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Granules
Why Granules?
To avoid powder segregation.
To enhance the flow of powder.
To produce uniform mixtures.
To produce dust free formulations.
To eliminate poor content uniformity.
To improve compaction
characteristics of mix.
Granules
Advantages
Granules are more flowable
compared to powder.
Segregation of the
constituents of the powder
mixture could be avoided by
granulation.
Granules are more stable
against humidity and
atmosphere.
Granules are more easily
wetted by liquids than light
and fluffy powders.
Disadvantages
TYPES
1:Effervescent granules
Effervescent granules are uncoated
granules generally containing acid
substances and carbonates or
hydrogen carbonates which react
rapidly in the presence of water to
release carbon dioxide.
They are intended to be dissolved or
dispersed in water before
administration.
Formula
Sodium bicarbonate
Citric acid
Tartaric acid
Contd...
Effervescent salts are granules or coarse
to very coarse powder containing a
medicinal agent in a dry mixture usually
composed of sodium bicarbonate, citric
acid and tartaric acid .
When added to water the acid and base
react to liberate carbon dioxide
resulting in effervescence.
The resulting carbonated solution mask
the undesirable taste of medicinal agent.
Effervescent granules
2:Coated granules
Coated granules are usually multidose preparations consist of granules
coated with one or more layers of
mixtures of various excipients.
The substances used as coatings are
usually applied as solution or
suspension in conditions in which
evaporation of the vehicle occur.
Coated granules
3:Gastroresistant granules
These are delayed release granules
that are intended to resist the gastric
fluid and to release the active
substance in intestinal fluid
These properties are achieved by
covering the granules with the
gastro-resistant material or by other
suitable means.
Gastro-resistant granules
Methods of Granulation
Dry Granulation
WET GRANULATION
Dry granulation
Dry granulation is performed by
two ways.
a) Roll compactor
b) Slugging
a) Roll compactor
Dry powder is passed through a roll
compactor and then through a granulating
machine.
A roll compactor, also called a roll press
or roller compactor, processes a fine
powder into dense sheets or forms by
forcing it through two mechanically
rotating metal rolls running counter to
each other .
The surface of the compacting rolls may
be smooth or may have pocket
indentations or corrugations that allow
compaction of different forms and textures
b)Slugging:
Slugging, is the compression of a
b)Slugging:
The slugs are granulated into the
desired particle size, generally for
use in the production of tablets.
The dry process often results in the
production of fines, that is, powder
that has not agglomerated into
granules.
These fines are separated, collected,
and reprocessed.
Wet granulation
In this, powdered medicament and
other excipients are moistened with
granulating agent.
Contd...
Other methods
FBG
Fluidization is the operation by
which fine solids are transformed into
a fluid like state through contact with
a gas.
Granulating and drying can be
completed in one step inside the
machine.
contd...
Freeze granulation Technology
Steam Granulation
Melt Extrusion Technology
Liquisolid Technique
TOPO Technology
Continuous Flow Technology
Granulation Characterization
Powders
Granules
Less likely
Good compressibility
Effervescent Granules
Definition: Mixture of organic acid and alkali
effervesces when subjected to water due to
reaction between the acid and the base with
evolution of co2
Examples: Citric or tartaric acids with
sodium carbonate or bicarbonate
Uses: The liberated carbon dioxide has
the following advantages:
It masks the bitter and nauseous taste.
It promotes gastric secretions.
It acts as a carminative.
psychological impression at the patient..
Effervescent Granules
Formulation:
- Bulk powders or divided powders
- Packed in separate packages of
contrasting colors.
- The contents are mixed in a quantity of
water at the time of dosing.
- The liquid is consumed just after the
reaction begin to subside.
Effervescent Granules
Definition: Sweetened effervescent
powders formulated as granules.
Granulation:
1- Wet method: By the addition of a
binding liquid (Alcohol is frequently used).
2- Dry method: Heating effloresced powder
to liberate the water of crystallization
which then acts as the binding agent
Effervescent Granules
Wet Granulation
Procedure:
1- The powders are mixed without pressure in a
suitable container.
2- Alcohol is added in portions with stirring until a
dough like mass is formed.
3- The materials are then passed through sieve # 6.
4- The resulted granules are dried at a temperature
not exceeding 50C.
5- The granules are packed in air tight containers