INTRODUCTION:

The most prescribed route for drug administration is the oral route. Its acceptance is about 55-65% of the total dosage form. Among these the most common are tablets because they can be prepared easily, administered easily, sable and dose uniformity as compared to oral liquids¹.

As it is difficult to swallow conventional tablets and capsules by geriatric and paediatric patients, mouth dissolving tablets were introduced in the later part of 1970s. Paediatric patients do not have developed muscles and nerves thus making swallowing difficult and geriatric patients may be mentally ill or bed ridden, they may be Parkinson patients, in case of non cooperative patients, patients having persistent cough and nausea need to be treated with mouth dissolving tablets. These tablets will be disintegrated in the mouth itself without the requirement of a lot of water for swallowing it. These tablets take about 1minute to dissolve in mouth with the help of saliva². Mouth dissolving tablets increase the bioavailability of the dosage form. A lot of natural and synthetic superdisintegrants are used to make fast disintegrating tablets. Superdisintegrants are substances which provide rapid disintegration in small amount, they help in swelling by taking up water and rapid breakdown in the mouth. These type of formulations are required mainly at the time of emergency³. Fast dissolving tablets can be used for other purposes like, for taste masking and increasing bioavailability. Sometimes there may be choking while swallowing conventional tablets, these are eliminated in MDTs. Good superdisintegrants are better compressable, compatable and mechanical strength on drugs with higher dose⁴. It is also called as orodispersive tablet. Orodispersive tablet is defined as those uncoated tablets that are taken inside the mouth and they disperse quickly within 3 minutes. Orodispersive term was given by European pharmacopoeia⁵. In case of MDT there is no fast pass metabolism. USFDA defined MDTs as “A solid dosage form that containing medicinal substances or active ingredients which disintegrates very rapidly within a few seconds when placed up on tongue”⁶. The centre for drug evaluation and research defines MDTs as “A solid dosage form which disintegrates rapidly within a matter of seconds when placed under the tongue”. European Pharmacopeia defines MDTs as “uncovered tablet which disperse before ingestion in the buccal cavity”⁷.

Advantages of Superdisintegrants^8-10

Good wetting capacity leading to faster disintegration.

No problem of sticking to dyes and punches.

Upon disintegration no lumping is formed.

Shows effect in less concentration.

Compressibility and flow ability is not considerably affected.

Do not adversely interact with additives and APIs which are commonly in use.

They are biodegradeable.

They show more effect intra-granularly.

Disadvantages of Superdisintegrants¹¹

They have higher cost.

Preparing them takes a lot of time.

They have high fragility.

Their sensitivity is high.

They are sensitive to water and are hygroscopic.

Classification Of Superdisintegrants^12-20

Natural superdisintegrants:

Ispaghula Husk Musilage:

It contains the dried seeds obtained from the plant Plantago ovata. It has mucilage inside the seed epidermis. These mucilage shave the quality of binding, dissolving etc. These mucilages have highswelling index so they are used to make fast disintegrating tablets as asuperdisintegrant. Kumar B Sutradhar et al. formulated and evaluated taste masked MDT of domperidone using ispaghula husk as a superdisintegrant, sublimation metod was used and disintegration time is 25 seconds.

Xanthan gum:

It is derived from Xanthomonas campestris. It is hydrophilic and has less tendency of forming gel. Its almost water insoluble and has greater tendency to swell for quick breakdown, hence it is used as superdisintegrant. Mukesh C. Gohel et al. fabricated modified release tablet formulation of metoprolol Succinate using Xanthan Gum. This initiates the disintegration of the dosage form.

Hibiscus Rosa Sinensis Linn Mucilage:

Its synnonyms are China rose, Chinese hibiscus. It contains mucilage inside it in large amount. Mucilage has thickening, spreading, water retaining and disintegrating properties. Its mucilage is used as superdisintegrants for making MDT because of its disintegrating nature. M Kaleemullah et al. developed and evaluated Ketoprofen sustained release matrix tablet using the mucilage of Hibiscus leaves.

Guar Gum:

Its molecular weight is high. It has the properties of thickening and stabilizing. This is why it is used in industries. Disintegrating power depends on its particle size, finer the particle more disintegration. It is generally used as binder and disintegrant in medicine industry. Venkatalakshmi Ranganathan et al. developed and evaluated MDT using guar gum as natural superdisintegrant. Tablet was disintegrated in vivo in 47-160 seconds.

Agar and treated agar:

It is a gel like substance which we get from delirium amansii. Agarose and agaropectin are the two polysaccharides that are present in agar. The strength of gel is due to agarose and viscosity is maintained by agaropectin. If the gel strength of the solution containing agar is high then the disintegrating power will be more hence it can be used in ODTs.

Mucilage of Lepidum Sativum:

Its common name is asaliyo and it is in use as herbal medicine for long time in India. The seeds of this plant contain mucilage which contains monomeric and dimeric imidazoline alkaloids. Hence this mucilage is obtained from the seeds and employed in developing mouth dissolving tablets.

Synthetic Superdisintegrants:

Modified starch (SSG, Primojel):

It is prepared by crosslinking potato starch which results into a compound with very good disintegrating power. Hence they are used in making ODTs. Natural starches swell upto 10-20% while modified starches swell upto 200-300% in water. Crosslinking affects by reducing the water soluble portion of the polymer as well as its viscosity. Remya KS et al. developed, evaluated and comparatively studied effects of superdisintegrants in cefixime oral disintegrating tablets using sodium starch glycolate, the tablet disintegrated within 60seconds.

Cross linked polyvinyl pyrrolidone (crospovidone): This compound readily helps saliva to enter into the tablet which causes the increase the tablet volume and finally cause rapid breakdown of the tablet inside the mouth itself. Its particles are porus in nature which helps the saliva to enter into the tablet and helps breaking it. It does not form gel unlike other superdisintegrants^. B.P. Patel et al. formulated MDT of Cinnarizine using crospovidone as superdisintegrant, the disintegration time is 25.3 seconds^.Andreas Gryczke et al. developed and evaluated orally disintegrating tablet containing Ibuprofen which are prepared through hot melt extrusion method, tablet was disintegrated within 30 seconds.

Alginates:

This polymer derived from seaweeds L-glucoronic and D-mannuronic units. It has greater affinity towards water and great sorption ability making it a very good disintegrant. Alginic acid in the concentration of 1-5% and alginate salt of sodium in 2-10% is mainly used as disintegrants. Ascorbic acid and in multivitamin tablet formulation are its main application. Nishant Vora et al. prepared and optimized MDT using glycine, sodium alginates as superdisintegrants.

Pre-gelatinized starch:

This is made directly from starch grains using a compressed approach that leaves the grains intact and partially hydrolyzed. It also contains pharmacological aids such as a disintegrant, filter, and binder; in this case, the concentration is mostly employed in around 5–10%, and swelling is the primary mode of operation in this case. In a few simple stages, the ppg starches enhanced the tablet's physical characteristics, resulting in ales complicated construction and significantly reduced costs. Its chemical formula provides for quick medication release. Kazuki Mimura et al. formulated study for MDT using pregelatinized starch as a binder.

Semi synthetic superdisintegrants:

Modified Celluloses (Croscarmellose Sodium):

They are not soluble in aqueous medium, it swells by four to eight times when it comes in contact with aqueous phase. Sodium carboxymethylcellulose in crosslinked form has very good absorption ability. Even at low concentrations it has the ability to swell and rapid breakdown ability. During formulation of tablet it can be used during wet granulation as well as dry granulation because of its wicking and ability to swell. Hence, it can be used to formulate fast disintegrating tablets. JinichiFukunamiet al. rapidly disintegrating tablet using glycine and croscarmellose sodium. Candela Juan et al. developed ivermectin orally disintegrating tablets using factorial design using croscarmellose sodium as superdisintegrant, the disintegration time was 30 seconds.

Microcrystalline Cellulose (Avicel):

It is a pure, slightly depolymerized form of cellulose which is white and has no taste, odour, and made of porous materials. They disintegrate rapidly even at concentrations less than 10%. Here water enters inside the tablet through pores which breaks the hydrogen bonds linking the microcrystals of cellulose. At higher concentrations it sticks with the tongue due to faster absorption through capillary and rapidly dehydrating the surface of tablet. This compound along with starch is a very effective combination for making rapid disintegrating tablets. B.P. Patel et al. formulated MDT of Cinnarizine using Avicel as superdisintegrant, the disintegration time is 25.3 seconds.

Low substituted hydroxy methyl cellulose:

Because of its big particle size, it has a high degree of swelling and is utilized to stop capping. These days, it is often utilized in both the immediately compressible and wet granulation methods. In this instance, low hydroxyl propyl cellulose and microcrystalline cellulose are combined.utilized to quickly break down the tablet. As these both have an 8:2 and 9:1 ratio to achieve quick disintegration.Yunxia BI et al. prepared and evaluated compressed rapidly disintegrating tablet using low hydroxyl propyl cellulose as superdisintegrant, it records the shortest time of disintegration.

Co processed superdisintegrants:

Ludiflash:

It is a novel, distinctive co-processed mixture of 5% crospovidone, 5% polyvinyl acetate, and 95% mannitol that is produced using a patented, proven technique. It has a delicate, creamy consistency and dissolves quickly in a matter of seconds. It is intended specifically for direct compression for the hard tablet with extremely low reliability using conventional high-speed tablet computers. It has a very rapid release rate. Ildiko Olah et al. evaluated superdisintegrantsfor their performance in MDT containing lysozyme enzyme used ludiflash as a superdisintegrant, the tablets were disintegrated within 30 seconds.

Pharmaburst:

Pharmaburst is a method of co-processed excipients that uses certain excipients and enables quick disintegration and little punch adhesion. RS Rao. Ponugotiet al. formulated and evaluated MDT of Tramadol Hydrochloride using Pharmaburstassuperdisintrgrants, disintegration occur within 15 seconds.

Modified chitosan with silicon dioxide:

Based on the co-precipitation of silica and chitosan, these are the novel excipients. Chitosan and silica physically combine to form an insoluble, hydrophilic, and highly absorbent substance, giving it an advantage in terms of water absorption and saturation for the development of gels. According to studies, chitosan-silica performs better when tablets are prepared by wet granulation technique at various concentrations.

Challenges In Developing Mouth Dissolving Tablets^21-23

Mechanical strength and disintrgration time:

This is a challenge because greater mechanical strength more disintegration time. But to get faster disintegration we need to formulate the tablet so that mechanical strength is much less or optimum.

Taste masking:

It is a very concerning challenge in formulating MDT because it is taken through oral route thus unpalatable or drugs with bad taste will not be patient compliant hence the taste needs to be masked.

Aqueous solubility:

Various challenges arise from water soluble drugs because of their tendency of forming eutectic mixtures. This causes a depression in freezing point and a glass like solid results that breaks down on drying as there is a supporting structure loss upon sublimation. By the use of mannitol this challenge can be overcome.

Amount of drug:

For the formulation of FDT the drug amount that can be that can be used for each of the unit doses is specific. It must be less than 400mg in case of lyophilized doses for insoluble drugs and 60mg in case of soluble drugs.

Size of tablet:

The easiest size of the tablet which can be swallowed is 7-8 mm while that to handle the size should be more than 8 mm. Hence, it is a challenge to achieve a size which is both easy to swallow and to handle.

Mouth Feel:

The FDTs are the compounds which disintegrate in the mouth so the disintegrated particles should be very small. Flavouring and cooling agents also generate a good mouth feel to the patient.

Factors To Be Considered During Selection of Superdisintegrants^2,4

Compactibility:

MDTs which are reasonably hard and are less friable are accepted. These eliminate the requirement of special packaging materials at the time of maximizing the speed of production.

Flow:

Super disintegrants are usually used at quantities between 2% and 5% of the tablet composition in traditional tablet formulations. Nevertheless, the disintegrant concentration might be significantly greater while creating ODTs.

Disintegration:

This material must be able to wick quickly and absorb water inside the tablet resulting in swelling and finally leading to bursting the tablet.

Bulking materials:

These are very essential component in tablet formulation. They help increasing the bulk of tablet so that it becomes easy to handle. These materials also improve the texture of the tablet which enhances the tendency of the tablet to breakdown in the mouth. Lacitol, mannitol, polydextrose are some examples of bulking agents which are used for the preparation of MDT.

Lubricants:

These are the excipients which help to remove the gritty feeling of the disintegrated tablets inside the mouth which improve patient compliance. They also make the formulation more palatable.

Mouth feel:

The FDTs are the compounds which disintegrate in the mouth so the disintegrated particles should be very small. Flavouring and cooling agents also generate a good mouth feel to the patient. Small particles make the formulation less gritty and give a better mouth feel.

Taste masking:

Taste masking is an important activity because if the taste of the formulation is bad then the patient will not like to take it. Moreover it will be disintegrated in the mouth thus its taste masking should be done. Various flavouring and perfuming agents are used. Fruit juices, lemon oils, herbs, spices are the natural taste masking agents.

Mechanism of Action of Superdisintegrants

Swelling:

This is the most common technique of tablet disintegration. Tablets which are highly porous do not have optimum force to swell and thus show fewer tendencies to disintegrate. When the disintegrants contacts with water they swell and disintegrate. The adhesive nature of the additives present in the tablet can be overcome which leads the tablet to break (Figure 1)^24-25.

Figure 1. Mechanism of drug disintegration by swelling²⁵

Figure 2. Mechanism of drug disingration by wicking²⁶

Porosity and capillary action (Wicking): I

n the case of disintegrants that do not have the ability to swell, they have pores through which water enters inside when kept inside it,displacing the air adsorbed inside the tablet and finally weakening the intermolecular bond which finally results the tablet to break apart. This way of taking up the liquid by capillary action is known as ‘wicking’(Figure 2)²⁶. For substances which break by this mechanism porous structure and less interfacial tension to aqueous fluid is a necessity as they help in tablet disintegration creating network of hydrophilic nature around drug material.

Combination action:

This is nothing but a combination of both the swelling and wicking mechanism leading in tablet disintegration²⁷.

Heat of wetting:

Disintegrants which have the ability to release heat energy is wetted, stress in the localised are is created by expansion of capillary air, leading the tablet to breakdown. This mechanism is relatively old and rare (Figure 3)^28-29.

Figure 3. Mechanism of action by wetting²⁹

Figure 4. Mechanism of action by deformation³¹

Deformation:

During the process of compressing the tablet the particles get deformed they again get back their original structure when it contacts with water. During this deformation the characteristic to swell improves which leads to better disintegration e.g. Starch which is elastic in nature but with huge compression force it breaks down and reforms into its original structure and deformation mechanism is followed (Figure 4)^30-31.

Enzymatic action:

The enzymes mainly act as a binder but sometimes they act as disintegrants. When there is huge water absorption inside the tablet they increase in volume or they swell, due to this swelling, there produces a pressure in the outward direction resulting the tablet to break (Figure 5)^32-33.

Figure 5. Mechanism of action by enzymatic action³³

Electrostatic repulsion:

In this mechanism we see swelling of tablets which are made of non swellable disintegrating agents. Guyot-Hermann proposes that tablet disintegration can be achieved by non swellable disintegrants by particle – particle repulsion. Water is an essential component in this mechanism. Water is penetrated in between the starch particles because they have affinity towards starch and due to repulsive forces between starch particles the bond breaks (Figure 6)^34.

Figure 6. Mechanism of action by repulsion³⁴

Patented Technology For Preparing Mouth Dissolving Tablet^35-36

OraSolv and DuraSolv Technology:

Among CIMA's primary ODT tablet-based technologies are OraSolv and DuraSolv. Polyols are used in the technology as fillers and disintegrants, and they may contain a taste, lubricant, sweetener, and effervescence pair. If necessary, the medication can be taste-masked, usually with a fluid-bed coating procedure. Direct compression is a part of the tabletting process, which can handle a large variety of potencies, from less than 1 mg to 500mg. Tablets made using OraSolv technology ought to include a couple of effervescence and medication microparticles enclosed in a rupturable coating.

WOWTAB technology:

The Japan-based Yamanouchi Pharmaceutical Co. Ltd. has created and introduced the WOWTAB® technology, "Without Water Tablet." This is hard enough to keep the dosage form's mechanical and physical integrity before coming into contact with saliva. WOWTAB® is made up of widely used tablet excipients. When it is placed on the tongue, saliva quickly absorbs into the tablet, causing it to quickly become soft and dissolve in 15 to 20 seconds. When pressure is given to WOWTAB® tablets using the upper jaw and tongue or by licking them, the pills dissolve or disintegrate more quickly. WOWTAB® is produced with great drug content homogeneity and batch-to-batch reproducibility thanks to the use of traditional granulators, tablet machines, and packaging equipment.

Flashtab® Technology:

A super disintegrant (crospovidone or croscarmellose) and a swellable agent (modified corn starch, or MCC) make up the Flashtab tablet matrix. Moreover, the system might include, based on Instead of the previously stated swellable agent, a polyol with binding qualities such as mannitol, sorbitol. This process is used to make long-lasting tablets, where the excipients are first crushed into small particles using either wet or dry granulation. Following which the excipient granules and coated medicine are combined and compacted into tablets.

AdvaTab™ Technology:

For designing of MDT (advatab) microcaps technology was used which have API which are taste masked. Saccharides and sugar alcohol are the basic constituents of the dosage and they have particles of size below 30mm including lubricant and disintegrant .Unlike normal formulations, which have an internal lubricant, the lubricant utilized in this formulation is used externally.

Frosta® Technology:

Tech from Frosta is owned by Akina. The techniqueuses a plasticmaterial, asubstance that improves the penetration of water, and a plastic material to make highly plastic granules. moist binder.

Lyoc:

It was the initial ODT technology to be launched based on freeze-drying. The procedure entails creating a liquid suspension or solution of the medication that contains surfactants, thickeners, fillers, sweeteners and flavorings that are not volatile.After that, this homogeneous liquid is placed within blister cavities and allowed to freeze-dry. When compared to other freeze-dried dosage forms, Lyoc has advantages such as the lack of preservatives.

Zydis Technology:

The medicine is entrapped physically as well as dissolved inside the matrix of rapidly dissolving carrier material in the novel Zydis formulation freeze-dried tablet. Upon adding zydis units to themouth, the freeze-dried component instantly dissolves and doesn't need water to make swallowing easier. The zydis matrix is made up of many materials intended to accomplish various goals.

Recent Developments^37-38

Solutab:

Superdisintegrant croscarmellose sodium has a strong dissolving agent effect. The mechanical action is radial expansion because of the strong affinity of water absorption. It offers thorough and effective pill or capsule breakdown. Even at modest doses, it works. In water, it is insoluble. It can grow back if you wet it. It's white in color powder that comes in SOLUTAB® A-IP, SOLUTAB®, and SOLUTAB® EDP, among other forms. It can be included into formulations for tablets, capsules, or pellets. Direct compression is the most often utilized preparatory technique.

Glycolys and explosol:

Different grades of these are used in the formulation to meet the requirements. Both of these guarantee the quick breakdown of solid dosage forms. You can use sodium starch glycolate in any kind of dosage form. GLYCOLYS® LV is intended for high-shear and moist granulation. For medications that are pH-sensitive, Low pH GLYCOLYS® is perfect.

Pearlitol flash:

An innovative co-processed excipient with self-disintegrating qualities was shown for orodispersible tablets. It is powder with a white hue. PEARLITOL® FLASH quickly melts in the mouth and moved quickly. The excipient is immediately compressed. It facilitates the quick disintegration of tablets and is appropriate for oro-dispersible tablets.Average diameter of pearlitol 100 SD is 100µm and that of pearlitol200 SD is 180µm.

Indion 414:

In nature, it's an ion exchange resin. It is easily accessible and employed as a superdisintegrant. It does not dissolve when moistened and does not have a sticky propensity.leading to a consistent breakdown of the pill. Indion 414 is a more potent superdisintegrant as compared to conventional disintegrants. It is used at doses between 0.5 and 2 percent to effectively dissolve pills. The antiasthmatic medicine montelukast sodium used as the model medication. Based on the assessment results, it was determined that, in contrast to traditional superdisintegrants, Indion 414 functions as a helpful superdisintegrant.

Mannogemez:

It had superior swelling characteristics and reduced hygroscopicity to keep out moisture. It vanished rapidly. Mannogem Mannitol opens the possibility of higher production rates.degrees of direct compression. Its creamy texture and subtle sweetness demonstrated its outstanding palatability.

APPLICATIONS^39-40

Pharmaceutical superdisintegrants:

Superdisintegrants that offer better compressibility than superdisintegrants from earlier generations. A particle agglomeration ofcoprocessed cellulose or starch and enough boosting substance to improve the compactibility are included in the superdisintegrants.

Rapidly disintegrating enzyme-containing solid oral dosage compositions:

The invention concerns fast-disintegrating oral solid dosage forms with a superdisintegrant and an effective concentration of an enzyme. This patent claims the enzyme lactase for solid oral preparations.

Fast Disintegrating Tablets:

Nimesulide with one or more disintegrants are combined as a fast-disintegrating tablet. In this study, sodium starch glycolate, croscarmellose cellulose, and crospovidone were employed as superdisintegrants.

Method of producing fast dissolving tablets:

A process for making tablets that melt quickly. Because there is no granulation stage in the process, it is more economical and energy-efficient. The group of sugar alcohols that dissolve quickly is composed of mannitol, sorbitol, erythritol, and xylitol, sugars, lactose, and dextrose. It is appropriate to give the active ingredient as microparticles or microcapsules with a median size of below 125µm.

Disintegrating loadable tablets:

A compressed version of a loadable tablet that disintegrates. A disintegrant or mixture of disintegrants satisfies the following requirements: a) hardness of at least 20 Newtons; b) porosity of 45% v/v or greater; and c) loading a capacity of a minimum of 30% of a liquid.

Rapidly disintegrating tablets:

The topic of the study is quickly dissolving tablets that can be employed as dispersible or orodispersible tablets. There is silicified microsrystallinecellulose in the pills. They work particularly well with antibiotics. Amoxicillin and clavulanic acid-containing rapidly dissolving tablets are also described.

CONCLUSIONS:

The overviews of the many kinds of superdisintegrants that are now on the market were covered in this article. Due to advancements in the creation of quickly dissolving tablets, these tablets can be prepared using a variety of low-concentration superdisintegrants. Roughly one-third of individuals require the medication to start working right away. Superdisintegrants provide a combination of benefits in terms of simplicity of usage, dissolution speed, ease of administration, release the medications at faster rate and offer safe, efficient drug delivery with improved patient compliance and increased therapeutic benefits.

CONFLICT OF INTEREST:

The authors have no conflicts of interest regarding this investigation.

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Received on 03.07.2024 Revised on 13.11.2024

Accepted on 10.02.2025 Published on 02.08.2025

Available online from August 08, 2025

Research J. Pharmacy and Technology. 2025;18(8):3945-3952.

DOI: 10.52711/0974-360X.2025.00567

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