A Summary Of Tablets As Dosage Form, With Particular Referencies To Fast Dissolving Tablets (FDTS)

Abstract

When it comes to medication therapy for any illness, the optimal dosage schedule is one that achieves the desired therapeutic concentration of the drug in plasma (or at the site of action) right away and keeps it there during the course of treatment. This can be accomplished by administering a traditional dosage form at a specific dose and frequency. As a result, the medication can be taken in different dosage forms and via different routes. Oral drug administration is a generally recognised, practical, and well-liked means of doing so. The last few decades have seen a significant evolution and change in the formulation of solid oral dosage forms, and tablets in particular, with the introduction of pre compression, ultra high speed presses, and induced die feeding. The formulation, design, and manufacturing of tablets have been impacted most recently by new concepts and federal regulations pertaining to bioavailability, bioequivalence, and validation.

Keywords

Formulation, manufacturing, tablet, bioavailability, bioequivalence

Introduction

Oral drug delivery is the most common method. Oral medicine administration usually results in swallowing, while some medications are meant to dissolve in the mouth. The oral route of medication administration is the most often used and has been effectively employed for traditional drug delivery when compared to other routes. It is regarded as the most inexpensive, simple, safe, easy to produce, natural, and flexible way to administer medication. It also allows for more design flexibility in dose forms. [1] Medications are taken orally in a range of pharmaceutical dosage formulations. Tablets, capsules, suspensions, and other medicinal solutions are the most widely used forms. Solid dosage forms are the recommended product class for medications that are taken orally. They are easy to make, store, handle, and use. They are also adaptable, flexible in dose strength, reasonably stable, and pose less of a formulation or packaging challenge. The medication is best protected against light, temperature, humidity, oxygen, and stress during transportation when it is in a solid dosage form. Tablets are a common oral dose form for solids.

Tablets[1]

Tablets are solid pharmaceutical dose forms made by compression or moulding that contain medications with or without appropriate excipients.

Advantages Of Tablet

The following are some possible benefits of tablets.

1. They are the unit dosage form having greatest capabilities amongst all the oral dosage form for the dose precision and least content variability.
2. Their cost is lowest amongst all the oral dosage forms.
3. They are the lightest and the most compact amongst all the oral dosage form.
4. They are easiest and cheapest for packaging and transportation.
5. They lend themselves to certain special release profile products such as enteric or delayed release products.
6. Tablets are better suited to large-scale production than other unit oral dosage forms.
7. They have the best-combined properties of chemical, mechanical, microbiological stability amongst all the oral dosage forms.

Classification Of Tablets [1]

The tablets are divided into the following categories based on how they are administered or intended use.

1. Tablets ingested orally.

a. Compressed tablet

b. Multiple compressed tablet

i. Layered Tablet

ii. Compression coated Tablet

c. Repeat action Tablet

d. Delayed action and enteric coated Tablet

e. Sugar and chocolate coated tablet

f. Film coated tablet

g. Chewable Tablet

2. Tablets used in the oral cavity.

a. Buccal Tablet

b. Sublingual Tablet

c. Troches and Lozenges

d. Dental cones

3. Tablets administered by other routes.

a. Implantation Tablet

b. Vaginal Tablets

4) Tablets used to prepare solution.

a. Effervescent Tablet

b. Dispensing Tablet

c. Hypodermic Tablet

d. Tablets Triturates

Methods for Manufacturing Tablets

Wet granulation, dry granulation, or direct compression are the methods used to make tablets.

1. Wet Granulation

The technique of adding a liquid to a powder in a vessel with any kind of agitation to create granules or agglomeration is known as wet granulation. After drying, these granules are compacted into tablets.

2. Dry Granulation:

In this technique, there is no use of liquids. The process involves the formation of slugs. Then the slugs are screened or milled to produce granules. The granules formed are then compressed to form tablets.

3. Direct compression:

The procedure of compressing tablets directly from powder mixes of the active drug and appropriate excipients, which will flow uniformly in the die cavity and create a hard compact, is referred to as "direct compression."

Benefits of the Direct Compression Technique

1. This procedure is more cost-effective. It saves personnel costs and process validation since it involves fewer manufacturing steps and less processing time.
2. There was no requirement for heat, wetness, or high compaction pressure throughout the processing phases.
3. The disintegration of tablets is optimised, allowing for the dissolving of every main drug particle that has been freed from the tablet mass.
4. Direct compression is a more efficient method of processing disintegrating substances, such as starch, than wet granulation.

Fast Dissolving Tablets

There has been a greater need for more patient-compliant dose forms within the last 20 years. The outcome has been a threefold annual growth in demand for the technology. Pharmaceutical companies are concentrating on the development of new drug delivery systems for current drugs with enhanced efficacy and bioavailability together with reduced dose frequency to minimise adverse effects, as the cost of developing a new chemical entity is very high. Approximately 35% of the general population is said to suffer from dysphagia, or difficulty swallowing. Numerous medical conditions, such as stroke, Parkinson's disease, AIDS, radiation therapy to the head and neck, and other neurological disorders like cerebral palsy, are also linked to this ailment.

Pharmaceutical preparations used for senior patients have recently been the subject of research aimed at enhancing patient quality of life and treatment compliance.[2,3] New developments in Novel Drug Delivery Systems (NDDS) seek to improve patient compliance while improving drug molecule safety and efficacy by developing an easy-to-administer dosage form. The "Mouth/Fast Dissolving Tablet" is one such method. With this cutting-edge tablet technology, the patient can have the maximum amount of convenience as the dose form containing the active medicinal components dissolves quickly—typically in a matter of seconds—without the need for water. These tablets are known by a number of names, including mouth dissolving (MD), rapid melting, fast dissolving, orally disintegrating tablets (ODT), according to inventors and inventor businesses.[4,5] The idea behind the Fast Dissolving Drug Delivery System was to give patients a more traditional way to take their medications. Dysphagia, or difficulty swallowing, affects people of all ages, but it is more common in the old and young due to physiological changes that are linked to these patient populations.[6,7] Other groups of patients who have trouble taking normal oral dosage forms include those who are mentally ill, agitated, and sick; they also include individuals who suffer from motion sickness, abrupt allergic reactions, or coughing fits. When water is scarce, it can occasionally be difficult to swallow conventional items.[8,9] Due to these issues, a brand-new class of solid oral dose form known as "Fast Dissolving Tablets" was created. The fast-dissolving tablet quickly disintegrated in the mouth. The tablet swelled upon coming into contact with water, and the medication was absorbed normally. Drugs may have a quick start to action and are readily absorbed in the stomach.[10] In these situations, the drug's bioavailability is noticeably higher than that of typical tablet dose forms.[11, 12] Recently, it was highlighted how important fast-dissolving tablets are becoming. Fast dissolving tablets, as defined by the European Pharmacopoeia, are those that dissolve in the mouth in between 10 and 3 minutes.[13]

Significance of the Fast Dissolving Drug Delivery System

1. Administration ease.
2. Quick absorption & medication disintegration.
3. Improved Bioavailability in certain circumstances.
4. Benefits of liquid medicine when prepared solid.
5. Excellent for elderly and paediatric clients.
6. Increased patient adherence.
7. Dosage accuracy.

The basics of tablets that dissolve quickly

Water needs to quickly permeate the tablet matrix in order to cause speedy disintegration and immediate dissolution of the tablet in order for the dosage form to dissolve quickly. To formulate the fast-dissolving tablet, these fundamentals are achieved by a variety of approaches. A few of the methods are explained here.

Method for Preparing Tablets for Mouth Dissolving

1. Freeze Drying
2. Moulding
3. Sublimation
4. Spray Drying
5. Direct compression

Patented Technologies

1. Zydis Technology.
2. Durasolve Technology.
3. Orasolve Technology.
4. Flash Dose Technology.
5. Wow Tab Technology.
6. Flash Tab Technology.

1. Freeze Drying (Zydis Method)[14]

Mouth-dissolving tablets, which are very porous and dissolve or disintegrate rapidly when in contact with saliva, can be made by freeze-drying or lyophillazation. Because the zydis units are not strong enough to withstand being pushed through the lidding foil of a conventional blister, this method involves incorporating the drug into a water-soluble matrix, which is then transferred to the preformed blister with peelable foil. Freeze drying is then performed to remove water by sublimation. Based on a patent granted to Gregory et al., R.P. Scherer patented the zydis technology by using a freeze-drying technique to prepare mouth-dissolving tablets.[15]Seager talked about the zydis technology-prepared fast-dissolving tablets' formulation, process technology, and bioavailability.[16] The main drawback of freeze-dried fast-dissolving tablets is their fragility, which makes traditional packaging challenging and poses stability issues when stored. However, Blank et al. found that by using mannitol and natural gum as a carrier material in the formulation of freeze-dried tablets, stability issues may be resolved. The tablets also demonstrated enhanced stability in blister packs, even when stored under demanding conditions.

2. Moulding[17]

Water-soluble components are used to make moulded tablets, which dissolve or disintegrate quickly and thoroughly. A hydroalcoholic solvent is used to moisten the powder, which is subsequently moulded under less pressure than a traditional dosage form to create tablets. Air drying eliminates the solvents. Because of its porous structure, the tablet dissolves easily. Sucrose, acacia, or PVP K-30, 22 may be added to the tablet to improve its mechanical strength. There is relatively little room for taste masking in tablets that are moulded. Van Scoik used particle cotton seed oil, lecithin, polyethylene glycol, sodium bicarbonate, and medication and combined them into a lactose-based triturate form to create taste-masked mouth dissolving tablets in order to cover up the unpleasant taste of medications.

3. Sublimation[18]

The fundamental steps in creating quickly dissolving tablets using the sublimation technique include adding a volatile salt to the tabletting ingredients, combining them to create a fairly homogenous mixture, and volatizing the volatile salt. When volatile salts are eliminated from a tablet, pores are created in the tablet that facilitate quick breakdown when saliva contacts the tablet. To make porous pills with strong mechanical strength, one can utilise ingredients such as camphor, naphthalene, urea, and ammonium bicarbonate. Mannitol was utilised as a diluent and camphor as a volatile ingredient by Koizumi et al. [19] to create porous compressed tablets. The tablets were placed under a 30-minute hoover at 800C to remove the camphor and create pores in the tablet. Water was used by Makino et al. [20] utilized water as a pore forming material in order to prepare porous tablets with excellent mechanical strength and dissolution character.

4. Spray Drying[21]

Spray drying is a useful technique for making tablets that dissolve quickly. This method is based on a spray-dried particle support matrix that is combined with other ingredients to create an aqueous composition that is both extremely porous and finely powdered. The active component is then combined with this and compacted into a tablet. Within twenty seconds, the spray-dried tablet that was made using the quick dissolving approach disintegrated.

5. Disintegrant addition (Direct compression)[22]

The disintegrant addition technique is a widely used method for creating mouth-dispersing tablets due to its affordability and ease of usage. The fundamental idea behind creating mouth-dissolving tablets using the disintegrant addition approach is to add superdisintegrants at the right concentration to provide both quick disintegration and a pleasant mouth sensation. The shortest disintegration time is achieved by combining microcrystalline cellulose with low substituted hydroxy propyl cellulose in an 8:2 to 9:1 ratio. Analgesic-active fast-dissolving tablets were created by combining various superdisintegrants. The anti-HIV medication efavirenz was developed into a fast-dissolving tablet by combining sodium starch glycolate and microcrystalline cellulose as a superdisintegrant.[23]

CONCLUSION

In order to improve patient convenience and compliance, fast-dissolving tablets can be considered a novel drug delivery strategy that is easy to formulate and administer without the need for water, has minimal side effects, and provides immediate release and enhanced bioavailability.

FINANCIAL SUPPORT AND SPONSORSHIP

Nil

CONFLICTS OF INTEREST

There are no conflicts of interest

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