Tablets

• Tablets are unit solid dosage form intended for

oral administration.
• Tablets are solid dosage forms usually
prepared with the aid of suitable
pharmaceutical excipients.
• Tablets 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.
• Tablets can be administered orally, sublingually,
buccally, or vaginally.
 Advantages
• Ease of Administration
• Surety of accurate dose
• Bitter, nauseating and unpleasant taste of drugs
can be masked by tablet coating
• More stable than liquid dosage form
• Flexibility of size and weight depending upon the
quantity of active ingredient
• Colored tablets can be prepared which are more
attractive to patient and easy identification
• Can be modified drug delivery systems
 Disadvantages
• Difficulty in swallowing
• Manufacturing cost is high
• Packaging also involves quite a lot of
expenditure.
 Types of tablets

1) Compressed tablets
Compressed tablets are made by compression and
in addition to active ingredient it contains
diluents, binders, disintegrants, lubricants,
colorants, sweetener etc. These tablets can also
be classified as uncoated tablets.

Paracetamol Tablet
Aspirin Tablet
2) Multiply compressed tablets
• Multiply compressed tablets are prepared by
subjecting the fill material to more than a single
compression.

• Layered tablets are prepared by initial

compaction of a portion of fill material in a die
followed by additional fill material and
compression to form two- or three- layered
tablets, depending on the number of separate
fills.
• Multilayered Tablets
• A tablet within a tablet
3) Sugarcoated tablets
• Compressed tablets may be coated with a
colored or an uncolored sugar layer.
• The sugarcoat protects the enclosed drug
from the environment and provides a
barrier to objectionable taste or odor.
• The sugarcoat also enhances the
appearance of the compressed tablet.

Ibuprofen Tablets
4) Film-coated tablets
• Film-coated tablets are compressed tablets
coated with a thin layer of a polymer
capable of forming a film over the tablet.
• It masks unpleasant taste of drug and to
prevent the tablets from external
conditions
• The film is usually colored and has the
advantage over sugarcoatings in that it is
more durable, less bulky, and less time
consuming to apply.
5) Gelatin-coated tablets
A recent innovation is the gelatin-coated
tablet.
The innovator product, the gelcap, is a
capsule-shaped compressed tablet that
allows the coated product to be about one-
third smaller than a capsule filled with an
equivalent amount of powder.
6) 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,
• is particularly irritating to the gastric
mucosa,
• when bypass of the stomach substantially
enhances drug absorption.
7) Buccal and sublingual tablets
• Buccal and sublingual tablets are flat oval
tablets intended to be dissolved in the
buccal pouch or beneath the tongue 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 dissolve
promptly and provide rapid drug effects.
8) Chewable tablets
• Chewable tablets, which have a smooth, rapid
disintegration when chewed or allowed to dissolve
in the mouth, have a creamy base, usually of
specially flavored and colored mannitol.
• Chewable tablets are especially useful for
administration of large tablets to children and
adults who have difficulty swallowing solid dosage
forms.
9) Effervescent tablets
• Effervescent tablets are
prepared by
compressing granular
effervescent salts that
release gas when in
contact with water.

• Dispirin Tab
• Calcium Tab
10) Tablet triturates
• Tablet triturates are small, usually cylindrical,
molded or compressed tablets containing
small amounts of usually potent drugs.
11) Immediate-release tablets
• Immediate-release tablets are designed to
disintegrate and release their medication with
no special rate-controlling features, such as
special coatings and other techniques.
12) Instantly disintegrating or dissolving tablets /
Oral dispersible tablets
• Instant-release tablets are characterized by
disintegrating or dissolving in the mouth within 1
minute, some within 10 seconds.
• Tablets of this type are designed for pediatric and
geriatric patients or for any patient who has
difficulty in swallowing tablets.
• A number of techniques are used to prepare these
tablets involving lyophilization, soft direct
compression, and other methods.
13) Hypodermic Tablets
• For parenteral injection, by dissolving the
tablet in a suitable vehicle and making it
isotonic before inj

14) Controlled / Modified Release Tablets

To release the drug slowly for more prolonged
drug release and sustained drug action.
 Tablet Manufacturing

Tablets may be made by three basic methods:

- wet granulation
- dry granulation
- direct compression
 Wet granulation
It is a widely employed method for the production of
compressed tablets. The steps required are:
• weighing and blending the ingredients
• preparing a damp mass
• screening the damp mass into pellets or granules
• drying the granulation
• sizing the granulation by dry screening
• adding lubricant and blending
• tableting by compression
① Weighing and blending
Specified quantities of active ingredient, diluent
or filler, and disintegrating agent are mixed by
mechanical powder blender or mixer until
uniform.

② Preparing the damp mass

• A liquid binder is added to the powder mixture
to facilitate the adhesion of the powder
particles.
• A damp mass resembling dough is formed and is
used to prepare the granulation.
• A good binder results in appropriate tablet
hardness and does not negatively impact on the
release of the drug from the tablet.
③ Screening the damp mass into pellets or
granules
The wet mass is pressed through a screen
(usually No. 6- or 8-mesh) to prepare the
granules.

④ Drying the granulation

Granules may be dried in thermostatically
controlled ovens which constantly record the
time, temperature, and humidity.
⑤ Sizing the granulation by dry screening
• After drying, the granules are passed through
a screen of a smaller mesh than that used to
prepare the original granulation.
• In general, the smaller the tablet to be
produced, the smaller are the granules used.
• Sizing of the granules is necessary so that the
die cavities for tablet compression may be
completely and rapidly filled by the free-
flowing granulation.
• Voids or air spaces left by too large a
granulation would result in the production of
uneven tablets.
⑥ Adding lubrication and blending
After dry screening, a dry lubricant is dusted over the
spread-out granulation through a fine mesh screen.
Lubricants contribute to the preparation of compressed
tablets in several ways:
• They improve the flow of the granulation in the
hopper to the die cavity;
• They prevent the adhesion of the tablet formulation
to the punches and dies during compression;
• They reduce friction between the tablet and the die
wall during the tablet’s ejection from the tablet
machine;
Wet Granulation
 Dry granulation
• By the dry granulation method, the powder
mixture is compacted in large pieces and
subsequently broken down or sized into
granules.
• By this method, either the active ingredient
or the diluent must have cohesive properties.
 Dry granulation is especially applicable to
materials that can not be prepared by wet
granulation due to their degradation by
moisture or by the elevated temperatures
required for drying the granules.
① Slugging
② Roller compaction
 Dry Granulation

• Primary powder particles are aggregated

under high pressure
• Powder is
squeezed between
Roller
Compaction two rollers to
produce sheet of
material

Dry
granulation

• Large tablets
Slugging produce in heavy
duty tablet press
Roller Compaction

30
Slugging
Dry Granulation
 Direct compression tableting

• Some granular chemicals, like potassium

chloride, possess free flowing and cohesive
properties that enable them to be compressed
directly in a tablet machine without need of wet
or dry granulation.

• For chemicals that do not possess this quality,

special pharmaceutical excipients may be used
which impart the necessary qualities for the
production of tablets by direct compression.
Tablet Manufacturing Summary
 Molded Tablets
• Molding is now replaced with compression
• Tablets prepared by molding are very soft and
soluble and are designed for rapid dissolution.
• The mold is made of hard rubber, hard plastic,
or metal.
• It has two parts, the upper part, or die
portion, and the lower part, containing squat,
flat punches.
• The die portion is a flat plate with the thickness of
the tablets to be produced, with 50 to 200
uniformly drilled and evenly spaced circular holes
• The lower part of the mold has corresponding
punches that fit the holes precisely. When the die
is filled with material and placed atop the
punches, the punches gently lift the fill material
from the holes to rest upon the punches for
drying.
 Tablet Coating
• Sugar Coating
• Film Coating
• Enteric Coating
 Sugar Coating
• Water proofing and Sealing Coat
Tablets that may absorb water and are adversely effected are
water proofed. Shellac is used for this purpose.
• Subcoating
Subcoating required 3-5 coats of heavy syrup contain gelatin
or acacia
• Smoothing and Final Rounding
5-10 coats of thick simple syrup
• Finishing and Coloring
Several Coats of thin syrup containing the desired color
• Polishing
Polish with fabrics or carnuba wax
 Film Coating
• Film-coated tablets are compressed tablets
coated with a thin layer of a polymer capable
of forming a film over the tablet.
• Sugar coating is very bulky to avoid this film
coating is preferred.
• Film Coating materials usually composed of
polymers (methyl cellulose) plasticizers (vinyl
acetate or PVP) and colors.
 Enteric Coating
• 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.
• Shellac
• Cellulose acetate pthlate
• Eudragit
Compendial Tests for Tablets
What are compandial tests?
Official Quality control tests for tablets (Compendial tests)
British Pharmacopoeia (B.P.) & US Pharmacopoeia (USP)

1- Uniformity of content of active ingredient (Uniformity of weight

& Content uniformity)
2- Disintegration test.
3- Dissolution test.
4- Friability test.

Non-Compandial tests

There are many tests that frequently applied to tablets for which
there are non-pharmacopoeial requirements but will form a part
of manufacture's owner product specifications.
1- Tablet thickness.
2- Tablet hardness.
Weight variation (uniformity of weight)
• The quantity of fill in the die of a tablet press
determines the weight of the tablet.
• During production, sample tablets are
periodically removed for visual inspection and
automated physical measurement
• Weigh individually 20 units taken at random
and determine the average mass. Not more
than 2 tablets should deviate from the
average mass (BP2013)
Weight variation testing
 Content Uniformity
• By the USP method, 10 dosage units are individually assayed for
their content according to the method described in the individual
monograph.

• Determining the amount of drug in a sample of tablets (10 ).

• The average drug content is calculated.
• The content of the individual tablets should fall within specified
limits in terms of % deviation from the mean (85 – 115%). If not
comply, repeat using 20 more tablets. No one should be 75 – 125%
deviation.

• If content uniformity test is required, the weight uniformity test is

not required.
Causes of variation

1. The size & distribution of the granules being compressed (presence of too
large or too fine granules).

2. Poor flow and high speed turret speed (incomplete filling of die),.

3. Poor mixing. (Sometimes the lubricants & glidants have not been
well distributed).

4. When lower punches are of unequal lengths, the fill of each die varies
because the fill is volumetric

5. Demixing or segregation of powder constituents of different crystalinity, size

and densities; in direct compression.
What Happens to Tablet/Capsules
after taken orally?
 Disintegration
• For the medicinal agent in a tablet to become
fully available for absorption, the tablet must
first disintegrate and discharge the drug to the
body fluids for dissolution.
• In these instances, tablet disintegration
provides drug particles with an increased
surface area for activity within the
gastrointestinal tract
• The apparatus consists of a basket and rack
assembly containing six open-ended
transparent tubes of USP-specified
dimensions, held vertically upon a 10-mesh
stainless steel wire screen
• During testing, a tablet is placed in each of the six tubes of
the basket, and through the use of a mechanical device, the
basket is raised and lowered in the immersion fluid at 29 to
32 cycles per minute, the wire screen always below the
level of the fluid.
• For uncoated tablets, buccal tablets, and sublingual tablets,
water at about 37°C serves as the immersion fluid unless
another fluid is specified in the individual monograph.
• For these tests, complete disintegration is defined as “that
state in which any residue of the unit, except fragments of
insoluble coating or capsule shell, remaining on the screen
of the test apparatus is a soft mass having no palpably firm
core”
 The disintegration apparatus

A cylindrical disk of transparent plastic is also

used if specified in monograph.

Six tubes opened at the upper end and closed by a screen at the lower
• Tablets must disintegrate within the times set forth in
the individual monograph, usually 30 minutes, but
varying from about 2 minutes for nitroglycerin tablets
to up to 4 hours for buccal tablets. If one or more
tablets fail to disintegrate, additional tests prescribed
by the USP must be performed.
• Enteric-coated tablets are similarly tested, except that
the tablets are tested in simulated gastric fluid for 1
hour, after which no sign of disintegration, cracking, or
softening must be seen. They are then actively
immersed in the simulated intestinal fluid for the time
stated in the individual monograph, during which time
the tablets disintegrate completely for a positive test.
• The simulated gastric fluid (0.1N HCl) for
specific time (2hr in B.P. and 1 hr in USP) for
a positive test, after which no signs of
disintegration, cracking or softening must be
seen, followed by immersion in stimulated
intestinal fluid (Phosphate buffer pH 6.8) for
the time stated in the individual monograph,
during which time the tablets disintegrate
completely.
Disintegration
 Dissolution
• Dissolution testing is routinely used to provide critical in
vitro drug release information for both quality
control purposes, i.e., to assess batch-to-batch consistency of
solid oral dosage forms such as tablets, and drug
development, i.e., to predict in vivo drug release profiles
 Dissolution
1. It guides formulation and product development toward
product optimization. Dissolution studies in the early
stages of a product’s development allow differentiation
between formulations and correlations identified with
in vivo bioavailability data.
2. Manufacturing may be monitored by dissolution
testing as a component of the overall quality assurance
program. The conduct of such testing from early
product development through approval and
commercial production ensures control of any
variables of materials and processes that could affect
dissolution and quality standards.
3. Consistent in vitro dissolution testing ensures
bioequivalence from batch to batch.
4. It is a requirement for regulatory approval of
marketing for products registered with the
FDA and regulatory agencies of other
countries.
 Apparatus
• The equipment consists of (a) a variablespeed stirrer
motor; (b) a cylindrical stainless steel basket on a
stirrer shaft (USP Apparatus 1) or a paddle as the
stirring element (USP Apparatus 2); (c) a 1,000-mL
vessel of glass or other inert transparent material fi
tted with a cover having a center port for the shaft of
the stirrer and three additional ports, two for removal
of samples and one for a thermometer; and (d) a water
bath to maintain the temperature of the dissolution
medium in the vessel. For use of USP Apparatus 1, the
dosage unit is placed inside the basket. For use of USP
Apparatus 2, the dosage unit is placed in the vessel.
• In each test, a volume of the dissolution medium
(as stated in the individual monograph) is placed
in the vessel and allowed to come to 37°C ±
0.5°C. Then the stirrer is rotated at the speed
specified, and at stated intervals, samples of the
medium are withdrawn for chemical analysis of
the proportion of drug dissolved. The tablet or
capsule must meet the stated monograph
requirement for rate of dissolution, for example,
“not less than 85% of the labeled amount is
dissolved in 30 minutes.”
Dissolution
Official Quality control tests for tablets (Compendial tests)
British Pharmacopoeia (B.P.) & US Pharmacopoeia (USP)

1- Uniformity of content of active ingredient (Uniformity of weight

& Content uniformity)
2- Disintegration test.
3- Dissolution test.
4- Friability test.

Non-Compandial tests

There are many tests that frequently applied to tablets for which
there are non-pharmacopoeial requirements but will form a part
of manufacture's owner product specifications.
1- Tablet thickness.
2- Tablet hardness.
 Friability
• A tablet’s durability may be determined through the
use of a friabilator. This apparatus determines the
tablet’s friability, or tendency to crumble, by allowing it
to roll and fall within the drum.
• The tablets are weighed before and after a specified
number of rotations and any weight loss is determined.
Resistance to loss of weight indicates the tablet’s ability
to withstand abrasion in handling, packaging, and
shipment.
• A maximum weight loss of not more than 1% generally
is considered acceptable for most products.
• For tablets equal or less than 650 mg take a
sample of whole tablets equivalent to 6.5g
weight.
• For more than 650 mg take 10 tablets.
• Rotate the drum 100 times (25 RPM).
Friability
 Tablet Hardness
• Non-official tests
• Hardness is the resistance of the tablet to chipping
abrasion or breakage under storage and
transportation and handling before usage.
• Special dedicated hardness testers or
multifunctional systems are used to measure
the degree of force (in kilograms, pounds)
required to break a tablet.
• A force of about 4 kg is considered the
minimum requirement for a satisfactory
tablet. Multifunctional automated equipment
can determine weight, hardness, thickness,
and diameter of the tablet. A tablet’s
Hardness Tester
 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.
• To produce tablets of uniform thickness during
and between batch productions for the same
formulation, care must be exercised to employ
the same factors of fill, die, and pressure. The
degree of pressure affects not only thickness but
also hardness of the tablet