INTRODUCTION:

Drug Delivery Programs (DDS) are a strategic way to expand markets/indicators, extend product life cycles and create opportunities. DDS makes a significant contribution to global drug sales through market segregation, and is moving very fast. Drug delivery systems are becoming increasingly complex as pharmaceutical scientists gain a better understanding of the physicochemical and biochemical parameters associated with their function. Despite significant advances in drug delivery, the oral route remains the preferred method of medical chemotherapy due to its low cost of treatment, easy administration, accurate dosage, antidepressants, pain prevention, versatility, leading to higher levels of patient compliance. Tablets and tablets of popular form are very popular.¹But one important problem with such dosage forms is ‘Dysphagia’ or difficulty swallowing. This seems to affect about 35% of the general population⁴⁴

The disease is also associated with many conditions such as:

1 Parkinsonism

2 Movement sickness

3 Ignorance

4 Elderly patients

5 Children

6 People with mental disabilities

7 Lack of access to water.²

Improvement of patient compliance has greatly benefited. As a result the demand for their technology also increases the number of folders. To develop a chemical business, it requires a lot of money, hard work and time. The focus is therefore on building new drug delivery systems that already exist, with improved performance and bioavailability, thus reducing volume and frequency of dosage to reduce side effects³. It is always the goal of a scientist or volume form designer to increase the safety of a drug molecule while maintaining it. its therapeutic. The latest development of Novel Drug Delivery Systems (NDDS) aims to do the same by creating a standardized, manageable formula to achieve better patient compliance. Medical professionals have done their best to make the Fast Dissolving Drug Delivery System⁴, which is the Mouth Dissolving Tablet.

Mouth dissolving tablet (MDT):

It is a tablet that breaks down and melts quickly on the soles, in just seconds without the need for drinking water or chewing. The oral elimination tablet usually dissolves in the oral cavity within 15 s to 3 min. Most MDTs include some large disintegrants and flavor masking agents.

Ideal Characteristics of MDT:

A MDT should have following properties:

· It should be less effective by environmental conditions like humidity, temperature etc.

· It should not leave any residue in the mouth after the administration of the tablet

· A MDT should be dissolve or disintegrate in the mouth within few seconds

· It should be cost effective.

· It should not require any liquid or water to show its action

· Not require water or other liquid⁵ to swallow.

· Easily dissolve or disintegrate in saliva within a few seconds.

· Have a pleasing taste.

· Leave negligible or no residue in the mouth when administered.⁶

· Be portable and easy to transport.

· Be able to be manufactured in a simple conventional manner within low cost.

· Be less sensitive to environmental conditions like temperature, humidity etc.^6,7

MDT Advantages:⁴⁵

· These MDT’s are stable for longer duration of time, till it is consumed.

· There is no risk of suffocation and chocking during MDT uptake

· Bioavailability of drug can be increased by avoiding the passage of the drug from pharynx and esophagus.

· Does not require water to take the tablet during travelling

· Easy for administration to patients which cannot swallow he tablets like pediatric and geriatric, unconscious and mentally disabled patients.⁸

· It is helpful in some cases like motion sickness, during coughing etc

· It has good mouth feel property that helps to take the medicine easily than the bitter pills in pediatric patients.

· Quick disintegration and dissolution of drug tablet to produce rapid action.

· No need of water to swallow the tablet.⁹

· Can be easily administered to pediatric, elderly and mentally disabled patients.

· Accurate dosing 9 as compared to liquids.

· Dissolution and absorption of drug is fast, offering rapid onset of action.

· Bioavailability of drugs is increased¹¹as some drugs are absorbed from mouth, pharynx and esophagus through saliva passing down into the stomach¹²

· Advantageous over liquid medication in terms of administration as well as transportation

· First pass metabolism is reduced, thus offering improved bioavailability and thus reduced dose and side effects.

· Free of risk of suffocation due to physical obstruction when swallowed, thus

· Offering improved safety. a. Suitable for sustained/controlled release actives.¹³

· Allows high drug loading.¹⁴

Criteria for drug selection:

The main criteria’s for a drug to be selected are as follows:

· It should not have bitter taste.

· The dose should be less than 20mg.

· Moderate molecular weight should be small.

· Should be of good solubility in water and saliva.

· Should have extensive First pass metabolism.

· Should have oral tissue permeability.

Conventional techniques for Mouth dissolving tablets:

There are many conventional techniques for the formulation of MDT’s. These are as follows¹⁵:

· Freeze drying/Lyophilization

· Spray drying

· Sublimation

· Direct compression

· Mass extrusion

· Tablet molding

Below its fall temperature provides the process of producing tablets with improved Freezedrying¹⁶:

Pills for dry suspension or lyophilisation are very worms in nature and deteriorate or melt quickly when they come in contact with saliva. In this process, water is reduced from the product after cooling. First, the material is frozen to bring it under its eutectic point. After that the main drying is done to reduce the humidity to about 4% w/w of dry product. Finally, a second drying is done to reduce the bound moisture to the required volume. As a result of lyophilization, the bulking agent and sometimes the drugs acquire a shiny amorphous structure so the solubility is improved. A tablet that dissolves rapidly in an aqueous solution incorporates a slightly collapsed matrix network that has dried over the deteriorating matrix temperature. The matrix is slightly dried below the freezing point of the matrix. The tablet freezer above its fall temperature, instead of freezing structural integrity, while rapidly decreasing at normal prices. However the use of ice suspension is limited due to the high cost of equipment and operation. Other major drawbacks of the final insertion forms include the lack of physical resistance to standard blister packs.

Spray drying:

The bold and well-prepared powder is prepared by drying the spray into a liquid form containing a support matrix and other materials. This is then combined with the active ingredient and pressed on the tablet. Allen and Wang¹⁷ used this method to prepare oral contraceptives, which last between 20 s

Sublimation:

This process involves the addition of certain unhealthy substances such as urea, urethane, naphthalene, camphor, etc. Sublimation removal¹⁸ by sublimation creates pores in the structure of the tablet, because the tablet dissolves when it comes in contact with saliva. In addition several solvents such as cyclohexane, benzene etc. can be used as pore forming agents. Mouth-melting tablets have a very strong structure and good mechanical strength developed in this way.^19,20

Direct compression:

Separate supplement technology^21,22 (direct compression) is the most preferred method of making pills due to certain benefits: a. Higher doses can be applied and the final weight of the tablet may exceed that of other alternatives. b. An easy way to make pills. c. Common resources and commonly available resources use d. No restrictions. Processing steps are involved. e. Cost - efficiency. Tablet size and stiffness significantly affect degraded performance. Sturdy and large tablets have more time to disperse than usual. Soft and very thin tablets with minimal repair power. Therefore, the appropriate type and concentration of degradation should be selected in order to achieve rapid dispersion and high levels of elimination. In addition to the critical concentration level, however, the dispersion time remains almost constant or increased.²³

Mass extrusion^24,25:

In this process, a mixture of the active ingredient and other ingredients is diluted with a solution of water-soluble polyethylene glycol, methanol and the softened mass extracted by an extruder or syringe to obtain a product cylinder, which is then cut in half with the help of thick leaves to get the pills. The dry cylinder can be used to cover the granules of spicy drugs and thus obscure their bitter taste.

Moulding:

Tablets prepared in this way are strong dispersions. The type of drug itself in the pills depends on how much of it is dissolved and to what extent in the amount of water.²⁶The drug can be discrete particles or small particles in the matrix. It can be completely dissolved into a solid solution or slightly dissolved in the dissolved carrier and, if present, remain undefined and dispersed in the matrix.²⁷ Duration of failure, rate of drug withdrawal and oral sensitivity will depend on the type of dispersion.

Different moulding techniques can be used to prepare mouth‐dissolving tablets:

a. Compression moulding:

The powder mixture previously wetted with a solvent like ethanol/water is compressed into mould plates to form a wetted mass.

b. Heat moulding:

A molten matrix in which drug is dissolved or dispersed can be directly moulded into Mouth dissolving tablets.²⁸

No vacuum lyophilization:

This process involves evaporation of solvent from a drug solution or suspension at a standard pressure.²⁹ Moulded tablets posess porous structure, which facilitates rapid disintegration and easy dissolution. Moulded tablets offer improved taste due to water‐soluble sugars present in dispersion matrix. But moulded tablets lack good mechanical strength and can undergo breakage or erosion during handling and opening of blister packs.³⁰ However, adding sucrose, acacia or polyvinyl pyrrolidone can increase mechanical strength.

PATENTED TECHNOLOGIES FOR MDT’s:

The main patented technologies for mouth dissolving tablets are as follows³¹:

Zydis technology:

Zydis was the first marketing technology developed by RP Scherer. Inc new generation tablet format. By stopping drying the drug in the matrix, containing a gelatin tablet Zydis was produced. The product is packaged in special blister packaging because it is very lightweight and weak. Due to the freezing of the ice, there is very little water left in the treeAttacks of microorganisms, so this preparation is self-sustaining. Tablets made by Zydisthe technology has very few seconds of dispersion time.

Durasolv technology:

This is CIMA labs patent technology³². The tablet contains drug filler and lubricant made by this technology. In this way the pills are prepared using regular tabletting equipment and has strong durability properties.

Orasolv technology:

This technology was also developed by CIMA labs³³. Reduce oral dislocation as well completion time, this is adjusted by direct pressure with low pressure. Orasolv is an example of a tablet that works less because it can melt faster in the mouth. In it works the ingredients are dispersed in the saliva due to the action of the effervescent agent and the taste is hidden.

The low power of the equipment is a major limitation of this technology. Tablets prepared by this method requires installation in a specially designed package because these are very soft as well naturally weak.

Wow tab technology:

This technology follows a combination of low and high saccharides for preparation oral contraceptive pills using the standard tablet procedure and the granulation process³⁴.According to the patent, the lowest levels of saccharides are lactose, mannitol, sucrose and glucoseetc., and high-yielding saccharides include maltitol, maltose, oligosaccharides and sorbitol, etc. When the pills are adjusted by compressing the lower and upper extremities saccharides, it is only then that the desired structures of hardness and rapid decay in the mouth can achieved.

Cotton candy technology:

This technology is patented by Fuisz³⁵. This technology produces a floss similar to the crystalline structure because of their unique spinning style. An active tablet for the tablet can be installed by crystalline sugar. The final product for this technology has a very high level of melting. It spreads and melts quickly, when placed on the tongue.

Oraquick technology:

Patented cover-up coverage technology uses the tablet’s oral decomposition. K V Pharmaceutical Company, says its flavor baking technology is microsphere technology has a high mouth it feels more than other ways of tasting. Any type of solvents are not used in the process of concealing taste. It therefore leads to higher and faster production. Apart from-Interfering with the taste of concealing high-strength pills is found in the background pressure. Only K V Pharmaceutical has its products on the market in different categories of drugs such as cough and cold, analgesic, psychotic and anti-infective in the developmental phase.

Flashtab technology:

Flashtab technology is patented by Prographarm³⁶ laboratories. In this technology the technology of a tablet containing an active ingredient in the form of a microcrystal's is processed, has rapid dispersal of property. By using common techniques such as microencapsulation, Preservation of microgranules for a simple pan coating can be repaired. Active ingredients of microgranules or microcrystal's compressed tablets by granulated a mixture of materials connected by adjustment in the form of wet or dry granulation. Tablets prepared for this the technology has less than one minute of dispersion and good repair power.

Marketed formulation of MDT’s:

Preformulation studies mouth dissolving tablet^{37, 38}

Preformulation study relates to pharmaceutical and analytical investigation carried out proceeding and supporting formulation development efforts of the dosage form of the drug substance. Preformulation yields basic knowledge necessary to develop suitable formulation for the toxicological use. It gives information needed to define the nature of the drug substance and provide frame work for the drug combination with pharmaceutical excipients in the dosage form. Hence, the following preformulation studies were performed on the obtained sample of drug.^47,
48

1. Bulk Density (Db):

It is a ratio of the total weight of the powder to the maximum volume of powder. Measured by pouring weight powder (exceeded by standard filter # 20) in the measuring cylinder and initial weight was detected. This first volume is called volume. From this the maximum size is calculated according to the method described below. It is expressed in g / ml and is given by

Db = M/ Vb

Where, M is the mass of powder, Vb is the bulk volume of the powder.

2. Tapped Density (Dt):

It is a measure of the total weight of the powder in a concentrated dose of powder. Volume was measured by tapping the flour 750 times and the taped volume was detected if the difference between the two categories was less than 2%. If it is more than 2%, tapping continues 1250 times and the volume touched was detected. Tapping is continued until the difference between successive volumes is less than 2% (using the maximum number). It is expressed in g / ml and is given by

Dt = M / Vt

Where, M is the mass of powder

Vt is the tapped volume of the powder.

3. Angle of Repose (q):

The friction forces in a loose powder can be measured by the angle of repose (q). It is an indicative of the flow properties of the powder. It is defined as maximum angle possible between the surface of the pile of powder and the horizontal plane

tan (q) = h / r

q = tan-1 (h / r)

Where, q is the angle of repose.

h is the height in cms

r is the radius in cms.

The powder mixture was allowed to flow through the funnel fixed to a stand at definite height (h). The angle of repose was then calculated by measuring the height and radius of the heap of powder formed. Care was taken to see that the powder particles slip and roll over each other through the sides of the funnel. Relationship between angle of repose and powder flow property.

Table 1: Angle of Repose as an Indication of Powder Flow Properties

Sr. No.	Angle of Repose	Type of Flow
1	<20	Exellent
2	20-30	Good
3	30-34	Passable
4	>34	Very Poor

4. Carr’s index (or) % compressibility: -

It indicates powder flow properties. It is expressed in percentage and is give

Dt – Db

I = ------------ x 100

Where, Dt is the tapped density of the powder and Db is the bulk density of the powder.

Evaluation of mouth dissolving tablets:

1) Weight variation:³⁹

20 tablets were selected randomly from the lot and weighted individually to check for weight variation. Weight variation specification as per I.P. is shown in Table 2.

Table 2: Weight Variation Specification as per IP

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

2) Hardness: -

Hardness or tablet crushing strength (fc), the force required to break a tablet in a diametric compression was measured using Monsanto tablet hardness tester. It is expressed in kg/cm2.

3) Friability (F)⁴⁰:

Friability of the tablet determined using Roche friabilator or Electro lab friabilator. This device subjects the tablet to the combined effect of abrasion and shock in a plastic chamber revolving at 25 rpm and dropping a tablet at I height of 6 inches in each revolution. Preweighted sample of tablets was placed in the friabilator and were subjected to the 100 revolutions. Tablets were dusted using a soft muslin cloth and reweighed. The friability (F) is given by the formula.

W initial – W final

F = ----------------------------- x 100

W initial

4) Mechanical Strength:

Tablets should possess adequate strength to withstand mechanical shocks of handling in manufacturing, packaging and shipping. Crushing strength and friability are two important parameter to evaluate a tablet for its mechanical strength.

5) Crushing Strength:

It is the force required to break the tablet by pressing on the spreading side, it is an important parameter in the formation of oral tablets because the force of excessive crushing greatly reduces the dispersion time. In the present study the crushing power of the tablet was measured using Pfizer hardness testers. Average three views reported.

6) Wetting time:⁴¹

Wetting time is closely related to the inner structure of the tablets and to the hydrophilicity of the excipient. According to the following equation proposed by Washburn E.W (1921), the water penetration rate into the powder bed is proportional to the pore radius and is affected by the hydrophilicity of the powders.

dl/dt = r¡cosq/(4hl)

When l penetration length, r is about capillary radius, ¡area height, h is the viscosity of the liquid, time, and q is the angle of contact. It is clear that the size of the pores becomes smaller and the damping time increases with increasing pressure or decreasing porosity. A direct relationship exists between the wet period and the separation period. Watering is therefore an important step in the dispersion process. A piece of folded tissue paper was placed on a Petri plate (internal diameter is 6.5 cm) containing 6ml of water. The tablet was placed on paper and the tablet's wetting time was completely measured in seconds. This method is slightly modified by keeping the water 37o. The wetting time coincides with the time taken for the tablet to disintegrate when kept in the tongue.

7) In vitro dispersion time⁴²

Tablet was placed in 10 ml phosphate buffer solution, pH 6.8±0.5°C. Time required for complete dispersion of a tablet was measured.

8) In-vitro disintegration time⁴²

The process of dividing a tablet into smaller particles is called dispersing. The duration of the in-vitro segmentation of the tablet was determined using the diagnostic testing tools according to I.P statistics. Clarification. One tablet was placed in each of the six tubes in the basket. Insert the disc into each tube and use the instruments using pH 6.8 (made of liquid saliva) stored at 37±20°C as immersion liquid. The assembly should be amplified and reduced between 30 cycles per minute at pH 6.8 maintained at 37±20C. The time taken in seconds for the complete separation of the tablet with no significant impact remaining on the apparatus was estimated and recorded.

9) Thickness Variation:⁴³

Ten tablets from each formulation were taken randomly and their thickness was measured with a digital screw gauge micrometer. The mean SD values were calculated.

CONCLUSION:

The technology described in this article indicates that recent developments have taken place development and processing technology meets the efforts to achieve complex drugs delivery system. Oral contraceptives, geriatric, sensible patients, bedridden and those who are busy traveling and do not need to check watering. Drugs delivered to MDT'S can enter very pregastric sites

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Received on 01.04.2021 Modified on 20.05.2021

Asian J. Pharm. Res. 2021; 11(3):180-186.

DOI: 10.52711/2231-5691.2021.00033

BRAND NAME	ACTIVE INGREDIENT	APPLICATION	COMPANY
Claritin	Loratadine	Antihistamine	Schetring
Feldene Melt	Piroxicam	NSAIDs	pfizer
Maxalt-MLT	Rizatriptan Benzoate	Migrane	Merck
Pepeid ODT	Femotidene	Anti-Ulcer	Merck
Zyperxa	Olazepine	Psychotropic	Eli Lilly
Zofran ODT	Olandansetron	Antiemetic	Galaxo Smith Kline
Resperdal M-Tab TM	Resperidone	Schizoprenia	Janssen
Klonopin Wafer	Clonazepam	Sedation	Roch
Imodium Instant Melts	Loperamide HCL	Antidiarrheal	Jannsen
Nasea OD	Ramosetoron HCL	Anti-Emetic	Yamanouchi
Tempra Quicksolv	Acetaminophen	Analgesic	Bristol-Mters Squibb