Orodispersable Tablet : A Review

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The concept of Mouth Dissolving Drug Delivery System emerged from the desire to provide patient with more conventional means of taking their medication.

It is difficult for many patients to swallow tablets and hard gelatin capsules. 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 conventional tablets may be difficult. Such problems can be resolved by means of Orodispersable Tablet. When put on tongue, this tablet disintegrates instantaneously, releasing the drug, which dissolves or disperses in the saliva. Present review article focuses on significance of Mouth Dissolving Dosage Forms and the techniques and technologies available for their manufacturing.

Introduction

Drug Delivery Systems (DDS) are a strategic tool for expanding markets/indications, extending product life cycles and generating opportunities. DDS make a significant contribution to global pharmaceutical sales through market segmentation and moving rapidly. Drug delivery systems are becoming increasingly sophisticated as pharmaceutical scientists acquire a better understanding of the physicochemical and biochemical parameters pertinent to their higher performance1. Despite of tremendous advancements in drug delivery, the oral route remains the perfect route for the administration of therapeutic agents because the low cost of therapy and ease of administration lead to high levels of patient compliance2. Many patients find it difficult to swallow tablets and hard gelatin capsules and do not take their medicines as prescribed. Difficulty in swallowing or dysphagia is seen to afflict nearly 35% of the general population. Many elderly persons will have difficulties in taking conventional dosage forms (solutions, suspensions, tablets and capsules) because of their hand tremors and dysphagia3. Swallowing problems are also common in young individuals because of their under developed muscular and nervous system. Other groups, who may experience problems in swallowing solid dosage forms, are the mentally ill, the developmentally disabled, uncooperative patient and reduced liquid intake plans or nausea. Dysphagia is also associated with number of medical conditions including Stroke, Parkinson’s disease, AIDS, head and neck radiation therapy and other neurological disorders including cerebral palsy.

In some cases such as motion sickness, sudden episode of allergic attack or coughing and an unavailability of water, swallowing of tablet or capsules may become difficult. In order to assist these patients, several fast-dissolving drug delivery systems have been developed4. A solid dosage form that dissolves or disintegrates rapidly in oral cavity, resulting in solution or suspension without the need of water is known as fast dispersing dosage form or Orodispersable Tablets. When this type of tablet is placed into the mouth, the saliva will serve to rapidly dissolve the tablet5-8.

Orodispersable Tablets disintegrate and/or dissolve rapidly in the saliva without the need for water. Some tablets are designed to dissolve in saliva remarkably fast, within a few seconds and are true fast-dissolving tablets. Others contain agents to enhance the rate of tablet disintegration in the oral cavity and are more appropriately termed fast-disintegrating tablets, as they may take up to a minute to completely disintegrate. When put on tongue, this tablet disintegrates instantaneously, releasing the drug, which dissolves or disperses in the saliva. 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 significantly greater than those observed from conventional tablet dosage form. In order to allow fast dissolving tablets to dissolve in the mouth, they are made of either very porous or soft moulded matrices or compressed into tablets with very low compression force, which makes the tablets friable and/or brittle, which are difficult to handle, often requiring specialized peel-off blister packaging9-11.

Patented Technologies

Several technologies are available for preparing Orodispersable Tablets. But some commercially useful technologies are12-18:

Zydis Technology

‘Zydis’ is the first mouth dissolving dosage form in the market. It is a unique freeze-dried tablet in which the active drug is incorporated in a water-soluble matrix, which is then transformed into blister pockets and freeze dried to remove water by sublimation. Zydis matrix is made up of a number of ingredients in order to obtain different objectives. Polymers such as gelatin, dextran or alginates are added to impart strength during handling. These form a glossy and amorphous structure. Mannitol or sorbitol is added to impart crystallinity, elegance and hardness. Various gums may be added to prevent sedimentation of dispersed drug particles. Water is used as a medium to ensure the formation of a porous dosage form. Collapse protectants like glycine may be used to prevent shrinkage of dosage form during freeze drying and long-term storage.32 If necessary, suspending agents and pH adjusting agents may be used. Preservatives may also be added to prevent microbial growth. Zydis products are packed in blister packs to protect the formulation from environmental moisture. A secondary moisture proof foil punch is often required as this dosage form is very moisture sensitive. When put into the mouth, Zydis unit quickly disintegrates and dissolves in saliva19.

Drawbacks:

a.  A water insoluble drug can be incorporated only upto 400 mg per tablet or less. On the

other hand water soluble drug can be incorporated only upto 60 mg

b. Fragility and poor stability of dosage form during storage under stressful conditions.

Orasolv Technology

It is CIMA lab’s first mouth dissolving formulation. This technology involves taste masking of active drug. Effervescent disintegrating agent is also used. Conventional blenders and tablet equipments are used for preparation of tablets.

Less force of compaction is used for manufacturing so as to obtain soft and quickly disintegrating tablets. There is a limitation of this technology that soft and fragile tablets are formed, therefore needed to be packed in specially designed pick and place package system.

Durasolv Technology

This too has been developed by CIMA labs. This is one of the suitable technologies to prepare products requiring low amounts of active drug. This technology uses drug, fillers and a lubricant to prepare the tablet. Conventional tabletting equipment is used to prepare the tablet. Due to higher force of compaction used, tablets prepared are rigid. Dosage form can be packaged into conventional packaging system like blisters.  

Wowtab Technology

Yamanauchi pharmaceutical company patented this technology.  ‘wow’ means  ‘without water’. The active ingredients may constitute upto 50% w/w of the tablet. In this technique, saccharides of both low and high mouldability are used to prepare the granules. Mouldability is the capacity of a compound to be compressed.   

Highly mouldable substance has high compressibility and thus shows slow dissolution. The combination of high and low mouldability is used to produce tablets of adequate hardness. Active ingredients are mixed with low mouldability saccharides and then granulated with high mouldabiity saccharides and then compressed into tablet. The Wowtab product dissolves quickly in 15 s or less. Wowtab product can be packed in both into conventional bottle and blister packs.

Flashdose Technology

This technology is patented by Fuisz. This system uses the combination of both Shearform and Ceform technologies in order to mask the bitter taste of the drug. A sugar based matrix, called ‘Floss’ is used, which is made up of a combination of excipients (crystalline sugars) alone or in combination with drugs. Nurofen meltlet, a new form of Ibuprofen, as a mouth-dissolving tablet is the first commercial product prepared by this technology and launched by Biovail Corporation.

Drawbacks:

a.  The dosage form can accommodate only up to 600 mg of drug.

b. Tablets produced are highly friable, soft and moisture sensitive. Therefore specialized  packing is required.

Flashtab Technology

Prographarm labs. have a patent over this technology. In this technology, microgranules of the taste-masked active drug are used. These may be prepared by using conventional techniques like coacervation, microencapsulation, and extrusion-spheronisation. All these processes utilize conventional tabletting technology.35 These taste-masked micro crystals of active drug, disintegrating agent, a swelling agent and other excipients like soluble diluents etc are compressed to form a multiparticulate tablet that disintegrates rapidly.

Shearform Technology

In this technology, a shearform matrix, ‘Floss’ is prepared. Feedstock prepared with a sugar carrier is subjected to flash heat processing. In this process, sugar is simultaneously subjected to centrifugal force and to a temperature gradient, which causes the temperature of the mass to rise and hence an internal flow condition is created, permitting part of it to move with respect of the mass. The flowing mass comes out through the spinning head that flings the floss. Theproduced floss isamorphous in nature. So by various techniques, it is further chopped and recrystallised to provide a uniform flow, thus facilitate blending. Then the recrystallised matrix, active drug and other excipients are blended together and finally compressed into tablets. Active drug and other excipients may be blended with the floss before recrystallising it.

Ceform Technology

This technology involves preparation of microspheres of the active drug. Drug material alone or in combination with other pharmaceutical substances, and excipients is placed into a precision engineered rapidly spinning machine. The centrifugal force comes into action, which throws the dry drug blend at high speed through small heated openings. Due to the heat provided by carefully controlled temperature, drug blend liquefies to form a sphere, without affecting the drug stability. The microspheres thus formed are compressed into tablets. As the drug and excipients both can be processed simultaneously, it creates a unique microenvironment in which the materials can be incorporated into the microspheres that can alter the characteristics of the drug, such as enhancing solubility and stability.

Nanocrystal Technology

For MDT, Elan's proprietary NanoCrystal technology can enable formulation and improve compound activity and final product characteristics. Decreasing particle size increases the surface area, which leads to an increase in dissolution rate. This can be accomplished predictably and efficiently using NanoCrystal technology. NanoCrystal particles are small particles of drug substance, typically less than 1000 nanometers (nm) in diameter, which are produced by milling the d For fast dissolving tablets, Elan's proprietary NanoCrystal technology can enable formulation and improve compound activity and final product characteristics. Decreasing particle size increases the surface area, which leads to an increase in dissolution rate. This can be accomplished predictably and efficiently using NanoCrystal technology.

NanoCrystal™ Fast dissolving technology provides for:

a. Pharmacokinetic benefits of orally administered nanoparticles (<2 microns)
in the form of a rapidly disintegrating tablet matrix

b.  Product differentiation based upon a combination of proprietary and patent-protected
technology elements.

c.   Cost-effective manufacturing processes that utilize conventional, scalable unit operations

d. Exceptional durability, enabling use of conventional packaging equipment and formats (i.e., bottles and/or blisters).

e.  Wide range of doses (up to 200mg of API per unit).

f.   Use of conventional, compendial inactive components.

g.   Employment of non-moisture sensitive inactives

NanoCrystal colloidal dispersions of drug substance are combined with water-soluble GRAS (Generally Regarded As Safe) ingredients, filled into blisters, and lyophilized. The resultant wafers are remarkably robust, yet dissolve in very small quantities of water in seconds.

Approaches For Preparation Of Mdt

Various technologies used in the manufacture of Orodispersable Tablets include20-26:

Freeze-drying

The tablets prepared by freeze-drying or lyophilization are very porous in nature and disintegrate or dissolve rapidly when come in contact with saliva. In this process, water is sublimated from the product after freezing. First of all, the material is frozen to bring it below its eutectic point. Then primary drying is carried out to reduce the moisture to around 4% w/w of dry product. Finally, secondary drying is done to reduce the bound moisture to the required volume. Due to lyophilization, bulking agent and sometimes drug acquire glossy amorphous structure and thus dissolution is enhanced. A tablet that rapidly disintegrates in aqueous solution includes a partially collapsed matrix network that has been vacuum dried above the collapsed temperature of the matrix. The matrix is partially dried below the equilibrium freezing point of the matrix. Vacuum drying the tablet above its collapse temperature, instead of freeze drying below its collapse temperature provides a process for producing tablets with enhanced structural integrity, while rapidly disintegrating in normal amounts of saliva. However the use of freeze-drying is limited due to high cost of equipment and processing. Other major disadvantages of the final dosage forms include lack of physical resistance in standard blister packs.

Sublimation

This process involves addition of some inert volatile substances like urea, urethane, naphthalene, camphor, etc to other excipients and the compression of blend into tablet. Removal of volatile material by sublimation creates pores in tablet structure, due to which tablet dissolves when comes in contact with saliva. Additionally several solvents like cyclohexane, benzene etc can also be used as pore forming agents. Orodispersable Tablets with highly porous structure and good mechanical strength have been developed by this method.

Spray Drying

A highly porous and fine powder is prepared by spray drying an aqueous composition containing support matrix and other components. This is then mixed with active ingredient and compressed into tablet.

Moulding

Tablets prepared by this method are solid dispersions. Physical form of drug in the tablets depends on whether and to what extent it dissolves in the wetted mass.The drug can exist as discrete particles or micro particles in the matrix. It can dissolve totally to form a solid solution or dissolve partially in the molten carrier and remaining, if any, stays undissolved and dispersed in the matrix. Disintegration time, drug dissolution rate and mouth feel will depend on the type of dispersion.  Different moulding techniques can be used to prepare mouth-dissolving tablets:

a. Compression moulding: The powder mixture previously wetted with a solvent ike ethanol/water is compressed into mould plates to form a wetted mass.

b. Heat moulding: A molten matrix in which drug is dissolved or dispersed can be directly moulded into Orodispersable Tablets.

c. No vacuum lyophilization: This process involves evaporation of solvent from a drug solution or suspention at a standard pressure.

Moulded tablets posess porous structure, which facilitates rapid disintegration and easy dissolution. Moulded tablets offer improved taste due to water-soluble sugars present in dispersion matrix. But moulded tablets lack good mechanical strength and can undergo breakage or erosion during handling and opening of blister packs.26 However, adding sucrose, acacia or polyvinyl pyrrolidone can increase mechanical strength. 

Mass Extrusion

In this technique, a blend of active drug and other ingredients is softened using solvent mixture of water soluble polyethylene glycol, using methanol and then the softened mass is extruded through the extruder or syringe to get a cylinder of product, which is finally cut into even segments with the help of heated blades to get tablets. The dried cylinder can be used to coat the granules of bitter tasting drugs and thereby masking their bitter taste.

Direct Compression

The disintegrant addition technology(direct compression) is the most preferred technique to manufacture the tablets due to certain advantages:

a.  High doses can be accommodated and final weight of the tablet can exceed that of other methods.

b. Easiest way to manufacture the tablets.

c. Conventional equipment and commonly available excipients are use

d. A limited number of  processing steps are involved.

e.  Cost-effectiveness.

Tablet size and hardness strongly affect the disintegrant efficacy. Hard and large tablets have more disintegration time than normally required. Very soft and small tablets have low mechanical strength. So, an optimum kind and concentration of disintegrant should be chosen to achieve quick disintegration and high dissolution rates. Above the critical concentration level, however, disintegration time remains approximately constant or even increases.

Ingredients Mostly Used In MDT

Super Disintegrants

Use of disintegrants is the basic approach in development of MDTs. Disintegrants play a major role in the disintegration and dissolution of MDT. It is essential to choose a suitable disintegrant, in an optimum concentration so as to ensure quick disintegration and high dissolution rates27.

Super disintegrants provide quick disintegration due to combined effect of swelling and water absorption by the formulation. Due to swelling of superdisintegrants, the wetted surface of the carrier increases, this promotes the wettability and dispersibility of the system, thus enhancing the disintegration and dissolution. The optimum concentration of the superdisintegrant can be selected according to critical concentration of disintegrant. Below this concentration, the tablet disintegration time is inversely proportional to the concentration of the superdisintegrant, whereas if concentration of superdisintegrant is above critical concentration, the disintegration time remains almost constant or even increases28.

Sodium starch glycolate, Ac-di-sol(crosscarmellose sodium), Crospovidone, Microcrystalline cellulose, Pregelatinised starch are some of examples of disintegrants.

Sugar Based Excipients

Sugar based excipients are used for taste masking and as bulking agents. Most of the dugs are having unpleasant or bitter taste. And the basic requirement for designing MDTs is that the drug should not have disagreeable taste. So taste masking is necessary in most of the cases. Sorbitol, mannitol, xylitol, dextrose, fructose, etc. are mainly used. Aqueous solubility and sweetness impart a pleasing mouth feel and good taste masking29. But not all sugar-based materials have fast dissolution rate and good compressibility or compactability. However technologies are developed to make use of the sugar based excipients in the design of fast dissolving tablets30-33.

Other ingredients commonly used are water soluble diluents, lubricants, antistatic agents, plasticizers, binders, colors and flavors34, 35.

Mechanism Of Action Of Disintegrants36-38

By Capillary Action

Disintegration by capillary action is always the first step. When we put the tablet into suitable aqueous medium, the medium penetrates into the tablet and replaces the air adsorbed on the particles, which weakens the intermolecular bond and breaks the tablet into fine particles. Water uptake by tablet depends upon hydrophilicity of the drug /excipient and on tableting conditions. For these types of disintegrants, maintenance of porous structure and low interfacial tension towards aqueous fluid is necessary which helps in disintegration by creating a hydrophilic network around the drug particles.

By Swelling

Perhaps the most widely accepted general mechanism of action for tablet disintegration 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. It is worthwhile to note that if the packing fraction is very high, fluid is unable to penetrate in the tablet and disintegration is again slows down.

Because of Heat of Wetting (Air Expansion)

When disintegrants with exothermic properties gets wetted, localized stress is generated due to capillary air expansion, which helps in disintegration of tablet. This explanation, however, is limited to only a few types of disintegrants and can not describe the action of most modern disintegrating agents.

Due to Release of Gases

Carbon dioxide released within tablets on wetting due to interaction between bicarbonate and carbonate with citric acid or tartaric acid. The tablet disintegrates due to generation of pressure within the tablet. This effervescent mixture is used when pharmacist needs to formulate very rapidly dissolving tablets or fast disintegrating tablet. As these disintegrants are highly sensitive to small changes in humidity level and temperature, strict control of environment is required during manufacturing of the tablets. The effervescent blend is either added immediately prior to compression or can be added in to two separate fraction of formulation.

By Enzymatic Reaction

Enzymes presents in the body also act as  disintegrants. These enzymes destroy the binding action of binder and helps in disintegration.

Actually due to swelling, pressure exerted in the outer direction or radial direction, it causes tablet to burst or the accelerated absorption of water leading to an enormous increase in the volume of granules to promote disintegration.

Due to Disintegrating Particle/Particle Repulsive Forces

Another mechanism of disintegration attempts to explain the swelling of tablet made with ‘non-swellable’ disintegrants. Guyot-Hermann has proposed a particle repulsion theory based on the observation that nonswelling particle also cause disintegration of tablets. The electric repulsive forces between particles are the mechanism of disintegration and water is required for it. Researchers found that repulsion is secondary to wicking.

Due to Deformation

Hess had proved that during tablet compression, disintegranted particles get deformed and these deformed particles get into their normal structure when they come in contact with aqueous media or water. Occasionally, the swelling capacity of starch was improved when granules were extensively deformed during compression. This increase in size of the deformed particles produces a break up of the tablet. This may be a mechanism of starch and has only recently begun to be studied.

Future Advantages Of MDT

Orodispersable Tablets can offer several biopharmaceutical advantages such as improved efficiency over conventional dosage forms. For example, they require smaller amounts of active ingredient to be effective, improve absorption profiles, and offer better drug bioavailability than regular tablets and capsules. In addition, MDTs may be suitable for the oral delivery of drugs such as protein and peptide-based therapeutics that have limited bioavailability when administered by conventional tablets. These products usually degrade rapidly in the stomach. Because drugs delivered in MDTs may be absorbed in the pregastric sites of highly permeable buccal and mucosal tissues of the oral cavity, they may be suitable for delivering relatively low-molecular weight and highly permeable drugs39-43.

Future possibilities for improvements in MDTs and drug delivery are bright, but the technology is still relatively new. Several drug delivery technologies that can be leveraged on improving drug therapy from MDTs have yet to be fully realized44.

Table 1 - Popular Disintegrants used in Tablet

Disintegrants

Mechanism

Concentration

%w/w

Starch

Disintegrate forms pathways throughout the tablet matrix that enable water to draw into the structure by capillary action, thus leading to disruption of tablet.

5-20

 

Pregelatinized starch

Responsible for increased dissolution rate from this tablet is rapid disintegration due to superior swelling capacity.

5-15

 

Sodium Starch Glycolate

(Explotab and Primogel)

involves rapid absorption of water leading to an enormous increase in volume of granules result in rapid and uniform disintegration.

1-3

Cross-linked polyvinyl Pyrrolidone (Cross Povidone, CrosspovidonM®, Kollidon®, Polyplasdone®)

 

The capillary activity of cross povidone for water is responsible for its tablet disintegration property.

0.5-5

 

Cellulose
 (Ac-Di-Sol, Nymce ZSX®, Primellose®. Solutab®

They show their ability to swell on contact with water results in rapid tablet disintegration.

1-3

 

Microcrystalline Cellulose
 (Avicel)

allowing water to enter the tablet matrix by means of capillary pores, which break the hydrogen bonding between adjacent bundles of cellulose microcrystals and exhibit very good disintegrant property

10-20

 

Alginates

(Alginic Acid, Satialgine®)

High affinity for water absorption and high sorption capacity make it an excellent disintegrant.

1-5

 

Soy polysaccharides

(Emcosoy®)

Natural super disintegrant, Rapid swelling in aqueous medium or wicking action, Does not contain any starch or sugar. Used in nutritional products.

 

5-15

Gums
(Guar Gums, Gum Karaya, Agar,         Gellan Gum)

As disintegrants because of their tendency to swell in water

3-8

Chitin and Chitosan

Moisture sorption and water uptake was found the major mechanism of disintegration while dissolution related to swelling capacity

1-5

Smecta

Their layered leaves like structure consist of aluminium and octahydral layers sandwiched between two tetrahydral silica layers. It has a large specific area and high affinity for water makes it good disintegrant.

5-15

Isapghula Husk

Plantago ovata seeds husk has high swellability and gives uniform and rapid disintegration.

5-15

Polacrillin Potassium 

It swells up at very fast rate upon contact with water or gastro intestinal fluid and act as an effective tablet disintegrant.

10-20

Ion Exchange Resins
Ambrelite IPR 88,

Indion, Doshion

Resins have ability to swell in the presence of water, showed disintegration of tablet.

0.5-5

 

Gas – Evolving disintegrants
(Citic Acid , tatric Acid, Sodium Bi Carbonate)

These react in contact with water to liberate carbon dioxide that disrupts the tablet.

 

>10%

Table 2-  Comparison of Fast Dissolving Techniques

ZYDIS (R.P. SCHERER, INC.)

               Novelty

          Handling/Storage

 Drug release/bioavailability

First to market

Do not push tablet through foil

Dissolves in 2 -10 s

 

Freeze Dried

Do not use dosage form from   damaged package

May allow for pre-gastric absorption leading to enhanced bioavailability

 

 

Sensitive to degradation at humidities > 65%

 

 

ORASOLV (CIMA LABS, INC.)

 

Unique taste masking


Packaged in patented oil packs

Disintegrates in 5 – 45 s depending upon the size of the tablet

Lightly compressed

No significant change in drug bioavailability

DURASOLV (CIMA LABS, INC.)

Similar to Orasolv, but with better mechanical strength

 

Packaged in foil or bottles

Disintegrates in 5 – 45 s depending upon the size of the tablet

 

Package in bottles

No significant change in drug bioavailability

WOWTAB (YAMANOUCHI PHARMA TECHNOLOGIES, INC.)

 

Compressed dosage form

 

 

Avoid exposure to moisture or humidity.

Disintegrates in 5 – 45 s depending upon the size of the tablet

 

Proprietary taste masking

Avoid exposure to moisture or humidity.

Require specialized

Packaging.

 


No significant change in drug bioavailability

FLASHDOSE (FUISZ TECHNOLOGIES, LTD.)

Unique spinning mechm producing floss-like crystalline
structure as cotton candy

 

Avoid exposure to moisture and humidity

 

Dissolves within 1 min.

Enhanced bioavailability.

FLASHTAB (PROGRAPHARM GROUP)

 

Compressed dosage form containing Drug as microcrystals

 

Dissolves within 1 min

Table 3 -  Some of Promising Drug Candidates for Orodispersable Tablets

S. No.

          Category

                                Examples

1.

 

Antibacterial agents

Ciprofloxacin, tetracycline, erythromycin, rifampicin, penicillin, doxycyclin, nalidixic acid, trimethoprim, sulphacetamide, sulphadiazine etc.

2.

Anthelmintics

Albendazole, mebendazole, thiabendazole, livermectin, praziquantel, pyrantel embonate, dichlorophen etc.

3.

Antidepressants

Trimipramine maleate, nortriptyline HCl, trazodone HCl, amoxapine, mianserin HCl, etc.

4.

Antidiabetics

Glibenclamide, glipizide, tolbutamide, tolazamide, gliclazide, chlorpropamide etc.

5.

Analgesics/anti-inflammatory agents

Diclofenac sodium, ibuprofen, ketoprofen, mefenamic acid, naproxen, oxyphenbutazone, indomethacin, piroxicam, phenylbutazone, etc.

6.

Antihypertensives:

Amlodipine, carvedilol, diltiazem, felodipine, minoxidil, nifedipine, prazosin HCl, nimodipine, terazosin HCl etc.

7.

Antiarrhythmics

Disopyramide, quinidine sulphate, amiodarone HCl, etc.

8.

Antihistamines

Acrivastine, cetrizine, cinnarizine, loratadine, fexofenadine, triprolidine, etc.

9.

Anxiolytics, sedatives hypnotics and neuroleptics

Alprazolam, diazepam, clozapine, amylobarbitone, lorazepam, haloperidol, nitrazepam , midazolam phenobarbitone, thioridazine, oxazepam, etc.

10.

Diuretics

Acetazolamide, clorthiazide, amiloride, furosemide, spironolactone, bumetanide, ethacrynic acid, etc.

11.

Gastro-intestinal agents

Cimetidine, ranitidine HCl, famotidine, domperidone, omeprazole, ondansetron HCl, granisetron HCl, etc.

12.

Corticosteroids

Betamethasone, beclomethasone, hydrocortisone, prednisone, prednisolone, methyl prednisolone, etc.

13.

Antiprotozoal agents

metronidazole, tinidazole, omidazole, benznidazole,

Table 4 - Marketed Products of MDT

Trade Name

Active Drug

 Manufacturer

Nimulid-MD

Nimesulide

Panacea Biotech, New Delhi, India

Feldene Fast Melt

Piroxicam

Pfizer Inc., NY, U.S.A

Zyrof Meltab

Rofecoxib

Zydus, Cadila, India

Pepcid RPD

Famotidine

Merck and Co., NJ, U.S.A

Romilast

Montelukast

Ranbaxy Labs Ltd., New Delhi, India

Torrox MT

Rofecoxib

Torrent Pharmaceuticals, Ahmedabad, India

Olanex Instab

Olanzapine

Ranbaxy Labs Ltd., New Delhi, India

Zofran ODT

Ondansetron

Glaxo Wellcome, Middlesex, UK

Mosid-MT

Mosapride citrate

Torrent Pharmaceuticals, Ahmedabad, India

Febrectol

Paracetamol

Prographarm, Chateauneuf, France

Maxalt MLT

Rizatriptan

Merck and Co., NJ, U.S.A

Zelapar TM

Selegiline

Amarin Corp., London , UK

Diagram Showing Advantages of MDT

Figure 1 - Diagram Showing Advantages of MDT

Schematic Diagram of Sublimation Technique for Preparation of MDT

Figure 2 - Schematic Diagram of Sublimation Technique for Preparation of MDT

Mechanism of Action of Superdisintegrants

Figure 3 Mechanism of Action of Superdisintegrants

Disintegration of Tablet by Wicking and Swelling

Figure 4 - Disintegration of Tablet by Wicking and Swelling

Disintegration by Deformation and Repulsion

Figure 5 - Disintegration by Deformation and Repulsion

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About Authors:

Shailesh Sharma, Dr. G. D. Gupta , Ms. Rajni Bala, Ms. Neelam Sharma, Ms. Nimrata Seth, Mr. J. P. Goswami

Shailesh Sharma

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. He has more than 20 articles in reputed peer reviewed journals. He has great intrest in tablet technology and its reproducibility.

Dr. G. D. Gupta

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.

Ms.Rajni Bala

Ms.Rajni Bala is a M.Pharm. final year student of ASBASJSM College of Pharmacy, Bela, Ropar, India.

Ms. Neelam Sharma

Ms. Neelam Sharma is a M.Pharm. final year student of ASBASJSM College of Pharmacy, Bela, Ropar , India .

 Ms. Nimrata Seth

Ms. Nimrata Seth is a M.Pharm. final year student of ASBASJSM College of Pharmacy, Bela, Ropar , India .

Mr. J. P. Goswami

Mr. J. P. Goswami  is a M.Pharm. final year (Pharmaceutics) student of ASBASJSM College of Pharmacy, Bela, Ropar , India .

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Smitarane's picture

overall t's a collection of good information.

smita rane