CONTENTS

UNIT TOPICS PAGE NO.

1. INTRODUCTION

1.1 Mouth dissolving tablet

1.1.1 Physiology of Mouth

1.1.2 Suitable drug candidates for Oral cavity :-

1.1.3 Types of mouth dissolving dosage forms

1.1.4 Tablet

1.1.5 Criteria for Fast Dissolving Drug Delivery System

1.1.6 Salient Feature of Fast Dissolving Drug Delivery System

1.1.7 Benefits of Mouth dissolving tablets

1.1.8 Limitations of Mouth Dissolving Tablets

1.1.9 Advantages

1.2 How dissolves faster

1.2.1 Disintegrants

1.2.2 Mechanism of Superdisintegrants

2. RESEARCH ENVISAGED AND PLAN OF WORK

3. LITERATURE SURVEY

4. DRUG PROFILE

5. PREFORMULATION STUDIES

6.

EXPERIMENTAL WORK

6.1 List material used with their source

6.2 List of equipments used & their makes

8. RESULT & DISCOUTION

9. REFERENCE

1. INTRODUCTION

1.1 “Mouth dissolving tablet”

Mouth dissolving tablets are solid dosage form containing medical substances which disintegrate

rapidly, usually within few seconds when placed upon tongue requiring no additional water to

facilate swallowing. It is suited for tablets undergoing high first pass metabolism and is

improving bioavailability with reducing dos-ing frequency to minimize side effect.[1]

1.1.1 Physiology of Mouth :-

The mouth (oral cavity, buccal cavity) is where food enters the digestive tract.

The following features are found in the mouth :-

The vestibule is the narrow region between the cheeks and teeth and between the lips and

teeth.

The tongue defines the lower boundary of the mouth. It helps position the food during

mastication (chewing) and gathers the chewed food into a ball, or bolus, in preparation for

swallowing. The tongue is covered with papillae, small projections that help the tongue

grip food. Many of the papillae bear taste buds.

The palate defines the upper boundary of the mouth. The forward portion is the hard

palate, hard because bone (maxillae and palatine) makes up this portion of it. Further back

in the mouth, the soft palate consists of muscle and lacks any bone support. A conical

muscular projection, the uvula, is suspended from the rear of the soft palate.

Saliva contains water (99.5 percent), digestive enzymes, lysozyme (an enzyme that kills

bacteria), proteins, antibodies (IgA), and various ions. Saliva lubricates the mouth,

moistens food during chewing, protects the mouth against pathogens, and begins the

chemical digestion of food. Chemical digestion is carried out by the digestive enzyme

salivary amylase, which breaks down polysaccharides (starch) into short chains of

glucose, especially the disaccharide maltose (which consists of two glucose molecules).

Saliva is produced by the following glands:

There are three pairs of salivary glands:

1.The parotid (located near the masseter muscle),

2. Submandibular (located deep in the mandible),

3. Sublingual (located under the tongue). They deliver their secretions to the

mouth via ducts.

Buccal glands are located in the mucosa that lines the mouth.[2,3,4]

1.1.2 Suitable drug candidates for Oral cavity:-

The drug have good in taste.

Primarily absorbed from mouth and oral cavity, e.g., esophagus, stomach etc.

Drug have dissolve and disintegrated in mouth.

Drug have absorb from mouth cavity and oral route.

The drug will pass the first metabolic pathway.[5,6]

1.1.3 Types of mouth dissolving dosage forms:-

There are many formulation which are used for the mouth dissolving dosage form

a. Mouth Dissolving Tablets

b. Buccal tablets

c. Sublingual tablets

d. Troches and lozenges

e. Dental cones

a. Mouth dissolving tablet :-

Mouth dissolving tablets are solid dosage form containing medical substances which

disintegrate rapidly, usually within few seconds when placed upon tongue requiring no

additional water to facilate swallowing. It is suited for tablets undergoing high first pass

metabolism and is improving bioavailability with reducing dos-ing frequency to minimize

side effect. [6, 7, 8]

b. Buccal tablets :-

Those two classes of tablet are intended to be held in the mouth, where they release their

drug contents for absorption directly through the oral mucosa.those tablet are usually small and

somewhat flat and are inrended tobe held between the cheek and teeth or ib the cheek pouch or

beneath the tongue. usually a small, flat tablet intended to be inserted in the buccal pouch,

where the active ingredient is absorbed directly through the oral mucosa; such a tablet dissolves

or erodes slowly [9]

c. Sublingual tablets :-

Sublingual tablet should bu formulated with bland excipients which do not stimulate

salivation.  one that dissolves when held beneath the tongue, permitting direct absorption of the

active ingredient by the oral mucosa.A sublingual tablet is usually a flat tablet that is small

enough to fit under your tongue, according to Drugs.com. The active ingredient of the

sublingual tablet is typically absorbed directly by the saliva and the tablet dissolves very

rapidly. You can take certain medications and vitamins sublingually. [10,11]

d. Troches and lozenges :-

A small oval, round, or oblong tablet containing a medicinal agent incorporated in a

flavored, sweetened mucilage or fruit base that dissolves in the mouth, releasing the drug. Also

called lozenge, rotula, trochiscus.Lozenge A form of oral medication formulated as a discoid

solid containing a therapeutic agent in a flavored base; a troche is placed in the mouth and

allowed to slowly dissolve, releasing its active ingredient–eg, analgesic, antibiotic,

antihistaminic, antiseptic, antitussive, decongestant, local anesthetic.[12]

Mouth dissolving tablet

A mouth dissolving drug delivery system, is a tablet that dissolves or disintrigrants in

the oral cavity without the need of water or chewing. Mouth dissolving tablets are solid

dosage form containing medical substances which disintegrate rapidly, usually within few

seconds when placed upon tongue requiring no additional water to facilate swallowing.

Recent advance in novel drug delivery system aims to enhance the safety and efficacy of the

drug molecule by formulating a dosage form being for the administration.

Difficulty in swallowing is experienced by patient such as pediatric, geriatric, be-dridden,

disabled and mentally ill, including motion sickness and sudden episodes of allergic attacks,

hence resulting in higher incidence of non-compliance and ineffective therapy.

To improve the quality of life and treatment compliances of such patients fast disintegrating or

orally disintegrating tablets dosage form is a batter alternative for oral medication.[13,14]

Mouth dissolving tablets are solid dosage form containing medical substances which

disintegrate rapidly, usually within few seconds when placed upon tongue requiring no

additional water to facilate swallowing. It is suited for tablets undergoing high first pass

metabolism and is improving bioavailability with reducing dos-ing frequency to minimize side

effect.

The aim is to formulate and characterize mouth dissolving tablets of Dompiridone for rapid

dissolution of drug and absorption, which may produce the rapid onset of action in the treatment

of throat infection.

It is suited for tablets undergoing high first pass metabolism and is improving bioavailability

with reducing dosing frequency to minimize side effect.[15]

Oral routes of drug administration have wide acceptance up to 50-60% of total dosage forms.

Solid dosage forms are popular because of ease of administration, accurate dosage, self

medication, pain avoidance and most importantly the patient compliance. The most popular solid

dosage forms are being tablets and capsules; one important drawback of this dosage forms for

some patients, is the difficulty to swallow. Drinking water plays an important role in the

swallowing of oral dosage forms. Often times people experience inconvenience in swallowing

Conventional dosage forms such as tablet when water is not available, in the case of the motion

sickness (kinetosis) and sudden episodes of coughing during the common cold, allergic condition

and bronchitis. For these reason, tablets that can rapidly dissolve or disintegrate in the oral

cavityhave attracted a great deal of attention. Or dispersible tablets are not only indicated for

people who have swallowing difficulties, but also are ideal for active people.[16,17]

The oral route of administration is considered as the most widely accepted route. But the most

evident drawback of the commonly used oral dosage forms like tablets and capsules is in saliva

and can be swallowed without the need of drinking water. Elimination difficulty in swallowing,

leading to patients incompliance particularly in case of pediatric and geriatric patients. Thus, a

new delivery system known as oral fast dissolving/disintegrating (FDDS)/melt-in-mouth tablets

gaining importance. These oral dosage forms dissolve rapidly of bitterness is an important

criterion in product formulation of mouth dissolving tablets.[18,19]

Superdisintegrants added in the formulation increase the dissolution characteristics thus

increasing the bioavailability of drug. Mouth dissolving tablet disintegrate in mouth and are

useful for potent drugs where fast absorption is required. Domperidon, an antiemetic agent has

been found to be an ideal candidate for mouth dissolving tablets.

Fast dissolving tablets are also called as mouth-dissolving tablets, melt-in mouth tablets,

Orodispersible tablets, rapimelts, porous tablets, quick dissolving etc. Fast dissolving tablets are

those when put on tongue disintegrate instantaneously releasing the drug which dissolve or

disperses in the saliva.[20]

The faster the drug into solution, quicker the absorption and onset of clinical effect. Some drugs

are absorbed from the mouth, pharynx and esophagus as the saliva passes down into the stomach.

In such cases, bioavailability of drug is significantly greater than those observed from

conventional tablets dosage form. The advantage of mouth dissolving dosage forms are

increasingly being recognized in both, industry and academics.[21,22]

Their growing importance was underlined recently when European pharmacopoeia adopted the

term “ Orodispersible tablet” as a tablet that to be placed in the mouth where it disperses rapidly

before swallowing.According to European pharmacopoeia, the ODT should disperse/disintegrate

in less than three minutes. The basic approach in development of FDT is the use of

superdisintegrants like cross linked carboxymethyl cellulose (croscarmellose), sodium starch

glycolate (primogel, explotab), polyvinylpyrollidone (polyplasdone) etc, which provide

instantaneous disintegration of tablet after putting on tongue, their by release the drug in saliva.

The bioavailability of some drugs may be increased due to absorption of drug in oral cavity and

also due to pregastric absorption of saliva containing dispersed drugs that pass down into the

stomach. More ever, the amount of drug that is subjected to first pass metabolism is reduced as

compared to standard tablet. The technologiesused for manufacturing fast-dissolving tablets are

freeze-drying, spray-drying, tablet molding, sublimation, sugar-based excipients, tablet

compression, and disintegration addition.As a result of increased life expectancy, the elderly

constitute a large portion of the worldwide population today. These people eventually will

experience deterioration of their physiological and physical abilities.[23]

1.1.4 Tablet

What is tablet?

Tablets are solid preparations each containing a single dose of one or more active substances and

usually obtained by compressing uniform volumes of particles. Tablets are intended for oral

administration. Some are swallowed whole, some after being chewed, some are dissolved or

dispersed in water before being administered and some are retained in the mouth where the

active substance is liberated.[24,25]

The particles consist of one or more active substances with or without excipients such as

diluents, binders, disintegrating agents, glidants, lubricants, substances capable of modifying the

behavior of the preparation in the digestive tract, coloring matter authorized by the competent

authority and flavorings substances.[26]

Tablets are usually right, circular solid cylinders, the end surfaces of which are flat or convex

and the edges of which may be bevelled. They may have lines or break-marks and may bear a

symbol or other markings. Tablets may be coated. Where applicable, containers for tablets

comply with the requirements for materials used for the manufacture of containers.[27]

1.1.5 Criteria for Fast Dissolving Drug Delivery System

The tablets should :-

Not require water to swallow, but it should dissolve or disintegrate in the mouth in matter of

seconds.

Be compatible with taste masking.

Be portable without fragility concern

Have a pleasant mouth feel

Exhibit low sensitive to environmental condition as temperature and humidity.

Allow the manufacture of the tablet using conventional processing and packagingequipments at low cost.

1.1.6 Salient Feature of Fast Dissolving Drug Delivery System:-

Ease of Administration to the patient who cannot swallow, such as the elderly, stroke

victims, bedridden patients, patient affected by renal failure and patient who refuse to

swallow such as pediatric, geriatric & psychiatric patients.

No need of water to swallow the dosage form, which is highly convenient feature for patients

who are traveling and do not have immediate access to water.

Rapid dissolution and absorption of the drug, which will produce quick onset of action.

Some drugs are absorbed from the mouth, pharynx and esophagus as the saliva passes down

into the stomach. In such cases bioavailability of drug is increased.

Pregastric absorption can result in improved bioavailability and as a result of reduced dosage;

improve clinical performance through a reduction of unwanted effects.

Good mouth feel property helps to change the perception of medication as bitter pill

particularly in pediatric patient.

The risk of chocking or suffocation during oral administration of conventional

formulation due to physical obstruction is avoided, thus providing improved safety.

New business opportunity like product differentiation, product promotion, patent

extensions and life cycle management.

Beneficial in cases such as motion sickness, sudden episodes of allergic attack or

coughing, where an ultra rapid onset of action required.

An increased bioavailability, particularly in cases of insoluble and hydrophobic drugs, due to

rapid disintegration and dissolution of these tablets.

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.

1.1.7 Benefits of Mouth dissolving tablets

Administered without water, anywhere, any time

Beneficial in cases such as motion sickness, suede episodes of allergic attack or coughing,

where an ultra rapid on set of action required.

An increased bioavailability, particularly in cases of insoluble and hydrophobic drugs,due to

rapid disintegration and dissolution of these tablets

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.

1.1.8 Limitations of Mouth Dissolving Tablets

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.

1.1.9 Advantages

Administered without water, anywhere, any time.

Suitability for geriatric and paediatric patients, who experience difficulties in swallowing.

An increased bioavailability, particularly in cases of insoluble and hydrophobic drugs due to

rapid and dissolution of these tablets.

Rapid dissolution and absorption of the drug, which will produce quick onset of action.

Some drugs are absorbed from the mouth, pharynx and oesophagus as the saliva passes

down into the stomach. In such cases bioavailability of drug is increased.

1.2 How dissolves faster

In fast dissolving tablets, water must moves quickly into the tablet matrix to cause rapid

disintegration and instantaneous dissolution of the tablet.

Basically, the disintegrant’s major function is to oppose the efficacy of the tablet binder and

the physical forces that act under compression to form the tablet.[28,29]

1.2.1 Disintegrants

Disintegrants are agents added to tablet formulations to promote the breakup of the tablet

into smaller fragments in an aqueous environment thereby increasing the available surface area

and promoting a more rapid release of the drug substance.[30]

1.2.2 Mechanism of Superdisintegrants

There are four major mechanisms for tablets disintegration as follows......

I. Swelling :-

Contact with water it tendency to swells and decrease the adhesiveness of the tablet. The most

widely accepted general mechanism of action for tablet disintegration masking. is swelling.

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.

II. Capillary action (Wicking)

Liquid is drawn up through capillary action and rupture the interparticulate bonds

causing the tablet to break apart.

WICKING SWELLING

III. Porosity

pathways for the penetration of fluid into tablets its impart their disintegrating action.

IV. Deformation

The compression forces involved in tableting causes deformation more permanently which on

exposure to water leads disintegration.[31,32]

DEFORMATION POROSITY

Example of Disintegrants

Starch

Lactose

Polacrilian K

Sodium alginate

Pregelatinized Starch (Starch 1500)  

Microcrystalline Cellulose (Avicel)  

Chitosan

Docusate sodium etc…

Super Disintegrants

which are decreases the disintegration time by various mechanism especially swell to

many times their original size when placed in water while producing minimal viscosity effects.

Example

1. Modified Starches- Sodium Carboxymethyl Starch (Chemically treated Potato Starch)

 Eg. Sodium Starch Glycolate (Explotab, Primogel)

Mechanism of Action: Rapid and extensive swelling with minimal gelling.

Effective Concentration: 4-6%. Above 8%, disintegration times may actually increase due

to gelling and its subsequent viscosity producing effects.

2. Cross-linked polyvinylpyrrolidone- water insoluble and strongly hydrophilic.

Eg. Crospovidone (Polyplasdone XL, Kollidon CL)

Mechanism of Action: Water wicking, swelling and possibly some deformation recovery.

3. Modified Cellulose- Internally cross-linked form of Sodium carboxymethycellulose.

Eg. Ac-Di-Sol (Accelerates Dissolution), Nymcel

Mechanism of Action: Wicking due to fibrous structure, swelling with minimal gelling.

Effective Concentrations: 1-3% (Direct Compression), 2-4% (Wet granulation).[33,34,35]

2. RESEARCH ENVISAGED

The concept of fast dissolving drug delivery system emerged from the desire to provide

more convenient means of taking medication for the patient. It is difficult for many patients to

swallow tablets and hard gelatin capsules. Due to decline in the swallowing ability with age so

many elderly patients complain that it is very difficult to take medication in the form of tablets.

Hence, they do not comply with prescription, which results in high incidence of non-compliance

and ineffective therapy. In some cases such as motion sickness, sudden episodes of allergic

attacks or coughing and unavailability of water, swallowing of conventional tablets may be

difficult. Such problems can be resolved by means of Fast Dissolving Tablet (FDT). In such

cases, bioavailability of drug is significantly greater than those observed from conventional

tablet dosage form.

Dompiridone is an Anti-emetic drug, which also acts as Dopamine antagonist. The drug

is of lypophilic character and it has been used for GIT related disorders. Since the drug is used in

condition with nausea and vomiting and a prompt action is needed in such cases which is not

displayed by the conventional dosage forms taken orally. Since they show their action after being

absorbed by GIT.

Hence in order to achieve a rapid action fast mouth dissolving tablet of Dompiridone,

will be formulated in the present work which will be absorbed from buccal cavity to provide

rapid absorption and relief to the patient. Morever the dosage form will be ready to use without

the need of fluid to swallow and hence can be taken readily when the need arises.

PLAN OF WORK

The present work aims at covering in-depth investigations on optimization, development of fast

dissolving drug delivery systems in general and applying the technology for the formulation

development of fast release drug delivery systems. The proposed plan of research work can be

briefly outlined as follows:

Survey of literature and published information on various technologies employed for the

formulation development of fast dissolving tablet dosage form.

Selection of potential drug candidates.

Selection of fast disintegrating agents.

Preformulation studies.

Development of fast dissolving tablet formulation.

Optimization of prepared dosage forms based on disintegration time and drug release

characterstics

Selection of optimized formulation

Characterization of designed formulations

In-vitro release studies

Result and discussion

Summary and Conclusion

References

3. LITERATURE SURVEY

Bhushan, S.Y. et al. (2000) described Rapidly Disintegrating Oral tablets and Fast Dissolving

Dosage forms in the mouth as the New Drug Delivery Systems for the elderly patients. Due to age

dependant changes such as physiological and pharmacokinetic changes, elderly patients do not

respond to the drug therapy in the same manner as younger adults. Pharmacodynamic changes also

play a major role in these age related changes. They described about the various difficulties elderly

may experience with existing dosage forms. Various new drug delivery systems for elderly suchas

jelly preparations, rapidly disintegrating and fast dissolving tablet dosage forms in the mouth were

also mentioned. In this they suggested various technologies for the development of rapid

disintegrating and fast dissolving tablet dosage forms, and concluded these trends are patient

friendly and will be a major area of research in the near future.

Reddy,L.H. et al. (2002) described Fast Dissolving Drug Delivery Systems as the ideal do-sage

forms for children and elderly, which have the advantages of both solid and liquid dosage forms,

and are having various advantages over the conventional oral solid dosage forms. The

characteristics offish Dissolving Delivery Systems such as taste of medicament, hydroscopicity,

friability are playing a major role in the manufacture of these systems. The various conventional

techniques used in the preparation of Fast Dissolving Drug Delivery Systems includes tablet

moulding, spray drying, lyophilization, sublimation, addition of disintegrates, taste masking also about

the various patented technologies such as Zydis, Orasolv, Durnacol, Flash dose, Wow tab, Flash

tab were nicely discussed by them. They concluded that the introduction of rapidly disintegrating

dosage forms has solved some of the problems encountered in administration of drugs to pediatric

and elderly patients, and because of increased patient demand, these dosage forms are expected to

become more popular.

Indurwade, N.H. et al.(2002) have indicated that Fast Dissolving Tablets are accepted widely

because it is a novel approach in drug delivery system indults and children. The swallowing of solid

dosage forms like tablet and capsules and improper dosing of suspension and emulsion may produce

difficulty for young and adult, and elderly patients suffering from dysphasia, tremors etc. Because of

these disadvantages, fast dissolving tablets were developed. They suggested that the main ingredients

of these dosage forms are appropriate disintegrating agents, maximizing porous structure of matrix

and highly hydrophilic excipients, and should possess some ideal characteristics, pharmacokinetic

and pharmcodynamic considerations. The author pointed out the fund mentals of designing and the

different technologies to the formulation of fast dissolving tablets such as moulding, spray drying,

sublimation, disintegrate addition, Zydis, Wowtab, Orasolv technologies.

Kuchekar, B.S.et al. (2003) have described the Mouth Dissolving Tablets as a novel drug delivery

system and the concept of these emerged from the desire to provide patients with more conventional

means of taking their medication. Mouth dissolving tablets a r e the ideal dosage form for the

patients who cannot swallow tablets and hard gelatin capsules, especially for pediatric and geriatric

patients. The author pointed out the various criteria for mouth dissolving drug delivery system, their

salient features and methods for their preparation such as freez drying, moulding, sublimation, spray

drying, mass extrusion, direct compression, and also the various patented technologies for their

manufacture. Finally listed out various examples of marketed preparations of melt-in mouth tablets.

Mane Avainash, R. et al. (2003)carried out the Preparation of Mouth Dissolving Tablets of Domp

iridone using the principle of sublimation, prepared busing two different components in different

ratios, which sublime readily(camphor, ammonium bicarbonate). Here accurately weighed quantities

of Dompiridone, volatilizable component, mannitol and Sodium saccharin were blended, granulated

using solution of PEG-4000 in ethanol and after lubrication compressed in to tablets in 8 mm

punches in a Cip–10 station tablet press. Then these tablets were kept in a hot air oven at 50ºC for

specified time period to allow for sublimation of volatile constituents. Four formulations with each

volatilizable component were prepared. Then the tablets were subjected to various quality control

tests and the results were compared with a marketed formulation of Dompiridone.

Kuchekar, B.S.etal.(2003)have described the Mouth Dissolving Tablets as a novel drug delivery

system and the concept of these emerged from the desire to provide patients with more conventional

means of taking their medication. Mouth dissolving tablets are the ideal dosage form for the patients

who cannot swallow tablets and hard gelatin capsules, especially for pediatric and geriatric patients.

The author pointed out the various criteria for mouth dissolving drug delivery system, their salient

features and methods for their preparation such as freez drying, moulding, sublimation, spray drying,

mass extrusion, direct compression, and also the various patented technologies for their

manufacture. Finally listed out various examples of marketed preparations of melt-in-mouth tablets.

Mane Avainash, R. et al. (2003)carried out the Preparation of Mouth Dissolving Tablets of

Dompiridone using the principle of sublimation, prepared byusing two different components

indifferent ratios, which sublime readily(camphor, ammonium bicarbonate). Here accurately weighed

quantities of Dompiridone, volatilizable component, mannitol and sodium saccharin were blended,

granulated using solution of PEG-4000 in ethanol and after lubrication compressed in to tablets in 8

mm punches in a Cip–10 station tablet press. Then these tablets were kept in a hot air oven at 50ºC

for specified time period bellow for sublimation of volatile constituents. Four formulations with each

volatilizable components were prepared. Thenthe tablets were subjected to various quality controls

tests and the results were compared with a marketed formulation of Dompiridone.Were prepared by

wet granulation technique. Camphor was sublime from the dried granules by exposure to vacuum.

The porous granules were then compressed into tablets and again exposed to vacuum. Then the

tablets were evaluated for percentage friability, wetting time and disintegration time, a 32full factorial

design was used to investigate thejoint influence of two formulation variables such as amount of

camphor and crospovidone. By the use of multiple linear regression analysis and contour plot, it is

revealed that for obtaining a rapidly disintegrating dosage form, tablets should be prepared using an

optimum concentration of camphor and higher concentration of crospovidone, and also the effect of

the independent variables on the disintegration time and percentage friability. Sublimation of camphor

from the tablets resulted in superior tablets as compared with the tablets prepared from granules that

were exposed to vacuum.

Mahajan, H. S.et al.(2004) prepared Mouth Dissolve Tablets of Samaritan Succinct, using

disintegrates sodium starch glycollate, carboxy methyl cellulose sodium and treated agar by

direct compression method. The prepared tablets were evaluated for thickness, uniformity of weight,

content uniformity, hardness, tensile strength, and porosity, friability, wetting time, water absorption

ratio, in vitro and in vivo disintegration time and invitro drug release. The tablets disintegrated in

vitro and in vivowithin10-16 seconds and 12-18 seconds respectively. Almost 90% of drug was

released from all formulations within 10 minute. The formulations containing combination of sodium

starch glycollate and carboxy methyl cellulose was found to give best results. The tablets apart from

fulfilling all official and other specifications, exhibits higher rate of drug release.