Tablet Granulation

Tablet Granulation
Anup Bajracharya, QA Officer,

anuuu8@hotmail.com,Quest
Pharmaceuticals (P) Ltd Nepal
Introduction
• Granulation is the process in which
primary powder particles are made to
adhere to form larger, multi particle
entities called granules.
• Pharmaceutical granules typically have a
size range between 0.2 and 4.0 mm.
• Granules are used in the production of
tablets or capsules.
• Granules in such cases are made as an
intermediate product and have a typical
size range between 0.2 and 0.5 mm.

Reasons for Granulation
• To prevent segregation of the
constituents of the powder mix.
– Segregation (or demixing) is due primarily to
differences in the size or density of the
components of the mix.
– The smaller and/or denser particles
concentrating at the base of a container
– The larger and/or less dense ones above them.
– An ideal granulation will contain all the
constituents of the mix in the correct proportion
in each granule and segregation of the
ingredients will not occur
Granulation prevent
segregation

• To improve the flow properties of
the mix
– Many powders, because of their small
size, irregular shape or surface
characteristics, are cohesive and do not
flow well.
– Poor flow will often result in a wide
weight variation within the final product
owing to variable fill of tablet dies etc.

• To improve the compaction
characteristics of the mix
– Some powders are difficult to compact even if
a readily compactable adhesive is included in
the mix and some are compacted easily.
– This is associated with the distribution of the
adhesive within the granule and is a function of
the method employed to produce the granule.
– Solute migration occurring during the
postgranulation drying stage results in a
binder-rich outer layer to the granules.
– This in turn leads to direct binder–binder
bonding, which assists the consolidation of
weakly bonding materials.
Other Reasons
• The granulation of toxic materials will reduce
the hazard associated with the generation of
toxic dust that may arise when handling
powders.
• Materials which are slightly hygroscopic may
adhere and form a cake if stored as a powder.
Granulation may reduce this hazard, as the
granules will be able to absorb some moisture
and retain their flow ability because of their
size.
• Granules, being denser than the parent
powder mix, occupy less volume per unit
weight. They are therefore more convenient
for storage or shipment.
Methods of Preparation
Wet Granulation Method

Wet Granulation
• Wet granulation is widely employed method
for the production of compressed tablets.
• The steps required for the wet granulation
can be divided into following stages:
– Weighing and blending the ingredients.
– Preparing the wet granulation.
– Screening the dam mass in to pellets or
granules.
– Drying the granules.
– Dry screening.
– Lubricating and blending.
– Tablet by compression.
WEIGHING AND BLENDING
• The active ingredients and any diluents
and disintegrating agent required in the
tablet formulation are weighed in the
amount required for the number of the
tablet to be produced.
• This mixture is mixed thoroughly .
• The diluents used for this purpose are
Lactose, kaolin, mannitol.
• Disintegrating agent used include corn and
potato starch, cellulose derivatives.

PREPARING THE WET
GRANULATION
• Granulation is accomplished by adding liquid
binder or adhesive to the powder.
• The wet mass is then passed through the screen
of desired mesh size.
• The granules so obtained are dried.
• Then again they are passed though a second
screen of smaller mesh size to further reduce
the size of the granules.
• The binding agent used are
– 10-20% aqueous preparations of corn starch.
– 25-50% solution of glucose.
– Natural gums (acacia)
– Cellulose derivatives ( methylcellulose, carboxy
methylcellulose)

SCREEING THE DAMP MASS
INTO PELLETS OR GANULES
• The wet granulation is pressed through a
No. 6 or 8 mesh size.
• This may be done with hand or special
machines.

DRYING THE GRANULATION
• The granules are dried in spl drying
cabinets the have circulating air systems
and are thermostatically controlled.
• Among the newer methods employed for
the drying is fluidization conducted in fluid
bed drier.

DRY SCREEING
• The degree to which the granules are reduced
depends upon the size of the punch and tablet
to be produced.
• The smaller tablet size, smaller the granules
used.
• Sizing of the granules is important so that die
cavity of die is fully filled with granules.
• The voids are air spaces could result in tablet of
varying evenness.

LUBRICATION
• After dry screening, dry lubricant Is
generally added.
• The more commonly used lubricants are
talc, magnesium stearate and calcium
stearate.
• Range at which it is added is from as low
as 0.1% to 5%.

UTILITY OF LUBRICANTS
• The improve the flow property of the
granules from hopper to the die.
• Prevent the adhesion of the tablet
formulation to the punches and die during
compression.
• They reduce the friction between the die
and the punch.
• They provide a sheen to the finished
product.
FLOW CHART FOR THE WET
GRANULATION


Tablet Granulation

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Tablet Granulation

Anup Bajracharya, QA Officer,

Anup Bajracharya, QA Officer,

Anup Bajracharya, QA Officer,

Anup Bajracharya, QA Officer,

Wet Granulation Method

Anup Bajracharya, QA Officer,

Anup Bajracharya, QA Officer,

Anup Bajracharya, QA Officer,

Anup Bajracharya, QA Officer,

Anup Bajracharya, QA Officer,

Anup Bajracharya, QA Officer,

Anup Bajracharya, QA Officer,

Anup Bajracharya, QA Officer,

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