INTRODUCTION:

Oral route of administration is the most convenient and promising route for the delivery of variety of dosage form. Conventional oral method of administration is the patient friendly dosage form due to accuracy of dosage, self medication and ease of administration.¹ The routine dosage form includes tablets and capsules, which are to be swallowed with water. However the certain group of patients such as pediatric, geriatric, mentally ill, non responsive patients find difficulty in swallowing the dosage form.² Fast dissolving tablets are the newer form of drugs which do not require water for their intake. They are not chewable and are very easy to take for the patients who have difficulty in taking tablets or capsules. These tablets can be dissolved into the mouth within a matter of seconds.

These release the drug in the mouth with the help of saliva and immediately show their effect.^3,4 These tablets are designed for the patient’s compliance. These can be given to the pediatric, geriatric or the patients who are bedridden or who have problem in swallowing of tablets. These are the solid dosage form which on placing on tongue disintegrate immediately and shows its instant effect.⁵

According to European pharmacopoeia, fast dissolving tablets should show their effect in less than three minutes because they should have instant action and if they delay this time period then they cannot be considered as fast dissolving tablets.⁶ They are also known as oral dispersing tablets, mouth-in-melt tablets, quick dissolving tablets, porous tablets, mouth dissolving tablets etc. these tablets get dissolve or disperse or disintegrate in the saliva and release the drug in mouth, pharynx and esophagus while going into the mouth.⁷ The fast dissolving dosage form provides fastest onset of action and increases bioavalbility. As the drug directly disintegrates in the mouth, so these do not undergo first pass metabolism due to which the chances of liver dysfunction also decreases. The bioavailability of these drugs may be increased due to the absorption in the oral cavity as most of the drug is absorbed in the mouth and start showing its effect. After the release of the drug, they immediately go to the target site where ever the instant action of drug is needed.⁸

The tablet is most widely used dosage form existing today because of its convenience in terms of self-administration, compactness (small size) and ease in manufacturing.⁹ It is the innovative drug delivery system that scientists have developed. Also called as Mouth Dissolving / Disintegrating tablets or Orally dispersible tablets or Orodispersible tablets or Quick Disintegrating Tablet or Porous tablet or Rapid melt tablet. They disintegrate /dissolve immediately in the mouth, useful for the bed ridden and patients who have swallowing problem.¹⁰ The benefits of MDTs is to improve patients compliance, rapid onset of action, increased bioavailability and good stability which make these tablets popular as a dosage form of choice in the current market.¹¹

CHARACTERSTICS^{12, 13}

They should-

1) Does not require water to swallow and should dissolve or disintegrate in the mouth within a few seconds.

2) Allow high drug loading.

3) Be compatible with taste masking and other excipient.

4) Have a pleasing mouth feel.

5) Leave minimal or no residue in the mouth after oral administration.

6) Have sufficient strength to withstand the rigors of the manufacturing process and post manufacturing handling.

7) Exhibit low sensitivity to environmental conditions such as humidity and temperature.

8) Be adaptable and amenable to existing processing and packaging machinery.

9) Allow the manufacture of tablets using conventional processing and packaging equipment at low cost.

10)Cost effective.

DISADVANTAGES^{12, 13}

1) It must be kept in dry place due to its hygroscopic nature i.e. it can rapidly come in contact with water.

2) If not formulated properly, then it may leave an unpleasant taste in the mouth which should be taken care off.

3) Drugs which have large doses are difficult to formulate into FDT.

4) The tablets usually have insufficient mechanical strength. Hence, careful handling is required during manufacturing process.

5) Some time it possesses mouth feeling.

6) Fast dissolving tablets requires special packaging for properly stabilization & safety of stable product.

PATENTED TECHNOLOGIES FOR FAST DISSOLVING TABLETS:

1) Lyoc (Cephalon Corporation):

Lyoc technique was owned by Cephalon Corporation. Lyoc utilizes a freeze drying process but differ from Zydis in that the product is frozen on the freeze dryer shelves. The liquid solution or suspension preparation evolves fillers, thickening agents, surfactant, nonvolatile flavoring agents and sweeteners along with drug. This homogeneous liquid is placed in blister cavities and subjected to freeze drying. To prevent inhomogeneity by sedimentation during this process, these formulations require a large proportion of undissolved inert filler (mannitol), to increase the viscosity of the in process suspension. The high proportion of filler reduces the potential porosity of the dried dosage form and results in denser tablets with disintegration rates are comparable to loosely compressed fast melt formulations.¹⁴

2) Frosta (Akina):

It utilizes the concept of formulating plastic granules and compressing them at low pressure to produce strong tablets with high porosity. Plastic granules composed of porous and plastic material, water penetration enhancer, and binder. The process involves mixing the porous plastic material with water penetration enhancer followed by granulating with binder. The tablets obtained have excellent hardness and rapid disintegration time ranging from 15 to 30 sec depending on size of tablet.¹⁵

3) AdvaTab (Eurand):

Wagh et al. International Journal of Drug Delivery 2 (2010) 98-107 104 In this technology, microencapsulation process is used for coating the drug particles with gastro soluble polymer so as to mask the taste along with restriction of drug dissolution in mouth cavity. AdvaTab tablets disintegrate rapidly in the mouth, typically in less than 30 seconds. These tablets are especially suited to those patients that experience difficulty in swallowing capsules and tablets. AdvaTab is distinct from other orally disintegrating tablet technologies as it can be combined with Eurand’s complimentary particle technologies like its world leading Microcaps® (tastemasking technology) and its Diffucaps® (controlled release technology).¹⁶

4) OraQuick (KV Pharmaceutical Co., Inc.):

OraQuick utilizes its own patented taste masking technology i.e. MicroMask®. In MicroMask® technology, taste masking process is done by incorporating drug into matrix microsphere. In this technique, tablet is prepared by dissolving the sugar (sucrose, mannitol, sorbitol, xylose, dextrose, fructose or mannose) and protein (albumin or gelatin) in a suitable solvent such as water, ethanol, isoproryl alcohol and ethanol-water mixture. The solution of matrix is then spray dried, yielding highly porous granules. Also, utilization of lower heat of production is advantageous for heat-sensitive drugs. Granules formed then mixed with drug and other excipients and compressed at low compression force. KV pharmaceuticals claimed that matrix formed protects and surrounds the drug powder in micro encapsulated particles is more reliable during this step.¹⁷

5)Multiflash (Prographarm):

Multiflash is a multi-unit tablet composed of coated microgranules and fast-disintegrating excipients. This multiparticulate tablet quickly disintegrates in the esophagus after being swallowed with a minimum amount of water. This tablet avoids mucosal adhesion, and coated pellets can match various dissolution rates.¹⁸

6) EFVDAS (Elan Corporation):

EFVDAS or Effervescent Drug Absorption System is a drug delivery technology that has been used in the development of a number of both OTC and prescription medications. This is particularly advantageous for conditions such as colds and flu, for which Elan has modified its EFVDAS technology to develop hot drink sachet products that combine medicines and vitamins for OTC use. The granular contents of the sachets can be added to boiling water to produce pleasant-flavored solutions. In these cases the effervescence of the granulate mixture is modified to accommodate the use of heated water. Examples of products that Elan has developed include effervescent ibuprofen, acetaminophen, cimetidine, naproxen, and acetaminophen and codeine combination product. ¹⁹

7) Pharmaburst technology:

SPI Pharma, New Castle have a patent over this technology. It utilizes the coprocessed excipients to develop MDTs, which dissolves within 30-40 s. This technology involves dry blending of drug, flavour, and lubricant followed by compression into tablets. Tablets obtained have sufficient strength so they can be packed in blister packs and bottles.²⁰

8) Nanocrystal technology:

Elan, King of Prussia have a patent over this technology. This technology includes Nanocrystal colloidal dispersions of drug substance are combined with water-soluble GRAS (Generally Regarded As Safe) ingredients, filled into blisters, and lyophilized. The resultant wafers are remarkably robust, yet dissolve in very small quantities of water in seconds. This method avoids manufacturing process such as granulation, blending, and tabletting, which is more advantageous for highly potent and hazardous drugs. As manufacturing losses are negligible, this process is useful for small quantities of drug.²¹

9) Frosta technology:

A new technology called Frosta (Akina) was developed for making FMTs. The Frosta technology utilises the conventional wet granulation process and tablet press for cost-effective production of tablets. The Frosta tablets are mechanically strong with friability of < 1% and are stable in accelerated stability conditions when packaged into a bottle container. They are robust enough to be packaged in multi-tablet vials. Conventional rotary tablet presses can be used for the production of the tablets and no other special instruments are required. Thus, the cost of making FMTs is lower than that of other existing technologies. Depending on the size, Frosta tablets can melt in < 10 s after placing them in the oral cavity for easy swallowing. The Frosta technology is ideal for wide application of FMTs technology to various drug and nutritional formulations. ^15,
22

10) Dispersible tablet technology:

Lek in Yugoslavia have a patent over this technology. Dihydroergotoxine is poorly soluble in water in the free base form. An improved dissolution rate of dihydroergotoxine methane sulphonate was observed with dispersible tablets containing 0.8-10%, preferably about 4% by weight, of an organic acids. One of the essential excipients in the cimetidine formulation was a disintegrating agent. The disintegrating agents include starch or modified starches, microcrystalline cellulose, alginic acid, cross-linked sodium carboxymethyl cellulose, and cyclodextrin polymers. Dihydroergotoxine and cimetidine, which were claimed to disintegrate in less than 1 minute when in contact with water at room temperature.²³

11) Durasolv Technology:

Durasolv is the patented technology of CIMA labs .The tablets made by this technology consist of drug, filter and a lubricant. Tablets are prepared by using conventional tabletting equipment and have good rigidity. These can be packaged into conventional packaging system like blisters. Durasolv is an appropriate technology for product requiring low amounts of active ingredients.²⁴

12) WOWTAB (Yamanouchi Pharma Technologies, Inc):

The WOWTAB fast-dissolving/disintegrating tablet formulation has been on the Japanese market for a number of years. It has just recently been introduced into the U.S. The WOWTAB technology utilizes sugar and sugar-like (e.g., mannitol) excipients. The two different types of saccharides are combined to obtain a tablet formulation with adequate hardness and fast dissolution rate. Due to its significant hardness, the WOWTAB formulation is a bit more stable to the environment than the Zydis or OraSolv. It is suitable for both conventional bottle and blister packaging. The taste masking technology utilized in the WOWTAB is proprietary, but claims to offer superior mouthfeel due to the patented SMOOTHMELT action .The WOWTAB product dissolves quickly in 15 seconds or less. The WOW in WOWTAB signifies the tablet is to be given With Out Water. Two WOWTAB formulations currently on the U.S. market are Benadryl Allergy & Sinus FASTMELT and Children's Benadryl Allergy & Cold FASTMELT.²⁵

SUPERDISINTEGRANTS:

Disintegrating agents are agents which are included in the tablet formulations to aid in the breakup of compacted mass when it is put into the fluid environment. It promotes moisture penetration and dispersion of tablet matrix. It is used in lower concentration and disintegration is at higher rate. Improved compressibility, compactibility.²⁶ No negative impact on mechanical strength of formulation containing higher dose drugs.²⁷ Natural superdisintegrants like gum karaya, modified starch, agar etc. Natural origin preferred over semi-synthetic substances because they are cheaper, abundantly available, non-irritating, non-toxic in nature.²⁸

Selection Criteria for Superdisintegrants^{27, 29}

1. Proceed for rapid disintegration, when tablet come in contact with saliva in mouth/oral cavity.

2. Be compactable to produce less friable tablets.

3. Produce good mouth feel to patients, thus small particle size is preferred to achieve patient compliance.

4. Have good flow, since it improves the flow characteristics of total blend.

Mechanism of Superdisintegrants:

Capillary action:

Disintegration by capillary action is always the first step. When we put the tablet into suitable aqueous medium, the medium penetrates into the tablet and replaces the air adsorbed on the particles, which weakens the intermolecular bond and breaks the tablet into fine particles. Water uptake by tablet depends upon hydrophilicity of the drug /excipient and on tableting conditions. For these types of disintegrants, maintenance of porous structure and low interfacial tension towards aqueous fluid is necessary which helps in disintegration by creating a hydrophilic network around the drug particles. Crospovidone and croscaramellose sodium shows wicking effect by capillary action as shown in fig 1.³⁰

Fig 1: Diagramatic representation of capillary action (Wicking action)

Swelling:

Perhaps the most widely accepted general mechanism of action for tablet disintegration is swelling as shown in fig 2. Tablets with high porosity show poor disintegration due to lack of adequate swelling force. On the other hand, sufficient swelling force is exerted in the tablet with low porosity. It is worthwhile to note that if the packing fraction is very high, fluid is unable to penetrate in the tablet and disintegration is again slows down.^{31, 32}

Fig 2: Diagramatic representation of swelling action

Heat wetting:

When disintegrants with exothermic properties gets wetted, localized stress is generated due to capillary air expansion, which helps in disintegration of tablet. This explanation, however, is limited to only a few types of disintegrants and cannot describe the action of most modern disintegrating agents.^33,34

Due to release of gases:

Carbon dioxide released within tablets on wetting due to interaction between bicarbonate and carbonate with citric acid or tartaric acid. The tablet disintegrates due to generation of pressure within the tablet. This effervescent mixture is used when pharmacist needs to formulate very rapidly dissolving tablets or fast disintegrating tablet.. As these disintegrants are highly sensitive to small changes in humidity level and temperature, strict control of environment is required during manufacturing of the tablets. The effervescent blend is either added immediately prior to compression or can be added in to two separate fraction of formulation.³⁵

By enzymatic action:

Here, enzymes present in the body act as disintegrants. These enzymes destroy the binding action of binder and helps in disintegration. Actually due to swelling, pressure exerted in the outer direction or radial direction, it causes tablet to burst or the accelerated absorption of water leading to an enormous increase in the volume of granules to promote disintegration.³⁶This is represented in fig 3.

Fig 3: Diagramatic representation of disintegration by enzymatic action

Deformation:

Starch grains are generally “elastic” in nature means that grains that are deformed under pressure will return to their original shape when that pressure is removed. But, when the compression forces involved in tableting applied, then these grains are deformed permanently and are said to be “energy rich” with this energy being released upon exposure to water. In other words, the ability for starch to swell is higher in “energy rich” starch grains than it is for starch grains that have not been deformed under pressure. It is believed that no single mechanism is responsible for the action of most disintegrants. But rather, it is more likely the result of inter-relationships between these major mechanisms as shown in fig 4.³⁷

Fig 4: Diagramatic representation of deformation

METHODS OF PREPARATION OF MOUTH DISSOLVING TABLETS:

1. Freeze drying:

It means drying at low temperature under condition that involves the removal of water by sublimation. In this, the drug is dissolved in aqueous solution of carrier. The mixture is poured into the wells of the preformed blister packs. The trays holding the blister packs are passed through liquid nitrogen freezing tunnel to freeze the drug solution. Then the frozen blister packs are placed in refrigerated cabinets to continue the freeze drying. Finally the blisters are packaged and shipped.³⁸The fig 5 represents the freeze dryer.

Fig 5: Freeze dryer

2. Moulding:

In this method, molded tablets are prepared by using water-soluble ingredients so that the tablets dissolve completely and rapidly. A water-soluble ingredients with a hydro-alcoholic solvent is used and is molded into tablets under pressure lower than that used in conventional tablet compression as shown fig 6.³⁹

Fig 6: Moulding method

3. Cotton candy process:

This process is so named as it utilizes a unique spinning mechanism to produce floss-like crystalline structure, which mimic cotton candy. Cotton candy involves the formation of matrix of polysaccharides by simultaneous action of flash melting and spinning. This candy floss matrix is then milled and blended with active ingredients and excipients after re-crystallization and subsequently compressed to FDT as shown in fig 7.⁴⁰

Fig 7: Cotton candy method

4. Spray drying:

This technology produces highly porous and fine powders as the processing solvent is evaporated during the process. In this method, hydrolyzed and non-hydrolyzed gelatins as supporting agents, mannitol as bulking agent, sodium starch glycolate or cross carmellosesodium as disintegrating agent and an acidic material (e.g. citric acid) and / or alkali material (e.g. Sodium bicarbonate) to enhance disintegration /dissolution as shown in fig 8.^41,42

Fig 8: Spray drying

5. Mass extrusion:

This technology involves softening the active blend using the solvent mixture of water-soluble polyethylene glycol and methanol and subsequent expulsion of softened mass through the extruder or syringe to get a cylinder of the product into even segments using heated blade to form tablets. The dried cylinder can be used to coat the granules of bitter tasting drugs and thereby masked their bitter taste.⁴³

6. Melt granulation:

In this process, MDTs can be prepared by incorporating a hydrophilic waxy binder (super polystate) PEG-6-stearate. Super polystate is a waxy material with an m. pt. of 33-37°C and a hydrophilic- lipophilic balance of 9. It not only acts as a binder and increases the physical resistance of tablets, but also helps in the disintegration of tablets as it melts in the mouth and solubilizes rapidly leaving no residue. Super polystate was incorporated in the formulation of MDTs by melt granulation method where granules are formed by the molten form of this material.⁴⁴

7. Phase transition process:

Tablets were produced by compressing a powder containing two sugar alcohols with high and low melting points and subsequent heating at a temperature between their melting points. Before heating process, the tablets do not have sufficient hardness because of low compatibility. The tablet hardness was increased after heating process, due to the increase of inter particle bond induced by phase transition of lower melting point sugar alcohol.^45,46

8. Sublimation:

The presence of a highly porous structure in the tablet matrix is the key factor for rapid disintegration of MDTs. Inert solid ingredients that volatilize rapidly like urea, camphor ammonium carbonate, ammonium bicarbonate, hexamethylenetetramine) 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 structure.^{47, 48}

9. Direct compression methods:

This is most popular technique because of its easy implementation and cost-effectiveness. The basic principle involves addition of disintegrants and water soluble excipients and effervescent agents. Superdisintegrants in optimum concentration (about 2-5%) are mostly used so as to achieve rapid disintegration along with the good mouth feel.

Table 1: Different marketed formulations

Trade name	Active drug	Manufacturer
Ugesic	Piroxicam	Mayer organic Ltd.
Torrox MT	Rofecoxib	Torrent pharma
Esulide MD	Nimesulide	Doff Biotech
Vomidon md	Domperidone	Olcare lab
kazoldil MD	Nimesulide	kaizen drugs
Zofer MD	Ondansetron	Sun pharma
Mosid md	Mosapride	Torrent pharma
Valus	Valdecoxib	Galen mark
Ondem MD	Ondencetrom	Alkempharma
Nimulid MDT	Nimesulide	Panacea Biotech
Rofixx md	Rofecoxib	Cipla ltd. Mumbai ,India
OlanexIstab	Olanzapine	Ranbaxy Labs Ltd.
Romilast	Montelukast	Ranbaxy Labs Ltd.
Zontec MD	Cetrizine	Zostapharma
India Nime MD	Nimesulide	Maiden pharma
Lonazep MD	Olnazepine	Sun pharma

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Received on 28.04.2016 Accepted on 10.06.2016

Asian J. Pharm. Tech. 2016; 6 (3): 148-154.

DOI: 10.5958/2231-5713.2016.00021.0