INTRODUCTION:

Now day’s formulation research is modified in such a way that the active ingredients can be delivered with a level of convenience, performance and bioavailability never seen in the market. The oral route of administration is regarded to be the most preferred route due to its various advantages like ease of administration, pain avoidance, versatility and most important patient compliance. Tablet is the most popular dosage form among all existing dosage form but in some instances due to the large size of dosage forms, and in some cases as of uncooperative, pediatric and dysphagia patients, it may create some problems, to overcome these problems, a new modified form of tablets is developed, which is known as fast dissolving tablet or mouth dissolving tablet. Due to decline in swallowing ability with age, many elderly patients complain that it is difficult for them to take some currently used dosage forms such as tablets, capsules, or powders, fast dissolving tablets are thus a best alternative of these dosage forms. These tablets are one of the most promising dosage forms in recent years; this type of tablet has attracted the interest of many researchers. Fast dissolving tablets are highly accepted fast growing drug delivery system. According to US FDA orodispersible tablets are defined as “A solid dosage form containing medicinal substances which disintegrates rapidly usually within a matter of seconds, when placed upon the tongue”.

European pharmacopeia defined orodispersible tablet as a “tablet that is to be placed in the mouth where it disperses, rapidly before swallowing despite various terminologies used”. Fast dissolving tablets are the best alternate to deliver the drug having bitter taste and poor bioavailability. The orodispersible tablets dissolves in the oral cavity without drinking water where it disintegrates within a fraction of seconds. The disintegrated mass slides down smoothly along the esophagus with the help of saliva, so even people who have swallowing or chewing difficulties can take it with ease. Most fast dissolving drug delivery system films must include substances to mask the active ingredient. This masked active ingredient is than swallowed by the patient’s saliva along with the soluble and insoluble excipients. These are also called as melt-in-mouth tablets, repimelts or porous tablets. Orodispersible tablets can be manufactured by different processes like lyophilisation, moulding and sublimation, using a sugar-floss system or direct compression. When the fast disintegrating tablet is orally applied, the drug substance has to be dissolved so that it can be absorbed. Dissolution process consists of various process, e.g. wetting, disintegration and dissolution. A fast disintegrating tablet which generally contains several excipients is involved in a complex series of dissolution process that begins when the solvent reaches the solid and penetrates the tablet matrix. Effects of excipients are assumed to be related to the surface properties of the particles and solid matrix structure. Recently, fast-dissolving drug delivery systems have started gaining popularity and acceptance as new drug delivery systems, because they are easy to administer and lead to better patient compliance. These orodispersible drug delivery systems are also used to improve bioavailability and patient compliance. Over the past three decades, orodispersible tablets (ODTs) have gained considerable attention as a preferred alternative to conventional tablets and capsules due to better patient compliance, improved solubility and stability profiles. In some commercialized preparation methods, the rapidly disintegrating tablets are produced by adding a solution or suspension of drug/excipients to the pockets of a blister pack sheet, and then freeze-or vacuum-drying the solution or suspension. The oral disintegration time of such tablets is very short because of their highly porous structure and the high solubility of the sugar alcohol or saccharide used as the diluents. On the other hand, some rapidly disintegrating tablets have been produced by compression of wet powder containing the drug and subsequent drying in an oven. Such processes provide tablets with excellent oral disintegration and greater hardness. In recent years, a new method of preparing RD tablets without any special apparatus has been reported. Mizumoto et al. focused on the compactibility of saccharides and reported that rapidly disintegrating tablets can be manufactured using a combination of low and high compactibility saccharides ^[1-19].

Advantages of Orodispersible Tablets

Fast dissolving tablets have the following advantages over other dosage forms, as follows:

• No water needed

• No chewing needed

• Better taste

• Improved stability

• Allows high drug loading

• Ability to provide advantages of liquid medication in the form of solid preparation.

• Cost‐ effective

• Rapid drug therapy intervention

• Have acceptable taste and pleasant mouth feeling.

• Leave minimum residue.

• Improved compliance/added convenience

• Ease administration for patients who are mentally ill, disabled and uncooperative

• Better taste obtained by taste masking

• Ability to provide advantages of liquid medication in the form of solid preparation

• Adaptable and amenable to existing processing and packaging high speed machinery

• The new proprietary method allows the incorporation of microencapsulated drugs for enhanced bioavailability, flexibility of dosing & immediate and/or controlled release

• For superior therapeutic benefit ^[19]

Challenges in Formulating ODTS

In the formulation of orodispersible tablets the following challenges are to be faced:

Palatability

As most drugs are unpalatable, orally disintegrating drug delivery systems usually contain the medicament in a taste-masked form. Delivery systems disintegrate or dissolve in patient’s oral cavity, thus releasing the active ingredients which come in contact with the taste buds; hence, taste-masking of the drugs becomes critical to patient compliance.

Mechanical strength

In order to allow ODTs to disintegrate in the oral cavity, they are made of either very porous and soft-molded matrices or compressed into tablets with very low compression force, which makes the tablets friable and/or brittle, difficult to handle, and often requiring specialized peel-off blister packing that may add to the cost.

Hygroscopicity

Several orally disintegrating dosage forms are hygroscopic and cannot maintain physical integrity under normal conditions of temperature and humidity. Hence, they need protection from humidity which calls for specialized product packaging.

Amount of drug

The application of technologies used for ODTs is limited by the amount of drug that can be incorporated into each unit dose. For lyophilized dosage forms, the drug dose must be lower than 400 mg for insoluble drugs and less than 60 mg for soluble drugs. This parameter is particularly challenging when formulating a fast-dissolving oral films or wafers.

Aqueous solubility

Water-soluble drugs pose various formulation challenges because they form eutectic mixtures, which result in freezing-point depression and the formation of a glassy solid that may collapse upon drying because of loss of supporting structure during the sublimation process. Such collapse sometimes can be prevented by using various matrix-forming excipients such as mannitol than can induce crystallinity and hence, impart rigidity to the amorphous composite.

Size of tablet

The degree of ease when taking a tablet depends on its size. It has been reported that the easiest size of tablet to swallow is 7-8 mm while the easiest size to handle was one larger than 8 mm. Therefore, the tablet that is both easy to take and easy to handle is difficult to achieve. ^[19]

The Need for Development of ODTS

The need for non-invasive delivery systems persists due to patients’ poor acceptance of, and compliance with, existing delivery regimes, limited market size for drug companies and drug uses, coupled with high cost of disease management ODT is one such dosage form which is useful for Geriatric patients mainly suffering from conditions like hand tremors and dysphasia.

· Pediatric patients who are unable to swallow easily because their central nervous system and internal muscles are not developed completely

· Traveling patients suffering from motion sickness and diarrhea that do not have easy access to water

· Especially for Patients with persistent nausea for a long period of time are unable to swallow

· Mentally challenged patients, bedridden patients and psychiatric patients ^[19-20]

COMPARISON BETWEEN DEVELOPMENTS OF ODT’s:

First-generation ODTs

While first‐generation ODT technologies produce tablets that dissolve rapidly in the mouth, provide convenience and ease of swallowing, and have had success in the market, some of them fall short in terms of taste masking and the accommodating high doses and because most first‐generation technologies can handle only low amounts of APIs, their therapeutic applications are limited and are used only in immediate‐release applications. First‐generation ODTs are commonly characterized by high porosity, low density, and low hardness, making them brittle and difficult to handle. As a result, they often require blister packaging, which is less convenient for patients than bottles and entails high production costs. As the ODT market matures, pharmaceutical companies are seeking additional capabilities from these dosage forms. These include higher API loading, more effective taste masking, controlled‐release capability, low friability, cost‐effective development, and more packaging options.

New generation of ODTs

New generation of ODTs available today, is one that can be combined with a proprietary process to improve taste masking, allow a modified‐release profile, and enhance bio‐availability. As a result, formulators can taste‐mask even extremely poor‐tasting drugs; use high doses of API, and expand the range of therapeutic applications. These ODTs comprises of rapidly dispersing micro granules, a direct compression blend, and an external tablet lubrication method. The result is an ODT with excellent physical robustness, mouth‐feel, and disintegration properties. The tablets dissolve in 15 to 30 seconds (depending on dosage strength) and produce a smooth, pleasant tasting mixture of API granules and carrier that is easy to swallow. The tablets are made on standard presses, accept printing on both sides, typically have a friability of less than 0.5 percent, and can be packaged in bottles or blister packs. Combining micro‐encapsulation with ODT technology effectively can masks bitter APIs and can be applied to soluble and poorly soluble substances, as well as to high‐dose products. One technology is based on coacervation, a coating technique that encapsulates individual drug particles completely and provides superior taste masking. This coacervation technique has taste‐masked a wide range of extremely poor‐tasting drugs, including zolpidem (for insomnia), Sumatriptan (for migraines), ranitidine (for gastro‐esophageal reflux disorder), and cetirizine (for allergic rhinitis). It has also been applied to theophylline, ibuprofen, acetaminophen, and pseudoephedrine, etc. ^[21]

Methods Used to Manufacture Orodispersible Tablets

Conventional technologies

i. Freeze Drying.

In this method, the material is frozen to bring it below the eutectic point. It is then dried out to reduce the bound moisture to the required volume ^[1].

ii. Tablet Molding

Moulding process is of two types, solvent moulding and heat moulding.

In solvent moulding method the powder blend is moistened with a hydroalcoholic solvent followed by pressing into mold plates to form wetted mass. The solvent is then removed by air drying ^[8].

In heat moulding method, a suspension containing drug, agar, and sugar is prepared; this suspension is then poured into blister packaging wells, followed by solidifying the agar at room temperature to form jelly and drying at 30^oC under vacuum ^[22].

iii. Direct Compression

It is the easiest method of all for the formulation of conventional dosage form. Conventional equipment, commonly available excipients and a limited number of processing steps are involved in direct compression technique, i.e. simple mixing of the ingredients and directly compressing them into tablet form by tablet punching equipment ^[18].

iv. Spray Drying

In this technique, a suspension is prepared containing hydrolyzed and unhydrolyzed gelatin as a supporting agent for matrix, bulking agent, and disintegrants. This suspension is then spray dried to yield a porous powder which is then compressed into tablets ^[20].

v. Sublimation

In this method, a subliming material like camphor is removed by sublimation from compressed tablets and high porosity is achieved due to the formation of many pores where camphor particles previously existed in the compressed tablets. Subliming material is sublimed from the dried granules by vacuum exposure ^[23].

vi. Mass extrusion

In this method, the active blend is softened using the solvent mixture of water-soluble polyethylene glycol and methanol. This softened mass is then subjected for subsequent expulsion through the extruder or syringe to get a cylinder of the product into seven segments using heated blade to form tablet. The dried cylinder can be used to coat granules for bitter drugs for achieving bitter taste masking ^[22].

Patented Technologies

i. Zydis Technology

In this technology the drug is physically trapped in water soluble matrix, and then freeze dried to produce a product that rapidly dissolves ^[17].

ii. Orasolv Technology

This technology produces tablets by low compression pressure. This technique uses an effervescent disintegration pair that releases gas upon contact with water. The effervescent pair used usually includes acid and carbonate source that on combination produces effervescence ^[17].

iii. Durasolv Technology

This technology is Cima’s second generation fast dissolving/disintegrating tablet formulation produced in a fashion similar to Orasolv^[24].

iv. Wow tab Technology.

This technology is patented by Yamanouchi Pharmaceutical Co. The WOW in Wowtab signifies the tablet is to be given “Wit out Water” ^[9].

v. Flash dose Technology

In this method the dosage form is manufactured by using shearform technology associated with the ceform technology for the bitter taste masking of the drug. A matrix known as “floss” is prepared by the excipients alone or by combination with the drug by using shear form technology ^[25].

vi. Flash tab Technology

This technology is patented by prographarm laboratories. A tablet prepared by this technology consists of an active ingredient in the form of microcrystal. Drug micro granules may be prepared by using the conventional techniques like coacervation, microencapsulation, and extrusion-spheronisation. All the processing utilized conventional tabletting technology^[19].

vii. Nanocrystal technology

In this technique crystal colloidal dispersions of the drug substances are combined with water soluble ingredients, followed by filling into blister and lyophillization. This technique avoids manufacturing processes. This is patented by Elan, King of Prussia ^[13].

viii. Quick-dis technology

This technology is a proprietary patented technology of Lavipharm Laboratories. It is a thin, flexible, and quick dissolving film ^[17].

Other Technologies

i. Melt granulation.

In this technique, granules are prepared in a high speed blade mixer at 40-44^oC, this granules were then allowed to blend with the polymers and compressed into tablets^[13].

ii. Phase transition process.

In this technique tablets were produced by compressing a powder containing two sugar alcohols with high- and low-melting points and subsequent heating at a temperature between their melting points ^[26].

iii. Nanonization.

This technique involves reduction in the particle size of drug to nanosize by milling the drug using a proprietary wet-milling technique^[20].

Industrial Applications

Industrial applications include the following:

· To develop an orally disintegrating dosage forms and to work with existing disintegrants

· To further improvise upon the existing technology of ODTs

· To optimize the blend of disintegrants or excipients to achieve ODTs

· To select and develop proper packaging material and system for enhanced stability of the product and also develop a cost-effective product

· To arrive at various taste-masking agents and prepare palatable dosage forms thereby increasing patient compliance

· To develop disintegrants from different polymers which are used as coating materials by certain modifications and use them for formulating orodispersible tablets ^[19].

TABLE 1:

The following table shows the works that has been done on fast dissolving dosage form:

Drug	Polymers Used	Method Used	Reference
Doxylamine Succinate	Croscarmallose sodium, Crospovidone, sodium starch glycolate(superdisintegrants), Indion 234 (taste masking agent)	Batch method	27
Pheneramine Maleate	Croscarmallose sodium, crospovidone, sodium starch glycolate	Direct compression	28
Ibuprofen	Crospovidone (super disintegrant), Mannitol (sweetener)	Direct compression	29
Atenolol	Kyron T-314 (super fast disintegrants)	Direct compression	30
Losartan potassium	Croscarmallose sodium, Polyplasdone XL-10, Explotab (superdisintegrants)	Direct compression	31
Chlorpromazine HCL	Sodium starch glycolate, crospovidone, Croscarmallose sodium, L-HPC, pregelatinised starch (superdisintegrants)	Direct compression	32
Oxcarbazepine	Crospovidone (superdisintegrant), aspartame (sweetener), PVP K-30 and Peg-6000 (solubility enhancers)	Direct compression and solid dispersion	33
Acetaminophen	Saccharides	Wet granulation	34
Crystallized paracetamol	PEG-6 stearate (waxy binder), Croscarmallose sodium (superdisintegrant)	We granulation and melt granulation	35
Promethazine HCL	Eudragit E-100 (taste masking agent), crospovidone, sodium starch glycolate, Croscarmallose sodium (superdisintegrants)	Extrusion method, direct compression method	36
Terbutaline sulphate	Sodium CMC, Ac-Di-Sol	Direct compression	37
Levocetrizine HCL	Sodium starch glycolate, Croscarmallose sodium	Direct compression and effervescent technique	38
Baclofen	Ac-Di-Sol, Sodium starch glycolate, crospovidone	Direct compression	39
Glipizide	Crospovidone, Croscarmallose sodium	Direct compression	40
Aceclofenac	Sodium starch glycolate, Cross carmallose sodium, pregelatinised starch	Wet granulation	41
Furosemide	Crospovidone	Solid Dispersion by Kneading Method, Tablet Compression by Direct compression	42
Lornoxicam	Sodium starch glycolate, crospovidone, Croscarmallose sodium (superdisintegrant) Beta cyclodextrin (taste masking agent)	Direct compression	43
Aceclofenac	Crospovidone, sodium starch glycolate (superdisintegrants), Camphor (subliming agent)	sublimation	44
Combination of Omeprazole and Domperidone	Kollidone CL, Ac-Di-Sol, sodium starch glycolate (superdisintegrants), Mannitol (sweetening agent)	Direct compression	45
Amlodipine besylate	Crospovidone (superdisintegrant), Mannitol, Aspartame, Acesulfame potassium (taste masking agents and sweeteners)	Direct compression	46
Amlodipine besylate	Sodium starch glycolate	Sublimation	47
Metoprolol tartarate	Plantago ovate mucilage (natural superdisintegrant)	Direct compression	48
Metoprolol tartarate	Crospovidone, Croscarmallose sodium	Direct compression	49
Granisteron Hydrochloride	Croscarmallose sodium	Direct compression	50
Granisteron hydrochloride	Crospovidone, sodium starch glycolate	Direct compression, effervescent, sublimation	51
Metoclopramide hydrochloride	Indion 204	Direct compression	52
Sertraline	Crospovidone, Croscarmallose, sodium starch glycolate	Direct compression	53
Naproxen sodium	Sodium starch glycolate, crospovidone, Croscarmallose sodium	Direct compression	54
Domperidone	Crospovidone	Sublimation	55
Cinnarizine	Crospovidone, Croscarmallose sodium, sodium starch glycolate	Direct compression	56
Diltiazem hydrochloride	Croscarmallose sodium, sodium starch glycolate	Wet granulation	57
Celecoxib	Sodium starch glycolate	Hot melt extrusion	58
Lornoxicam	Kyron t-314	Sublimation	59

CONCLUSION:

Fast dissolving drug delivery systems are thus novel drug delivery systems that are formulated to improve patient compliance and improve bioavailability. These formulations are cost effective and provide ease of administration to the pediatric, geriatric and such patients that feel difficulty in swallowing. This dosage form does not require water for the administration. With continued development of new pharmaceutical excipients, one can expect the emergence of more novel technologies for ODTs in the days to come.

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Received on 20.04.2013 Modified on 01.05.2013

Research J. Pharm. and Tech 6(6): June 2013; Page 597-602