New Generation of Tablet: Fast Dissolving Tablet
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 h case of uncooperative patients, the problem of swallowing is common phenomenon which leads to poor patient compliance1.
To overcome these drawbacks, mouth dissolving tablets (MDT) or orally disintegrating tablets; (ODT) has emerged as alternative oral dosage forms. These are novel types; of tablets that disintegrate/dissolve/ disperse in saliva within few seconds'. According to European Pharmacopoeia, the ODT should disperse/disintegrate in less than three minutes. The basic approach used in development of MDT is the use of superdisintegrants like Cross linked carboxymelhylcellulose (Croscarmeliose), Sodium starch glycolate (Primogel, Explotab). Polyvinylpyrrolidone (Polyplasdone) etc. which provide instantaneous disintegration of tablet after putting on tongue, thereby releasing the drug in saliva. 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 tablets. 1-3
A fast-dissolving drug delivery system, in most cases, is a tablet that dissolves or disintrigrants in the oral cavity without the need of water or chewing. Most fast-dissolving delivery system films must include substances to mask the taste of the active ingredient. This masked active ingredient is then swallowed by the patient's saliva along with the soluble and insoluble excipients.4-5
These are also called melt-in-mouth tablets, repimelts, porous tablets, oro-dispersible, quick dissolving or rapid disintegrating tablets.
Requirements Of Fast Dissolving Tablets
An ideal FDT should6
ØRequire no water for oral administration, yet dissolve / disperse/ disintegrate in mouth in a matter of seconds.
ØHave a pleasing mouth feel.
ØHave an acceptable taste masking property.
ØBe harder and less friable
ØLeave minimal or no residue in mouth after administration
ØExhibit low sensitivity to environmental conditions (temperature and humidity).
ØAllow the manufacture of tablet using conventional processing and packaging equipments.
Advantages of FDT4,6
ØAdministration to the patients who can not 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.
ØRapid drug therapy intervention.
ØAchieve increased bioavailability/rapid absorption through pregastric absorption of drugs from mouth, pharynx & oesophagus as saliva passes down.
ØConvenient for administration and patient compliant for disabled, bedridden patients and for travelers and busy people, who do not always have access to water.
ØGood mouth feel property helps to change the perception of medication as bitter pill particularly in pediatric patients.
ØThe risk of chocking or suffocation during oral administration of conventional formulations due to physical obstruction is avoided, thus providing improved safety.
ØNew business opportunity like product differentiation, product promotion, patent extension and life cycle management.
Salient Features of Fast Dissolving Drug Delivery System
ØEase of administration to patients who refuse to swallow a tablet, such as paediatric and geriatric patients and, psychiatric patients.
ØConvenience of administration and accurate dosing as compared to liquids.
ØNo 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.
ØGood mouth feels properly of MDDS helps to change the basic view of medication as "bitter pill", particularly for paediatric patients.
ØRapid dissolution of drug and absorption which may produce rapid, onset of action.
ØSome drugs are absorbed from the month pharynx and oesophagus as the saliva passes down into the stomach, in such cases bioavailability of drugs is increased.
ØAbility to provide advantages of liquid medication in the form of solid preparation.
ØPregastric absorption can result in improved bioavailability and as a result of reduced dosage, improved clinical performance through a reduction of unwanted effects.
Following conventional techniques are used for preparation of fast dissolving drug delivery system7-9
Disintegrant addition technique is one popular techniques 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. Agar powder is used as disintegrant for the development of rapidly disintegration tablets by enhancing the porosity of agar by water treatment. Rapidly disintegrating tablets of bitter drugs oxybutynin & pirenzepine were prepared by using the taste masked granules and h mixture of excipients consisting of crystalline cellulose (Avicel PH 02) and low-substituted hydroxypropy cellulose HPC, LH-11), Ishikawa et al. prepared rapidly disintegrating tablets using microcrystalline cellulose (Avicel PH-M series) that was spherical and had a very small particle size 7-32 μm). instead of conventional microcrystalline cellulose (PH 102). Tablets prepared using microcrystalline cellulose; PH-M06 and L-HPC in the ratio of 9:1 were very rapidly disintegrating) in saliva. They concluded that Avicel PH-M06 was superior to Avicel PH 102 in terms of the feeling of roughness in the mouth. Fast dissolving table of efavirenz (anti HIV agent) were formulated by using combination of microcrystalline cellulose and sodium starch glycolate as super disintegrant. Gillis et al, prepared a fast-dissolving tablet of galanthamine hydrobromide which comprises of spray dried mixture of lactose monohydrate and microcrystalline cellulose (75:25) as a diluent, a cross linked polymeric disintegrant such as cross povidone and with a direct compression process of preparing such fast-dissolving tablets. Fast-dissolving tablets having analgesic activity was formulated using a combination of superdisintegrants. Rapid oral disintegration tablets were developed by direct compression using co-ground mixture of D-mannitol and crospovidone. CIMA labs patented Orasolv technology by employing the evolution of carbon dioxide or the effervescence as disintegration mechanism in the formulation of fast-dissolving tablets. The OraSolv technology is an oral dosage form, which combines taste-masked drug ingredients with a quick dissolving effervescent excipient system. Taste masking is achieved through a process of microencapsulation, which coats or entraps the active compound in an immediate release matrix. The effervescent excipient system aids in rapid disintegration of the tablet, permitting swallowing of pharmaceutical ingredients before they come in contact with the taste bud. The OraSolv tablet dissolves quickly without chewing or without water and allows for effective taste masking of a wide variety of active drug ingredients, both prescription and non-prescription. Flashtab technology™ is a patented technology of Prographarm, which employ combination of taste-masked multiparticulate active drug substances, a disintegrating agent, a swelling agent and other excipients to form a multiparticulate tablet that disintegrates rapidly. Rapidly disintegrating multiparticulate tablet was prepared by using taste-masked microcrystals of drugs, crosslinked disintegrating agent and soluble diluent with binding properties.
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.
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 air-drying. Molded tablets are very less compact than compressed tablets. These possess porous structure that enhances dissolution.
The slow dissolution of the compressed tablet containing even highly water-soluble ingredients is due to the low porosity of the tablets. Inert solid ingredients that volatilize readily (e.g. urea, ammonium carbonate, ammonium bicarbonate, hexa methelene tetramine, 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,
Fig.1 – Steps Involved in sublimation
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.
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.
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. 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 For Fast Dissolving Tablets 10-14
Zydis, the best known of the fast-dissolving/disintegrating tablet preparations was the first marketed new technology tablet. 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. The product is very lightweight and fragile, and must be dispensed in a special blister pack. Patients should be advised not to push the tablets through the foil film, but instead peel the film back to release the tablet. The Zydis product is made to dissolve on the tongue in 2 to 3 seconds. The Zydis formulation is also self-preserving because the final water concentration in the freeze-dried product is too low to allow for microbial growth.
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.
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.
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.
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.
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.
Drugs To Be Promising In Corporated In Fast Dissolving Tablets15-17
There are no particular limitations as long as it is a substance which is used as a pharmaceutical active ingredient.
Analgesics and Anti-inflammatory Agents:
Aloxiprin, Auranofin, Azapropazone, Benorylate, Diflunisal, Etodolac, Fenbufen, Fenoprofen Calcim, Flurbiprofen, Ibuprofen, Indomethacin, Ketoprofen, Meclofenamic Acid, Mefenamic Acid, Nabumetone, Naproxen, Oxaprozin, Oxyphenbutazone, Phenylbutazone, Piroxicam, Sulindac.
Albendazole, Bephenium Hydroxynaphthoate, Cambendazole, Dichlorophen, Iverrnectin, Mebendazole, Oxarnniquine, Oxfendazole, Oxantel Embonate, Praziquantel, Pyrantel Embonate, Thiabendazole.
Amiodarone, Disopyramide, Flecainide Acetate, Quinidine Sulphate,
Benethamine Penicillin, Cinoxacin, Ciprofloxacin, Clarithromycin, Clofazimine, Cloxacillin, Demeclocycline, Doxycycline, Erythromycin, Ethionamide, Imipenem, Nalidixic Acid, Nitrofurantoin, Rifampicin, Spiramycin, Sulphabenzamide, Sulphadoxine, Sulphamerazine, Sulphacetamide, Sulphadiazine, Sulphafurazole, Sulphamethoxazole, Sulphapyridine, Tetracycline, Trimethoprim.
Dicoumarol, Dipyridamole, Nicoumalone, Phenindione. Anti-Depressants: Amoxapine, Ciclazindol, Maprotiline, Mianserin, Nortriptyline, Trazodone, Trimipramine Maleate., Acetohexamide, Chlorpropamide, Glibenclamide, Gliclazide, Glipizide, Tolazamide, Tolbutamide.
Beclamide, Carbamazepine, Clonazepam, Ethotoin, Methoin, Methsuximide, Methylphenobarbitone, Oxcarbazepine, Paramethadione, Phenacemide, Phenobarbitone, Phenytoin, Phensuximide, Primidone, Sulthiame, Valproic Acid.
Amphotericin, Butoconazole Nitrate, Clotrimazole, Econazole Nitrate, Fluconazole, Fiucytosine, Griseofulvin, Itraconazole, Ketoconazole, Miconazole, Natamycin, Nystatin, Sulconazole Nitrate, Terbinafine, Terconazole, Tioconazole, Undecenoic Acid.
Allopurinol, Probenecid, Sulphinpyrazone.
Amlodipine, Carvedilol, Benidipine, Darodipine, Dilitazem, Diazoxide, Felodipine, Guanabenz Acetate, Indoramin, Isradipine, Minoxidii, Nicardipine, Nifedipine, Nimodipine, Phenoxybenzamine, Prazosin, Reserpine, Terazosin.
Amodiaquine, Chloroquine, Chlorproguanil, Halofantrine, Mefloquine, Proguanil, Pyrimethamine, Quinine Sulphate. Anti-Migraine Agents: Dihydroergotamine Mesyiate, Ergotamine Tartrate, Methysergide Maleate, Pizotifen Maleate, Sumatriptan Succinate.
Atropine, Benzhexol, Biperiden, Ethopropazine, Hyoscine Butyl Bromide, Hyoscyarnine, Mepenzolate Bromide, Orphenadrine, Oxyphencylcimine, Tropicamide.
Anti-Neoplastic Agents And Immunosuppressants:
Aminoglutethimide, Amsacrine, Azathiopnne, Busulphan, Chlorambucil, Cyclosporin, Dacarbazine, Estramustine, Etoposide, Lomustine, Melphalan, Mercaptopurine, Methotrexate, Mitomycin, Mitotane, Mitozantrone, Procarbazine, Tamoxifen Citrate, Testolactone.
Anti Protozoal Agents:
Benznidazole, Clioquinol, Decoquinate, Diiodohydroxyquinoline, Diloxanide Furoate, Dinitolmide, Furzolidone, Metronidazole, Nimorazole, Nitrofurazone, Omidazole, Tinidazole.
Anxiolytic, Sedatives, Hypnotics And Neuroleptics:
Alprazolam, Amyiobarbitone, Barbitone, Bentazeparn, Bromazepam, Bromperidol, Brotizoiam, Butobarbitone, Carbromal, Chlordiazepoxide, Chlormethiazole, Chlorpromazine, Clobazam, Clotiazepam, Clozapine, Diazepam, Droperidol, Ethinamate, Flunanisone, Flunitrazepam, Fluopromazine, Flupenuiixol Decanoate, Fluphenazine Decanoate, Flurazepam, Haloperidol, Lorazepam, Lormetazepam, Medazepam, Meprobamate, Methaqualone, Midazolam, Nitrazepam, Oxazepam, Pentobarbitone, Perphenazine Pimozide, Prochlorperazine, Suipiride, Temazepam, Thioridazine, Triazolam, Zopiclone.
Acebutolol, Alprenolol, Atenoiol, Labetalol, Metoptolol, Nadolol, Oxprenolol, Pindolol, Propranolol.
Cardiac Inotropic Agents:
Amrinone, Digitoxin, Digoxin, Enoximone, Lanatoside C, Medigoxin.
Beclomethasone, Betamethasone, Budesonide, Cortisone Acetate, Desoxymethasone, Dexamethasone, Fludrocortisone Acetate, Flunisolide, Flucortolone, Fluticasone Propionatu, Hydrocortisone, Methylprednisolone, Prednisolone, Prednisone, Triamcinolone.
Acetazolarnide, Amiloride, Bendrofluazide, Bumetanide, Chlorothiazide, Chlorthalidone, Ethacrynic Acid, Frusemide, Metolazone, Spironolactone, Triamterene. Enzymes : All The Enzymes.
Bromocriptine Mesylate, Lysuride Maleate.
Bisacodyi, Cimetidine, Cisapride, Diphenoxylate, , Domperidone, Famotidine, Loperamide, Mesalazine, Nizatidine, Omeprazole, Ondansetron, Ranitidine, Sulphasaiazine.
Histamine H,-Receptor Antagonists:
Acrivastine, Astemizole, Cinnarizine, Cyclizine, Cyproheptadine, Dimenhydrinate, Flunarizine, Loratadine, Meclozine, Oxatomide, Terfenadine, Triprolidine.
Lipid Regulating Agents:
Bezafibrate, Clofibrate,Fenofibrate, Gemfibrozil, Probucol.
Neuro -Muscular Agents:
Nitrates And Other Anti-Anginal Agents:
Amyl Nitrate, Glyceryl Trinitrate, Isosorbide Dinitrate, Isosorbide Mononitrate, Pentaerythritol Tetranitrate.
Betacarotene, Vitamin A, Vitamin B 2 , Vitamin D, Vitamin E, Vitamin K.
Codeine, Dextropropyoxyphene, Diamorphine, Dihydrocodeine, Meptazinol, Methadone, Morphine, Nalbuphine, Pentazocine.
Vaccines Designed To Prevent Or Reduce The Symptoms Of Diseases Of Which The Following Is A Representative
Influenza, Tuberculosis, Meningitis, Hepatitis, Whooping Cough, Polio, Tetanus, Diphtheria, Malaria, Cholera, Herpes, Typhoid, Hiv, Aids, Measles, Lyme Disease, Travellers Diarrhea, Hepatitis A, B And C, Otitis Media, Dengue Fever, Rabies, Parainfluenza, Rubella, Yellow Fever, Dysentery, Legionnaires Disease, Toxoplasmosis, Q-Fever, Haemorrhegic Fever, Argentina Haemorrhagic Fever, Caries, Chagas Disease, Urinary Tract Infection Caused By E.Coli, Pneumoccoccal Disease, Mumps, File://H:\Gits Mdt\Fast Dissolving Tablet The Future Of Compaction And Chikungunya.
Proteins, Peptides And Recombinant Drugs:
Insulin(Hexameric/Dimeric/Monomeric Forms), Glucagon, Growth Hormone (Somatotropin), Polypeptides Or Their Derivatives, (Preferably With A Molecular Weight From 1000 To 300,000), Calcitonins And Synthetic Modifications Thereof, Enkephalins, Interferons (Especially Alpha-2 Inter Feron For Treatment Of Common Colds).
Clomiphene Citrate, Danazol, Ethinyloestradiol, Medroxyprogesterone Acetate, Mestranol, Methyltestosterone, Norethisterone, Norgestrel, Oestradiol, Conjugated Oestrogens, Progesterone, Stanozolol, Stiboestrol, Testosterone, Tibolone.
Amphetamine, dexamphetamine, dexfenfluramine, fenfluramine, mhazindol, pemoline.
There are no particular limitations on the amount of these drugs to be mixed as long as it is the usual effective treatment amount. It should be around 50 weight/weight % or below of the entire tablet, and is preferably 20 weight/weight % or below.
Optimal disintegration properties often have medium to small size and /or high friability and low hardness. Breakage of tablet edges during handling and tablet rupture during the opening of blister alveolus, all result from insufficient physical resistance.
Evaluation Of Blends18
The quality of tablet, once formulated by rule, is generally dictated by the quality of physicochemical properties of blends. There are many formulation and process variables involved in mixing and all these can affect the characteristics-of blends produced.
The various characteristics of blends tested are as given below:
1. Angle of Repose
The frictional force in a loose powder can be measured by the angle of repose θ. It is defined as, the maximum angle possible between the surface of the pile of the powder and the horizontal plane. If more powder is added to the pile, it slides down the sides of the pile until the mutual friction of the particles producing a surface angle θ, is in equilibrium with the gravitational force.
The angle of repose was determined by the funnel method suggested by Newman. Angle of repose is determined by the following formula
Tan θ = h/r
Therefore θ = Tan-1 h/r
Where θ = 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.
Density is defined as weight per unit volume. Bulk density, pb , is defined as the mass of the powder divided by the bulk volume and is expressed as gm/ cm 3 .
The bulk density of a powder primarily depends on particle size distribution, `particle shape and the tendency of particles to adhere together. There are two types of bulk density.
The particles are pack in such a way so as to leave large gaps between their surfaces 'resulting up in light powder of low bulk density.
Here the smaller particles shift between the large particles resulting in heavy powder of high bulk density.
Bulk density is very important in the size of containers needed for handling, shipping, and storage of raw material and blend. It is also important in size blending equipment. A standard procedure used for obtaining bulk density or its reciprocal bulkiness is given, below
A sample of about 50 cm 3 (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 cm 3.
Where p b =Bulk Density "
M = Weight of sample in gm
V = Final volume of blend in cm 3
Specific bulk volume or reciprocal of bulk density is called bulkiness or bulk.
Bulkiness increases with a decrease in particle size. In mixture of material of different sizes, however the smaller particle shifts between the larger particles and tends to reduce the bulkiness.
The bulkiness can be calculated by the following formula
Bulkiness= I/ p b where, p b = Bulk Density.
Loose bulk density
It is defined as the ratio of weight of blend in gms to the loose bulk volume (untapped volume) in cm 3 Loose bulk density is given by
Loose bulk density p u = Weight in gms / V b
Where V b = Bulk volume (untapped volume)
The volume of the spaces is known as the void volume "v" and is given by the formula
Where Vb = Bulk volume (volnme_before tapping)
V = True volume (volume after tapping)
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
Porosity is frequently expressed in percentage and is given as
%€ = (1 - Vp/ Vb) X 100
The porosity of powder indicates the types of packaging a powder undergoes when subject to vibrations, when stored, or in tablet machine when passed through hopper or feed frame.
It is an important measure obtained from bulk density and is defined as,
If the bed of particles is more compressible the blend will be less flowable and flowing materials.
Evaluation Of Fast Dissolving Tablet19-20
Tablets from all the formulation were subjected to following quality control test.
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.
Size and Shape
The size and shape of the tablet can be dimensionally described, monitored and controlled.
Tablet thickness is an important characteristic in reproducing 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 was recorded using micrometer.
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. The weight variation test would be a satisfactory method of determining the drug content uniformity.
Average weight of Maximum percentage
Tablets (mg)__________ different allowed___________
130 or less 10
More than 324 5
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 Monsato Hardness tester.
It is measured of mechanical strength of tablets. Roche fribaiator was used to determine the friability by following procedure. A preweighed tablet was placed in the fribaiator. Fribaiator 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 friabalator for at least 4 minutes. At the end of test tablets were dusied 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
In Vivo Dsintegration test
The test was carried out on 6 tablets using the apparatus specified in I.P.-1996 distilled water at 37ºC ± 2ºC was used as a disintegration media and the time in second taken for complete disintegration of the tablet with no palable mass remaining in the apparatus was measured in seconds.
The method reported by yunixia et al., was followed to measure tablet wetting time. A piece of 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 was 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.
Stability testing of drug (temperature dependent stability studies)
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 (Vissual defects, Hardness, Friability, Disintegrations, 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.
Expensive packaging, specific processing, and special care are required during manufacturing and storage to protect the dosage of other fast-dissolving dosage forms. Unlike these other 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.
Fast dissolving tablets constitute an innovative dosage form, which overcomes the problem of swallowing and provides a quick onset of action. The paediatric and geriatric populations are the primary. Targets, as both the groups found it difficult to swallow conventional tablets. The basic approach followed by all the currently available technologies engaged in the formulation of Fast dissolving tablets is to maximize the porous structure of the tablet matrix and incorporate super disintegrating agents in optimum concentration so as to achieve rapid disintegration and instantaneous dissolution of the tablet along with good taste masking properties and excellent mechanical strength The availability of the various technologies and manifold advantages of Fast dissolving tablets will surely increase its popularity in the near future
Marketed Fast Dissolving Tablets in India
Quick releasing antiulcer
Mosid – MT
Mouth melt tablet of Mosapride
Immediate Dissolving formulation of Calritin
Nimulid – MD
piroxicam (10 or 20 mg),
rizatriptan (5 or 10 mg),
famotidine (20 or 40 mg),
olanzapine (5, 10, 15 or 20 mg),
ondansetron (4 or 8 mg),
mirtazepine (15, 30, or 45 mg),
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Dr. G. D. Gupta is working as a professor and principal in ASBASJSM College of Pharmacy, Bela, Ropar, India. Dr. Gupta has author of number of books and published more than 100 Research Paper / Abstract in National and International conferences.
Shailesh Sharma is working a lecturer cum research scholar in department of pharmaceutics in ASBASJSM College of Pharmacy, Bela, Ropar, India.He had completed his graduation from B . R. Nahata College of pharmacy, Mandsaur, (MP) and post graduation from B.N.College of pharmacy, Udaipur, Raj. He has very good academic and extra circular record.
Sudhir Bhardwaj is working a lecturer cum research scholar in department of pharmaceutics in ASBASJSM College of Pharmacy, Bela, Ropar, India . Mr. Bhardwaj has author of number of books and published several Research Paper / Abstract in National and International conferences. He is a Memership Coordinator for INPHARM Association, active member of FIP, International Society of Agriculture and Applied Science, and APTI
Mr. Varun Hans is a B.Pharm. final year student of ASBASJSM College of Pharmacy, Bela, Ropar, India.