INTRODUCTION:

The safe and economical method of drug delivery is achieved through oral drug delivery. The popular route of systemic effects is converted through this administration due to ease of ingestion, accurate dosage, self-medication, pain avoidance. Fast dissolving drug delivery system is considered as a novel drug delivery system for designing dosage forms, convenient to be manufactured and administer without water, free of side effects, offering quick release and increased bioavailability, so as to achieve better patient compliance.

According to United States Food and Drug Administration (USFDA), fast dissolving tablet (FDT) is defined as “a solid dosage form containing medicinal element or active ingredient which Disintegrator dissolves rapidly within seconds when placed upon the tongue”. Fast dissolving tablets can also be considered as mouth-dissolving tablets, rapid dissolving, melt in the mouth tablets, or dispersible tablets, melts, porous tablets, quick dissolving, quick melt, and quick disintegrating tablets. Nearly one-third of the population (paediatric and geriatric) has difficulty in swallowing, which results in poor compliance with oral tablet drug therapy. Due to these reasons, tablets that can be dissolved or disintegrated in the oral cavity have attracted a great deal of attention. These tablets are designed in such a way that, they are dissolved rapidly in the saliva less than 60 sec. The two most popular techniques by which FDTs are formulated includes use of super disintegrates and freeze drying. Direct compression method is preferred among all the other methods because of its effortlessness, quick procedure and cost-effectiveness. Absorption of drugs in oral cavity and pre-gastric absorption of saliva containing dispersed drugs that pass down into the stomach may increase the bioavailability of some of the drugs. Compared to the conventional tablets the amount of drug that is subject to first pass metabolism is reduced^1-4.

CHARACTERISTICS OF FDTs^5-6:

· Need no water for oral administration.

· Have a pleasant feeling for your mouth.

· Have an acceptable property for masking flavour.

· Be more difficult and less pleasant.

· After administration, leave minimal or no traces in the mouth.

· Exhibit low vulnerability to environmental factors (temperature and moisture).

· Allow the production of tablets by standard equipment for processing and packaging.

CHALLENGES FOR DEVELOPING FDTs^7-13:

· The patient may suffer from muscle spasms, which may lead to problems in taking powder and liquid medication. In dysphasia, gastrointestinal ulceration may be caused by physical barriers and adherence to the oesophagus.

· Ingestion of solid dosage forms such as tablets and capsules may create problems for young adults by disrupting muscle and nervous system growth.

· Liquid medicinal products such as suspensions and emulsions are packed in multi-dose containers: the uniformity of substance in each dose cannot therefore be retained.

· Buccal and sublingual formulation may trigger oral mucosal irritation.

· If the mechanical strength is greater, disintegration time will be extended, so excellent cooperation between these two parameters is always required.

· The bitter drugs must be effectively masked to prevent the taste of the drug from being felt in the oral cavity.

· There should be very tiny particles generated after the FDT disintegration. After oral administration, FDT should not leave any residue in the mouth. Adding flavours and menthol-like cooling agents improves the mouth feel.

· FDTs should be low sensitive to circumstances such as humidity and temperature.

· The technology implemented for an FDT should be satisfactory as far as the final product costs are concerned.

ADVANTAGES OF FDTs^15-20:

· No need to swallow the tablet with water.

· Masking compatible with taste and feeling pleasant to the mouth.

· Paediatric, elderly and mentally handicapped patients can be readily administered.

· No residue after administration in the oral cavity.

· Using standard processing and packaging equipment, tablets can be delivered at minimum price.

· Allow drug loading to be high.

· Accurate dose as compared to liquids may be provided.

· The medicine is dissolved and absorbed quickly, delivering a rapid onset to action.

· Advantageous in terms of administration and transportation over fluid medication.

· Some drugs are absorbed from the mouth, pharynx and oesophagus as the saliva moves into the stomach, thereby decreasing the metabolism of the first pass, which promotes bioavailability and decreases the dose and side effects.

· No risk of suffocation when swallowed owing to physical disturbance, thus enhancing safety.

· ODTs are appropriate for sustained and controlled release actives.

· Packaging for each unit.

LIMITATIONS OF FDTs^21-24:

· Usually tablets have inadequate mechanical strength. It is therefore essential to handle conscientiously.

· Unless correctly formulated, tablets may leave an unpalatable flavour and gritty in the oral cavity.

· Drugs with massive doses can cause issues in the formulation of FDTs.

· Patients receiving anticholinergic drugs at the same time are not appropriate candidates for FDTs.

COMMONLY USED EXCIPIENTS FOR FDTs^25-30: List of various excipients used in FDTs are mentioned in Table 1

Table 1. List of various excipients used in FDTs

Excipient	Example	% w/w
Superdisintegrants	Croscarmellose sodium, crospovidone, sodium starch glycolate, microcrystalline cellulose, carboxy methyl cellulose, modified corn starch, polacrilin potassium etc.	1-15 %
Binders	Polyvinylpyrolidone, polyvinyl alcohol, hydroxy propyl methylcellulose etc.	5-10 %
Antistatic agents (or) Lubricants	Sodium laury lsulfate, sodium dodecyl sulfate, polyoxyethylene sorbitan fatty acid esters, polyoxyethylene stearates etc.	0-10 %
Diluents	Sugar-based: Mannitol, polydextrose, lactose and starch hydrolysate etc. Inorganic: Magnesium carbonate, calcium sulphate, magnesium trisilicate etc.	0-85 %
Emulsifying agents	Alkyl sulfates, propylene glycol esters, lecithin, sucrose esters etc.	0.05% -15%
Sweeteners	Nutritive: sugar, dextrose and fructose etc. Non-nutritive: aspartame, sodium saccharin, sugar alcohols and sucralose etc.	0.5-1%
Flavours	Naturally identical synthetic flavours	0.1-0.5%

MECHANISMS OF SUPER DISINTEGRANTS^31-32:

Swelling:

Although water infiltration is an important initial step for breaking down, swelling is presumably the most generally acknowledged component of activity for tablet disintegrants. Particles of disintegrants swell on interacting with reasonable medium and a swelling force creates which prompts separation of the matrix. Tablets with high porosity show poor disintegration because of absence of sufficient swelling force. It is beneficial to take note of that if the packing fraction is extremely high, liquid can't infiltrate in the tablet and disintegration is again backs off.

Wicking or capillary action:

Effective disintegrants that don't swell are accepted to confer their disintegrating action through porosity and capillary action. Tablet porosity gives pathways to the entrance of liquid into tablets. When we place the tablet in appropriate aqueous medium, the medium penetrates into the tablet and replaces the air adsorbed on the particles, which debilitates the intermolecular bond and breaks the tablet into fine particles. Water take-up by tablet relies on hydrophilicity of the medication/excipient and on tabletting conditions. Disintegration of tablet by swelling and wicking forces was depicted in Fig.1.

Fig.1. Disintegration of tablet by swelling and wicking

Repulsion:

This is the principle of disintegration by swelling of tablet made with non-swell able disintegrants. Water enters into tablet through hydrophilic pores of a consistent starch network, conferring a huge hydrostatic pressure. The electric repulsive forces between particles are the mechanism of disintegration and aqueous liquid is essential for it.

Deformation:

The shape of disintegrant particles is mutilated during pressure and the particles come back to their pre-pressure shape after wetting. Such a marvel might be a significant part of the mechanism of action of disintegrants. e.g. crosspovidone and starch that show almost no swelling. Disintegration of tablet by repulsion and deformation forces was depicted in Fig.2.

Fig.2. Disintegration of tablet by repulsion and deformation

Electrostatic Repulsion:

The electric repulsive forces between particles are the mechanism of disintegration and water is required for it. Particle repulsion theory is based on the observation that non swelling particle e.g. alginic acid also causes disintegration of tablets. Disintegration of tablet by electrostatic repulsion forces was depicted in Fig.3.

Fig.3. Disintegration of tablet by electrostatic repulsion

Heat of wetting:

When disintegrants with exothermic properties get wetted, restricted pressure is made because of capillary air extension, which helps in disintegration of tablet.

Chemical reaction (Acid-base response):

The tablet is immediately broken separated by inside release of CO₂ due to interaction of organic acids (tartaric and citric acid) with soluble carbonates or bicarbonates (sodium bicarbonate) in presence of water. As these disintegrants are exceptionally delicate to little changes in humidity level and temperature, severe control of condition is required during preparation of the tablets. The effervescent mix is either added promptly preceding compression or can be included two separate fractions.

Enzymatic reaction:

Enzymes present in the GIT act as disintegrants. Because of swelling, weight is applied on the external heading that makes the tablet burst or the quickened retention of water prompts a tremendous increment in the volume of granules to advance disintegration.

CONVENTIONAL TECHNOLOGIES OF FDTs^33-35:

Freeze-drying or Lyophilisation:

Freeze drying is the majorly used process in which water is sublimed from the product after it is frozen. This technique engenders an amorphous porous structure that can dissolve rapidly.

Tablet moulding:

Moulding procedure is of two sorts i.e., solvent technique and heat strategy.

a. Compression moulding:

Includes dampening the powder mix with a hydro alcoholic solvent pursued by compression at low pressures in moulded plates to frame a wetted mass. The solvent is then expelled via air-drying. The tablets manufactured as such are less compact than packed tablets and have a permeable structure that hastens dissolution.

b. Heat moulding:

Includes preparation of a suspension that contains a medication, agar and sugar (e.g. mannitol or lactose) and pouring the suspension in the blister packaging wells, solidifying the agar at the room temperature to form a jelly and drying at 30°C under vacuum. The mechanical quality of heat moulded tablets involves incredible concern, binding agents, will increment the mechanical quality of the tablets.

Spray drying:

Spray dried powder, which compressed into tablets demonstrated quick disintegration and upgraded dissolution. Gelatin can be used as a supporting agent and as a matrix in this technique, mannitol can be used as a bulking agent along with superdisintegrants. Tablets fabricated from the spray-dried powder have been accounted for to disintegrate with in 20 sec in aqueous medium.

Sublimation:

Together with various excipients, highly volatile substances (e.g. ammonium bicarbonate, ammonium carbonate, benzoic acid, camphor, naphthalene, urea, urethane and phthalic anhydride) could be compacted into a tablet. This volatile material is then evacuated by sublimation abandoning a profoundly permeable matrix which disintegrate in 10-20 sec. Indeed, volatile solvents like cyclohexane, benzene can be utilized as pore forming agents. The process of sublimation technique was depicted in Fig.4.

Fig.4. Process of sublimation technique

Direct compression:

Direct compression speaks to the least difficult and most financially savvy tablet producing procedure. In this technique, tablets are obtained by compression of the mixture of drug and excipients with no primer treatment. The mixture which is to be compressed must have great flow properties.

Nanonization:

Includes decrease in the particle size of medication to nanosize by processing the medication utilizing a restrictive wet-milling method. The nanocrystals of the drug are settled against agglomeration by surface adsorption on chose stabilizers, which are then consolidated into FDTs. This method is particularly favourable for inadequately watersoluble drugs. Increase in dissolution/disintegration, bioavailability and decrease in dose, price, are the advantages of this technique.

Fast dissolving films:

A non-aqueous solution with water-soluble film forming polymer (e.g. pullulan, carboxy methylcellulose, hydroxypropyl methylcellulose, hydroxyl ethylcellulose, hydroxyl propylcellulose, polyvinylpyrrolidone, polyvinyl liquor or sodium alginate, etc.), is prepared, drug and other ingredients are dispersed and allowed to form a film after solvent evaporation. This film, when set in mouth, melts or dissolves quickly, discharges the drug in solution or suspension form.

Patented Technologies of Fdts:

Patented technologies of FDTs are tabulated in Table 2.

Table 2. Patented technologies of FDTs

Patented technology	Organization
Zydis® ³⁶	R.P. Scherer, Inc.
Orasolv®³⁷	Cima Labs, Inc.
Durasolv®³⁸	Cima Labs, Inc.
Orodis® ³⁹	Physica Pharma Ltd.
Melt Ease® ⁴⁰	Eurand Pharmaceuticals Ltd.
Quick Dis® ⁴¹	Lavipharm Laboratories Inc.
Wow Tab® ⁴²	Yamanouchi Pharma Technologies
Flashdose® ⁴³	Fuisz Technologies, Ltd
Flash Tab® ⁴⁴	Ethypharm, Ltd.
Oraquick®⁴⁵	KV Pharmaceuticals, Ltd.
Nanomelt^TM ⁴⁶	Elan Ltd.
AdvaTab® 47	Eurand Pharmaceuticals Ltd.
Pharmaburst® ⁴⁸	SPI Pharma Ltd.
Frosta® ⁴⁹	Akina Ltd.
Sheaform® ⁵⁰	Fuisz Technologies Ltd.
Ceform® ⁵¹	Fuisz Technologies Ltd.
Lyoc®⁵²	Pharmalyoc, Inc.

EVALUATION OF FDTs^{53, 54}:

a. Pre-compression studies:

Angle of repose (θ):

θ can be determined by Funnel method. In a funnel, the precisely weighed blend was taken. The funnel height was adjusted so that the funnel tip touches the apex of the blend's heap. The blend was permitted to flow freely to the ground through the funnel and the powder cone's diameter was measured.

θ = Tan ^-1h/r--------------------------------------Eq. No. (1)

Where:

h= height of the powder cone,

r = radius of the powder cone.

Bulk density (BD):

BD was determined by pouring into a graduated cylinder a weighed amount of blend and measuring its volume.

BD = wt. of blend/ Bulk volume ---------------Eq. No. (2)

Tapped density (TD):

TD was determined by by pouring into a graduated cylinder a weighed amount of blend. The cylinder was permitted to drop at 2-second intervals on a surface below its own weight from the height of 10 cm. The tapping continued until no additional volume shift was observed.

TD = Wt. of blend / Tapped volume-----------Eq. No. (3)

Compressibility Index (CI): By using Carr’s index the compressibility of the blends can be determined.

CI = (TD-BD) ×100/TD -------------------------Eq. No. (4)

Hausner’s Ratio (HR):

Is a number that correlates to the flow ability of a powder. It is calculated by the equation.

HR =TD/BD --------------------------------------Eq. No. (5)

b. Post-compression studies:

%Weight variation:

The weight variation test is performed to assure uniformity in the tablet weight of each batch. First, determine the total weight of 20 tablets from each formulation and calculate the average weight. Each tablet's individual weight is also determined to determine the weight variation. The following formula gives weight variation.

% wt variation = (Individual wt - Avg wt) x 100 /Avg wt

-----------------------------------------------------Eq. No. (6)

Hardness:

Hardness is also called the tablet's crushing force; the energy needed to break a tablet in a diametric compression was measured using a Monsanto tablet hardness tester. Its units are Kg/cm².

Thickness:

Thickness of 3 tablets from each formulation was determined using Vernier callipers. Its units are mm.

% Friability (% F):

% Friability can be determined by using Roche friabilator. Friability is the tablet's weight loss in the container owing to the detachment of the fine particles from the surface. Friability testing is performed to determine the tablet's capacity to resist abrasion in packaging, handling and transportation. Weigh the 20 tablets per lot and position them in a friabilator that will rotate for 4 min at 25 rpm. Dust and weigh the tablets all over again.

% F=(Initial Wt.- Wt. after friability) × 100 / Initial Wt. -------------------------------------------------------Eq. No. (7)

Wetting time (WT) and Swelling Index (SI):

A piece of tissue paper folded twice was placed in petri dish having an internal diameter of 5.5 cm, containing 6 mL of water. A tablet was placed on the paper and the time required for complete wetting was measured as wetting time, using a stopwatch. The wetted tablet was then reweighed and swelling index was determined using the following equation.

SI = [(W_a – W_b) / W_b] × 100----------------------Eq. No. (8)

Where,

W_b and W_a were the weights of the tablet before and after swelling.

In vitro disintegration time and fineness of dispersion:

It is specified in the European Pharmacopeia (EP 6.0), the disintegration time determination procedure for fast disintegrating tablets is same as that of conventional uncoated tablets and the tablets should be dispersed within less than 3 min. The obtained tablet’s dispersion was passed through a sieve screen with a nominal mesh aperture of 710mm to confirm the fineness of dispersion.

Assay:

To evaluate the drug assay, 3 tablets (n=3) from each batch were powdered in mortar with pestle. Blend equivalent to 1mg of drug was accurately weighed and transferred into pH 6.8 phosphate buffer and ultra-sonicated for 2 min to extract the drug from the tablet blend and filtered through 0.45µm poly tetra flour ethylene (PTFE) filter disc. The filtrate was suitably diluted if necessary and its absorbance was measured by a suitable spectrophotometric method.

In vitro dissolution studies:

The release of the drug in vitro was determined by assessing the dissolution profile, using the USP type 2 (paddle) at 50rpm, using 900mL of pH 6.8 phosphate buffer as a dissolution medium.

Future Prospectives for Fdts^55,56:

There are now numerous commercially accessible products that are manufactured by rapidly dissolving tablet techniques. Research on this technology still has a broad region. Some of the challenges such as formulating a bitter taste drug and moisture absorbing nature generate issues for scientists working on the FDTs. Future prospective with on-going innovations in pharmaceutical excipients, will continue to bring distinct technological disciplines together to generate new advancements. Weight and volume of FDTs are substantial kept minimum by justified use of flavouring, sweeteners, taste masking and super disintegrants. There is also scope for improved packaging system development to make FDTs more stable during shelf life and handling. List of the marketed FDTs are tabulated in Table 3.

Table 3. Some of the marketed FDTs

Trade Name	API	Manufacturer
Felden fast melt	Piroxicam	Pfizer Inc., NY, USA
Ugesic	Piroxicam	Mayer organic Ltd.
Esulide MD	Nimesulide	Doff Biotech
Kazoldil MD	Nimesulide	Kaizen Drugs
Mosid MD	Mosapride	Torrent Pharma
Valus	Valdecoxib	Glenmark
Vomidon MD	Domperidone	Olcare lab
Claritin redi Tab	Loratidine	Schering Plough Corp., USA
Maxalt MLT	Rizatriptan	Merck and Co., NJ, USA
Zyprexia	Olanzapine	Eli Lilly., Indianapolis, USA
Pepcid RPD	Famotidine	Merck and Co., NJ, USA
Zofran ODT	Ondansetron	GlaxoWellcome, Middlesex, UK
Zofer MD	Ondansetron	Sun Pharma
Ondem MD	Ondansetron	Alkem Pharma
Zoming-ZMT	Zolmitriptan	AstraZenecea, USA
Zeplar TM	Selegilline	Amarin Corp. London
TempraQuiclets	Acetaminophen	Bristol Myers Squibb. USA
Febrectol	Paracetamol	Prographarm. France
Nimulid MDT	Nimesulide	Panacea Biotech. India
Torrox MT	Rofecoxib	Torrent Pharmaceuticals, India
Rofixx md	Rofecoxib	Cipla ltd. Mumbai, India
OlanexInstab	Olanzapine	Ranbaxy Lab. Ltd, India
Romilast	Monteleukast	Ranbaxy Lab. Ltd, India
Zontec MD	Cetrizine	Zosta Pharma India
Lonazep MD	Olnazepine	Sun Pharma
Nime MD	Nimesulide	Maiden Pharma
Imodium lingual	Imodium	R.P. Scherer Corp., U.S.A
PepcidinRapitab	Pepcid	Merck and Co., U.S.A
Cibalginadue Fast	Ibuprofen	Novartis Consumer Health
NurofenFlashtab	Ibuprofen	Boot healthcare
Hyoscyamine sulphate ODT	Hyoscyaminesulfate	Ethex Corporation
Risperdal M Tab	Risperidone	Janssen
Imocdium Instant Melts	Lopermide HCl	Janssen
Propulsid Quick Sol	Cisapride monohydrate	Janssen
Alavert	Loratadine	Wyeth Consumer Healthcare
NuLev	Hyoscyaminesulfate	Schwarz Pharma
Kemstro	Baclofen	Schwarz Pharma
Nasea OD	Ramosetoron HCl	Yamanouchi
Gaster OD	Famotidine	Yamanouchi
Fluoxetine ODT	Fluoxetine	Biovail
Zolpidem ODT	Zolpidem tartrate	Biovail
Excedrin Quick Tabs	Acetaminophen	Bristol-Myers Squibb
AbilifyDiscmelt	Aripiprazole	Otsuka America
Aricept ODT	Donepezil	Eisai Co.
FazaClo	Clozapine	Azur Pharma
Relivia Flash dose	Tramadol HCl	Fuisz Technology, Ltd
Domray MD	Domperidone	Ray Remedies

CONCLUSION:

FDTs are dosage forms that are generally formulated to dissolve (or) disintegrate rapidly within a few seconds in the saliva. FDTs give many benefits over conventional dosage forms such as enhanced efficacy, bioavailability, rapid onset of action, enhanced compliance with patients. In particular, FDTs provide paediatric and geriatric patients with greater convenience. FDTs can be prepared using several methods based on the drug and additives used. FDTs usually have less mechanical strength. But it is possible to prepare FDTs with adequate mechanical strength by implementing some recent techniques and additives. The basic principle used in the FDTs growth is to maximize its pore structure by vacuum and freezing drying methods. Using taste masking agents, even bitter drugs can be integrated into FDTs. Due to its market potential, many drugs (e.g. neuroleptics, CVS, analgesics, antihistamines and erectile dysfunction) will be developed as FDTs in the future.

ACKNOWLEDGEMENT:

The authors are thankful to Padmasree Dr. M. Mohan Babu, Chairman, Sree Vidyanikethan Educational Institutions, Tirupati; A.P.; INDIA for providing us the required facilities and infrastructure to carry out this academic review work.

CONFLICT OF INTEREST:

The authors declare no conflict of interest.

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Received on 29.08.2019 Modified on 30.09.2019

Res. J. Pharma. Dosage Forms and Tech.2019; 11(4):296-303.

DOI: 10.5958/0975-4377.2019.00049.1