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FAST DISSOLVING TABLET USING SOLID DISPERSION TECHNIQUE
                                                           Santhosh R.Iyer*, P.Siva  
  Grace College of Pharmacy, Palakkad  
                                                          santhoshiyer6@gmail.com                                Review Article

ABSTRACT
Fast dissolving tablets has emerged as alternative to oral dosage forms. A fast dissolving tablet can be defined as a solid dosage form that can disintegrates into smaller granules which slowly dissolve in the mouth. A number of methodologies can be adapted to improve solubilization of poor water soluble drugs and further to improve its bioavailability are Solid dispersion, Particle size reduction, Nanosuspension technology, Surfactant, Salt formation, pH adjustment, Hydrotrophy . Solid dispersion refers to a group of solid products consisting of at least two different components, generally a hydrophilic matrix and a hydrophobic drug. The popular carriers used in the formation of solid dispersion are polyethylene glycol and 2HP-�-cyclodextrin. Solid dispersions are generally prepared by fusion method, hot melt extrusion, solvent method, and supercritical fluid method.The basic approaches to developing fast dissolving tablets include maximizing the porous structure of the tablet matrix, incorporating the appropriate disintegrating agent, and using highly water-soluble excipients in the formulation.Conventional Techniques used for the preparation of Fddds are disintegration addition, freeze drying, moulding, sublimation, spray drying, mass-extrusion, and direct compression. Patented technologies for fast dissolving tablets are Zydis, durazolv, orazolv, flash dose, wow tab technology etc. Powder Properties of tablet are evaluated by angle of repose, bulk density, bulkiness, void volume, and porosity and percent compressibility.  Fast dissolving tablets are evaluated by general appearance, size and shape, tablet thickness, friability, uniformity of weight, tablet hardness, invivo disintegration test, wetting time, invitro dispersion time and stability studies. The introduction of fast dissolving dosage forms has solved some of the problems encountered in administration of drugs to the pediatric and elderly patients. Hence, patient demand and the availability of various technologies have increased the market share of Fast dissolving tablets, which in turn prolongs the patent life of a drug.

 Key words: Solid dispersion, fast dissolving tablet, patient compliance
INTRODUCTION
Tablet is the most popular among all dosage forms existing today because of its convenience of self administration, compactness and easy manufacturing; however hand tremors, dysphasia in case of geriatric patients, the underdeveloped muscular and nervous systems in young individuals and in the case of uncooperative patients, the problem of swallowing is common phenomenon which leads to poor patient compliance. 

To overcome these defects, fast dissolving tablets has emerged as alternative oral dosage forms. The bioavailability of some drugs may be increased due to absorption of drugs in oral cavity and also due to pregastric absorption of saliva containing dispersed drugs that pass down into the stomach. Moreover, the amount of drug that is subject to first pass metabolism is reduced as compared to standard tablets9, 10.

The rate of absorption and the extent of bioavailability for such insoluble hydrophobic drug are controlled by the rate of dissolution. Hence, an attempt has been made to increase the dissolution of such poorly water soluble drugs. Techniques that have commonly been used to improve dissolution and bioavailability of poorly water-soluble drugs, in general, include micronization, the use of surfactant, and the formation of solid dispersions. Solid dispersions are used to increase their effectiveness and simultaneously reduce their doses and hence the toxic effect. Solid dispersions traditionally have been used as an effective method to improve the dissolution properties and bioavailability of poorly water soluble drugs. Many substances can be employed as carriers to prepare solid dispersions. Among the popular carriers used in the formation of solid dispersion are polyethylene glycol and 2HP-�-cyclodextrin. Both polymers are often employed as a vehicle due to its low toxicity, low melting point, rapid solidification rate, high aqueous solubility. These and other properties make them a very suitable vehicle for formulations into dosage forms.

SOLID DISPERSION
Definition of solid dispersions [ 2]
The term solid dispersion refers to a group of solid products consisting of at least two different components, generally a hydrophilic matrix and a hydrophobic drug. The matrix can be either crystalline or amorphous. The drug can be dispersed molecularly, in amorphous particles (clusters) or in crystalline particles (Chiou and Riegelman, 1971)Various techniques for enhancement of solubility of poor water soluble drug [ 1]                  A number of methodologies can be adapted to improve solubilization of poor water soluble drugs and further to improve its bioavailability are Solid dispersion, Particle size reduction, Nanosuspension technology, Surfactant, Salt formation, pH adjustment, Hydrotrophy
Advantages of solid dispersion [ 2,  3]
Particles with reduced particle size
Particles with improved wettability
 Particles with higher porosity
Drugs in amorphous state


Disadvantages of Solid Dispersions  [ 3]
The major disadvantages of SDs are related to their instability. Moisture and temperature have more of deteriorating effect on solid dispersions than on physical mixtures. 

Limitations of Solid Dispersions [ 3]
Problems of solid dispersion involve (i) the physical and chemical stability of drugs and vehicles, (ii) method of preparation, (iii) reproducibility of its physicochemical properties, (iv) formulation of solid dispersion into dosage forms, and (v) scale-up of manufacturing processes

Types of solid dispersion [ 1-3]
On the basis of molecular arrangement, six types of molecular dispersion can be distinguished.
Solid eutectic mixture
A simple eutectic mixture consists of two components which are completely miscible in liquid state but to a limited extend in solid state. These are prepared by rapid solidification of fused melt of two components. 
Solid solution 
In a solid solution, the two components crystallize together in a homogeneous one phase system. On the extend of miscibility of two components, solid solution is classified as continuous and discontinuous. In continuous solid solution, the two components are miscible in the solid state in all proportions. In discontinuous solid solutions, the solubility of each of the components in the other component is limited. 
Glass solution and suspension
A glass is a homogenous glassy system in which solute dissolves in the glassy system. A glass suspension refers to a mixture in which precipitated particles are suspended in a glassy solvent. 
Amorphous precipitations in crystalline carrier   
In the group of dispersions drug is precipitated out amorphous form while in simple eutectic mixture it is in crystalline form.
Example: Sulfathiazole in crystalline urea

Preparation of solid dispersions [ 1 - 3  ]
Various preparation methods for solid dispersions have been reported in literature. 
 A. Fusion method
The fusion method is sometimes referred to as the melt method. The first solid dispersions created for pharmaceutical applications were prepared by the fusion method. The dispersion consisted of sulfathiazole and urea as a matrix which was melted using a physical mixture at the eutectic composition, followed by a cooling step. The eutectic composition was chosen to obtain simultaneous crystallization of drug and matrix during cooling. Poly ethylene glycol (PEG) is a hydrophilic polymer often used to prepare solid dispersions with the fusion method.  
The fusion method has serious limitations. Firstly, a major disadvantage is that the method can only be applied when drug and matrix are compatible and when they mix well at the heating temperature. This can be prevented by using surfactants. Secondly, a problem can arise during cooling when the drug-matrix miscibility changes. In this case phase separation can occur. 
Thirdly, degradation of the drug and or matrix can occur during heating to temperatures necessary to fuse matrix and drug. 
B. Hot melt extrusion
Melt extrusion is essentially the same as the fusion method except that intense mixing of the components is induced by the extruder. When compared to melting in a vessel, the product stability and dissolution are similar (Forster et al., 2001), but melt extrusion offers the potential to shape the heated drug-matrix mixture into implants, ophthalmic inserts, or oral dosage forms (Breitenbach, 2002).Compared to the traditional fusion method, this technique offers the possibility of continuous production, which makes it suitable for large-scale production.

C. Solvent method
The first step in the solvent method is the preparation of a solution containing both matrix material and drug. The second step involves the removal of solvent(s) resulting in formation of a solid dispersion.  Chloroform (Betageri and Makarla, 1995) or dichloromethane (Damian et al., 2002) have been used to dissolve both drug and PVP as matrix simultaneously. These solvents are used also in other preparation methods. However, according to the ICH-Guidelines, these solvents belong to Class I, comprising the most toxic solvents. Therefore, the use of these solvents is unacceptable and impractical .The last strategy for the dissolution of both drug and matrix is the use of solvent mixtures. Water and ethanol (Kushida et al., 2002), or dichloromethane and ethanol (Cilurzo et al., 2002) have been used for this purpose. 
The second challenge in the solvent method is to prevent phase separation, e.g. crystallization of either drug or matrix, during removal of the solvent(s). Drying at high temperatures speeds up the process and reduces the time available for phase separation. Afterwards the formed solid dispersion is often stored in vacuum desiccators to remove the residual solvent. Vacuum drying at elevated temperature bears the risk of phase separation because the mobility of drug and matrix decreases slowly.

 Another drying technique is spray drying. The solution is dispersed as fine particles in hot air. Due to the large specific surface area offered by the droplets, the solvent rapidly evaporates and the solid dispersion is formed within seconds, which may be fast enough to prevent phase separation. 

An alternative to these drying techniques is freeze drying.  Sublimation during freeze drying is only possible when the solvent stays frozen. Low sample temperatures are required which slows down the process. To obtain a lyophiliation process of acceptable duration, the solvent should have a sufficiently high vapour pressure.A suitable solvent that meets both requirements is 2- methyl-2-propanol or tertiary butanol (TBA), because it has a high melting temperature as well as a high vapour pressure. An important advantage of freeze drying is that the drug is subjected to minimal thermal stress during the formation of the solid dispersion. However, the most important advantage of freeze drying is that the risk of phase separation is minimized as soon as the solution is vitrified. 

An even more promising drying technique is spray-freeze drying. The solvent is sprayed into liquid nitrogen or cold dry air and the frozen droplets are subsequently lyophilized. The large surface area and direct contact with the cooling agent result in even faster vitrification, thereby decreasing the risk for phase separation to a minimum . Moreover, spray freeze drying offers the potential to customize the size of the particle to make them suitable for further processing or applications like pulmonary (Maa et al., 1999), or nasal administration (Maa et al., 2003).
D. Supercritical fluid methods
Supercritical fluid methods are mostly applied with carbon dioxide (CO2), which is used as either a solvent for drug and matrix or as an anti-solvent. When supercritical CO2 is used as solvent, matrix and drug are dissolved and sprayed through a nozzle, into an expansion vessel with lower pressure and particles are immediately formed. The adiabatic expansion of the mixture results in rapid cooling. This technique does not require the use of organic solvents and since CO2 is considered environmentally friendly, this technique is referred to as �solvent free�. The technique is known as Rapid Expansion of Supercritical Solution (RESS). The application of this technique is very limited, because the solubility in CO2 of most pharmaceutical compounds is very low (<0.01wt-%) (Subramaniam et al., 1997) and decreases with increasing polarity. Therefore, scaling up this process to kilogram-scale will be impractical.

Alternative strategies
Spraying on sugar beads using a fluidized bed coating system
Direct capsule filling
Electrostatic spinning method
Surface-active carriers

FAST DISSOLVING TABLET

Definition [ 5]
The Center for Drug Evaluation and Research (CDER), US FDA defined Oral Disintegrating Tablets (ODT) as �A solid dosage form containing medicinal substances, which disintegrates rapidly, usually within a matter of seconds, when placed upon the tongue.�
A fast dissolving tablet can be defined as a solid dosage form that can disintegrates into smaller granules which slowly dissolve in the mouth.  The disintegration time for fast dissolving tablet varies from a few seconds to more than a minute depending on the formulation and the size of the tablet.
A fast disintegrating or dissolving system or tablet can be defined as a solid dosage form that can disintegrate or dissolve within 30 seconds, in the oral cavity resulting in a solution or suspension without administration of water. 

Drug selection criteria [12-15]
The ideal characteristics of a drug for oral dispersible tablet include 
Ability to permeate the oral mucosa.
At least partially non-ionized at the oral cavity pH.
Have the ability to diffuse and partition into the epithelium of the upper GIT.
Small to moderate molecular weight.
Low dose drugs preferably less than 50 mg.
Short half life and frequent dosing drugs are unsuitable for ODT.
Drug should have good stability in saliva and water.
Very bitter or unacceptable taste and
odor drugs are unsuitable for ODT

Ideal Properties of FDT [ 5, -15]
Require no water for oral administration, yet dissolve / disperse/ disintegrate in mouth in a matter of seconds.
Have a pleasing mouth feel.
Have an acceptable taste masking property.
Be harder and less friable
Leave minimal or no residue in mouth after administration
Exhibit low sensitivity to environmental conditions (temperature and humidity).
Allow the manufacture of tablet using conventional processing and packaging equipments.

Advantages of FDT   [ 7- 9, 11- 15 ]
Administration to the patients who cannot swallow, such as the elderly, stroke victims, bedridden patients, patients affected by renal failure & patients who refuse to swallow such as pediatric, geriatric & psychiatric patients.
Rapid drug therapy intervention.
Achieve increased bioavailability/rapid absorption through pregastric absorption of drugs from mouth, pharynx & esophagus as saliva passes down.
Convenient for administration and patient compliant for disabled, bedridden patients and for travelers and busy people, who do not always have access to water.
Good mouth feel property helps to change the perception of medication as bitter pill particularly in pediatric patients.
The risk of chocking or suffocation during oral administration of conventional formulations due to physical obstruction is avoided, thus providing improved safety.
New business opportunity like product differentiation, product promotion, patent extension and life cycle management.
Disadvantages of FDT   [ 12]
Fast dissolving tablet is hygroscopic in nature so must be keep in dry place. 
Some time it possesses mouth feeling. 
MDT requires special packaging for properly stabilization & safety of stable product 

Salient Features of Fast Dissolving Drug Delivery System [ 12, 7]
Ease of administration to patients who refuse to swallow a tablet, such as paediatric and geriatric patients and, psychiatric patients.
Convenience of administration and accurate dosing as compared to liquids.
No need of water to swallow the dosage from, which is highly convenient feature for patients who are traveling and do not have immediate access to water.
Good mouth feels properly of MDDS helps to change the basic view of medication as �bitter pill�, particularly for paediatric patients.
Rapid dissolution of drug and absorption which may produce rapid, 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 drugs is increased.
Ability to provide advantages of liquid medication in the form of solid preparation.
Pregastric absorption can result in improved bioavailability and as a result of reduced dosage, improved clinical performance through a reduction of unwanted effects.

Approaches for Fast Dissolving Tablets 
The basic approaches to developing fast dissolving tablets include maximizing the porous structure of the tablet matrix, incorporating the appropriate disintegrating agent, and using highly water-soluble excipients in the formulation.

Conventional Techniques Used For Preparation of Fddds  [ 5 - 9.11 -15]
Disintegrant Addition
Disintegrant addition technique is one popular technique for formulating Fast-dissolving tablets because of its easy implementation and cost-effectiveness. The basic principle involved in formulating Fast-dissolving tablets by disintegrant addition technique is addition of superdisintegrants in optimum concentration so as to achieve rapid disintegration along with the good mouth feel. Microcrystalline cellulose and low substituted hydroxypropylcellulose were used as disintegrating agents in the range of 8:2 � 9.1 to prepare fast dissolving tablet. 
Freeze Drying
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. 
Moulding
In this method, molded tablets are prepared by using water soluble ingredients so that the tablets dissolve completely and rapidly. The solvent is then removed by air-dryingSublimation
The slow dissolution of the compressed tablet containing even highly water-soluble ingredients is due to the low porosity of the 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 cross carmellose 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. 

Mass-Extrusion
This technology involves softening the active blend using the solvent mixture of water soluble polyethylene glycol, using methanol 

Direct Compression
It is the easiest way to manufacture tablets. Conventional equipment, commonly available excipients and a limited number of processing steps are involved in direct compression. 


Patented technologies for fast dissolving tablets    [5,-9, 11-15]
Zydis Technology
The tablet dissolves in the mouth within seconds after placement on the tongue. A Zydis tablet is produced by lyophilizing or freeze-drying the drug in a matrix usually consisting of gelatin. 
Durasolv Technology
Durasolv is the patented technology of CIMA labs. The tablets made by this technology consist of a drug, fillers and a lubricant. Durasolv is an appropriate technology for products requiring low amounts of active ingredients.

Orasolv Technology
Orasolv Technology has been developed by CIMA labs. In this system active medicament is taste masked. It also contains effervescent disintegrating agent. 
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 consist of self binding shear form matrix termed as �floss�. Shear form matrices are prepared by flash heat processing.
Wow tab Technology
Wow tab 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. 
Flash tab Technology
Prographarm laboratories have patented the Flash tab technology. Drug micro granules may be prepared by using the conventional techniques like coacervation, micro encapsulation, and extrusion spheronisation. 


Promising Drugs to be Incorporated in Fast Dissolving Tablets   [5,- 9]
Analgesics and Anti-inflammatory Agents: Aloxiprin, Auranofin, Azapropazone
Anthelmintics:Albendazole,BepheniumHydroxynaphthoate,Cambendazole Anti-Arrhythmic Agents: Amiodarone, Disopyramide, Flecainide Acetate
Anti-bacterial Agents: Benethamine,Penicillin,Cinoxacin,Ciprofloxacin,Clarithromycin 
Anti-coagulants: Dicoumarol, Dipyridamole, Nicoumalone, Phenindione. 
Anti- Depressants:  Amoxapine, Ciclazindol,  Maprotiline, Mianserin, Nortriptyline, 
Anti-Epileptics: Beclamide, Carbamazepine, Clonazepam, Ethotoin, 
Anti-Fungal Agents: Amphotericin,ButoconazoleNitrate, Clotrimazole, , Fluconazole, 
Anti-Gout Agents: - Allopurinol, Probenecid, Sulphinpyrazone.
Anti-Hypertensive Agents: Amlodipine, Carvedilol, Dilitazem, Diazoxide, Felodipine, 
Anti-Malarials:Amodiaquine, Chloroquine, Chlorproguanil, Halofantrine, Mefloquine, 
Anti-MigraineAgents: Dihydroergotamine Mesyiate, Ergotamine Tartrate, Methysergide 
Anti-Neoplastic Agents And Immunosuppressant: Busulphan, Chlorambucil, Cyclosporin, 
AntiProtozoalAgents: Benznidazole, Decoquinate, Diiodohydroxyquinoline
Anti-Thyroid Agents: - Carbimazole, Propylthiouracil.
Anxiolytic, Sedatives, Hypnotics And Neuroleptics:Alprazolam, Amyiobarbitone
Cardiac Inotropic Agents:Amrinone, Digitoxin, Digoxin,Lanatoside C, Medigoxin.
Corticosteroids:Beclomethasone,  Betamethasone, Budesonide, Cortisone Acetate 
Diuretics:Acetazolarnide,      Amiloride   Bumetanide, Chlorothiazide,      
Enzymes: All the Enzymes.
Anti-Parkinsonian Agents: - Bromocriptine Mesylate, Lysuride Maleate.
Gastro-Intestinal Agents:Bisacodyl, Cimetidine, Domperidone, Famotidine, Loperamide Histamine H,-Receptor Antagonists:Acrivastine,  Astemizole,  Cinnarizine, Cyclizine 
Lipid Regulating Agents:- Bezafibrate,Clofibrate,Fenofibrate, Gemfibrozil, Probucol.
Local Anaesthetics:-  Lidocaine
Neuro -Muscular Agents:-  Pyridostigmine.
Nitrates and Other Anti-Anginal Agents:Amyl Nitrate, Glyceryl Trinitrate
Nutritional Agents: Betacarotene, Vitamin A, Vitamin B 2 , Vitamin D, Vitamin E
Opioid Analgesics:Codeine, Diamorphine,  Dihydrocodeine, Meptazinol, Methadone, 
Oral Vaccines:Influenza, Tuberculosis, Hepatitis,  Polio, Tetanus, Diphtheria, 
Proteins, Peptides and Recombinant Drugs:Insulin, Glucagon, Growth Hormone 
Sex Hormones:Clomiphene Citrate, Danazol, Ethinyloestradiol,  Mestranol,
Stimulants: - Amphetamine, dexamphetamine, dexfenfluramine, fenfluramine, pemoline.

List of commercially available tablets 9

Trade NameActive DrugManufacturerFelden fast meltPiroxicamPfizer Inc., NY, USAClaritin redi TabLoratidineSchering plough Corp., USAMaxalt MLTRizatriptanMerck and Co., NJ, USAZyprexiaOlanzapineEli Lilly, Indianapolis, USA
Other excipients
Bulking Materials:
The recommended bulking agents for this delivery system should be more sugar-based such as mannitol, polydextrose, lactitol, DCL (direct compressible lactose) and starch hydrolystate 
Emulsifying agents:
Emulsifying agents are important excipients for formulating fast-melting tablets they aid in rapid disintegration and drug release without chewing, swallowing or drinking water. A wide range of emulsifiers is recommended for fast-tablet formulation, including alkyl sulfates, propylene glycol esters, lecithin, sucrose esters and others. 
Lubricants:
Lubricants, assist in making these tablets more palatable after they disintegrate in the mouth.
Flavours and sweeteners:
Flavours and taste-masking agents make the products more palatable and pleasing for patients. Both natural and synthetic flavours can be used
Super disintegrants:  [12]
A disintegrant is an excipient, which is added to a tablet or capsule blend to aid in the breakup of the compacted mass when it is put into a fluid environmentSome super disintegrants are: Sodium Starch Glycolate (Explotab, primogel) used in concentration of 2-8 % & optimum is 4%.

 

Evaluation of Powder Properties of Tablet [5, 7, 11, 12]
The various characteristics of blends tested are as given below:
1. Angle of Repose: - It is defined as, the maximum angle possible between the surface of the pile of the powder and the horizontal plane. The angle of repose was determined by the funnel method suggested by Newman. Angle of repose is determined by the following formula
tan � = h/r
Therefore � = tan-1 h/r

Where � = Angle of repose
h = height of the cone
r= Radius of the cone base
Angle of Repose less than 30� shows the free flowing of the material.
2. Bulk Density:- Bulk density, pb, is defined as the mass of the powder divided by the bulk volume and is expressed as gm/ cm3.A sample of about 50 cm3 (blend) is carefully introduced in a 100ml graduated cylinder. The cylinder is dropped onto a hard wood surface three times from a height of 1 inch at two second interval. The bulk density is then obtained by dividing the weight of sample in gms by final volume in cm3.
Pb=M/Vp    
Where   pb = Bulk Density 
M = Weight of sample in gm
V = Final volume of blend in cm 3
3. Bulkiness: - Specific bulk volume or reciprocal of bulk density is called bulkiness or bulk. Bulkiness increases with a decrease in particle size. The bulkiness can be calculated by the following formula
Bulkiness= I/ pb 
Where, pb = Bulk Density.
4. Void Volume: - The volume of the spaces is known as the void volume �v� and is given by the formula
V=Vb-Vp
Where  Vb = Bulk volume (volume before tapping)
Vp = True volume (volume after tapping)
5. Porosity:-  The porosity �  of powder is defined as the ratio of void volume to the bulk volume of the packaging.
The porosity of the powder is given by
� = Vb - Vp/ Vp =1- Vp/Vb
6. Percent Compressibility: - It is an important measure obtained from bulk density and is defined as,
C= Pb-Pu/Pb x100


Evaluation Test for Fast Dissolving Tablet   [5, 11-15]
Tablets from all the formulation were subjected to following quality control test.
1. General Appearance 
The general appearance of a tablet, its visual identity and over all �elegance� is essential for consumer acceptance. Include in are tablet�s size, shape, colour, presence or absence of an odour, taste, surface texture, physical flaws and consistency and legibility of any identifying marking.
2. Size and Shape
The size and shape of the tablet can be dimensionally described, monitored and controlled.
3. Tablet thickness
Tablet thickness is an important characteristic in reproducing appearance and also in counting by using filling equipment. Ten tablets were taken and their thickness was recorded using micrometer.
4. Uniformity of weight   
I.P. procedure for uniformity of weight was followed, 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. 
5. Tablet hardness
Hardness of tablet is defined as the force applied across the diameter of the tablet in the order to break the tablet. Hardness of the tablet of each formulation was determined using Monsanto Hardness tester.
6. Friability
It is measured of mechanical strength of tablets. Roche fribilator was used to determine the friability by following procedure. A pre weighed tablet was placed in the fribilator. Fribilator consist of a plastic-chamber that revolves at 25 rpm, dropping those tablets at a distance of 6 inches with each revolution. The tablets were rotated in the fribilator for at least 4 minutes. At the end of test tablets were dusted and reweighed, the loss in the weight of tablet is the measure of friability and is expressed in percentage as
%Friability = loss in weight / Initial weight x 100
7. In Vivo Dsintegration test
The test was carried out on 6 tablets using the apparatus specified in I.P.-1996 distilled water at 37�C � 2�C was used as a disintegration media and the time in second taken for complete disintegration of the tablet with no palatable mass remaining in the apparatus was measured in seconds.
8. Wetting time
A piece of tissue paper (12 cm X 10.75 cm) folded twice was placed in a small Petri dish (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.
In vitro dispersion time - In vitro dispersion 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.
9. Stability Study (Temperature Dependent)
The fast 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.

Packaging [12]
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

Patient counseling points for ODT [9, 15]
As pharmacist are ideal person to become familiar with recent technology advancement in novel dosage form, thus have opportunity to counsel the patient for effective treatment. Educating the patients about ODT can avoid any confusion and misunderstanding of this dosage form. 
Counseling points to the patients include:
Patients may mistake ODT for effervescent tablets, pharmacist need to be clearly told about the different between them. The cima technologies orosolv and durasolv use slight effervescence, patients may experience a pleasant tingling effect on the tongue.
ODT need to be handled carefully because some of ODT developed may not have sufficient mechanical strength.
Patients with dryness of mouth  or who taking anticholinergic drugs may not be suitable population for administering ODT
Although no water is needed to allow the drug to dispense quickly and efficiently but most technologies of ODT utilizes the body own salivation but decreased volume of saliva may slow down dissolution/ disintegration/ bioavailability of the product.
Although chewable tablets have been in the market for long time, patients need to be counseled properly the difference between chewable and ODT tablets.ODT can be used easily in children who have lost their primary teeth but do not have full use of their  permanent teeth and also for geriatric patients who have lost their teeth permanently.



CONCLUSION
Therapeutic effectiveness of a drug depends upon the bioavailability and ultimately upon the solubility of drug molecules. Solubility behavior of a drug is one of the key determinants of its oral bioavailability. Solid dispersion is unique technique to increase solubility, dissolution, and bioavailability of poorly water soluble drugs. Fast dissolving tablets have significant advantages of both solid and liquid dosage forms, as they remain solid during storage, which aid in stability of dosage forms and transform into liquid form within few seconds after its administration. Besides delivering drug to the body, a drug delivery system aim to improve patient compliance and convenience, and fast dissolving tablets are no exception. The introduction of fast dissolving dosage forms has solved some of the problems encountered in administration of drugs to the pediatric and elderly patient, which constitutes a large proportion of the world's population. Hence, patient demand and the availability of various technologies have increased the market share of Fast dissolving tablets, which in turn prolongs the patent life of a drug. Keeping in view of the advantages of the delivery system, rapidly disintegrating dosage forms have been successfully commercialized, and because of increased patient demand, these dosage forms are expected to become more popular.



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XkXlX�X�X�X�X�X�X>Y?YnYuYvY|Y~Y�Y�Y�Y�Y�Y-Z.ZPZ`ZcZfZgZ�Z�Z�Z������������������������������������������������������������hZ~h�1CJOJQJaJUhZ~h>5�CJOJQJ\�aJ"hZ~h>5�6�CJOJQJ]�aJhZ~h>5�CJOJQJaJhZ~h�1VCJOJQJaJEer presented at: Industry Applications Society Annual Meeting,
Toronto, Ontario, Canada, October 2-8, 1993. Conference Record of the 1993 IEEE. 3: 1698-1703.
Eriksson HJC, Hinrichs WLJ, van Veen B, Somsen GW, de Jong GJ and Frijlink HW (2002). Investigations intothe stabilisation of drugs by sugar glasses: I. Tablets prepared from stabilised alkaline phosphatase. Int. J. Pharm., 249(1-2): 59-70.
Forster A, Hempenstall, J, Tucker I and Rades T (2001). Selection of excipients for melt extrusion with two poorly water-soluble drugs by solubility parameter calculation and thermal analysis. Int. J. Pharm., 226(1- 2): 147-161.
Forster A, Hempenstall J, Tucker I and Rades T (2001). The potential of small-scale fusion experiments and the Gordon-Taylor equation to predict the suitability of drug/polymer blends for melt extrusion. Drug Dev. Ind. Pharm., 27(6): 549-560.
Forster A, Hempenstall J and Rades T (2001). Characterization of glass solutions of poorly watersoluble drugs produced by melts extrusion with hydrophilic amorphous polymers. J. Pharm. Pharmacol., 53(3): 303-315.








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