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TABLET DOSAGE FORM

Rashed M. Almuqbil PharmD, Ph.D.

Assistant Professor
COCP, KFU

Learning outcomes
Upon completing this chapter you will be able to:
 List the advantages and disadvantages of solid
dosage forms compared to other dosage
forms.
 Describe the advantages and limitations of
tablets.
 Describe three methods of tablet preparation

 Evaluate tablets as a unit dosage form by

performing and analyzing data from official
USP test

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TABLETS

 Pharmaceutical tablets are solid flat or

biconvex discs prepared by compressing a
drug or a mixture of drugs, with or
without diluents.

Advantages and Disadvantages of Tablets

ADVANTAGES
 Ease of accurate dosing
 Good physical and chemical stability
 Competitive unit production costs
 High level of patient acceptability
 High convenience

DISADVANTAGES
 Irritant effects on the GI mucosa by some solids
(e.g., aspirin)
 Possibility of bioavailability problems resulting from
slow disintegration and dissolution

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TYPES OF TABLETS
Compressed Molded Coated
tablets tablets Tablets

Multiple
Machine Sugar
compressed
made coated
tablets

Tablet Manually Film coated

triturates molded

Chewable
tablets

Tablets Excipients
Their role:
To ensure that tablets of specified quality are prepared.
The common types of tablet’s excipients are described in the
figure.

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In addition to the drug, tablets contain a number of inert materials,

known as additives or excipients. They are classified according to
the part they play in the finished tablet.

1- The first group contains excipients that help in imparting

satisfactory compression characteristics to the formulation. These
include; diluents, binders glidants, and lubricants.

2- The second group helps to give additional desirable physical

characteristics to the finished tablet. These include; Disintegrants,
coloring, flavoring and sweetening agents.

A typical tablet contains

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Tablet excipients

• Filler (or diluent): lactose

A filler, such lactose, is included to increase the size of the tablet.
This is necessary as often the amount of 'active ingredient' is so tiny
that the tablet would be too small to handle without it.
• Binder: Starch paste
A binder, such as starch paste or HPMC, is added to hold the tablet
together after it has been compressed, stopping it from breaking
down into its separate ingredients.
• Disintegrant: Sodium Starch Glycolate
Disintegrants, such as starch help the tablet to break down into
small fragments, when it is ingested. This helps the medicine to
dissolve and be taken up by the body so that it can act more quickly.

Tablet excipients

• Glidant: Fumed silicon dioxide

The glidants improve the flowability of the tablet granules or
powder by reducing the friction between particles, preventing
formation of lumps.
• Antiadherent: Mg stearate
The antiadherents stop the powder from sticking to the equipment
as the tablet is being made.
• Lubricant: talc
Lubricants ensure that the tablet has a smooth surface, they reduce
the friction occurs between the walls of the tablets and the walls of
the die cavity when the tablet is ejected.
• Flavor: Flavoring agents help to make the tablet taste better.
• Colorant: Colors are added to help you to recognize your tablet
and to make it easier to take your medicine correctly.

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Ideal properties required by an excepient

Excipients should have:

 no bioactivity,

 no reaction with the drug substance,

 no effect on the functions of other

excipients,
 no support of microbiological growth in
the product.

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Tablet disintegration may be critical to subsequent drug

dissolution rate and to satisfactory bioavailability

Disintegration Deaggregation

in the GIT in the GIT

Intact tablet Granules Primary drug particles

Drug dissolution

Drug in solution in GIT fluids

Absorption Drug in blood

Molded tablets

 Molded tablets are prepared by tablet

machinery or manually by forcing
dampened tablet material into a mold of
any shape. The formed tablet is then
ejected from the mold and allowed to dry.
Molding is generally reserved for
laboratory and small-scale production.

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Tablet triturates
 small, usually cylindrical tablets containing
small amounts of potent drugs.
 A combination of sucrose and lactose is
usually used as diluents. They are prepared
mainly by compression (rather than
molding).
 Readily and completely soluble in water. So
avoid any water-insoluble material in the
formulation.
 Prepared by compression, only a minimal
amount of pressure is applied.

Tablet Triturates

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Uses:
1. Used for oral administration or sublingual use
(e.g., nitroglycerin tablets).
2. They can be inserted into capsules, and this
eliminates the problems of measuring the
accurate amount of potent drugs in the powder
form.
3. They can also be dissolved in a small amount of
water which can be subsequently mixed with the
required volume of the liquid medication.

CHEWABLE TABLETS
 Prepared mainly by wet
granulation and
compression.
 They disintegrate rapidly
when chewed or allowed to
dissolve in the mouth.
 Useful in children
 Eg: Multiple vitamin tablets.

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Layered-tablets
 A portion of fill material in a die is
compressed initially, and then Disadvantage:
another portion of fill material is Requires special machines
added to the same die. which can place the
 Each additional fill material is preformed tablet precisely
compressed to form multi- layered within the die for the second
tablets. compression.
 Each layer of the fill material
contains a different drug.

Advantages:
 Allows formulation of different drugs
which are incompatible each other in one
tablet.
 Each layer of the multiple-layered
tablets can also provide different drug
release profiles for controlled release.
 Each portion of the fill is usually colored
differently for the unique appearance.

SUGAR COATED TABLETS

Compressed tablets can be coated with a sugar layer. Since the
coating is water-soluble, it is quickly dissolved in aqueous
environment (e.g., in the gastric juice after oral administration).

The main purposes of having a sugar coating are:

(1)to protect the drug from the air and humidity;
(2)to provide a taste or a smell barrier to objectionable tasting or smelling
drug;
(3)to enhance the appearance of compressed tablets.

DISADVANTAGES
1) Sugar coating of compressed tablets requires more time and expertise,
and this may increase the cost of manufacturing.
2) Sugar coating also increases the size and weight of the compressed
tablets.
3) If the size of tablets is too small then the size is increased intentionally
by sugar coating.

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FILM COATED TABLETS

 Compressed tablets can be
coated with a thin layer of a
polymer, which may be either
water-soluble or water-
insoluble.
 The polymer film has an
advantage over sugar-coating
in that the polymer film is
more durable, less bulky, and
less time-consuming to apply.
 Upon oral administration, the
polymer film may remain
intact or dissolve in the GI
tract depending on the water-
solubility

Manufacturing Procedure
Direct compression:
Direct compression consists of compressing tablets
directly from powdered materials without modifying
the physical nature of materials.
This method is applicable for crystalline chemicals
having good compressible characteristics and flow
properties .
Eg: Potassium salts (chlorate, chloride, bromide),
sodium chloride, ammonium chloride, Methenamine,
etc.

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Tablet manufacturing process

COMPRESSION CYCLE

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 DRY GRANULATION: Slugging may be used to

form granules if the
tablet ingredients are
sensitive to
moisture and/or unable to
withstand elevated
temperature during
drying.

 Compaction of the components of a tablet

formulation by means of a flat punch.
 These compact masses, called slugs, are
then milled and screened to produce
granules.
 Specially designed machines called roller
compactors and are used for dry
compaction on a large scale.

The processing steps involved are:

 Raw material → weighing → Screening→
Mixing → Slugging → Milling → Screening
→ Mixing → Compression

WET GRANULATION DRY GRANULATION DIRECT

COMPRESSION
๑. Milling and mixing of drugs and excipients
๒. Preparation of binder ๒. Compression into ๒. Compression of
solution slugs or roll tablet
compaction
๓. Wet massing by addition ๓. Milling and screening
of binder solution or of slugs and
granulating solvent compacted powder
๔. Screening of wet mass ๔. Mixing with lubricant
and disintegrant
๕. Drying of the wet granules ๕. Compression of tablet

๖. Screening of dry granules

๗. Blending with lubricant

and disintegrant to
produce “running
powder”
๘. Compression of tablet

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Weighing, blending and Screen drying

Quality Control Tests

1. Hardness test
2. Friability test
3. Disintegration test
4. Dissolution test
5. Content uniformity

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Hardness Test
 The test measures Pfizer Tester
crushing strength Monsanto
property of the tablet. Tester
 Defined as the
compressional force
applied diametrically
to a tablet which just
fractures it. Strong Cobb
 Manual measuring Tester
devices: the Monsanto
tester, Pfizer tester,
Strong cobb hardness
tester.

https://www.youtube.com/watch?v=CsxeNS-NjUQ

Friability Test
 During manufacturing and
handling, tablets are subjected
to stresses from collision and
tablet sliding towards one
another and other solid
surfaces, which can result in
the removal of small
fragments and particles from
the tablet surface.
 Test: Accurately weigh 10
tablets(initial).
 Load 10 tablets into the drum.
 Turn the knob to the desired
number of rotations
(25rotations/min).
https://www.youtube.com/watch?v=1QKKSS2tCgU

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Friability Test - Calculations

 Wait until the drum returns to a stationary position.
 Remove the tablets and brush away any loose
powder from them. Again weigh the tablets(final)
%weight Loss = W(inital)– W(Final) X 100
W(initial)
Eg: Initial wt of 10 tabs = 20gm, final wt after
test=19gm
(20g-19.0g)/20g X 100 = 5% (fails the test)

Limits: Loss should Not be greater than 2%

Disintegration Test
 One tablet is placed in
each tube and the basket
rack is positioned in a 1-L
beaker of water or
simulated gastric fluid or
simulated intestinal fluid
 Temp: at 37 ± 20 C
 Tablet remain 2.5 cm
below the surface of
liquid on their upward
movement and not closer
than 2.5 cm from the
bottom of the beaker in
their downward
https://www.youtube.com/watch?v=F3pbsO4
movement. SCQE

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 Move the basket containing the tablets up

and down at a frequency of 28 to 32 cycles
per minute.
 Floating of the tablets can be prevented by
placing perforated plastic discs on each
tablet.
 According to the test the tablet must
disintegrate and all particles must pass
through the 10 mesh screen in the time
specified.
 If any residue remains, it must have a soft
mass.
 Standard Disintegration time:
Uncoated tablet: 5-30 minutes
Coated tablet: 1-2 hours

Dissolution Test
 A volume of the dissolution
medium (typically 900 mL)
is placed in the 1-L vessel.
 The temperature
maintained at 37 °C.
 A single tablet (or capsule)
to be tested is immersed in
the vessel and stirred using
a variable-speed stirrer
motor at the speed
specified in the individual
mono-graph.
 At timed intervals, aliquots
of the medium are
withdrawn for analysis of
the dissolved drug.
 Paddle type: Type I
 Basket type: Type II
Paddle(type I) Basket(Type II)

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Content Uniformity
 Randomly select 30 tablets.
 10 of these assayed individually.
 The Tablet pass the test if 9 of the 10 tablets
must contain not less than 85% and not more
than 115% of the labeled drug content
 And the 10th tablet may not contain less than
75% and more than 125% of the labeled
content.
 If these conditions are not met, remaining 20
tablet assayed individually and none may fall out
side of the 85 to 115% range.

THANK YOU

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