2. Advanced methods of
granulation:
These methods exploited the short comings of dry
and wet granulation methods and paid more
attention to the properties of materials being
processed.
They are:
1- steam granulation.
2- melt granulation.
3- Moisture activated dry granulation.
4- Foam granulation.
5- Freeze granulation.
6- Thermal adhesion granulation
3. 1- Steam Granulation:
This process is a modification of the conventional
wet granulation.
In this method steam is used as a binder instead
of water.
The required amount of liquid is pumped as a form
of steam.
4. Advantages of steam
granulation:
1- High distribution uniformity.
2- Higher diffusion rates into the powder.
3- Steam granules are more spherical.
4- higher surface area and shorter processing
time.
5- Environmentally friendly.
5. Disadvantages of steam
granulation:
1- require special equipment for steam
generation and transportation.
2- Require higher energy input.
3- not suitable for heat labile materials.
4- more safety measurements are required.
6. 2- Melt granulation:
In this process granulation is achieved by the
addition of molten binder or a binder that melt
during the process.
The binder is solid at room temperature but it
melts at temperature range of 50-80˚ C.
There is no require for drying phase since dry
granules are obtained by cooling it to the room
temperature.
7. The process of granulation consist of three main
steps:
1- wetting and nucleation.
Nucelation happens by two proposed
mechanisms:
Immersion and distribution.
2- coalescence step.
3- attrition and breakage.
8.
9. Meltable binders:
It must be solid at room temperature and melt
between 40 and 80°C.
o Its physically and chemically stable
o Its hydrophilic-lipophilic balance (HLB) to
ensure the
correct release of the active substance.
o There are two type of Meltable binder
1) Hydrophilic Meltable binders
2) Hydrophobic Meltable binder
10. Advantages and disadvantages of
melt granulation:
-Heat sensitive materials are
poor candidates
- Lower-melting-point binder
may melt/ soften during
handling and storage
-Higher-melting-point binders
require high melting temp. and
can contribute instability
problems for heat-labile
materials.
13. Advantages and disadvantages of
MADG:
1- It utilize less amount of granulating fluid.
2- Decreased drying time and produce granules
with excellent flow properties.
3- use less equipment.
4- lower tablet capping.
5- no over or under granulation.
#Disadvantages:-
Moisture sensitive and high moisture absorbing
APIs are poor candidates.
14. Freeze granulation:
Developed by the Swedish Ceramic Institute
(SCI).
-By spraying a powder suspension into liquid
nitrogen, the drops (granules) are
instantaneously frozen. In a subsequent freeze-
drying the granules are dried by sublimation of
the ice without any segregation effects.
-Finally it produces spherical, free flowing
granules.
The granules size distribution will be controlled
by the suspension rheology (flow properties) and
15.
16. Advantages of freeze
granulation:
1- control of granule density by controlling the solids
content in the suspension.
2- mild drying prevent serious oxidation of non-
oxides and metals.
3- no cavities in the granules.
4- low material waste and ease of cleaning of
equipment.
5- small and large granules quantities can be
produced to equal qualities.
6- possibility to recycle organic solvents.
17. Thermal adhesion granulation
process:
This method is applicable in the preparation of
direct tableting formulations.
The process is preformed under low moisture or
low content of pharmaceutically acceptable
solvent.
The process is done by subjecting a mixture of
excipients and API to temperature range from
30˚C to 130˚C in a closed system under mixing
by tumble rotation until the formation of
granules.
18. -This method provides granules with:
-Good flow properties.
-Binding capacity to form tablets with low
friability.
-Adequate hardness.
--Drying and milling to form the desired
granules are
unnecessary in the present invention due to the
low
-amount of moisture introduced to the tableting
mixture
19. Conclusion:
All these methods together serve the purpose of
enhancing the current methods of granulation
used in pharmaceutical manufacturing.
There are other methods that hadn’t been
mentioned here that worth searching and
knowing so go for it who knows you might find
them interesting.
These are:
-Granulex technology.
-TOPO technology.
-- continueous flow technology.
-- Pneumatic Dry Granulation.
20. References:
Review article: recent advances in granulation
technology by : Himanshu.K.Solanki*, Tarashankar
Basuri, Jalaram H.Thakkar, Chirag A. Patel
department of Pharmacy, SSR College of Pharmacy,
Sayli-silvassa Road, Sayli, UT of D& NH-396230, India.
Published in International Journal of Pharmaceutical
Sciences Review and Research on November-
December 2010 issue
- A powerpoint presentation by Mr. NAMDEO SHINDE
SATARA COLLEGE OF PHARMACY, SATARA.
About granulation.
Aulton pharmaceutics.
Handout of granulation.