Available Online at www.ijpba.info.

International Journal of Pharmaceutical & Biological Archives2010; 1(1): 1 – 10

REVIEW ARTICLE

Recent Trends of Fast Dissolving Tablet - An Overview of

Formulation Technology

A Gupta1*, AK Mishra1, V Gupta1, P Bansal2, R Singh3, AK Singh4

1
National Institute of Ayurvedic Pharmaceutical Research, Patiala, India.
2
Baba Farid University of Health Sciences, Faridkot, India.
3
School of Pharmaceutical Sciences, Shobhit University, Meerut, India.
4
National Botanical Research Institute, Rana Pratap Marg, Lucknow, India.

ABSTRACT
In recent decades, a variety of pharmaceutical research has been conducted to develop
new dosage forms. Among the dosage forms developed to facilitate ease of medication, the rapid
disintegrating tablet (RDT) is one of the most widely employed commercial products. As our
society is becoming increasingly aged, the development of Fast- or mouth dissolving tablets have
been formulated for pediatric, geriatric, and bedridden patients and for active patients who are
busy and traveling and may not have access to water. Such formulations provide an opportunity
for product line extension in the many elderly persons will have difficulties in taking
conventional oral dosage forms (viz., solutions, suspensions, tablets, and capsules) because of
hand tremors and dysphagia. Swallowing problems also are common in young individuals
because of their underdeveloped muscular and nervous systems. Other groups that may
experience problems using conventional oral dosage forms include the mentally ill, the
developmentally disabled, and patients who are uncooperative, on reduced liquid-intake plans, or
are nauseated. In some cases such as motion sickness, sudden episodes of allergic attack or
coughing, and an unavailability of water, swallowing conventional tablets may be difficult. This
paper summarizes the formulation methods and drug formulation coming in market.

Key Words: Mouth dissolving, Lyophilization, Direct compression, Fast dissolving tablet.

INTRODUCTION
Recent developments in the technology have drug delivery has lately become an important
presented viable dosage alternatives from oral route of drug administration. Various
route for pediatrics, geriatric, bedridden, bioadhesive mucosal dosage forms have been
nauseous or noncompliant patients. Buccal developed, which includes adhesive tablets,
gels, ointments, patches and more recently the
*Corresponding Author: Abhishek Gupta use of polymeric films for buccal delivery,
Email: abhibbd2006@gmail.com, also known as mouth dissolving films [1]. A
akhileshmishra2010@gmail.com fast-dissolving drug delivery system, in most
Contact No: 09023468460, 09023467630 cases, is a tablet that dissolves or disintrigrants
in the oral cavity without the need of water

1
Abhishek Gupta et al. / Recent Trends of Fast Dissolving Tablet - An Overview of Formulation Technology.
or chewing. Most fast-dissolving delivery Different types of technologies have been
system films must include substances to mask employed for the formulation of mouth
the taste of the active ingredient. This masked dissolving tablets viz freeze-drying, Tablet
active ingredient is then swallowed by the Molding, Direct Compression Method, spray
patient's saliva along with the soluble and drying and sublimation Technology etc. have
insoluble excipients.2-3. These are also called been tried by researchers to maximize the pore
melt-in-mouth tablets, repimelts, porous tablets, structure of tablet matrix [9-13].
oro-dispersible, quick dissolving or rapid
disintegrating tablets, Moth dissolving tablets, Requirements of Fast Dissolving Tablets an
fast dissolving, rapid –dissolve, fast melts, ideal FDT should [14]
Effervescent Drug Absorption system, Orosolv, 1.Require no water for oral administration, yet
Zydis etc. Mouth dissolving films, a new drug dissolve / disperse/ disintegrate in mouth in
delivery system for the oral delivery of the a matter of seconds.
drugs, was developed based on the technology 2.Have a pleasing mouth feel.
of the transdermal patch. The delivery system 3.Have an acceptable taste masking property.
consists of a very thin oral strip, which is 4.Be harder and less friable
simply placed on the patient’s tongue or any 5.Leave minimal or no residue in mouth after
oral mucosal tissue, instantly wet by saliva the administration
film rapidly hydrates and adheres onto the site 6.Exhibit low sensitivity to environmental
of application. It then rapidly disintegrates and conditions (temperature and humidity).
dissolves to release the medication for 7.Allow the manufacture of tablet using
oromucosal absorption or with formula conventional processing and packaging
modifications, will maintain the quick- equipments.
dissolving aspects allow for gastrointestinal
absorption to be achieved when swallowed. In Advantages of Fast Dissolving Tablets [15]
contrast to other existing, rapid dissolving 1.Ease of administration to patients who
dosage forms, which consist of liophylisates, the cannot swallow, such as the elderly,
rapid films can be produced with a strokvictims and bedridden patients; patients
manufacturing process that is competitive with who should not swallow, such as
the manufacturing costs of conventional tablets renalfailure patients; and who refuse to
[4]
. These are novel types; of tablets that swallow, such as paediatrics, geriatric and
disintegrate/dissolve/ disperse in saliva within psychiatric patients [16-17].
few seconds. According to European 2.Patient’s compliance for disabled bedridden
Pharmacopoeia, the ODT should patients and for travelling and busy people,
disperse/disintegrate in less than three minutes. who do not have ready access to water.
The basic approach used in development of 3.Good mouth feel property of MDDDS helps
MDT is the use of superdisintegrants like Cross to change the basic view of medication as
linked carboxymethyl cellulose (Croscar- "bitter pill", particularly for paediatric
meliose), Sodium starch glycolate (Primogel, patients due to improved taste of bitter
Explotab). Polyvinylpyrrolidone (Polyplasdone) drugs.
etc. which provide instantaneous disintegration 4.Convenience of administration and accurate
of tablet after putting on tongue, thereby dosing as compared to liquid Formulations.
releasing the drug in saliva. The bioavailability 5.Benefit of liquid medication in the form of
of some drugs may be increased due to solid preparation.
absorption of drugs in oral cavity and also due 6.More rapid drug absorption from the pre-
to pregastric absorption of saliva containing gastric area i.e. mouth, pharynx and
dispersed drugs that pass down into the oesophagus which may produce rapid onset
stomach. Moreover, the amount of drug that is of action [17-18].
subject to first pass metabolism is reduced as 7.Pregastric absorption can result in improved
compared to standard tablets [5-8]. Another bioavailability, reduced dose and improved
approach used in developing MD tablets is clinical performance by reducing side effects
[19]
maximizing pore structure of the tablets. .

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8.New business opportunities: product where camphor particles previously existed in
differentiation, line extension and life-cycle the compressed tablets prior to sublimation of
management, exclusivity of product the camphor. A high porosity was achieved due
[17-18]
promotion and patent-life extension . to the formation of many pores where camphor
particles previously existed in the compressed
METHODOLOGY EMPLOYED FOR mannitol tablets prior to sublimation of the
FAST DISSOLVING FORMULATIONS camphor. These compressed tablets which have
high porosity (approximately 30%) rapidly
1. Melt granulation dissolved within 15 seconds in saliva [23].
Melt granulation technique is a process Granules containing nimusulide, camphor,
by which pharmaceutical powders are crospovidone, and lactose were prepared by wet
efficiently agglomerated by a meltable binder. granulation technique. Camphor was sublimed
The advantage of this technique compared to a from the dried granules by vacuum exposure
[24]
conventional granulation is that no water or . Conventional methods like dry granulation,
organic solvents is needed. Because there is no wet granulation and direct compression with
drying step, the process is less time consuming highly soluble excipients, super disintegrants
and uses less energy than wet granulation. It is a and/or effervescent systems can also be used.
useful technique to enhance the dissolution rate
of poorly water-soluble drugs, such as 4. Three-dimensional Printing (3DP)
griseofulvin [20]. This approach to prepare FDT Three-dimensional printing (3DP) is a
with sufficient mechanical integrity, involves rapid prototyping (RP) technology. Prototyping
the use of a hydrophilic waxy binder involves constructing specific layers that uses
(Superpolystate©, PEG – 6 – stearate). powder processing and liquid binding materials.
Superpolystate© is a waxy material with a A novel fast dissolving drug delivery device
melting point of 33–37°C and a HLB value of 9. (DDD) with loose powders in it was fabricated
So it will not only act as a binder and increase using the three dimensional printing (3DP)
the physical resistance of tablets but will also process. Based on computer-aided design
help the disintegration of the tablets as it melts models, the DDD containing the drug
in the mouth and solublises rapidly leaving no acetaminophen were prepared automatically by
residues [21]. 3DP system [25]. It was found that rapidly
disintegrating oral tablets with proper hardness
2. Phase transition process can be prepared using TAG. The rapid
It is concluded that a combination of low disintegration of the TAG tablets seemed due to
and high melting point sugar alcohols, as well the rapid water penetration into the tablet
as a phase transition in the manufacturing resulting from the large pore size and large
process, are important for making FDTs without overall pore volume [26].
any special apparatus. FDT were produced by
compressing powder containing erythritol 5. Mass Extrusion
(melting point: 122 °C) and xylitol (melting This technology involves softening of
point: 93 95 °C), and then heating at about 93 the active blend using the solvent mixture of
°C for 15 min. After heating, the median pore water soluble polyethylene glycol and methanol
size of the tablets was increased and tablet and expulsion of softened mass through the
hardness was also increased. The increase of extruder or syringe to get a cylindrical shaped
tablet hardness with heating and storage did not extrude which are finally cut into even segments
depend on the crystal state of the lower melting using heated blade to form tablets. This process
point sugar alcohol [22]. can also be used to coat granules of bitter drugs
to mask their taste [15, 27].
3. Sublimation
In this method a subliming material like 6. Spray Drying
camphor, is removed by sublimation from In this technique, gelatin can be used as
compressed tablets and high porosity is a supporting agent and as a matrix, mannitol as
achieved due to the formation of many pores a bulking agent and sodium starch glycolate or

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crosscarmellose or crospovidone are used as amorphous sugar mass and subsequently
superdisintegrants. Tablets manufactured from converting the remaining portion of the mass to
the spray-dried powder have been reported to complete crystalline structure. This process
disintegrate in less than 20 seconds in aqueous helps to retain the dispersed drug in the matrix,
medium. The formulation contained bulking thereby minimizing migration out of the mixture
[33]
agent like mannitol and lactose, a .
superdisintegrant like sodium starch glycolate & b) Floss Processing
croscarmellose sodium and acidic ingredient The floss formation machine uses flash heat and
(citric acid) and/or alkaline ingredients (e.g. flash flow processes to produce matrix from the
sodium bicarbonate). This spray-dried powder, carrier material. The machine is similar to that
which compressed into tablets showed rapid used in ‘cotton-candy’ formation which consists
disintegration and enhanced dissolution. of a spinning head and heating elements. In the
Maximum drug release and minimum flash heat process, the heat induces an internal
disintegration time were observed with Kollidon flow condition of the carrier material. This is
CL excipient base as compared to tablets followed by its exit through the spinning head
prepared by direct compression, showing the (2000–3600 rpm) that flings the floss under
superiority of the spray dried excipient base centrifugal force and draws into long and thin
technique over direct compression technique floss fibers, which are usually amorphous in
[28]
. nature [34-36].
c) Floss Chopping and Conditioning
7. Cotton Candy Process This step involves the conversion of fibers into
The FLASHDOSE® is a MDDDS smaller particles in a high shear mixer
manufactured using Shearform™ technology in granulator. The conditioning is performed by
association with Ceform TI™ technology to partial crystallization through an ethanol
eliminate the bitter taste of the medicament [29- treatment (1%) which is sprayed onto the floss
30]
. The Shearform technology is employed in and subsequently evaporated to impart
the preparation of a matrix known as ‘floss’, improved flow and cohesive properties to the
made from a combination of excipients, either floss [31].
alone or with drugs. The floss is a fibrous d) Blending and Compression
material similar to cotton-candy fibers, Finally, the chopped and conditioned floss
commonly made of saccharides such as sucrose, fibers are blended with the drug alongwith other
dextrose, lactose and fructose at temperatures required excipients and compressed into tablets.
ranging between 180–266 °F [31]. However, In order to improve the mechanical strength of
other polysaccharides such as polymaltodextrins the tablets, a curing step is also carried out
and polydextrose can be transformed into fibers which involves the exposure of the dosage
at 30–40% lower temperature than sucrose. This forms to elevated temperature and humidity
modification permits the safe incorporation of conditions, (40 °C and 85% RH for 15 min).
thermolabile drugs into the formulation [32. The This is expected to cause crystallization of the
tablets manufactured by this process are highly floss material that results in binding and
porous in nature and offer very pleasant bridging to improve the structural strength of
mouthfeel due to fast solubilization of sugars in the dosage form [37].
presence of saliva. The manufacturing process
can be divided into four steps as detailed below. 8. Tablet Molding
Molding process is of two type’s i.e.
a) Floss Blend solvent method and heat method. Solvent
In this step, 80% sucrose in combination with method involves moistening the powder blend
mannitol/dextrose and 1% surfactant is blended with a hydro alcoholic solvent followed by
to form the floss mix. The surfactant acts as a compression at low pressures in molded plates
crystallization enhancer in maintaining the to form a wetted mass (compression molding).
structural integrity of the floss fibers. It also The solvent is then removed by air-drying. The
helps in the conversion of amorphous sugar into tablets manufactured in this manner are less
crystalline form from an outer portion of compact than compressed tablets and posses a

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porous structure that hastens dissolution. The preparation of ODT because of the availability
heat molding process involves preparation of a of improved excipients especially
suspension that contains a drug, agar and sugar superdisintegrants and sugar based excipients.
(e.g. mannitol or lactose) and pouring the a) Superdisintegrants:
suspension in the blister packaging wells, In many orally disintegrating tablet
solidifying the agar at the room temperature to technologies based on direct compression,
form a jelly and drying at 30○C under vacuum. the addition of superdisintegrants principally
The mechanical strength of molded tablets is a affects the rate of disintegration and hence
matter of great concern. Binding agents, which the dissolution. The presence of other
increase the mechanical strength of the tablets, formulation ingredients such as water-
need to be incorporated. Taste masking is an soluble excipients and effervescent agents
added problem to this technology. The taste further hastens the process of disintegration.
masked drug particles were prepared by spray For the success of fast dissolving tablet, the
congealing a molten mixture of hydrogenated tablet having quick dissolving property
cottonseed oil, sodium carbonate, lecithin, which is achieved by using the super
polyethylene glycol and an active ingredient disintegrants, Some important examples of
into a lactose based tablet triturate form. super disintegrants are given in Table 1
Compared to the lyophillization technique, with their mechanism of action.
tablets produced by the molding technique are b) Sugar Based Excipients:
easier to scale up for industrial manufacture [38]. This is another approach to manufacture
ODT by direct compression. The use of
9. Lyophilization or Freeze-Drying sugar based excipients especially bulking
Freeze drying is the process in which agents like dextrose, fructose, isomalt,
water is sublimed from the product after it is lactilol, maltilol, maltose, mannitol, sorbitol,
frozen. This technique creates an amorphous starch hydrolysate, polydextrose and xylitol,
porous structure that can dissolve rapidly. A which display high aqueous solubility and
typical procedure involved in the manufacturing sweetness, and hence impart taste masking
of ODT using this technique is mentioned here. property and a pleasing mouthfeel.
The active drug is dissolved or dispersed in an Mizumito et al have classified sugar-based
aqueous solution of a carrier/polymer. The excipients into two types on the basis of
mixture is done by weight and poured in the molding and dissolution rate.
walls of the preformed blister packs. The trays
holding the blister packs are passed through 11. Nanonization
liquid nitrogen freezing tunnel to freeze the A recently developed Nanomelt
drug solution or dispersion. Then the frozen technology involves reduction in the particle
blister packs are placed in refrigerated cabinets size of drug to nanosize by milling the drug
to continue the freeze-drying. After freeze- using a proprietary wet-milling technique39. The
drying the aluminum foil backing is applied on nanocrystals of the drug are stabilized against
a blister-sealing machine. Finally the blisters are agglomeration by surface adsorption on selected
packaged and shipped. The freeze-drying stabilizers, which are then incorporated into
technique has demonstrated improved MDTs. This technique is especially
absorption and increase in bioavailability. The advantageous for poor water soluble drugs.
major disadvantages of lyophillization Other advantages of this technology include fast
technique are that it is expensive and time disintegration/dissolution of nanoparticles
consuming; fragility makes conventional leading to increased absorption and hence
packaging unsuitable for these products and higher bioavailability and reduction in dose,
poor stability under stressed conditions [38]. cost effective manufacturing process,
conventional packaging due to exceptional
10. Direct Compression [38] durability and wide range of doses (up to 200
Direct compression represents the simplest and mg of drug per unit) [15].
most cost effective tablet manufacturing
technique. This technique can now be applied to

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Table 1: List of Super Disintegrants
Superdisintegrants Example Mechanism Of Special comment
action
Crosscarmellose® Crosslinked -Swells 4-8 folds in < 10 -Swells in two dimensions.
Ac-Di-Sol® cellulose seconds. -Direct compression or
Nymce ZSX® -Swelling and wicking granulation
Primellose®Solutab® both. -Starch free
Vivasol®L-HPC
Crosspovidone Crosslinked -Swells very little -Water insoluble and
Crosspovidon M® PVP andreturns to original size spongy in nature so get
Kollidon® aftercompression but act porous tablet
Polyplasdone® by
capillary action
Sodium starch Crosslinked -Swells 7-12 folds in < 30 -Swells in three
glycolate starch seconds dimensions and high level
Explotab® serve as sustain
Primogel® release matrix
Alginic acid NF Crosslinked -Rapid swelling in -Promote disintegration
Satialgine® alginic acid aqueous medium in both dry or wet
or wicking action granulation
Soy polysaccharides Natural super -Does not contain any -
Emcosoy® disintegrant starch or sugar. Used in
nutritionalproducts
Calcium silicate -Wicking action Highlyporous,Optimum
concentration is between
20-40%

Important marketed preparation of fast dissolving tablets are listed in table 2 and table
dissolving films and fast dissolving tablets 3 respectively.
There are number of important marketed
preparation of fast dissolving films and fast
[40-46]
Table 2: List of Marketed Fast Dissolving Films
S. No. Product Manufactured By
1. Dextromethorphan HBr (cough suppressant), MonoSolRx
Diphenhydramine Citrate (cough and cold), Breath
Strips
2. Doneprezil rapid dissolving films, Ondansatron rapid Labtec Pharma
dissolving films
3. Life-saving rotavirus vaccine to infants Johns Hopkins undergraduate
biomedical engineering
students
4. Methylcobalamin fast dissolving films, Hughes medical corporation
Diphemhydramine HCl fast dissolving films,
Dextromethorphan fast dissolving films,
Folic Acid 1mg fast dissolving films, Caffeine fast
dissolving films
5. Altoid cinnamon strips, Boots vitamin c strips, Cool Dow chemical company
shock peppermint strips, Benzocaine films, Caffeine
films
6. Listerine Pocket Paks Breath Freshening Strips Pfizer's Warner-Lambert
consumer

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7. Energy strips - Caffeine 20mg, Acetyl Salicylic Acid ODF Technologies Inc.
(ASA), Ondansetron HCl, Dexamethasone,
Nitroglycerine, Risperidone Vitamin B12, melatonin,
folic acid, biotin Benzocaine, Diphenhydramine HCl,
Dextrometorphan

Table 3: List Of Marketed Fast Dissolving Tablets [47-48]

S. No. Trade Name Active Drug Manufacturer
1. Felden fast melt Piroxicam Pfiser Inc., NY, USA
2. Claritin redi Tab Loratidine Schering plough Corp., USA
3. Maxalt MLT Rizatriptan Merck and Co., NJ, USA
4. Zyprexia Olanzapine Eli lilly, Indianapolis, USA
5. Pepcid RPD Famotidine Merck and Co., NJ, USA
6. Zofran ODT Ondansetron Glaxo Wellcome, Middlesex, UK
7. Zoming-ZMT Zolmitriptan AstraZeneca, Wilmington, USA
8. Zeplar TM Selegilline Amarin Corp., London, UK
9. Tempra Quiclets Acetaminophen Bristol myers Squibb, NY, USA
10. Febrectol Paracetamol Prographarm, Chateauneuf,
France
11. Nimulid MDT Nimesulide Panacea Biotech, New delhi ,
India
12. Torrox MT Rofecoxib Torrent pharmaceuticals , India
13. Olanex instab Olanzapine Ranbaxy lab. Ltd. New-delhi,
India
14. Romilast Montelukast Ranbaxy lab. Ltd. New-delhi,
India
15. Benadryl Fastmelt Diphenhydramine Warner Lambert, NY, USA
and pseudoephedrine
16. Propulsid Quicksolv Cisapride monohydrate Janssen pharmaceutics
17. Risperdal MTab Risperidone Janssen pharmaceutics
18. Spasfon Lyoc) Phloroglucinol Hydrate Farmalyoc
19. Nurofen FlashTab) Ibuprofen Ethypharm
20. Tempra Quicklets Paracetamol Cima Labs,Inc.
21. Zolmig Repimelt Zolmitriptan Cima Labs,Inc.
22. (NuLev Hyoscyamine Sulfate Cima Labs, Inc.
23. Gaster D) Famotidine Yamanouchi Pharma Tech. Inc.
24. Cibalgina DueFast Ibuprofen Eurand International
25. Relivia Flash dose Tramadol HCl Fuisz Technology, Ltd.
26. Hyoscyamine Sulfate Hyoscyamine Sulfate KV Pharm.Co.,Inc.
ODT
27. Abilify Discmelt Aripiprazole Otsuka America/Bristol-Myers
Squibb
28. Allegra ODT Fexofenadine Sanofi Aventis
29. Aricept ODT Donepezil Eisai Co.
30. Clarinex RediTabs Desloratadine Schering-Plough
31. Alavert Quick Dissolving Loratadine Wyeth
Tablets
32. Clonazepam ODT Clonazepam Par Pharmaceutical
33. FazaClo Clozapine AzurPharma
34. Jr. Tylenol Meltaways Acetaminophen McNeil Consumer Healthcare
35. Klonopin Wafers[26] Clonazepam Roche

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36. Loratadine Redidose Loratadine Ranbaxy
37. Mirtazapine ODT Mirtazapine Teva Pharmaceuticals
38. Niravam Alprazolam Schwarz Pharma
39. Ondansetron ODT Ondansetron Teva Pharmaceuticals
40. Orapred ODT Prednisolone Sciele Pharma
41. Parcopa Carbidopa/levodopa Schwarz Pharma
42. Prevacid SoluTab Lansoprazole Takeda Pharmaceuticals
43. Remeron SolTab Mirtazapine Schering-Plough
44. Risperdal M-Tab Risperidone Janssen
45. UNISOM SleepMelts Diphenhydramine Chattem
46. Zomig-ZMT Zolmitriptan AstraZeneca
47. Zyprexa Zydis Olanzapine Eli Lilly and Company
48. Citalopram ODT Citalopram Biovail
49. Metoclopramide Zydis Metoclopramide Salix Pharmaceuticals
50. Reglan ODT Metoclopramide Schwarz Pharma[
51. Tramadol/Acetaminophen Tramadol/Acetaminophen Biovail
ODT
52. Zolpidem ODT Zolpidem Biovail

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