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 compliance^[1]. 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^[2-4]. Basic approach used in developing ODTs is by increasing the porosity of tablet by using high water soluble excipients in the formulation and by incorporating the appropriate disintegrating agents^[5]. These dosage forms rapidly dissolves in mouth when they immediately come into contact with saliva and releases the drug.

There is even no need of water during administration of drug which will be highly useful for pediatric and geriatric patients^[6]. Orodispersible tablets are the tablets which is not coated and when kept in the mouth disperses rapidly before swallowing. 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^[7]. 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 second^[8]. The European Pharmacopoeia defines ODT as “A tablet which is to be placed in mouth disperses rapidly within three minutes before swallowing”^[9]. For elderly patients administering conventional tablets are not easy because of their regular requirement of tablets for maintaining their healthy lifestyle, because of the underdeveloped muscular and nervous system 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^[10]. 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 profits^[11]. Recent literature review indicates that half the patients population prefer orodispersible tablet than other dosage forms^[13]. The disintegration time for ODTs ranges from several seconds to about a minute^[14]. For composition of this dosage form appropriate disintegrants with water soluble excipients are incorporated^[5].

IDEAL PROPERTIES OF ORODISPERSIBLE TABLETS:

· Requires no water for taking orally^[7,17,18].

· ODT shows less sensitivity to environmental conditions and temperature.

· High drug loading is allowed.

· Less friable and have sufficient hardness^[4].

· After administration it should not leave any or minimal residue in the mouth.

· ODTs should produce pleasing, acceptable mouth feel and taste masking of drug incorporated.

· Method of production should be cost effective.

· Preparation and packaging must be done through conventional methods.

SALIENT FEATURES OF ORODISPERSIBLE TABLETS:

· Easily ingested by the patients who don’t swallow such as pediatric, gediatric, patients who are psychiatric, bedridden patients and patients affected by renal failure^{[20,21,22,23,24].}

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

· The good mouth feel property of the drug helps to change the perception of medication as “bitter pill” particularly in pediatric patient.

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

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

CHALLENGES:

Mechanical Strength and Disintegration Time:

ODTs should have less disintegration time, which is done by maintainance of good hardness is a major challenge, because orodispersible tablets are easily breakable and have high chance of breaking during packaging and transporting^[25].

Taste Masking:

Patient compliance and acceptance of a drug is affected when tablet of bitter drug dissolves in oral cavity, so drug is taste masked so that bitter taste is not felt in the mouth^[25].

Size of Tablet:

Easy administration of tablets depends on the size of the tablets, which cannot be achieved easily^[26].

Amount of Drug:

Weight of the tablet should not be more than 500mg which is challenging when formulating a ODT^[27].

Hygroscopicity:

Under normal conditions of temperature and humidity physical integrity is not maintained by hygroscopic ODT so they are protected from humidity which is done by special product packaging^[27].

Mouth Feel:

Disintegration of ODT should not have bigger particles instead the particles should be small with pleasant mouth feel^[25].

Good Packaging Design:

At initial stage, packaging design should be improved for protecting ODTs from environment and moisture^[26].

ADVANTAGES:

· It’s easier way of administration is the major advantage for the patients who have problem with swallowing of drugs such as patients in shock state, stroke victim, bedridden patients, patients who are suffering from kidney failure, pediatric, geriatric patients^[28,29].

· Produces pleasant taste effect that change the medication perception. This factor is useful while preparing dose for pediatric patients^[30].

· There is no risk of suffocation due to physical obstruction when swallowed, thus offers improved safety^[9,17,33,34].

· Rapid absorption or increase in bioavailability is achieved through pregastric absorption of drugs from mouth, pharynx and esophagus as saliva passes down.

· Rapid drug therapy intervention.

· Accurate dosing when compared to liquids.

· After administration it should not leave any residue in the mouth^[21].

· New business opportunities like product differentiation, life cycle management, exclusivity of product promotion and patent life extension^[35].

DISADVANTAGES:

· Sometimes ODTs are highly fragile^[18].

· In each dose low amount of drug can be incorporated^[24,38].

· Since ODTs don’t have enough hardness they must be handled with great care^[39].

· ODTs are not for fill coating process^[31,40].

INGREDIENTS USED FOR PREPARATION OF ODTs:^[41,42,50].

Superdisintegrants:

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

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

Lubricants:

Lubricants reduces the friction during compaction and ejection of tablets.

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, Polyvinylalcohol.

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: Sodiumdodecylsulphate.

Colour:

Addition of colour will enhance appearance of dosage form.

Examples: Amaranth 3, Sunsetyellow, Redironoxide.

Flavours:

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

Examples: Citrus Oil, Vanila, 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.

MECHANISM OF DISINTEGRATION:^{[44,45,46,47]}

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. Inturn makes intermolecular bond weak and breaks into fine particles that makes tablets porous.

Example: Crosspovidone, Croscarmellosesodium.

Swelling:

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

Example: Sodium StarchGlycolate, PlantagoOvata.

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 helps 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.

CONVENTIONAL TECHNIQUES:

Direct Compression:

It is simple and cost effective tablet manufacturing technique for manufacturing ODT^[49]. In direct compression method few processing steps and commonly available excipients are used^[48]. Without any preliminary treatment tablets are compressed. The mixture which have to be made into tablet should have better flow property to avoid wet granulation pretreatment. In direct compression method type of disintegrant and proportion of disintegrant is very important and in this technology addition of disintegrant is cost effective and are easy to apply at industrial level^[50]. The dissolution and disintegration of the compressed tablets depends on water soluble excipients, effect of disintegrants and effervescence agents. Addition of superdisintegrants provides rapid disintegration because of combined effect of water absorption and swelling^[51]. By concentrating the disintegrants we can optimize the disintegrating time of tablets. At below critical concentration disintegrating time is inversely proportional to disintegrant concentration and disintegrating time remains constant above critical concentration level^[16,52].

Lyophilization:

The process involves removal of solvent from a frozen suspension or drug^[51]. In this method the material is freezed below its eutectic point, after drying it decreases the amount of bound moisture. By this method we can achieve a glossy amorphous structure and enhanced dissolution of drug^[54,3]. By using this method porous open matrix network tablets are prepared which disintegrates rapidly when it is kept in oral cavity. Here the drug is entrapped in a water soluble matrix which disperses rapidly in mouth after lyophilization^[50]. In this process after freezing, water is sublimated from the product which is suitable only for heat sensitive drug and drugs that are biologically low at temperature below -18°c because at this condition only removal of water is achieved^[16,52]. Lyophilization improves absorption and bioavailability.

Tablet Molding:

In tablet molding tablets produced are solid dispersions. Depending upon dissolution of the drug in the molten carrier the drug may dissolve totally or partially in molten carrier and the remaining particles will stay undissolved and gets dispersed in the matrix^[56].

Spraydrying:

In spraydrying technology many spray dryers are used. In this the solvent is evaporated to produce highly porous fine powder which is used to produce rapid disintegrating tablets^[50]. The main aim of spray drying technology is to obtain a dry particles with desired properties. By spraydrying, an aqueous continuous support matrix is prepared, aqueous composition contains active ingredients mixed with support matrix and other components which is finally molded into tablets. In preparation of orodispersible tablets hydrolyzed gelatin is used as supporting matrix, bulking agent is mannitol and for disintegrating agent sodiumstarchglycolate and croscarmellosesodium is used. For improving the disintegration and dissolution citric acid and sodiumbicarbonate is used^[16]. ODTs which are prepared from spray dried powder when immersed in aqueous medium disintegrates within 20 seconds^[19]. By comparing spray dried tablets with compressed tablets maximum drug release and minimum disintegration time is observed with kollidonCL excipient base, as a result the spray dried tablets shows superior when compared over direct compression method^[35].

Example: Allen and Wang prepared orodispersible tablets by employing spraydrying technique^[51].

Sublimation:

In sublimation water converts into vapour state without undergoing liquid state^[39]. By sublimation we can produce ODT with highly porous structure and mechanical strength^[31]. In ODT rapid disintegration is due to porosity of tablet but in conventional tablet due to ingredients which is soluble in water they have low porosity and does not dissolve rapidly, so for generating porous matrix, volatile ingredients has been used and then subjected to process of sublimation^[7]. Some of the inert solid ingredients such as camphor, naphthalene, urea, ammonium biocarbonate, urethane that volatize readily mixed to excipients of the tablets and then these mixture is pressed into tablets^[50]. By removing volatile substance by sublimation creates highly porous structure in the tablets so that it dissolves rapidly when it comes into contact with saliva. Some solvents cyclohexane and benzene are also used as poreforming agents^[39]. In this process mannitol was used as matrix and camphor is used as subliming material. Camphor is vapourized by subliming in vaccum at 80°c for 30 minutes for developing pores in the tablets^[50].

Example: Suresh et al used volatile substance like Camphor/Ammonium bicarbonate for preparation end evaluation of salbultamol sulphate ODTs and the disintegration time was calculated as 5-40 seconds^[52].

Mass Extrusion :

In Massextrusion technology drug is embedded in a polymeric carrier, then the material is shaped to form a pharmaceutical product. By this technique we can produce taste masked granules by using superdisintegrants like sodiumstarchglycolate, croscarmellose sodium^[59]. The mixture and other ingredients with drug is made softer by PEG which is water soluble polyethylene glycol and menthol. To get a cylindrical structured product, softened mass is removed through the extruder. Finally to get the tablet, the cylindrically structured product is cut into even segment with heated blades. This process can be used for tastemasking of bitter drug by coating the granules of bitter drugs^[30,32].

Example: Tramadol Hcl orodispersible tablet was prepared by Mansing G. Patil et al by using Eudagrit E100 as taste masking agent for achieving quick onset of action^[36].

Cotton Candy Process:

In this method Shearform technology is used for preparing matrix called floss which is done by blending of recepients alone or with drugs^[39]. Here crystalline structure called floss is produced by spinning mechanism that resembles cotton candy process^[34]. It has production of matrix made up of polysaccharides (polymaltodextrins and polydextrose at lower temperature range) or saccharides (dextrose, fructose and lactose at temperature between 180°c-260°c) by simultaneous action of flash melting and spinning . For improving compressibility and flow property the formed cotton candy matrix is partially recrystallized and milled, finally mixed with excipients, active ingredients and pressed into tablets. By this technique high dose of drug can be accomodated and mechanical strength can be improved^[39,37].

Melt Granulation:

The new approach for preparing ODT is described by Abdelbery et al which is by agglomeration of pharmaceutical powders by using binders that melt relatively at low temperature which is also called meltable binder^[43]. High shear mixers with temperature above melting point of binder is used. For preparing ODT with sufficient mechanical strength hydrophilic waxy binder superpolystate is used, which not only increases the hardness of the tablets also dissolves in oral cavity without leaving any residue and solubilizes rapidly^[34].

PATENTED TECHNOLOGIES:

Zydis Technology:

In this technology drug is introduced into water solube matrix, transferred into blister packets and finally lyophilized to remove water by sublimation^[26]. Zydis technology is owned by Scherer which is a subsidiary of Cardial Health^[52]. The ingredients of polymers like dextran, gelatin imparts hardness by forming glossy and amorphous structure. Sacharrides such as mannitol or sorbitol are incorporated for obtaining elegance, crystallinity and hardness. To ensure the production of porus units, water is used in manufacturing process. Glycine which act as collapse protectant is used to prevent shrinking during lyophilization^[39]. The zydis product dissolves within 2 to 3 seconds and they are very light weight and fragile, so they readily absorb water^[62].

Orasolv Technology:

Orasolv technology is a patented technology of CIMA labs. The disintegration of ODT is due to the action of effervescent agent which gets activated when they come into contact with saliva in which generally 20-25% of effervescent agent is used^[39]. In this technology the tablet matrix dissolves by leaving coated drug powder because here taste masking is done by coating the drug powder. Over the counter formulations are frequently developed by this method and ODT tablets should contain more than 1.0 gm of drug^[63,64]. Low compression force is applied to reduce the oral dissolution time of the tablet^[51]. Orasolv tablets are more fragile when compared to conventional dosage form, to overcome this CIMA developed special handling and packaging techniques^[63,64].

Durasolv Technology:

It is the patented by CIMA labs which consist of drug, lubricant and filler which requires less amount of active ingredients^[39]. By using higher compaction pressure at tableting, durosolv has higher mechanical strength and good rigidity, since tablets are more durable they are packed in blister packets, pouches and vials^[65].

Flashtab Technology:

Flash tab technology is patented by Prographarm labs in which the preparation of rapidly disintegrating tablets contains active ingredients in the form of microcrystals. By using conventional techniques like simple pancoating methods, coacervation, microencapsulation and extrusion spheronization drug microgranules are prepared. Here disintegration time is less than one minute and good mechanical strength^[66].

Flashdose Technology:

By using “Nurofen meltlet” technology ODT tablet is prepared which is the first product launched by Bioavail Corporation^[62]. This technology uses unique mechanism of spinning that gives a floss like crystalline structure which resembles cotton candy process^[26]. Tablets are manufactured by using shearform matrix which contains fibrous polysaccharides that is compressed to form fine sugar fibres which disintegrates rapidly when comes in contact with saliva. The tablets produced by this method are soft, friable, moisture sensitive and have high surface area for dissolution, so disintegrates within few seconds^[9,64].

Wowtab Technology:

This technology is patented by Yamanochi Pharmaceutical company, in this technology WOW means “Without water”. In this tablet formulation two different types of saccharides are combined, such as saccharides with high moldability of hardness more than 2 kg and with low moldability with hardness 0-2kg^[9]. Saccharides with high moldability (maltose, mannitol, sorbital and oligosaccharides) is combined with low moldability (lactose, glucose, mannitol, xylitol) and compressed into tablets^[39]. With the help of these combination of saccharides fast dissolution rate and adequate hardness can be achieved. In WOW tab formulation, because of its significant hardness it is more stable to environment. In this technology a good taste masking agent is used to produce good mouth feel by use of patented smoothmelt action^[63,67].

Quickdis Technology:

In this technology formulation is kept on tongue to release the drug for local and systemic absorption. If the film with 2mm thickness breaks within 5-10seconds when brought into contact with water it is the typical disintegration time. If the 2mm thickness film breaks or dissolves around 30seconds when brought into contact with aqueous media then it is typical dissolving time and the typical release profile of active ingredient within 30seconds is 50% and within 1 minute is 95^[63,66].

Oraquick Technology:

Patented taste masking technology is used in oraquick technology which donot utilize any solvents for taste masking that leads to more efficient production. This technology is suitable for heat sensitive drug because this technology is processed using low heat. KV Pharmaceuticals claims “MicromaskTechnology” which is superior mouth feel technology than other tastemasking methods^[3].

Pharmaburst Technology:

It is a quick dissolving system which contain coprocessed excipients that involves the blend of drug, lubricant, flavour and then compressed into tablets that dissolves within 30-40seconds, since the tablets have sufficient mechanical strength they are packaged in blister packets^[13].

Melt Ease Technology:

It is developed by nutrition formulators that allows dissolution of tablet within 5seconds plays a very important role in children and elderly patients in nutritional supplement formulations^[66].

Lyoc Technology:

Lyoc technology is the first lyophization based technique for ODTs. In this technology the preparation of suspension of drugs contains fillers, thickening agent, surfactants, nonvolatile flavouring agents and sweeteners that is poured into blister cavities and lyophilized^[9].

Orodis Technology:

It is the compressed technology that produce ODT which disintegrates within 15-30 seconds in mouth that gives smooth mouth feel with pleasant taste. Materials used in this method meets USP and EP standards, produces formulations that are easy to handle that can be packed in push through blisters^[68].

EVALUATION OF ORODISPERSIBLE TABLETS:

General Appearance:

The general appearance of a orodispersible tablet is very important i.e its visual identity, presence or absence of colour, size and shape, surface texture, consistency and overall elegance is essential for the patient acceptance^[48].

Uniformity of Weight:

20 tablets were taken individually and their weight is calculated by weighing on digital balance and average weight of 1 tablet is calculated from the total weight^[48].

Friability:

It is the ability of the tablet to withstand the mechanical shocks while handling, packaging and transporting. Hardness is determined by Roche Friabilator which is used for measuring the friability of tablets and expressed in percentage. Initially 10 tablets were weighed, placed in friabilator and operated at 25rpm for 4minutes, then tablets were again weighed which is final. The measure of friability is loss in tablet weight due to abrasion^[70].

Hardness:

In order to break the tablet, force is applied across the diameter of the tablet^[9]. From each formulation 10 tablets are selected and hardness is determined by Pfizer hardness tester. Tablet is placed over hardness tester to measure the required load to crush the tablet. For ODTs mechanical strength is kept below conventional tablet because disintegration delays with increase in hardness^[45,71].

Wetting Time and Water Absorption Ratio:

For identifying wetting time, tissue paper is double folded and kept in petridish which contains 6ml of water. By placing tablet over the tissue paper wetting time is calculated. For water absorption ratio the wetted tablet is weighed and the amount of water absorption is determined by the following equation^[72].

Where;

Wa = Weight of tablet after water absorption

Wb = Weight of tablet before water absorption

Finess of Dispersion:

In this test 2 tablets are kept in 100ml water which is stirred gently for complete disintegration. If complete dispersion passes through a sieve screen with mesh aperture of 110nm without leaving any residue on mesh, then the formulation considered to form a finer dispersion^[72].

Tablet Porosity:

Penetration porosimeter is used to measure the tablet porosity that is calculated using following formula^[73].

Where,

m = Weight of tablet

= True density

V = Volume of the tablet

PACKAGING:

Packaging requires special care during manufacturing and storage in order to protect dosage form. By selecting rigid and multilayer foil based barrier material, moisture and physical issues can be solved. In ODT usage of regular push through blister packaging breaks the tablet so peelable closure packaging is used and specialized packaging equipment is used for blister packaging. Finally packed ODT dosage form is evaluated by immersing the blister in water for a specified period of time which is vaccumed and by opening the blisters manually presence of water droplets is checked^[74,18].

CONCLUSION:

Orodispersible tablets are widely preferred over conventional dosage form due to many advantages like patient compliance, easier administration for pediatric and gediatric patients, patients with allergies, motionsickness etc. With the help of conventional and patented technologies cost effective ODTs are produced and also unpalatable drugs curing many diseases can be incorporated in orodispersible tablets. The development of orodispersible tablets are increasing day by day and ODTs are also available as over the counter medication.

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Received on 22.09.2019 Modified on 06.11.2019

Research J. Pharm. and Tech 2020; 13(5): 2522-2529.

DOI: 10.5958/0974-360X.2020.00449.7