1. INTRODUCTION:

Medicinal and other curative agents which produces the systemic effect that can be taken by several routes of administration, but oral route is considered to be more effective route and possess high degree of patient compliance¹. Dissolution of drug, absorption of drug, onset of clinical effect of drug and bioavailability of drug is significantly higher in orally disintegrating tablets when compared to conventional dosage form. Basic approach used in developing orodispersible tablets (ODTs) is by increasing the porosity of tablet by using high water soluble excipients in the formulation and by incorporating the appropriate disintegrating agents.

These dosage forms rapidly dissolve in mouth when they immediately come into contact with saliva and releases the drug. Orodispersible tablets are also known as Fast dissolving tablets².

There is even no need of water during administration of drug which will be highly useful for paediatric and geriatric patients. Orodispersible tablets are the tablets which is not coated and when kept in the mouth disperses rapidly before swallowing³. Orodispersible tablets are also known as “Melt in mouth tablets”, “Mouth dissolving tablets”, “Rapimelt tablets”, “Porous tablets”, “Quick dissolving tablets” and “Fast dissolving drug delivery”. Recently the term ODT is approved by US Pharmacopoeia, (CDER) Centre for Drug Evaluation and Research and British Pharmacopoeia. According to US FDA, ODT is a solid dosage form which contains drug substances that rapidly disintegrates when placed upon tongue usually disintegrates within a matter of seconds. The European Pharmacopoeia defines ODT as “A tablet which is to be placed in mouth disperses rapidly within three minutes before swallowing”. For elderly patients, administering conventional tablets are not easy because of their regular requirement of tablets for maintaining their healthy lifestyle⁴. Children may also have difficulty in ingesting, problem of swallowing tablets also seen in travelling patients, these problems can be solved by means of orodispersible tablets. When formulation of drug comes to end of its patent, the formulation and development of a drug into a new dosage form enables pharmaceutical companies for attracting new consumers through the product promotion plans, advertisement and also increases profits⁵. Recent literature review indicates that half the patient’s population prefer orodispersible tablet than other dosage forms. The disintegration time for ODTs ranges from several seconds to about a minute. For composition of this dosage form appropriate disintegrants with water soluble excipients are incorporated⁶.

1.1 Salient Features of Orodispersible Tablets:

1. Easily ingested by the patients who don’t swallow such as paediatric, geriatric, patients who are psychiatric, bedridden patients and patients affected by renal failure⁷.

2. It produces quick onset of action due to rapid disintegration, dissolution and absorption of tablets.

3. The good mouth feel property of the drug helps to change the perception of medication as “bitter pill” particularly in paediatric patient⁸.

4. The pregastric absorption results in improved bioavailability and less dosage improves clinical performance by reducing the side effects.

5. Due to solid form of drug it is stable for long duration of time.

1.2 Ideal Properties of Drug for Development of Fast Dissolving Tablets (FDTs):

The ideal properties of drug for development of mouth dissolving tablets include:

1. Those drugs which are able to diffuse into epithelial of upper GIT (log P > 2).

2. Drugs that produce toxic metabolites by first-pass metabolism⁹.

3. Sustained and controlled release drugs are unsuitable for MDTs.

4. Very bitter drugs with unacceptable taste are unsuitable for MDTs.

1.3 Potential Drug Candidates for Fast Dissolving Tablets:

· Non-steroidal Anti-Inflammatory Drugs: Ketoprofen, Piroxicam, Paracetamol, Rofecoxib, Nimesulide, Ibuprofen.

· Antiparkinsonian Drugs: Selegiline.

· Anti-ulcer Drugs: Famotidine, Lansoprazole.

· Antidepressants Drugs: Mitraxepine, Fluoxetine.

· Antimigrane Drugs: Sumatriptan, Rizatriptan benzoate, Zolmitriptan.

· Anti-histaminic Drugs: Loratadine, Diphenhydramine, Meclizine.

· Antiemetic Drugs: Ramosetoron HCl, Ondansetron, Baclofen.

1.4 Advantages:

· It’s easier means of administration is the main benefit for the patients who have difficulty with swallowing of drugs such as patients in shock state, stroke victims, bedridden patients, patients who are suffering from kidney failure, paediatric, geriatric patients¹⁰.

· Produces pleasant taste effect that change the medication perception. This factor is helpful while preparing dose for paediatric patients.

· There is no danger of suffocation due to physical obstruction when swallowed, thus offers improved safety.

· Fast absorption or enhance in bioavailability is achieved through pregastric absorption of drugs from mouth, pharynx and oesophagus as saliva passes down¹¹.

· Accurate dosing when compared to liquids.

· New business opportunities like product differentiation, life cycle management, exclusivity of product promotion and patent life extension¹².

1.5 Disadvantages:

1. Sometimes ODTs are highly easily broken.

2. In each dose low amount of drug can be incorporated.

3. Since ODTs don’t have enough hardness they must be handled with great care.

4. ODTs are not for fill coating process¹³.

2. Challenges in Formulation of ODTs:

A. Disintegration time and mechanical strength:

ODTs are formulated to get disintegration time typically less than a minute. While doing so, maintaining a good mechanical strength is a main challenge. Many ODTs are fragile and there are chances that such fragile tablet will fracture during packing, transport or handling by the patients. It is very natural that increasing the mechanical strength will delay the disintegration time. Therefore, a good compromise between these two parameters is always necessary¹⁴.

B. Taste masking:

Many drugs are bitter in taste. A tablet of bitter drug dissolving/ disintegration in mouth will seriously affect patient compliance and acceptance for the dosage form. So effective taste masking of the bitter drugs must be done so that the taste of the drug is not felt in the oral cavity¹⁵.

C. Sensitivity to environmental conditions:

ODTs generally should exhibit low sensitivity to environment conditions such as humidity and temperature as most of the materials used in ODTs are meant to dissolve in minimum quantity of water¹⁶.

D. Mouth feel:

ODTs should not disintegrate into larger particles in the oral cavity. The particles generated after disintegration of the ODTs should be as small as possible. ODTs should leave minimal or no residue in mouth after oral administration. Moreover, addition of flavours and cooling agents like menthol improve the mouth feel¹⁷.

E. Cost:

The technology used for ODTs must be acceptable in terms of cost of the final product¹⁸.

F. 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 7-8mm while the easiest size to handle was one larger than 8mm. Therefore, the tablet size that is both easy to take and easy to handle is difficult to achieve¹⁹.

3. Ingredients Used for Preparation of fast dissolving Tablets:

Superdisintegrants:

The rate of disintegration and dissolution is increased by addition of superdisintegrants. They have greater disintegrating efficiency and are effective at low concentration²⁰.

Examples: Crosspovidone, Microcrystalline Cellulose, Sodium Starch Glycolate, CMC.

Lubricants:

Lubricants reduces the friction during compaction and ejection of tablets²¹.

Examples: Magnesium stearate and Talc.

Binders:

The selected binders must have proper melting characteristics, desired binding quality and produce fast release of active ingredients. Stability and integrity of tablets are maintained by proper selection of binders.

Examples: Hydroxy propyl methyl cellulose, PVP, Polyvinyl alcohol.

Emulsifying Agents:

By incorporating emulsifying agents, it helps in enhancement of bioavailability and stabilizing the immiscible blends. By reducing the interfacial tension, it improves the solubility of ODTs.

Example: Sodium dodecyl sulphate.

Colours:

Addition of colour will enhance appearance of dosage form.

Examples: Amaranth 3, Sunset yellow, Redironoxide.

Flavours:

Addition of flavours overcomes the undesirable taste and bitterness which improves acceptability and patient compliance.

Examples: Citrus Oil, Vanilla, Clove Oil, Peppermint Oil.

Bulking Agents:

Addition of bulking agents will improve the textural characteristics of the drug which will increase the disintegration in the mouth.

Examples: Mannitol and Starch hydrolysate.

4. Mechanism of Disintegration:

Capillary action (Wicking):

Capillary action is the first step in the tablet disintegration. When the ODT is added to aqueous medium then aqueous medium will penetrate into tablet, this leads to replace the air which is absorbed over particles. In turn makes intermolecular bond weak and breaks into fine particles that makes tablets porous.

Example: Crospovidone, Croscarmellose sodium²².

Swelling:

In this mechanism disintegrating agent starch imparts the disintegrating effect. Because of inadequate swelling force, highly porous tablets show less disintegration whereas with sufficient force the tablets show low porosity with good disintegration.

Example: Sodium Starch Glycolate

Air Expansion:

The disintegrants which are having exothermic properties gets wetted, then stress is produced because of air expansion which is responsible for tablets disintegration.

Repulsive force between particles:

It is also the mechanism of disintegration which explains about tablet swelling made out of “nonswellable” disintegrants in which electric repulsive force within particles are responsible for disintegration.

Release of gases:

On wetting of the tablet, the interactions within carbonate and bicarbonate with tartaric acid or citric acid releases carbondioxide and pressure within the tablet that makes the tablet to disintegrate. Rapidly dissolving tablets are formulated by mixing with this effervescent mixture. The liberation of carbondioxide enhances the taste masking effect and dissolution.

Enzymatic Reaction:

Some enzymes which are present in our body act as disintegrants. These enzymes help in disintegration of tablets by destroying the binding action of the binder. Because of swelling the pressure which is exerted in the tablet, increases absorption of water which leads to increase in disintegration.

Deformation:

The starch grains which is elastic are deformed when pressure is applied and when pressure is removed they return to the original shape.

5. Technologies Used to Manufacture Fast Dissolving Tablets:

· Freeze Drying

· Tablet Moulding

· Spray Drying

· Sublimation

· Direct compression

· Mass Extrusion

· Nanonization

Freeze drying or lyophilisation:

A process in which water is sublimated from the product after freezing is called lyophilisation. It is a pharmaceutical technology which allows drying of heat sensitive drugs and biologicals at low temperature under conditions that allows removal of water by sublimation. Lyophilisation results in preparations which are highly porous, with a very high specific surface area and which dissolve rapidly and show improved absorption and bioavailability. Tablets prepared by lyophilisation are fragile and possesses low mechanical strength which make them difficult to handle and they also exhibit poor stability on storage under stressed conditions²³.

Moulding:

Moulded tablets disintegrates more rapidly and offer improved taste because the dispersion matrix is generally made from water soluble sugars. The active ingredients in most cases is absorbed through the mucosal lining of the mouth. In the manufacturing process of moulding tablets 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 and possesses porous structure²⁴.

Spray Drying:

Spray drying is a process by which highly porous, fine powders can be produced. The formulations that were produced contained hydrolyzed and unhydrolyzed gelatin as a support agent for the matrix, mannitol as a bulking agent and sodium starch glycolate or crosscarmellose as a disintegrant. Disintegration and Dissolution was further enchanced by adding an acid or an alkali. The formulation was spray dried to yield a porous powder and the tablet manufactured from this powder disintegrates in less than 20 seconds in an aqueous medium²⁵.

Sublimation:

The presence of porous structure in the tablet matrix is the key for rapid disintegration of tablet. A porous matrix is formed by compressing the volatile ingredients along with other excipients into tablets, which are finally subjected to a process of sublimation. Ammonium bicarbonate, Ammonium carbonate, benzoic acid, camphor, Hexamethonium teramine, Napthalene, Pthalic anhydride, Urea and Urethane were compressed along with other excipients into a tablet. The volatile material was then removed by sublimation leaving behind a porous matrix.

Direct Compression:

It is the easiest way to manufacture tablets. Conventional equipments, 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 tablets can easily exceed than that of other production methods²⁶.

Mass Extrusion:

This technology involves softening of the active blend using 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 making their bitter taste²⁷.

Nanozination:

It is the process of size-reducing of the drug particles with or without stabilizer to less than 1000nm and preferably less than 100nm. Nanomelt technology involves reduction in the particle size of drug to nanosize by milling the drug using a proprietary wet-milling technique. The nano crystals of the drug are stabilized against agglomeration by surface adsorption on selected stabilizers, which are then incorporated into the ODTs. This technique is especially advantageous for poor water soluble drugs that lead to fast disintegration, increased absorption and hence higher bioavailability. Nanonization is a cost effective manufacturing process needs conventional packaging due to exceptional durability and wide range of doses.

6. Patented Technologies:

Zydis Technology:

ZYDIS are the inventors of this technology. It is the best known of the fast dissolving/disintegrating tablet preparations, and was the marketed new technology tablet. The tablet dissolves in the mouth within seconds after placement on the tongue. Zydis tablet is produced by lypophilizing or freeze drying the drug in a matrix usually consisting of gelatine. The product is very light weight and fragile and must be dispensed in a special blister pack²⁸.

Orasolv Technology:

Cima labs are the inventors of this technology. The orasolv tablets are lightly compressed, yielding a weaker and more brittle tablet in comparison with conventional tablets but it has the appearance of a traditional compressed tablet. In orasolv tablet the particle coating used for taste masking is not compromised by fracture during processing.

Durasolv Technology:

Cima labs are the inventors of this technology. It is the second generation fast-dissolving/disintegrating tablet formulation. Durasolv has much higher mechanical strength than its predecessor due to the use of higher compaction pressures during tableting thus it is produced in faster and more cost effective manner.

Flash Dose Technology:

Fuisz is the inventor of this technology. The flash dose technology utilizes a unique spinning mechanism to produce a floss-like crystalline structure, much like cotton candy. This crystalline sugar can then incorporate the active drug and be compressed into a tablet. The final product has a very high surface area for dissolution. It disperses and dissolves quickly once placed onto the tongue.

Wowtab Technology:

Yamanouchi pharmaceuticals are the inventors of this technology. The WOW in WOWTAB signifies the tablet is to be given “without water”. The wowtab technology utilizes sugar and sugar-like excipients. This process uses a combination of low mouldability saccharides and high mouldability saccharides. The two different types of saccharides are combined to obtain a tablet formulation with adequate hardness and fast dissolution rate.

7. Evaluation of Orodispersible Tablets:

A. Weight variation test: To study weight variation, 20 tablets of each formulation were weighed using an electronic balance and test was performed according to Indian Pharmacopoeia.

Table No. 1: Weight variation specification as per IP

Average Weight of Tablet	% Deviation
80 mg or less	±10
More than 80 mg but less than 250 mg	±7.5
More than 250 mg	± 5

B. Thickness:

Tablet thickness can be measured using a simple procedure. 5 tablets were taken and their thickness was measured using vernier calipers.

C. Crushing Strength:

It is the force required to break a tablet by compression in the radial direction. In the present study the crushing strength of the tablet was measured on the day of compression, using Monsanto hardness tester. An average of three observations is reported.

D. Friability testing:

Friability is a measure of mechanical strength of the tablet. If a tablet has more friability it may not remain intact during packaging, transport or handling. Roche friabilator is used to determine the friability by following procedure. Pre weighed tablets are placed in the friabilator. Friabilator consist of a plastic chamber that revolves at 25 rpm, dropping those tablets at a distance of 6 inches with each revolution. The tablets are rotated in the friabilator for at least 4 minutes. At the end of test tablets are dusted and reweighed; the loss in the weight of tablet is the measure of friability and is expressed in percentage as:

Initial Weight – Final Weight

% Friability = --------------------------------------- × 100

Initial Weight

E. Simulated wetting time:

Wetting time of dosage form is related with the contact angle. Wetting time of the MDT is an important parameter, which needs to be assessed to give an insight into the disintegration properties of the tablet. Lower wetting time implies a quicker disintegration of the tablet. A piece of tissue paper folded twice was placed in a Petri dish with 10 cm diameter. Ten ml of water (containing water soluble dye Eosin) was added to the Petri dish. A tablet was placed on the surface of the tissue paper. The time required for complete wetting was measured as the wetting time²⁹.

Figure No. 1: Simulated wetting time measurement

F. Water Absorption Ratio: A piece of tissue paper folded twice was placed in a small Petridish (internal diameter = 6.5 cm) containing 6 ml of water. A tablet was placed on the paper and time required for complete wetting was measured. The wetted tablet was then weighed. Water absorption ratio (R) was determined using following equation.

R = 100 x { (Wa – Wb)/ Wb}

Where Wa - Weight of tablet after water absorption

Wb - Weight of tablet before water absorption

G. In-vitro drug release:

The development of dissolution methods for ODTs is comparable to the approach taken for conventional tablets, and is practically identical. Dissolution conditions for drugs listed in a pharmacopoeia monograph, is a good place to start with scouting runs for a bioequivalent ODT. Other media such as 0.1N HCl and buffers (pH - 4.5 and 6.8) should be evaluated for ODT much in the same way as their ordinary tablet counter parts. The USP 2 Paddle apparatus is used for this purpose which is the most suitable and common choice for orally disintegrating tablets, with a paddle speed of 50rpm commonly used. Typically, the dissolution of ODT is very fast when using USP monograph conditions; hence slower paddle speeds may be utilized to obtain a profile. The USP 1 Basket apparatus may have certain applications but sometimes tablet fragments or disintegrated tablet masses may become trapped on the inside top of the basket at the spindle where little or no effective stirring occurs, yielding irreproducible dissolution profiles³⁰.

H. In vitro Dispersion Time:

In vitro dispersion time was measured by dropping a tablet in a measuring cylinder containing 6ml of phosphate buffer pH 6.8 (simulated saliva fluid). The time for the tablet to completely disintegrate into fine particles was noted. Three tablets from each batch were randomly selected and in vitro dispersion time was performed.

8. CONCLUSION:

Oral drug delivery is the most preferable route of administration due to its safest, most convenient and most economical method of drug delivery. A novel tablet concept which offers ease of oral administration and benefits of increased patient compliance is the ODTs. They have better patient acceptance and compliance and may offer improved biopharmaceutical properties, improved efficacy, and better safety compared with conventional oral dosage forms. Prescription ODT products initially were developed to overcome the difficulty in swallowing conventional tablets among paediatric, geriatric and psychiatric patients with dysphagia. Today, ODTs are more widely available as over the counter product for treatment of allergies, cold, flu symptoms. The target population has expanded to those who want convenient dosing anywhere, anytime, without water. Such product provide opportunity for the product line extension in the market place. Due to this wide significance of ODTs, this drug delivery system may lead to better patient compliance and ultimate clinical output. Future might provide many more classes of drugs developed in the form of ODT.

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Received on 17.10.2021 Modified on 11.12.2021

Asian J. Pharm. Tech. 2022; 12(2):183-189.

DOI: 10.52711/2231-5713.2022.00031