This document provides information about pharmaceutical tablets, including their manufacturing process, types, components, quality standards, and testing methods. Tablets are solid oral dosage forms made using compression. The manufacturing process involves mixing and granulating powders, then compressing them into tablets using punches and dies. Tablets can have various coatings, release mechanisms, and purposes. Quality is ensured through testing weight variation, disintegration, dissolution, and other physical properties. Proper manufacturing and testing helps ensure tablets safely and effectively deliver medication.

1. PHARMACEUTICAL TABLET
DOSAGE FORMS
PREPARED BY:
RUMAISHA KHALID (R-072)
FILZA TANVEER (R-027)
MAHNOOR JALIL (R-042)
NEHA NASEEM (R-066)
SYED ABDUL AHAD (R-087)

2. WHAT ARE TABLETS?
Tablets are solid dosage form usually
prepared with the aid of suitable
pharmaceutical excipient. They may
vary in size, shape, weight ,hardness,
thickness, disintegration, and
dissolution characteristics and in
other aspects, depending on their
intended use and method of
manufacture.

3. MANUFACTURING METHOD OF TABLETS:
Tablets are typically manufactured by a compression process. Tablet compression
consists generally of three phases:
1. FILLING:
The powder formulation (e.g., drug + excipients blended together to
form a homogeneous mixture) is stored in a hopper, a container that holds the
powder and dispenses it through the force of gravity. In the filling stage, the tablet
powder is volumetrically filled from the hopper into a die, which helps form the
size and shape of the tablet.
FILLING
COMPRESSION
EJECTION

4. 2. COMPRESSION:
The die contains a lower punch, which compresses the powder held within the die when an upper punch
descends into the die.
3. EJECTION:
The upper punch is then removed, allowing the compressed tablet to
fall out of the die.
Suitable powder flow is needed from the hopper to the die to ensure reproducible dosing. To improve flow
properties, the powder is often granulated prior to compression.
GRANULES:
A granule is defined as an agglomerate of powder particles that are bound together through compression or by the use
of a binder (i.e., an excipient that promotes powder cohesiveness and facilitates formation of granules) such that the
original particles can still be identified. Granulation can increase the homogeneity and bulk density of the mixture to
allow for easier filling into the tablet dies. This is similar to the improved flow properties observed with granulated
sugar, compared to a fine powder (i.e., a powder having a small particle size distribution) like confectioners’ sugar.

5. PROCESS OF GRANULATION:
Granules are created through a process of wet or dry granulation. Rapid disintegration of
granules in water or aqueous-based liquid increases the available surface area of the
particles and facilitates dissolution of drug.
1. WET GRANULATION:
In wet granulation, the drug powder is first mixed with a diluent. The powder blend is wetted with a binder and
water or non-aqueous solvent and thoroughly mixed, resulting in the formation of a wet mass. The solvent is
removed by a drying process to form a dried solid mixture, which is then sieved to create uniformly sized granules.
Additional excipients are then added to the mixture to facilitate the function of the tablet and/or manufacturing.
2. DRY GRANULATION:
Dry granulation involves the application of a dry binder to the powder formulation without the use of a liquid. The
blend is then compressed together in a tablet press to form a large tablet called a slug. A sieve, a mesh screen with
small, uniform openings, is used to separate the slug into uniformly sized granules that are compressed again to form
the final tablet. Alternatively, roller compaction may be used, in which the powder mixture is passed between two
contra-rotating cylindrical rollers to form a compacted powder ribbon. This ribbon is sieved, mixed with additional
excipients and then compressed into tablets.

6. TABLET COATING:
After compression, tablets may be coated. Tablet coatings serve a variety of
functions, such as:
(a) Enhancing aesthetic appearance
(b) Providing product identification
(c) Acting as a physical barrier between the drug and the environment
(d) Increasing strength
(e) Facilitating swallowing
(f) Taste-masking
(g) Modifying the release characteristics of the drug from the dosage form
The typical method of coating tablets is film coating in which a liquid
composition containing polymer(s), plasticizer, pigment, and solvent is sprayed
onto the tablet core while the solvent is concurrently dried during the application of
the liquid to the tablet surface. Aqueous film coatings are often used instead of non aqueous
film coatings that employ organic solvents, due to environmental, toxicity,
and cost concerns.

7. The choice of excipients for the film-coating process is dependent upon the intended purpose of coating and the
desired release profile of the drug. Manufacturing concerns related to the viscosity of the coating formulation, and
the mechanical strength, flexibility, and adhesion properties of the coating onto the tablet surface will also influence
the selection of coating excipients.
Defects in the tablet coating may occur, including picking, mottling, orange peel effect, cracking, and peeling of the
coating, and resolution of these issues requires alterations in the film-coating process or choice of excipients. The
pharmacist must watch for any of these defects when dispensing film-coated tablets because these defects may
affect the performance of the tablet.
COMPONENTS OF TABLETS:
In addition to the medicinal agents, compressed tablets usually contain a
number of pharmaceutical excipient, including
1. DILUENT:
Which add the necessary bulk to a formulation to prepare tablet of
desired size.

8. 2. BINDERS:
It promotes adhesion of the particles of the formulation, allowing a granulation to be prepared and
maintaining the integrity of the final tablet.
3. DISINTEGRANTS OR DISINTEGRATING AGENTS:
It promotes breakup of tablets after administration into smaller particles.
4. ANTI - ADHERANTS, GLIDANTS, LUBRICANTS:
It enhance the flow of material into the tablet dies, minimize wear of the punches and dies, prevents fill
material from sticking to the punches and dies and produce tablets with a sheen miscellaneous adjuncts such
as colorants and flavorants.

9. TYPES OF TABLETS:
1. MULTIPLE COMPRESSED TABLETS:
Multiple compressed tablets are prepared by subjecting the fill material to more than a single compression The
result may be a multiple-layer tablet or a tablet within a tablet, the inner tablet being the core and the outer
portion being the shell. Each layer may contain a different medicinal agent, separated for reasons of chemical or
physical incompatibility, staged drug release, or simply the unique appearance of the layered tablet.
2. SUGAR-COATED TABLETS:
Compressed tablets may be coated with a coloured or an uncoloured sugar layer.
The coating is water soluble and quickly dissolves after swallowing. The sugar-
coat protects the enclosed drug from the environment and provides a barrier to
objectionable taste or odour. disadvantages to sugar-coating tablets are the time
and expertise required in the coating process and the increase in size, weight,
and shipping costs. Sugar-coating may add 50% to the weight and bulk of the
uncoated tablet.

10. 3. FILM COATED TABLETS:
Film-coated tablets are compressed tablets coated with a thin layer of a
polymer capable of forming a skin-like film. The film is usually coloured and
has the advantage over sugar coatings in that it is more durable, less bulky,
and less time-consuming to apply. By its composition, the coating is designed
to rupture and expose the core tablet at the desired location in the
gastrointestinal tract.
4. ENTERIC-COATED TABLETS:
Enteric-coated tablets have delayed-release features. They are designed to
pass unchanged through the stomach to the intestines, where the tablets
disintegrate and allow drug dissolution and absorption and/or effect. Enteric
coatings are employed when the drug substance is destroyed by gastric acid
or is particularly irritating to the gastric mucosa or when bypass of the
stomach substantially
enhances drug absorption.

11. 5. BUCCAL AND SUBLINGUAL TABLETS:
Buccal and sublingual tablets are flat, oval tablets intended to be dissolved in
the buccal pouch (buccal tablets) or beneath the tongue (sublingual tablets)
for absorption through the oral mucosa. They enable oral absorption of
drugs that are destroyed by the gastric juice and/or are poorly absorbed
from the gastrointestinal tract. Buccal tablets are designed to erode slowly,
whereas those for sublingual use (such as nitro-glycerine [NTG]) dissolve
promptly and provide rapid drug effects.
6. CHEWABLE TABLETS:
Chewable tablets have a smooth, rapid disintegration when chewed or
allowed to dissolve in the mouth, have a creamy base, usually of specially
flavoured and coloured mannitol. Chewable tablets are especially useful for
administration of large tablets to children and adults who have difficulty
swallowing solid dosage forms.

12. 7. EFFERVESCENT TABLETS:
Effervescent tablets are prepared by compressing granular effervescent salts
that release gas when in contact with water. These tablets generally contain
medicinal substances that dissolve rapidly when added to water.
8. MOLDED TABLETS:
Certain tablets, such as tablet triturates, may be prepared by molding rather
than by compression. The resultant tablets are very soft and soluble and are
designed for rapid dissolution.
9. GELATIN-COATED TABLETS:
Compressed tablet with a layer of gelatin-based coating. An example is a gel cap Facilitates swallowing and
provides tamper evident technology.

13. 10. EXTENDED RELEASE TABLETS:
Tablets formulated to release drug over an extended period of time following ingestion. Synonyms include
controlled release and sustained release
11. VAGINAL TABLETS:
Uncoated tablet intended for insertion into the vagina, typically for local therapeutic effect.
12. MODIFIED-RELEASE TABLETS:
Tablets designed in such a way as to alter the release of drug from the tablet, such as by delaying drug release
or extending drug release. The term modified release is used to describe both delayed release and extended
release dosage forms, including tablets

14. REASONS FOR COATING TABLETS:
The reasons for coating pharmaceutical oral solid dosage forms are quite varied. The more common reasons
include (no order of importance implied):
1. Providing a means of protecting the drug substance (active pharmaceutical ingredient)from the
environment, particularly light and moisture, and thus potentially improving product stability.
2. Masking the taste of drug substances that maybe bitter or otherwise unpleasant.
3. Improving the ease of swallowing large dosage forms, especially tablets. Tablets that are coated are
considered by patients to be somewhat easier to swallow than uncoated tablets.
4. Masking any batch differences in the appearance of raw materials and hence allaying patient concern
over products that would otherwise appear different each time prescription is dispensed or product
purchased(in the case of over-the-counter products).
5. Providing a means of improving product appearance and aiding in brand identification.

15. 6. Facilitating the rapid identification of a product by the manufacturer, the dispensing pharmacist and the
patient. In this case the coatings would almost certainly be coloured. It is important here to emphasize that
efficient labelling and the associated procedures are the only sure way of identifying a product. However,
product colour is a useful secondary check.
7. Enabling the coated product (especially tablets)to be more easily handled on high-speed automatic filling
and packaging equipment. In this respect the coating often improves product flow, increases the
mechanical strength of the product and reduces the risk of cross-contamination by minimizing ‘dusting
'problems.
8. Imparting modified-release characteristics that allow the drug to be delivered in a more effective manner.

16. TABLET COATING DEFECTS:
1. PICKING:
Occurs when tablets stick together and separate, resulting in areas of the coating being pulled away from the
tablet core.
2. MOTTLING:
Uneven distribution of color within the tablet coating. May result from poor colorant dispersion or migration of
filming coating components in which the colorant is soluble.
3. ORANGE PEEL:
Surface roughness on tablet resulting from poor spreading of film coating.

17. 4. CRACKING:
Splitting of the tablet coating that may occur as a result of tablet core expansion, poor flexibility of the
coating, or mechanical stress upon the coating.
5. PEELING:
Separation of film coating from tablet core due to poor adhesion between coating and core, stresses on film
coating, or poor flexibility of film coating.
QUALITY STANDARD AND COMPENDIAL REQUIREMENTS OF TABLETS:
In addition to the apparent features of tablets, tablets must meet other physical specifications and quality standards.
These include criteria for weight, weight variation, content uniformity, thickness, hardness, disintegration, and
dissolution. These factors must be controlled during production (in-process controls) and verified after the
production of each batch to ensure that established product quality standards are met

18. TABLET WEIGHT AND USP WEIGHT VARIATION TEST:
The quantity of fill in the die of a tablet press determines the weight of the tablet. The volume of fill is adjusted
with the first few tablets to yield the desired weight and content.
CONTENT UNIFORMITY:
By the USP method, 10 dosage units are individually assayed for their content according to the method described in
the individual monograph. Unless otherwise stated in the monograph, the requirements for content uniformity are
met if the amount of active ingredient in each dosage unit lies within the range of 85% to 115% of the label claim
and the standard deviation is less than 6%. If one or more dosage units do not meet these criteria, additional tests
as prescribed in the USP are required

19. TABLET THICKNESS:
The thickness of a tablet is determined by the diameter of the die, the amount of fill permitted to enter the die,
the compaction characteristics of the fill material, and the force or pressure applied during compression.
PACKAGING OF TABLETS:
Glass bottles with screw or snap-on caps; glass or plastic tube with polyethylene closure, possibly with prongs or
plastic coil to prevent rattling; extruded aluminium container with screw cap; unit packs in foil and film.

20. TABLET TESTING:
After preparation of tablet, testing is done to ensure the efficient production of tablet.
Some test methods are described in pharmacopoeias, and these tests are traditionally concerned with the
content and the in vitro release of the active ingredient. While, the tests which are not described in
pharmacopoeias are sometimes referred to as no compendia and concern a variety of quality attributes that need
to be evaluated, such as the porosity of tablets.
METHODS OF TABLET TESTING:
1. UNIFORMITY OF CONTENT OF ACTIVE INGREDIENTS:
The test for uniformity of drug content is performed by collecting a sample of tablets followed by
determination of the amount of drug in each tablet. The average drug content is calculated, and the content
of the individual tablets should fall within specified limits.

21. 2. DISINTEGRATION:
The process of drug release from tablets often includes a step in which the tablet disintegrates into smaller
fragments. To assess this, disintegration test methods have been developed, and examples of these can be
found in pharmacopoeias. The test is performed by agitation of a given number of tablets in an aqueous
medium at a defined temperature, and the time to reach the end point of the test is recorded. The end point
of the test is the point at which all visible parts of the tablets have been eliminated from a set of tubes in
which the tablets have been held during agitation. The tubes are closed at the lower end by a screen, and the
tablet fragments formed during the disintegration are eliminated from the tubes by passing the screen
openings, i.e. disintegration is considered to be achieved when no tablet fragments remain on the screen
(fragments of coating may, however, remain).

22. 3. DISSOLUTION:
Dissolution testing is the most important way to study, under in vitro conditions, the release of a drug from a
solid dosage form. With respect to preparations, the maintest methods can be classified into two groups.
• Stirred-Vessel Methods:
The most important stirred-vessel methods are the rotating-basket method and the paddle
method. Both use the same type of vessel, which is filled with a dissolution medium of controlled
volume and temperature.
• Continuous-Flow Methods:
In the continuous-flow, the preparation is held within a flow cell, through which the dissolution
medium is pumped at a controlled rate from a large reservoir. The liquid which has passed the flow
cell is collected for analysis of drug content. The continuous-flow cell method may have advantages
over stirred-vessel methods, e.g. it maintains sink conditions throughout the experiment and
avoids floating of the preparation.

23. 4. MECHANICAL STRENGTH:
The mechanical strength of a tablet is associated with the resistance of the solid specimen to fracturing
and attrition. An acceptable tablet must remain intact during handling at all stages, i.e. during
production, packaging, warehousing, distribution, dispensing and administration by the patient. Thus,
an integral part of the formulation and production of tablets is the determination of their mechanical
strength.
A number of methods are available for measuring mechanical strength, and they give different results.
In addition, the hardness of a tablet is sometimes measured by indentation testing. The most commonly
used methods for strength testing can be subcategorized into two main groups:
• Attrition Resistance Methods (Friability tests)
The idea behind attrition resistance methods is to mimic the kind of forces to which a tablet is
subjected during handling between its production and its administration. These are also
referred to as friability tests; a friable tablet is one that is liable to erode mechanically during
handling.

24. During handling, tablets are subjected to stresses from collisions and tablets sliding towards one
another and other solid surfaces, which can result in the removal of particles or particle clusters
from the tablet surface. The result will be a progressive reduction in tablet weight and a change in
its appearance. Thus, an important property of a tablet is its ability to resist attrition so as to
ensure that the correct amount of drug is administered and that the appearance of the tablet does
not change during handling.
The most common experimental procedure for determining attrition resistance involves the
rotation of tablets in a cylinder, followed by the determination of weight loss after a given number
of rotations. Another approach is to shake tablets intensively in a jar of dimensions similar to those
of a pack-jar. Normally, weight loss of less than 1% during a friability test is required. In addition,
the tablets should not show capping or cracking during such testing.
• Fracture Resistance Methods:
Analysis of fracture resistance of tablets involves the application of a load on the tablet and the
determination of the force needed to fracture or break the specimen along its diameter. In such
compression testing the tablet is placed against a platen (a flat metal plate) and the load is applied
along its diameter by a movable platen.

25. The tablet fails ideally along its diameter, i.e. parallel to the compression load, in a single fracture
into two pieces of similar size and the fracture force is recorded. The force needed to fracture the
tablet by diametral compression is often somewhat unfortunately referred to as the crushing
strength of the tablet. The fracture of tablet depends upon the dimensions of the tablet. An ideal
test, however, should allow comparison between tablets of different sizes or even shapes.
This can be accomplished by assessing the strength of the tablet, i.e. the force needed to fracture
the tablet per unit fracture area. A strength test requires that the fracture mode (i.e. the method
by which the crack is formed) can be controlled and that the stress state along the fracture plane
can be estimated.
Alternative procedures to measure the tensile strength of a tablet include breaking the tablet in a
bending test or directly pulling the tablet apart until it fractures.

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