Granulation Instruments PDF
Granulation Instruments PDF
Granulation Instruments PDF
GRANULATION:
Granulation is the process in which primary powder particles
are made to adhere to form larger multi particles entities
called granules.
Pharmaceutical granules typically have a size range between
0.2-4.0 mm.
Granulation generally commences after initial dry mixing of
the necessary powdered ingredients so that a uniform
distribution of each ingredient through the mix is achieved.
Reasons:
1)
2)
3)
4)
5)
6)
Advantages:
Granules have smaller surface area than a comparable
volume of powders. This makes granules more stable
physically and chemically than the corresponding powders.
Granules are less likely to cake or harden upon standing
than are powders.
Granules are more easily wetted by a solvent than are certain
powders, so that granules are also preferred in making
solutions.
Granules produce particle-size uniformity, thus content
uniformity.
Methods of granulation:
Granulation methods can be divided into two types:
Wet
methods
Dry
methods
Dry granulation:
Compaction
of powder
Milling
Screening
1. Slugging:
Disadvantage:
2.Roller compaction:
Roller compaction method is an alternative gentle method, the
powder mix being squeezed between two counter rotating rollers
to form a compressed sheet.
As the volume decreases through the region of maximum
pressure, the material is compressed into dense sticks or weak
sheets.
These sheets are then granulated through a milling system and
series of screens to achieve the precise, uniform granule size
specified.
Advantages:
Process:
Mixing:
Planetary Mixer
Granulation:
Drying:
The granules can be collected on trays and
transferred to a drying oven.
Sieving:
Advantages:
The process is not very sensitive to changes in the characteristics
of the granule ingredients (e.g. surface area variations in different
batches of an excipient)
Disadvantages:
Long duration
High-shear mixer/granulators
The granulator has a stainless steel
chopper
(breaker
blade)
Process:
The unmixed dry powders are placed in the bowl and mixed by the
Advantages:
Disadvantages:
The process needs to be controlled with care.
The process is also sensitive to variations in
raw materials
Process:
Powder
particles are
fluidized in a
stream of air
Heated and
filtered air is
blown
Granulating
fluid is
pumped
through spray
nozzles.
Granules
are
formed
Advantages.
Disadvantages
Spray drying
This process has been divided in three stages:
Atomization of
a liquid feed
into fine
droplets
The mixing of
spray droplets
with a heated
gas streams
The dried
powder is
separated from
the gas stream
Advantages:
It is a very rapid and continuous process.
Minimal exposure of product to heat due short
residence time.
It helps in the overall cost reduction by avoiding the
labour intensive drying and the granulation steps.
It is suitable for heat sensitive product
Disadvantages:
Extrusion/spheronization
Extrusion/ spheronization is a multistep process
used to make uniformly sized spherical particles.
It is used primarily to produce multiparticulates for
controlled drug release applications.
Wet massing
Extrusion
Spheronization
Drying
Screening
Extrusion Spheronizer
Advantages:
1. Two or more active agents can be easily
combined in any ratio in the same unit.
2. Physical characteristics of the active
ingredients and excipients can be modified.
3. Particles having high bulk density, low
hygroscopicity, high spherocity, dust free, narrow
particle size distribution and smoother surface can
be produced.
Rotor granulator:
Rotor Granulator
Continued.
These spheres are dried by the heated inlet air
from the air chamber, which also acts as a
positive- coating solution on to the rotating dried
pellets.
In pressure seal during granulation, layered
pellets can be produced.
By using this technique it is possible to continue
the uncoated pellets as nuclei in a second
granulation with process and coat the pellets by
subsequently spraying a powder mix of a second
ingredient
or
ingredients.
Steam Granulation
Melt Granulation
Thermal Adhesion Granulation Process
(TAGP)
Freeze granulation Technology
Foam binder Technology
TOPO Technology
Advantages
Disadvantages
powder particles
transportation.
Time efficient
Maintain sterility
(PEG)
propylene glycol
Disadvantages
Advantages
Controlling and
modifying the release of
drugs
Advantages
Disadvantages
Preparation
of suspension
Spray the
suspension
into liquid
nitrogen
Homogenization
Freezing
Dried the
granules by
sublimation
of ice
Drying
Advantages:
Serious oxidation of non-oxides and metals is
prevented by mild drying.
There is low material waste (high yield)
Small (50-100 ml suspension) as well as large
granule quantities can be produced to equal
quality.
Processing:
Preparation
of binder
solution
Prepare the
powder bed
Binder
solution in
the form of
foam is
sprayed
throughout
the powder
bed
Granules are
formed
Advantages
Increase in the liquid surface area and volume
of polymeric binder foams
They spread very rapidly and evenly over
powder surface.
TOPO Technology
HERMES PHARMA has developed unique
technology for carrying out single pot
granulation
TOPO Granulator was employed for producing
effervescent granules or tablets
Ingredients:
API
Organic acid
Alkaline or alkaline earth metal carbonates
Processing:
Mixing of
ingredients
API, acid,
carbonates,
excipients
Addition of
small volume
of solvent
Water or
water/etanol
Characterization:
Parameters
Method
Granules Morphology
Microscopy
Moisture content
IR balance, balance
Surface Area
Gas adsorption
Granules Porosity
Density
Density apparatus