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Jadhav Yogesh L et al. / International Journal of Advances in Pharmaceutical Research 

IJAPR 

Available Online through 

www.ijapronline.org 

Review Article 

ISSN: 2230 – 7583 

AN OVERVIEW: MOUTH DISSOLVING TABLET 

Jadhav Yogesh L*., Dr. Parashar Bharat 

Department Of Pharmaceutics, Manav Bharti University, Solan. (H.P.) 

Received on 20 – 07 - 2012 Revised on 15 – 08- 2012 Accepted on 01– 09 – 2012 

ABSTRACT 

Swallowing a pill is a major difficulty encountered in case of geriatric and pediatric patient which leads to poor 

patient compliance due to unpalatable taste of drug. To troubleshoot these problems a new dosage form known as 

mouth-dissolving tablet (MDT), has been developed which rapidly disintegrate and dissolve in saliva.MDT are 

intended and designed to disintegrate and dissolve in saliva and then easily swallowed without need of water which 

is a major benefit over conventional dosage form. These dosage forms are also used to attain instant a higher 

concentration of drug in body for immediate actions. Mouth dissolving tablets can be prepared by using various 

conventional methods like direct Compression, wet granulation, moulding, spray drying, freeze drying, and 

sublimation method and by using different type of superdisintegrants like Cross linked carboxymelhylcellulose 

(Croscarmelose),Sodium starch glycolate (Primogel, Explotab),Polyvinylpyrrolidone (Polyplasdone) etc. This 

review discusses the method of preparation, advantages, disadvantage, characterization ,mechanisms; drugs to be 

incorporated in the mouth dissolving tablet and evaluation of the product and future trend of the mouth dissolving 

tablet. 

Key Words: Mouth dissolving tablets, Conventional techniques, patented technology. 

INTRODUCTION 

A mouth dissolving system can be defined as a solid 

dosage form for oral administration, which when 

placed in mouth, rapidly dispersed or dissolved and 

can be swallowed in the form of liquid. Mouth 

dissolving tablets are solid tablets and designed to 

dissolve/disintegrate in the patient’s mouth within 

few seconds or minutes, without the need to drink or 

chew 1 . The fear of taking solid tablets and the risk of 

choking for certain patient populations still exist 

despite their short disintegration/dissolution times. 

However some patients, particularly pediatrics and 

geriatric patients have difficulty swallowing or 

chewing solid dosage forms (conventional dosage 

forms) to fear of choking and unwillingness 2 . Mouth 

dissolving and mouth dispersing drug delivery 

system may offer a solution to these problems. 

Author Correspondence 

Jadhav Yogesh L. 

Department Of Pharmaceutics, 

Manav Bharti University, 

Solan. (H.P.) 

Jadhav.yogesh530@gmail.com 

08421504215 

When the mouth disintegrating tablet is orally 

applied, the drug substance has to be dissolved so 

that can be absorbed. Dissolution process consists of 

various processes, e.g. wetting, disintegration and 

dissolution. Mouth disintegrating tablets which are 

generally contains several excipients are involved in 

complex series of dissolution process that begin 

when the solvent contacts the solid and penetrates 

the tablet matrix 3 . Effect of excipients is assumed to 

be related to the surface properties of the particles 

and solid matrix structure 4,5 . 

Recently mouth dissolving formulation 

is popular as Novel Drug Delivery Systems because 

they are easy to administer and lead to better patient 

compliance. Pediatric and geriatric patient have 

difficulty in swallowing the conventional dosage 

forms these dosage forms dissolve or disintegrate in 

the cavity within a minute without the need of water 

or chewing. For these formulations, the small 

volume of saliva is usually sufficient to result in 

tablet disintegration in the oral cavity. The 

medication can then be absorbed partially or entirely 

into the systemic circulation from blood vessels in 

the sublingual mucosa, or it can be swallowed as a 

IJAPR / Sept. 2012/ Vol. 3 /Issue. 9 / 1100 – 1105 1100


solution to be absorbed from the gastrointestinal 

tract. 6-8 

The dispersible tablets allows dissolution 

or dispersion in water prior to administration but the 

Mouth Dissolving Tablet instead of dissolving or 

disintegrating in water is expected to dissolve or 

disintegrate in oral cavity without drinking water. 

The disintegrated mass then slides down smoothly 

along the esophagus along with saliva. The growing 

importance of mouth dissolving tablet was 

underlined recently when European Pharmacopoeia 

adopted the term “Or dispersible Tablet” as a tablet 

that to be placed in the mouth where it disperses 

rapidly before swallowing. 9 

The main criteria for mouth 

disintegrating(dissolving) tablet is to disintegrate or 

dissolve rapidly in oral cavity with saliva in 15 to 60 

seconds, without need of water and should have 

pleasant mouth feel. Mouth dissolving tablets are 

also known as mouth dissolving tablet, melt in 

mouth tablet, rapiment, porous tablet, orodispersible 

tablet, Rapidly Disintegrating tablet, or mouth 

disintegrating tablet. 

Benefits of Mouth Dissolving Tablets: 10,13,14,15 

1. Administered without water, anywhere, any time. 

2. Suitability for geriatric and pediatric patients, who 

experience difficulties in swallowing and for 

the other groups that may experience problems using 

conventional oral dosage form, due to being 

mentally ill, the developmentally disable and the 

patients who are un-cooperative, or are on reduced 

liquid intake plans or are nauseated. 

3. Beneficial in cases such as motion sickness, suede 

episodes of allergic attack or coughing, where an 

ultra rapid onset of action required. 

4. An increased bioavailability, particularly in cases 

of insoluble and hydrophobic drugs, due to rapid 

disintegration and dissolution of these tablets. 

5. Stability for longer duration of time, since the 

drug remains in solid dosage form till it is consumed. 

So, it combines advantage of solid dosage form in 

terms of stability and liquid dosage form in terms of 

bioavailability. 

Limitations of Mouth Dissolving Tablets: 10,11 

The tablets usually have insufficient mechanical 

strength. Hence, careful handling is required. The 

tablets may leave unpleasant taste and/or grittiness in 

mouth if not formulated properly. 

Fundamentals of Mouth Dissolving Tablet: 12 

For rapid dissolution or disintegration of dosage 

form, water must rapidly penetrate into the tablet 

matrix to cause quick disintegration and 

instantaneous dissolution of the tablet. Several 

techniques are used to achieve these fundamentals, 

to formulate mouth-dissolving tablet. Some of the 

techniques are described below. 

TECHNIQUES FOR PREPARING MOUTH 

DISSOLVING TABLETS 

Conventional Techniques: 16,20 

Disintegrates addition: Disintegrate addition 

technique is one popular techniques for formulating 

Mouth-dissolving tablets because of its easy 

implementation and cost-effectiveness. The basic 

principle involved in formulating Mouth-dissolving 

tablets by disintegrates addition technique is addition 

of superdisintegrants in optimum concentration so as 

to achieve mouth dissolving along with the good 

mouth feel. 

Moulding: In this method, molded tablets are 

prepared by using water-soluble ingredients so that 

the tablets dissolve completely and rapidly. The 

powder blend is moistened with a hydro-alcoholic 

solvent and is molded into tablets under pressure 

lower than that used in conventional tablet 

compression. The solvent is then removed by airdrying. 

Molded tablets are very less compact than 

compressed tablets. These possess porous structure 

that enhances dissolution. 

Freeze drying: A process in which water is 

sublimated from the product after freezing. 

Lyophilization is a pharmaceutical technology which 

allows drying of heat sensitive drugs and biological 

at low temperature under conditions that allow 

removal of water by sublimation. Lyophilization 

results in preparations, which are highly porous, with 

a very high specific surface area, which dissolve 

rapidly and show improved absorption and 

bioavailability. 

Sublimation: The slow dissolution of the 

compressed tablet containing even highly watersoluble 

ingredients is due to the low porosity of the 

tablets. Inert solid ingredients that volatilize 

readily (e.g. urea, ammonium carbonate, ammonium 

bicarbonate, camphor etc.) 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 structures. 

Additionally, several solvents (e.g. cyclohexane, 

benzene) can be also used as pore forming agents. 

Spray-Drying: Spray drying can produce highly 

porous and fine powders that dissolve rapidly. The 

formulations are incorporated by hydrolyzed and non 

hydrolyzed gelatins as supporting agents, mannitol 

as bulking agent, sodium starch glycolate or 

crosscarmellose sodium as disintegrating and an 

acidic material (e.g. citric acid) and or alkali material 

(e.g. I sodium bicarbonate) to enhance disintegration 

and dissolution. Tablet compressed from the spray 

dried powder disintegrated within 20 seconds when 

immersed in an aqueous medium. 

Mass-Extrusion: This technology involves 

softening the active blend using the solvent mixture 



of water soluble polyethylene glycol, using methanol 

and 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 also be used to coat granules of 

bitter tasting drugs and thereby masking their bitter 

taste. 

Direct Compression: Direct compression method is 

the easiest way to manufacture tablets. Conventional 

equipment, commonly available excipients and a 

limited number of processing steps are involved in 

direct compression. Also high doses can be 

accommodated and final weight of tablet can easily 

exceed that of other production methods. Directly 

compressed tablet's disintegration and solubilization 

depends on single or combined action of 

disintegrants, water soluble excipients and 

effervescent agent. 

PATENTED TECHNOLOGIES 16 

Flashtab Technology: Prographarm laboratories 

have patented the Flashtab technology. Tablets 

prepared by this system consist of an active 

ingredient in the form of micro crystals. Drug micro 

granules may be prepared by using the conventional 

techniques like coacervation, micro encapsulation, 

and extrusion spheronisation. All the processing 

utilized conventional tabletting technology. 

Wowtab Technology: Wowtab Technology is 

patented by "Yamanouchi Pharmaceutical Co. " 

WOW means "Without Water ". In this process, 

combination of low mouldability saccharides and 

high mouldability saccharides is used to obtain a 

rapidly melting strong tablet. The active ingredient is 

mixed with a low mouldability saccharide and 

granulated with a high mouldability saccharide and 

compressed into tablet. 

Flash Dose Technology: Flash dose technology has 

been patented by "Fuisz". Nurofen meltlet, a new 

form of ibuprofen as melt-in-mouth tablets, prepared 

using flash dose technology is the first commercial 

product launched by" Biovail Corporation". Flash 

dose tablets consists of self binding shearform matrix 

termed as "floss". Shearform matrices are prepared 

by flash heat processing. 

Orasolv Technology: Orasolv Technology has been 

developed by "CIMA" labs. In this system active 

medicament is taste masked. It also contains 

effervescent disintegrating agent. Tablets are made 

by direct compression technique at low compression 

force in order to minimize oral dissolution time. 

Conventional blenders and tablet machine is used to 

produce the tablets. The tablets produced are soft and 

friable and packaged in specially designed pick and 

place system. Durasolv Technology: Durasolv is the 

patented technology of "CIMA" labs. The tablets 

made by this technology consist of a drug, fillers and 

a lubricant. Tablets are prepared by using 

conventional tableting equipment and have good 

rigidity. These can be packed into conventional 

packaging system like blisters. Durasolv is an 

appropriate technology for products requiring low 

amounts of active ingredients. 

Zydis Technology: This technology involves 

softening the active blend using the solvent mixture 

of water soluble polyethylene glycol, using methanol 

and 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 also be used to coat granules of 

bitter tasting drugs and thereby masking their bitter 

taste. 

CRITERIA FOR DRUG SELECTION 18 

The ideal characteristics of a drug for in vivo 

dissolution from an MDT include 

1. No bitter taste. 

2. Dose lower than 20mg. 

3. Small to moderate molecular weight. 

4. Good stability in water and saliva. 

5. Partially non-ionized at the oral cavities 

pH 

6. Ability to diffuse and partition into the 

epithelium of the upper GIT 

7. Ability to permeate oral mucosal tissue. 

8. Unsuitable drug characteristic for MDT 

9. Short half-life and frequent dosing. 

10. Very bitter or otherwise unacceptable 

taste because taste masking cannot be 

achieved. 

11. Required controlled or sustained 

release. 

DRUGS USED IN MOUTH DISSOLVING 

DRUG DELIVERY SYSTEM 21-23 

1. Analgesic and anti-inflammarory Agents- 

Ibuprofen, Proxicam, Mefenamic Acid 

2. Anti-bacterial Agent-Erythromycin, 

Tetracycline, Doxycycline, Rifampcin 

3. Anti-fungal Agents-Griseofulvin, Miconazole 

4. Anti-Malarials-Chlorquine, Amodiaquine 

5. Anti-Gout Agent- Allopurinol, Probenecid 

6. Anti-Hypertensive -Amlodipine, Nefidipine 

7. Anti-Coagulants-Glipizide, Tolbutamide 

8. Anti-Protozoal Agents- Benznidazole, Tinidazole 

9. Anti-Thyroid agent-Carbimazole 

10. Cardiac Inotropic Agent-Digitoxin,Digoxis 

11. Gastro-Intestinal Agents- Omeprazole, 

Ranitidine, Fomatidine 

12. Nutritional Agents-Vitamin A, Viitamin B, 

Vitamin D, etc. 



13. Oral Vaccine-Influenza, Hepatitis, Polio, 

Tuberculosis,etcs 

SUPER DISINTEGRANTS USED IN MDTS 17-19 

As day’s passes, demand for mouther 

disintegrating formulation is increased. So, 

pharmacist needs to formulate disintegrants i.e. 

Superdisintegrants which are effective at low 

concentration and have greater disintegrating 

efficiency and they are more effective 

intragranularly. 

Various types of super disintegrants used are as 

follows: 

1. Crosspovidone 

2. Microcrystalline cellulose 

3. Sodium starch glycollate 

4. Sodium carboxy methyl cellulose or cross 

carmelose sodium 

5. Pregelatinzed starch 

6. Calcium carboxy methyl cellulose 

7. Modified corn starch. 

8. Sodium starch glycollate 

9. crosscarmellose sodium. 

Factors to be considered for selection of 

superdisintegrants 

1. It should produce mouth dissolving when 

tablet meets saliva in the mouth 

2. It should be compactable enough to produce 

less-friable tablets. 

3. It can able to produce good mouth feel to 

the patient. Thus, small particle size is 

preferred to achieve patient compliance. 

4. It should has good flow since it improve the 

flowability of the total blend. 

EVALUATION OF TABLETS 24-26 

General Appearance: The general appearances of a 

tablet include size, shape, colour, taste, odour, 

surface texture. 

Size, Shape, Thickness And Diameter: The size 

and shape of the tablet can be dimensionally 

described, monitored and controlled. Thickness of 

tablets is an important characteristic for appearance 

and also in counting by using filling equipment. 

Some filling equipment utilizes the uniform 

thickness of the tablets as a counting mechanism. 

Ten tablets were taken and their thickness measured 

by vernier caliper. 

Measurement Of Tablet Tensile Strength The 

tablet tensile strength is the force required to break a 

tablet by compressing it in the radial direction and is 

measured using a tablet hardness tester. For 

measuring the hardness of the tablets, the plunger of 

the hardness tester is driven down at a speed of 20 

mm/min. Tensile strength for crushing (T) is 

calculated using equation I 

Eq. I. T= 2F / πdt 

Where, F is the crushing load, and d and t denote the 

diameter and thickness of the tablet, respectively. 27 

Measurement Of Tablet Porosity The mercury 

penetration porosimeter can be used to measure the 

tablet porosity which is a relative assessment of the 

degree of water penetration in the formulation, 

responsible for its mouth disintegration. This 

instrument is based on the capillary rise phenomenon 

where in an excess pressure is required to cause a 

non-wetting liquid to climb up a narrow capillary. 

The pressure difference across the interface is given 

by the Washburn equation II, where the pressure 

drop is inversely related to the pore size 

(perpendicular radius) 28 

Eq. II. ΔP = −(2γ/r) cos θ 

Where, γ is the surface tension of the liquid, r is the 

perpendicular radius and θ is the angle of contact 

between the liquid and the capillary walls. Pore 

radius is calculated from eq II using experimental 

data obtained in the form of P. In this test, the 

contact angle between mercury and the tablet is kept 

at 140° and the surface tension at the interface of 

mercury and the tablet is 0.486 N/m. Pore sizes in 

the range of 0.06–360 μm, can be efficiently 

measured by this technique. 29,30 Otherwise, the tablet 

porosity (ε) can also be calculated using equation III: 

Eq. III. ε = 1-m / (ρtV) 

Where, ρt is the true density, and m and V are the 

weight and volume of the tablet, respectively. 

Tablets prepared by spray drying, lyophilization and 

cotton candy process generally possess high porosity 

and therefore, have extremely low disintegration 

time. 

Wetting Time and Water Absorption Ratio A 

study on wetting time and water absorption ratio 

reported the use of a piece of double folded tissue 

paper placed in a petridish containing 6 ml of water. 

One tablet was placed on this paper and the time for 

complete wetting of tablet was noted as wetting time. 

The wetted tablet was then weighed and the water 

absorption ratio, R, was determined according to 

equation IV 

Eq. IV. R = 100 (Wa−Wb)/Wb 

Where, Wb and Wa are the weights of tablet before 

and after water absorption, respectively. 

Fineness of Dispersion This is a qualitative test 

specified by EP for dispersible tablets. 31 We 

recommend performing this test on tablets which are 

not truly mouth dissolving, but are mouth oral 

disintegrating tablets (ODTs). It is an assessment of 

the grittiness which arises due to disintegration of 

the tablet into coarse particles. The test is performed 

by placing two tablets in 100 ml water and stirring it 

gently, till the tablets get completely disintegrated. 

The formulation is considered to form a smooth 

dispersion if the complete dispersion passes through 



a sieve screen with a nominal mesh aperture of 710 

μm without leaving any residue on the mesh. 

Uniformity of weight: In Indian Pharmacopoeia 

procedure for uniformity of weight was followed, ten 

or twenty tablets were taken and their weight was 

determined individually and collectively on a digital 

weighing balance. The average weight of one tablet 

was determined from the collective weight. The 

weight variation test would be a satisfactory method 

of determining the drug content uniformity. 

Hardness of Tablets: Hardness of tablet is defined 

as the force applied across the diameter of the tablet 

in the order to break the tablet. The resistance of the 

tablet to chipping, abrasion or breakage under 

condition of storage transformation and handling 

before usage depends on its hardness. Hardness of 

the tablet of each formulation was determined using 

Monsanto Hardness tester. 

Friability of tablets: Friabrater consist of a plasticchamber 

that revolves at 25 rpm, dropping those 

tablets at a distance of 6 inches with each revolution. 

The tablets were rotated in the friabrater for at least 4 

minutes. At the end of test tablets were removed and 

reweighed, the loss in the weight of tablet is the 

measure of friability and is expressed in percentage 

as, 

%Friability = intial weight - Final weight/intial 

weight x 100 

Wetting Time: In this method measure tablet 

wetting time. Simple tissue paper (12 cm X 10.75 

cm) folded twice was placed in a small petridish (ID 

= 6.5 cm) containing 6 ml of Sorenson’s buffer pH 

6.8. A tablet was put on the paper, and the time for 

complete wetting was measured. Three trials for 

each batch and the standard deviation were also 

determined. 

Solution Volume: In this test take one tablet in a 

Petri –dish with suitable solvent. One or two drop of 

solvent used until the tablet shows soluble property 

that is called soluble or solution volume. V = Final 

volume of blend in cm3 

In Vitro Disintegration Test: In Vitro disintegration 

time was measured by dropping a tablet in a beaker 

containing 50 ml of Sorenson’s buffer pH 6.8. Three 

tablets from each formulation were randomly 

selected and In Vitro dispersion time was performed. 

32,33 

In Vivo Disintegration Test: The test was carried 

out on 2 or 3 tablets using in the mouth and the time 

in second taken for complete disintegration of the 

tablet was measured in few seconds. 34 

In Vitro Dissolution Test: In-vitro dissolution study 

was performed by using USP Type II Apparatus 

(Paddle type) [Electro lab (ETC-11L) Tablet 

Dissolution Tester] at 50 rpm. Phosphate buffer pH 

6.8, 900 ml was used as dissolution medium which 

maintained at 37±0.5°C. Aliquot of dissolution 

medium (10 ml) was withdrawn at specific time 

intervals (2 min) and was filtered. The amount of 

drug dissolved was determined by UV 

spectrophotometer (Shimadzu, Japan) by measuring 

the absorbance of the sample at 248.0 nm. Three 

trials for each batch were performed and average 

percentage drug release with standard deviation was 

calculated and recorded. 32-35 

Stability Study (Temperature Dependent): The 

mouth dissolving tablets are packed in suitable 

packaging and stored under the following conditions 

for a period as prescribed by ICH guidelines for 

accelerated studies. 

(i) 40 ± 1 °C 

(ii) 50 ± 1°c 

(iii) 37 ±1 ° C and RH 75% ± 5% 

The tablets were withdrawn after a period of 15 days 

and analyzed for physical characterization (Visual 

defects, Hardness, Friability, Disintegrations, and 

Dissolution etc.) and drug content. The data obtained 

is fitted into first order equations to determine the 

kinetics of degradation. Accelerated stability data are 

plotting according Arrhenius equation to determine 

the shelf life at 25°C. 32-35 

Packaging: Packaging special care is required 

during manufacturing and storage to protect the 

dosage of other mouth-dissolving dosage forms. 

Quick-dispersing and/or dissolving oral delivery 

systems, the system can be packaged using various 

options, such as single pouch, blister card with 

multiple units, multiple unit dispenser, and 

continuous roll dispenser, depending on the 

application and marketing objectives. 35 

FUTURE TRENDS 

These dosage forms may be suitable for the oral 

delivery of drugs such as protein and peptide-based 

therapeutics that have limited bioavailability when 

administered by conventional tablets. These products 

usually degrade rapidly in the stomach. Should next 

generation drugs be predominantly protein or peptide 

based, tablets may no longer be the dominant format 

for dosing such moieties. Injections generally are not 

favored for use by patients unless facilitated by 

sophisticated auto-injectors. Inhalation is one good 

alternative system to deliver these drugs, but the 

increased research into biopharmaceuticals so far has 

generated predominantly chemical entities with low 

molecular weights. The developments of enhanced 

oral protein delivery technology by ODTs which 

may release these drugs in the oral cavity are very 

promising for the delivery of high molecular weight 

protein and peptide. 



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Totally three types 

FICPHS (Fellowship in International Congress in Pharmacy and Health Sciences), MICPHS (Member in International Congress in 

Pharmacy and Health Sciences), AMICPHS (Associate Member in International Congress in Pharmacy And Health Sciences) 

Eligibility 

FICPHS: Ph.D in Chemistry/ Pharmacy / M.Sc / M.Pharm with 2 years experience, MICPHS: M.Sc / M.Pharm (or) B.Sc / B.Pharm with 

2 years experience, AMICPHS: B.Sc (or) B.Pharmacy

formulation and characterizatin of transdermal patches by using ...

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