An overview of Immediate Release Tablets

Aishwarya bodke1*.
Ravindra Gambhir Sapkal College of Pharmacy

Corresponding Author-
Name- Aishwarya bodke
Contact Number- 9158286843
Contact Mail- aishu007bodke@gmail.com
Address- Ravindra Gambhir Sapkal College of Pharmacy
Abstract-
Tablet is the greater among the all of the dosage forms survive today because of it gives
satisfaction of self administration, compactness and easy manufacturing; although in more cases
immediate onset of action is mandtory than conventional therapy. In immediate release tablet
formulation of the tablet is the use of superdisintegrants such as croscarmellose, sodium starch
glycolate, and crospovidone, etc. These superdisintegrants gives instantaneous disintegration of
the tablet after administration in the stomach. There are novel types of dosage forms that act very
rapidly after the administration.. Immediate release liquid dosage forms and parenteral dosage
form have also been used for treatment. These progress of immediate release system also brings
an opportunity for increase in the marketplace, A different type of drugs (e.g., neuroleptics,
cardiovascular drugs, analgesics, antihistamines, and drugs can be considered contender for this
immediate release dosage form. These review provides a significant detail about these immediate
release tablet and its mechanism of action and Preparation technique, excipients and evaluation
of these dosage form.

KeyWords- Immediate release tablet, Oral dosage form, disintegrants, evaluation,

Pharmacodynamics study, Pharmacokinetic study.

Introduction-
Immediate release drug delivery systems are described as immediate release tablets that are
manufactured to disintegrate and release the drug without special rate controlling features such
as special coatings or alternative technologies, hence the traditional type of drug delivery. It's
also a system. Oral administration is one of the most popular routes of administration for
systemic effects due to its ease of ingestion, simplicity, safety, convenience, non-invasiveness,
versatility, and most importantly, patient compliance. Solid oral administration systems are
inexpensive to manufacture because they do not require sterile conditions [1].
Although the field of controlled-release and targeted drug delivery systems has received
increasing attention and interest in recent years, solid dosage forms designed to be swallowed
disintegrate, releasing drugs rapidly and violently in the gastrointestinal tract. The ideal dosing
regimen for drug therapy achieves the desired therapeutic plasma (or site of action) drug
concentration immediately and maintains it constant throughout the course of treatment.
Recently, scientists have turned their attention to immediate release tablet formulations [2].
Attempts to develop rapidly disintegrating tablets are achieved through the use of suitable
diluents and superdisintegrants. Immediate release tablets are invented to match dose type
without special rate control options. B. Special coatings and various techniques to decompose
and release. Immediate-release tablets are tablets that rapidly disintegrate and dissolve to release
the drug. Ability to rapidly release drug in response to disintegration, dissolution, and many
physiological factors [3].
Immediate release dosage forms help manufacturers diversify their markets and provide patients
with convenient dosage forms or schedules. Excipients correspond to the properties of the active
ingredient in the immediate release dosage form. This requires a thorough understanding of the
chemistry of these excipients to prevent them from interacting with the active ingredient. The
role of these excipients is important in the formulation of fast-dissolving tablets. These inert,
food-grade ingredients, when incorporated into formulations, impart desired organoleptic
properties and product efficacy [4].

Ideal Properties
An immediate release dosage form is required. A fixed dose should dissolve or break down in
the stomach within a short period. It should show initial absorption and dissolution of the drug. A
rapid onset of action is always observed with fast-acting tablets. Must be compatible with taste
masking. You can carry it around without worrying about its fragility. There should be minimal
residue in the mouth after oral administration. It guarantees a pleasant mouthfeel. Low sensitivity
to environmental conditions such as humidity and temperature. It can be manufactured at low
cost using conventional processing and packaging equipment [5, 6].

Salient Features
Drugs should have long biological half-lives for immediate release drug delivery. The drug is
released quickly and completely in one shot. High bioavailability expected in an immediate
release dosage form. Lower clearance and elimination half-life are also requirements for
immediate release drug delivery systems. However, the main criteria for immediate release
dosage forms are the low solubility of the drug and the need for immediate effect of the drug to
treat the undesirable defect or disease. Prompt pharmacotherapeutic intervention is possible.
New business opportunities such as product differentiation, line expansion and lifecycle
management, excluding product promotion [7, 8].

Mechanism of Action-
Water transport, expansion, and possibly deformation recovery. It disperses and swells quickly in
water, but does not gel even after long exposure. Maximum swelling rate compared to other
explosives. Larger surface area to volume ratio than other explosives. Water-insoluble low-
substituted hydroxypropyl cellulose. Swells rapidly in water. Grades LH-11 and LH-21 show the
greatest degree of swelling. Certain grades can also provide some bonding properties while
maintaining disintegration capabilities. Recommended concentration 1-5%. Conventional rapid-
release tablet manufacturing technology [9, 10]

Figure Number- The flow of mechanism of Immediate Release Tablets

Conventional Techniques Used for Preparation of Immediate Release Tablets-

Several technologies are available to manufacture immediate-release tablets. The most common
preparation methods are molding, lyophilization or freeze drying, direct compression, spray
drying and sublimation.

Tablet Molding Technique-

This technology uses water-soluble chemicals to dissolve and break down the tablet more
quickly. Utilizing moistened powder mixtures and compression pressure that is lower than that of
traditional tablets, hydroalcoholic solvents are employed to form the tablets. Afterward, air
drying is used to remove the solvent. The porous design of moulded tablets improves dissolution
[11].

Direct Compression-
A method known as direct compression is one in which tablet formulations are made directly
from a powder mixture of acceptable excipients and API. It is not essential to first granulate the
mixed powder using a dry or wet process. Its benefits mostly relate to quick manufacturing
because it uses less equipment, fewer workers, less unit activities, and processing time while also
improving product stability [12].

Granulation Technique-
Small particles expand in size and become physically stronger through a process called size
enlargement. Avoiding product component segregation, improving powder flow and handling,
and reducing dustiness are all advantageous. It is perfectly spherical, and the smaller particles
effectively cover the gaps between the granules. This approach falls into two categories as well
[13].

Wet Granulation: The manufacture of severity-feed drugs is made simple by the wet
granulation technique. An aqueous solution of a binding polymer is often added to fine particles
of a granulated quick release formulation. Granulated formulation for controlled release with
added binder polymer solution [14].

Dry Granulation: The powder combination is compacted during the dry granulation process
without the use of heat or solvent. The two fundamental steps are to compress the material into a
compact, and then to mill the compact to produce granules. Two techniques are shown below for
dry granulation [15].

Mass-Extrusion-
In this technology, methanol, polyethylene glycol, and a mixture of the active medicine are
softened before being added to a cylinder-shaped product and sliced using a hot blade to create a
dosage form known as tablets [16].

Solid Dispersions-
Solid products containing at least two different components, mainly hydrophilic matrix and a
hydrophobic drug. The matrix can be either crystalline or amorphous. This method deal with the
challenge of mixing a matrix and drug, preferably on a molecular level, while matrix and drug
are generally poorly miscible. When formulating immediate release solid dosage forms from
solid amorphous dispersion for oral administration to effective use in an environment such as the
GI tract of a human, it is often desirable to increase the amount of dispersion occurs in the
dosage form [17].

Lyophilization-
It depends on simple principle i.e. sublimation. The sublimation is processed in which
conversion of a substance from a solid state to vapor state, without changing in the liquid phase.
Lyophilisation is performed at temperature and pressure conditions below the triple point. The
whole process is performed at low temperature and pressure by applying vacuum; hence it is
suitable for drying of thermolabile compounds [18].

Pneumatic Dry Granulation (PDG)-

It is a novel technique of dry method in which the formulation of granules is carried out by
automatically or semi-automatically. This techniques granule has excellent properties as
compared to dry granulation, direct compression, wet granulation and granules are showing high
compressibility and flowability The outcome can be attained without utilizing exotic and high-
cost excipients [19].

Freeze Granulation Technology (FGT)-

Integrated Biosystems, Inc. (California, USA) had patented freeze GT that results in spherical
and free flowing granules with ideal homogeneity. Its require spraying of a suspension
containing powder into liquid nitrogen where the drops were swiftly frozen to form granules
which upon subsequent freeze-drying yields dry granules [20].

Spray Drying Granulation-

This technology facilitated to improved flow, homogeneous distribution of colors, drug and
required less lubricant as compared to wet massed products. It can be co-precipitate an active
pharmaceutical ingredient with a suitable polymer to form a stable amorphous solid dispersion
and promote improved bioavailability and dissolution rate of many drug products [21]

Thermal Adhesion Granulation Process-

Agglomeration is created using a little amount of binder liquid, heat, and an alternative to moist
granulation. Heat is sometimes used to facilitate the granulation process. To create the
agglomeration process that results in the powder particle, the excipient and API mixture is heated
at 30-130 °C temperature in a closed chamber that is configured for tumble rotation. Because less
liquid is needed and consumed during the aggregation of powder particles, this method stops the
drying process. Granules can be obtained in the necessary particle size after chilling and sifting
[22].

Granurex Technology-
This technology consistently and precisely accomplishes the powder layering processes, single
coating, and multiple coating processes and powder layers that manifest the accuracy and better
drug release mechanism [23]

Mechanism of Disintegration-
Disintegrants are substances that are added to tablet and different encapsulated formulations to
speed up the breakdown of the tablet and capsule "slugs" into tiny pieces in an aqueous
environment, increasing the accessible surface area and encouraging a quicker release of the
medicinal component. They cause the tablet matrix to disperse and absorb moisture. Tablet
disintegration has drawn a lot of interest as a crucial stage in obtaining rapid medication release.
The following list identifies the four main mechanisms of tablet disintegration:
Swelling-
The most commonly accepted general mechanism of action for tablet disintegration is swelling.
Tablets with high porosity show weak disintegration due to lack of adequate swelling force. On
the flip side, sufficient swelling force is exerted in the tablet with low porosity. It is worthwhile
to note that if the packing fraction is very high, fluid is not able to penetrate in the tablet and
disintegration is again slows down [24].

Capillary Action / Wicking-

Those disintegrating agents do not get swells so they acted by the mechanism of capillary action
and porosity. Tablet’s porosity provides a direction to penetrate the fluid into the dosage form.
The disintegrating particles those having low compressibility and cohesiveness they facilitate the
high porosity and provide a pathway to wicked and drawn up liquid in the tablets drawn through
capillary action and break the bonding of inter particles which leads the tablet to break apart
[25].

Chemical Reaction (Acid-Base Reaction)-

Due to the interaction of tartaric acid and citric acid (acids) with alkali metal carbonates or
bicarbonates (bases) in the presence of water, the tablet soon breaks apart by the internal release
of CO2 in water. The tablet disintegrates as a result of pressure generation. API's ability to
dissolve in water and its ability to disguise flavours thanks to its release into CO2 gas. Because
these disintegrants are extremely sensitive to even tiny changes in humidity level and
temperature, a careful control environment is required during the manufacture of the tablets. The
effervescent blend can be introduced either immediately before compression or in two separate
formulation fractions [26].

Deformation-
Because of their elastic nature, starch granules can be easily bent under pressure before quickly
resuming their original location and shape. However, when tableting forces are applied, these
grains are permanently damaged and referred to as "energy-rich," and this is energy released
when come into contact with water as seen in [27]

Pharmacokinetics [28-30]-
It is the research into nutrient uptake, distribution, metabolism, and excretion. Both the rate and
the extent of absorption are crucial because after absorption, a drug reaches a therapeutic level
and induces a pharmacological action. Since there is a delay in the disintegration process in
conventional dosage forms, the dissolution is quick. Drug distribution is influenced by a variety
of variables, including illness severity, drug interactions, tissue permeability, perfusion rate, and
drug binding to tissue. The amount of time a drug remains in the body or how quickly it
transforms at its site of action determines how strong and long its effects are. The
biotransformation of drugs by oxidation, reduction, and hydrolysis is inhibited by a decrease in
liver volume and regional blood flow to the liver. The half-life of medicines secreted by the
kidneys extends as renal clearance is slowed.

Pharmacodynamics [31, 32]-

Due to improper organ development, drug reception interaction is hampered in both elderly and
young adults. When taking an antihypertensive drug like prazosin, side effects include decreased
cardiac output, orthostatic hypotension, and decreased reflex response may occur. decrease in the
CVS's susceptibility to -adrenergic agonist and antagonist. When administering antibiotics,
immunity is reduced and taken into account. Theophylline's bronchodilator function in older
people is decreased, and they are more sensitive to barbiturates. Elderly patients frequently have
concurrent ailments, which is taken into account when prescribing numerous pharmacological
therapies. Clinical medication combinations for many kinds of cardiovascular medicines,
diuretics, anti-hypertensive, etc. have been studied by researchers for rapid release dosage forms.
The patient's illness state determines the combination that is used.

Precompression study Studies [33-36]-

Angle of repose-
A cone-shaped pile of material created via various techniques assumes a three-dimensional angle
(relative to the horizontal base) known as the angle of repose. In several scientific fields, the
angle of repose has been employed to describe how solids flow. The literature has a number of
ways for calculating angle of repose, but the constant height method is the most used. Use a
funnel that was fastened with the tip at a specific height (2 cm) above the graph paper that was
placed on a flat, horizontal surface for the fixed funnel method. The mixture of granules or
tablets was gently poured through the funnel until the top of the conical pile barely touched the
funnel's tip.
Tan θ = h / r

Where,
h = height of the powder pile
r = radius of pile circle

Bulk Density (ρB) -

Using a graduated cylinder and the constant mass method, bulk density is calculated. An
apparent density is the bulk density. The mass-to-volume ratio of an untouched powder sample,
taking into account the inter particulate void volume, is known as the bulk density of a powder. It
is provided by and stated in gm/ml.
Bulk density (ρB) = M / Vo
Where,
M = mass of the powder (weight taken in g)
Vo = Void volume (Untapped Volume in ml)

Tapped density
The powder's tapped density is determined by dividing its total mass by its tapped volume. A
measuring cylinder is taped until the reading changes only slightly or not at all to determine the
taped volume. It is provided by and is measured in gm/ml.
Tapped density (ρT) = M / Vf

Where,
M = mass of the powder (weight taken in g)
Vf = Tapped Volume (Final bulk volume after tapped in ml)
Hausner ratio
Hausner ratio is an indirect index to predict of powder flow. It is calculated by the following
formula.
Hausner ratio = Tapped density (ρT) / Bulk density (ρB)

Compressibility index (Carr’s index)

Compressibility index (Carr’s index) is an indirect parameter to assume flow property of powder.
Compressibility index determined by measuring the initial volume (Vo) and final volume (Vf)
after complete tapings of powder sample in a measuring cylinder.
It is calculate using an equation.
Compressibility index (CI) = (Vo – Vf X 100)/Vo

Post compression study [36-42]-

The appearance, thickness, diameter, hardness, friability, uniformity of weight, disintegration
time, medication content, and in vitro dissolution studies are just a few of the factors that are
analysed for each tablet.

Appearance-
A tablet's general appearance serves as its visual identity, and this may be determined simply by
looking at tablets. Elegance, shape, colour, and surface textures are all components of
appearance. Each of these criteria is necessary for suitability and consumer acceptance.

Dimensional Analysis-
Thickness and diameter of tablets are determined using Vernier Caliper. Randomly twenty
tablets selecte from each batch are use and average values are calculated. Thickness is expressed
in Mean ±SD and unit is mm.

Hardness-
The strength of a tablet's resistance to capping, abrasion, or breakage under conditions of storage,
transportation, and handling prior to use is indicated by the tablet's hardness. The force necessary
to break a tablet using a given tool is measured as hardness. 10 tablets are chosen at random from
a batch to have their hardness tested by different hardness testers (Monsanto hardness tester,
Pfizer hardness tester). Hardness expressed as kg/cm2

Weight variation test-

Weight variation test is carried out in order to ensure uniformity in the weight of tablets in a
batch. Individual weights of 20 tablets are taken randomly from whole batch. Individual weight
is then compared with the average weight for the weight variations. USP 30-NF25 limits for
weight variation in case of tablets weighting up to 130mg or less is ± 10%, 130 mg to 324 mg is
± 7.5% and more than 324 mg is ± 5%. IP limit for weight variation in case of tablets weighting
up to 80mg or less is ± 10%, 80 mg to 250 mg is ± 7.5% and more than 250 mg is ± 5%

PD = [(Wavg – Winitial) / (Wavg)] x 100

Where,
PD = Percentage deviation,
Wavg = Average weight of tablet,
Winitial = Individual weight of tablet

Friability test-
The tablet friability test is determined on compressed, uncoated tablets containing a grinding
agent. Tablet friability measurements complement other physical strength measurements. B.
Tablet breaking strength. For tablets with a unit mass of 650mg or less, sample the whole tablet
as close to 6.5g as possible. For tablets with a unit mass greater than 650 mg, sample all 10
tablets. Tablets should be carefully dusted before testing. Accurately weigh the tablet sample and
put the tablets into the drum. Rotate the drum 100 times and eject the tablets. As before, remove
loose dust from tablets and weigh accurately. The drum is mounted on the horizontal axis of the
machine rotating at 25 ± 1 rpm. Therefore, with each rotation, the tablets roll or slide and fall
onto the wall of the drum or onto each other. A maximum average mass loss of 1.0% or less
from triplicate samples is considered acceptable for most products.

% friability = [(Initial weight - final weight) /Initial weight]× 100

Wetting time study -
Five circular tissue papers with a diameter of 10 cm were placed in a petri dish containing a
0.2% w/v solution of amaranth (10 ml). Gently place the tablet on the surface of the tissue paper.
The time required for a blue color to develop due to the water-soluble dye amaranth on the top
surface of the tablet was recorded as the wetting time.

Water absorption ratio-

A small tissue paper folded in half was placed in a small Petri dish containing 6 mL of water.
Prior to recording the initial weight of the tablet, the tablet was placed on paper. The wet tablets
are then weighed. Water absorption (R) is determined using the formula:

R = (Wa – Wb) / Wa × 100

Where,
Wa = weight of the tablet before absorption.
Wb = weight of the tablet after absorption

Disintegration test-
A disintegration test is performed using a disintegration apparatus. Place one unit of measure in
each tube (6) of Pannet and use discs if prescribed. Unless otherwise specified, use water as the
immersion liquid and maintain 37 ± 2 oC in the immersion liquid. Operate the device until each
unit dose emerges from the basket. 15 minutes for uncoated tablets. 30 minutes for uncoated
tablets, and 60 minutes for coated tablets and pills. If one or two tablets do not disintegrate
completely, repeat the test with another 12 tablets. At least 16 out of 18 total tablets have
disintegrated.

Drug content-
Ten tablets were powdered and 100 mg of drug equivalent powder was dissolved in the
appropriate medium (buffer or 0.1N HCl). The volume of the solution up to 100 mL in this
medium. The solution was filtered, diluted 100-fold, analyzed spectro-photometrically, and
further calculated to determine the drug content in the tablets.
In- vitro drug release -
Study drug release studies were performed in a dissolution tester using a specified volume of 900
ml dissolution medium maintained at 37±0.5°C. Tablets are stored in a cylindrical basket or
placed directly into the medium and immediately run the device at the specified speed. Collect
samples from the intermediate zone between the surface of the eluate and the top of the rotating
basket or blade within the specified time intervals (5, 10, 15, and 30 min) or at specified time
intervals. Keep at least 10 mm away from the vessel wall and replace the same amount of fresh
medium each time.
The sample is filtered and 1 ml is taken from the filtrate and diluted to 10 ml. These samples are
analyzed and further calculations are performed to obtain drug release. Drug release data were
plotted and tested for 0th order (cumulative % drug released vs. time) and 1st order (log %
remaining vs. time). In vitro dissolution kinetic parameters, dissolution rate constants, correlation
coefficients and dissolution efficiency were calculated. The current Q6A guidance from the
International Conference on Harmonization (ICH) recommends the use of single-point assays to
measure the release of drug substances from immediate-release medicinal products.

Table Number 01- Lists of different excipients used in the design of tablets [43-45]
Excipients Functions Examples
Lactose, starch, mannitol, sucrose,
Diluents are used as fillers designed to
Diluents
make up the required bulk of the tablet. sorbitol, etc
Binders and These are used to produce cohesive Hydroxy propyl methyl cellulose,
Adhesives compact, acacia, starch,
Starch, clays, cellulose, alginate,
Disintegrants Used to facilitate a breakup of the tablet.
povidone, etc
Colors, Used to enhance the Organoleptic FD & C, D&C dyes and lakes,
flavors, and properties and acceptability of the banana, bubble gum, strawberry,
sweeteners product. vanilla flavors,
Glidants or Used to promote the flow of the tablet
Silica derivatives, talc, corn starch,
flow granules or powder material by reducing
etc.
promoters friction within particles
Conclusion:
Most patients require rapid therapeutic effects of drugs, resulting in poor compliance with
conventional pharmacotherapy and poor overall therapeutic efficacy. Immediate-release tablets
are designed to release the drug at an increased rate. As highlighted above for current
technology, there is still an unmet need for improved manufacturing processes for immediate-
release pharmaceuticals that are mechanically robust, easy to handle and package, and
competitively priced to manufacture conventional tablets. The additional market exclusivity that
can be provided by the immediate-release dosage form will lead to increased revenue and target
underserved and undertreated patient populations. A newer dosage form, the immediate release
formulation, has been developed, which combines the advantages of ease of administration and
convenience of administration. These tablets are made to release the drug from the dosage form.
To meet this medical need, formulators have expended considerable effort to develop new types
of tablet dosage forms that disintegrate rapidly and dissolve with improved dissolution.

Conflicts of interest-
There are no conflicts of interest or disclosures regarding the manuscript.

Acknowledgment-
The authors express their sincere gratitude to Ravindra Gambhir Sapkal College of Pharmacy,
University Libraries, and all other sources for their cooperation and advice in writing this review.

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