture of active with solvent molded by one of the two methods (compression molding
and heating molding) into tablets under low pressure than in conventional tablets compression
method. The resulted tablets have higly porous structure, which increase the disintegration rate
of the product. Mostly the hydroalcholic solvent and water soluble materials are used for this
methodology/ technique.

SUBLIMATION:
The highly porous structure of a product is key for the rapid dissolution of it. In this method the
easily evaporated solids like ammonium carbonate, urea, ammonium bicarbonate, and
camphor are used in formulation of ODTs. Then, these volatile substances removed via
evaporation by sublimation method in order to formed ODTs. Easily evaporated solid ingredients
like camphor are used in the ODT.

SPRAY DRYING:
This method is used to a great extent in pharmaceutical and biochemical procedures for the
formulation of ODTs. It is rapid and economically efficient way to eliminate solvents and
produced highly porous structure which will increase its ability to disintegrate rapidly. This
method was employed by Allen and wang.
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MASS EXTRUSION:
In this technique the mixture of active with other water soluble ingredients is extruded through
the syringe/ extruder to get the product, which is finally cut into segments with the help of
heated blades to get tablets. Then the dried tablets masked due to its bitter taste.

DIRECT COMPRESSION:
It is easiest and economically cost effective technique, in which combinations of excipients with
active undergo direct compression to form a product which can provide fast disintegration and
optimum physical resistance.

ORAL FILMS/WAFERS:
In this technique the water soluble film forming polymers (e.g. sodium alginate, carboxy
methylcellulose), active and taste masking agents are dissolved in a non-aqueous solvent. After
the evaporation of the solvent, a film is formed. By this method different methods can be
evaluate for ODTs in term of production and quality control parameters.

NANOCRYSTAL TECHNOLOGY:
This technology is based on the decreasing the particles size to nanoscale which is obtained by
milling. The tablet formed by this method is very fast disintegrated.

COTTON CANDY METHOD:

This method includes the polysaccharides matrix of melting suddenly. Then, this candy matrix is
blended with an active material and other formulation ingredients to ODT formulation.

PHASE TRANSITION METHOD:

In this method the ODTs formed by combination of high and low melting point sugar alcohols,
and providing phase transition during production.

Where, other new method for the formulation of ODTs are also in research study which are
direct compression process by artificial neural network (ANN) and deep neural network (DNN)
techniques. The implementation of these predictable models of formulations will may be
effectively reduce drug product development timeline and material usage, and proactively
facilitate the development of a robust drug product.

EVALUATION OF FAST DISSOLVING TABLETS:

1. Precompression characterization of tablets
2. Postcompression characterization of tablets
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PRECOMPRESSION CHARACTERIZATION OF TABLETS:

It includes these tests: Angle of repose, Bulk density and tapped density, and Hausner’s ratio.

POSTCOMPRESSION CHARACTERIZATION OF TABLETS: It includes

Weight variation test, Tablet hardness, Tablet Friability, Wetting time, in-vitro, in-vivo
disintegration tests, taste sensation/mouth feel, Thickness, In vitro dispersion time and Water
absorption ratio (R).

CONCLUSION:
As a conclusion; by the comparison of ODTs with conventional oral dosage forms, we can say
that it have an important advantages like patients compliance and high bioavailability.
Nevertheless, it have some disadvantages also like packaging and handling problems., but it
consider as the first option for geriatric and paediatric populations and also for those having
problem in swallowing .

REFERENCES:
 Dahiya, M. (2016). Oral Disintegrating Tablets: A Review.

 Han, R., Yang, Y., Li, X., & Ouyang, D. (2018). Predicting oral disintegrating tablet
formulations by neural network techniques. Asian Journal of Pharmaceutical Sciences,
13(4), 336–342. https://doi.org/10.1016/j.ajps.2018.01.003
 Badgujar, B., & Mundada, A. (2011). The technologies used for developing orally
disintegrating tablets: A review. Acta Pharmaceutica, 61(2), 117–139.
https://doi.org/10.2478/v10007-011-0020-8
 Gujarati, N. (2017). Oral Disintegrating Tablets: Background and Review on Recent
Advancements.
 Akdag, Y., Gulsun, T., Izat, N., Cetin, M., Oner, L., & Sahin, S. (2020). Evaluation of
preparation methods for orally disintegrating tablets. Medicine Science | International
Medical Journal, 9(1), 259. https://doi.org/10.5455/medscience.2019.08.9167
 Rangasamy, M. (2009). Oral disintegrating tablets: A Future compaction.