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EXPLORING THE ADVANTAGES AND CHALLENGES OF MOUTH DISSOLVING TABLETS: A COMPREHENSIVE REVIEW
Surendar Angothu
Asst. Professor, Department of Pharmacognosy, Princeton College of Pharmacy, Hyderabad, Telangana, India
Boggula Ratnakumari
Asst. Professor, Department of Pharmacognosy, Princeton College of Pharmacy, Hyderabad, Telangana, India
Abstract - The oral route is regarded as the most convenient, safest, and most cost-effective method of drug administration due to its high rate of patient compliance. One of the most advantageous examples of oral drug delivery is fast- dissolving tablets. Without the use of water, these tablets easily dissolve or break down in saliva in less than 60 seconds. They have been made for bedridden, elderly, and pediatric patients. Additionally, these dosage forms are ideal for patients who are active, busy, and may not have access to water. FDTs have attracted a lot of attention for patients with dysphagia and hand tremors who have trouble swallowing. They also help unconscious, young patients whose nervous and muscular systems aren't fully developed. This audit portrays the different benefits, limits, wanted attributes, detailing viewpoints, superdisintegrants utilized;
technologies made for FDTs, evaluation tests, and formulations that are sold.
Keywords: Thymoquinone, antitubercular medications, and renal toxicity.
1 INTRODUCTION
Because of their convenience, compactness, ease of manufacturing, and self-administration capabilities, solid dosage forms like tablets and capsules are the most widely used among all of the dosage forms that are currently available. When there is no water available, tablets and hard gelatin capsules can be difficult to swallow, as can motion sickness, allergic attacks of coughing during the common cold, and bronchitis. As a result, tablets are referred to as "fast dissolving tablets" because of their ability to rapidly dissolve or break down in the mouth. When swallowed, these tablets instantly break down, releasing the medication, which, in the absence of water, dissolves or disperses in saliva within 60 seconds.
FDTs are ideal not only for active people but also for people who have difficulty swallowing.
Other names for fast-dissolving tablets include mouth-dissolving tablets, melt-in-mouth tablets, orodispersible tablets, rapidly melts tablets, porous tablets, and so on. As saliva descends into the stomach, some drugs are absorbed from the mouth, pharynx, and oesophagus.
The drug's bioavailability is significantly higher in these situations than in conventional tablet dosage forms. The drug's absorption and onset of clinical effect are accelerated the faster it is dissolved in the solution. The fundamental strategy for developing FDTs is to make use of
superdisintegrants like
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glycolate, polyvinylpyrollidone, crosspovidone, and others. These superdisintegrants help break down tablets quickly and release drugs into saliva. Additionally, compared to standard tablets, the amount of drug subjected to first pass metabolism is reduced. FDTs are simple to use for patients whose chewing is difficult and painful. Children who have lost their teeth but still lack full use of their permanent teeth can also easily use fast-dissolving tablets. Frost- drying, tablet molding, spray-drying, sugar-based excipients, sublimation, tablet compression, disintegration addition, and numerous other pat ended technologies are the technologies utilized in the production of fast-dissolving tablets. According to a recent market study, FDTs are preferred by more than half of the world's population to other dosage forms.
1.1 Advantages of Fast Disintegrating Tablets
Technology that dissolves quickly offers:
• Ease of administration for patients whose swallowing difficulties are a problem.
• The dosage form does not require water to be swallowed.
• Useful for patients with mental health, geriatric, and pediatric conditions.
• Possess adequate taste-masking properties.
• Increase bioavailability by allowing drugs to pass through the mouth, pharynx, and oesophagus before entering the stomach.
• Feel good in the mouth and leave little or no residue in the mouth after being taken.
• The drug should dissolve and be absorbed quickly, resulting in a rapid onset of action.
• It combines the stability and bioavailability of a liquid dosage form with those of a solid dosage form.
Drug Properties: Drug properties can have an impact on FDT performance.
The solubility, crystal morphology, particle size, hygroscopicity, compressibility, bioavailability, flow property, bulk density, and final tablet characteristics like disintegration and strength of a drug, for instance, can all have a significant impact.
Taste of Active Ingredients: The drug will partially dissolve in close proximity to the taste buds when FDTs dissolve or disintegrate in the patient's mouth. There should be little or no residue left in the mouth after swallowing. The ideal taste-masking technology ought to deliver drugs with a pleasant taste and no grittiness.
Moisture Sensitivity: There should be little humidity sensitivity in these tablets. This issue can be particularly challenging due to the use of numerous highly water-soluble excipients in formulation to improve fast dissolving properties and mouthfeel. Moisture can damage those highly water-soluble excipients;
some will try and deliquesce at high mugginess.
1.2 Drug Selection Criteria
• Have a better soluble nature.
Promethazine, for instance For
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readily available to penetrate oral mucosal tissue.
• Taste less or not as bitter.
• Excellent stability in saliva and water. For example rizatriptine benzoate
Super-Disintegrants: Superdisinteg- rants are substances added to tablet formulations to increase the available surface area and encourage the breakup of the tablets into smaller pieces in an aqueous environment.
Mechanism of Superdisintegrants:
There are four major mechanisms for tablet disintegration as follows:
Swelling The most widely accepted general mechanism of action for tablet disintegration is swelling. Tablets that lack sufficient swelling force and have high porosity exhibit poor disintegration. The tablet has low porosity and exerts sufficient swelling force. Fluid cannot penetrate the tablet if the packing fraction is very high, and disintegration again slows down.
Porosity and Capillary Action (Wicking): It is believed that effective disintegrants that do not swell impart their dissolving action through capillary and porosity action. The porosity of a tablet makes it possible to form fluid into tablets through the use of channels. The disintegrant particles themselves make the tablet more porous and provide entryways.
Through capillary action, liquid is drawn up or "wicked" into these pathways, breaking the terparticulate bonds and causing the tablet to break apart.
Due to disintegrating particle/
particle repulsive forces Another
disintegration mechanism tries to explain why tablets made with
"nonswellable" disintegrants swell.
Based on Guyot-Hermann's observation that tablets also break apart when nonswelling particles are present, he proposed the particle repulsion theory. Water is required for the disintegration mechanism, which is the electric repulsive forces between particles.
2 CONVENTIONAL TECHNIQUES USED FOR PREPARATION OF FDTS 1) Disintegration Addition: The principle involved in formulating FDTs by disintegrant addition technique is the addition of superdisintegrants in optimal concentration in order to achieve rapid disintegration and a pleasant mouthfeel. This makes the disintegrant addition technique one of the most popular methods for creating FDTs.
2) Freeze drying: a method in which the product's frozen water is sublimated. Lyophilization is a pharmaceutical technique that enables heat-sensitive drugs and biologicals to be dried at a low temperature under conditions that permit the sublimation of water.
Preparations made by lyophilization are highly porous, have a very high specific surface area, dissolve quickly, and have improved bioavailability and absorption.
3) Moulding: Using water-soluble ingredients, these molded tablets are prepared so that they dissolve completely and quickly. A hydro- alcoholic solvent is used to moisten the powder mixture before molding it into tablets under a pressure that is
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tablet compression.
4) Spray- Drying: Spray drying can result in powders that are extremely porous and fine, and they dissolve quickly. As supporting agents, the formulations incorporate mannitol as a bulking agent, sodium starch glycolate or crosscarmellose sodium as a disintegrating agent, and an acidic material (such as citric acid) and/or alkali substance (such as sodium bicarbonate) to boost dissolution and disintegration.
5) Mass- Extrusion: In order to cut a cylinder of the product into even segments using heated blades to form tabets, this technology involves softening the active blend with a solvent mixture of water-soluble polyethylene glycol and methanol, then extruding the softened mass through an extruder or syringe.
3 EVALUATION TESTS FOR FAST DISSOLVING TABLETS
3.1 In Vitro Evaluation Methods General Appearance: Consumer acceptance of a tablet is dependent on its overall "elegance," visual identity, and general appearance. The tablet's size, shape, color, physical flaws, odour, taste, surface texture, consistency, and legibility of any identifying marking are all included.
Tablet Thickness: The thickness of the tablet is an important property for reproducing appearance and counting with filling equipment. The uniform thickness of the tablets is used as a counting mechanism in some filling equipment. The thickness of ten tablets was measured with a micrometer.
Uniformity of Weight: Twenty tablets were taken, and their individual and collective weights were measured on a digital weighing balance in accordance with the I.P. procedure for uniform weight.
Tablet Hardness: Hardness of tablet is defined as the force applied across the diameter of the tablet in the order to break the tablet. Hardness of the tablet of each formulation was determined using Monsanto Hardness tester and many other testers like the Strong-Cobb tester, the Pfizer tester, the Erweka tester, and the Schleuniger tester available for determining hardness of particular tablet.
Disintegration Test: There are a number of limitations to the standard disintegration test for FDTs, and it does not adequately measure very short disintegration times. Because ODT requires disintegration without water, the test should mimic disintegration in salivary contents, necessitating a modification to the disintegration time. For this reason, a petridish (10cm width) was loaded up with 10 ml of water. The time it took for the tablet to completely disintegrate into fine particles was recorded after it was carefully placed in the petridish's center.
Wetting Time: The approach that yunixia et al. describe, was followed to gauge tablet wetting time. A small dish with an ID of 6.5 cm and 6 ml of Sorenson's buffer at pH 6.8 was filled with a piece of tissue paper that measured 12 cm x 10.75 cm and had been folded twice. The time required to completely wet the paper was measured by placing a tablet on it.
Each batch underwent three trials,
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calculated.
4 CONCLUSION
Some of the issues with administering medications to children and the elderly, who make up a large portion of the world's population, have been resolved by the introduction of dosage forms that dissolve quickly. As a result, patient demand and the availability of various technologies have increased the acceptance of tablets that dissolve quickly, which extends a drug's useful life.
Maintaining considering the upsides of the conveyance framework, quick breaking down measurement structures have been effectively popularized and these dose shapes very much acknowledged at specialists as well as quiet level.
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