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What is Granulation.
Why we need Granules.
Types of granulation.
Excepients.
Modern Granulation techniques.
SAJJAD 2
Granulation is the size enlargement process in
which primary powder particles are made to
adhere to form larger, multi particle entities
called granules.
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WHY we prepare Granules when we have
powders…….?
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To enhance flow of powders.
To avoid weight variation.
To produce uniform mixture.
To avoid poor content uniformity.
To improve compaction.
To produce dust free enviornment.
To avoid powder segregation.
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SAJJAD 6
Wet Granulation
Dry Granulation
Direct Compression
SAJJAD 7
Most widely used method.
It involves addition of liquid solution to
powder to form wet mass.
When to use…….
For the Products not degraded by
Moisture
Heat
SAJJAD 8
SAJJAD 9
weighing
Seiving
Pre Mixing
Kneading/Addition of binder
Seiving of wet mass
Drying of wet mass
Seiving of dried mass
Final Mixing
SAJJAD 10
Weighing
Acuretly weigh all the excepients and API.
Sieving
Sieving reduce particle size and ensure uniform mixing due to similar particle
size.
Increase surface area.
Enhance rate of dissolution.
Different seive numbers are used.
Pre Mixing
To achieve optimum mixing of different ingredients for wetting.
Depends upon formulation
API+diluents
API+diluents+Disintegrents
Equipment used are sigma mixer,cone mixer,high sher Granulators.
SAJJAD 11
Addition Of Binder
Binder may be in form of
Solution (PVP in IPA)
Suspension (HPC in IPA)
Paste (Starch in Hot water)
Solvent used should be
Volatile
Non Toxic
Solvent With Or Without Binder Convert Powder into
Wet mass.
Equipment used are sigma mixer,Diosna mixer,High
sheer Granulators.
SAJJAD 12
Seiving Of wet Mass
wet mass produced is not of uniform size.
Wet mass is seived to obtain uniform size.
To increase surface area of wet grains.
Increased surface area results in decreased drying time.
Drying of wet mass
seived wet mass is dried either in
FBD
or
Tray dryers
Hot air evaporates solvent leaving behind dried grains.wet mass is dried
untill residual moisture content 2-3% or according to specifications.
SAJJAD 13
Seiving of Dried Mass
Dried mass have not uniform size.
Dried mass is seived to obtain uniform sized grains.
Dried mass is passed throuhg a specified seive No.e.g 12,16,20 etc.
For small size tablets higher seive no is used to facilitate uniform die
filling.
For large size tablet usually small seive no is used.(Exception
Dissolution problem)
Final Mixing
Last step of wet granulation.
Dried seived grains are mixed with specified exceptients
e.g Disintegrants,colourants,Flavourants,Glidents or lubricants.
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To enhance bulk weight.
Examples
Lactose Starch
Manitol Dextrose
DCP
Disintegrents
To break down tablets and granules.
Examples
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Binders
For binding the powder particles
Examples
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Glidents
Reduce inter particle friction.
Enhance Flow.
Examples
Colloidal silicon dioxide (Aerosil)
Lubricants
Reduce friction between grains and machine Parts.
Prevent sticking.
Are of 2 types
1 Hydrophobic e.g Mg Stearate
2 Hydrophylic e.g Sodium steryl Fumarate
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Amount Of binder
Increased binder results in harder grains.
Effect dissolution and D.T.
Less amount of binder results fragile grains.
Results friability and capping.
Amount Of Solvent
Higher quantity of solvent may cause Over wetting.
Over wetting results in harder grains.
Lower solvent quantity may cause under wetting.
Under wetting results fragile grains.
Increased amount of fines.
Kneeding/Wetting Time
Increased mixing time after addition of solvent results in harder grains.
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Drying Time
Over drying results friability and capping.
Under drying results picking and sticking.
Produce higher quantity of fine.
Blending/Mixing Time
Lower mixing time effects content uniformity.
Prolong mixing results in segregation.
Prolong mixing after hydrophobic Lubricants effects Disintegration
and Dissolution.
SAJJAD 19
Large no of materials can be granulated by this
method.
Higher quality grains are produced by this method.
Wide range of excepients is available.
Good content Uniformity.
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What Is Dry Granulation
It is the process in which granules are formed by the
application of pressure.
Pressure can be applied by using
Rotery Compression
or
Chilsonater
When to Use……….
For Materials sensitive to
Heat
Moisture
SAJJAD 21
Weighing
Seiving
Pre Mixing
Formation Of Sluggs/Powder Sheets
Screening of Sluggs/Powder Sheets
Final Mixing
SAJJAD 22
Weighing
Acuretly weigh all the excepients and API.
Sieving
Sieving reduce particle size and ensure uniform mixing due to similar
particle size.
Increase surface are
Enhance rate of dissolution
Different seive numbers are used.
Pre Mixing
To achieve optimum mixing of different ingredients for slugging.
Depends upon formulation
API+diluents
API+diluents+Disintegrents
Equipment used are sigma mixer,cone mixer.
SAJJAD 23
Formation Of Sluggs/Powder Sheets
Fine powder is converted into grains by two
methods
Slugging (Large Size Tablets)
chilsonator (Roller Compaction)
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Chilsonater (Roller Compaction)
Fine powder is converted into powder sheets.
Two counter rotating rollers are used for pressure.
Powder is passed through the rollers and the
pressure of rollers convert fine powder into
powder sheets.
Screening of Sluggs/Powder Sheets
Sluggs or powder sheets are crushed by using
osscilating granulator or Fitz Petrik Mill to obtain
grains.
SAJJAD 25
Final Mixing
Last step of Dry granulation.
Seived grains are mixed with specified exceptients
e.g Disintegrants,colourants,Flavourants,Glidents or
lubricants.
Exceptients For Dry Granulation
Dilluents
Disintegrents
Glidants
Lubricants
SAJJAD 26
Less number of equipments are required.
No Need of moisture and heat.
Coast effective.
SAJJAD 27
When to use……….
For crystalline materials.
For free flowing materials.
For materials having good compressibility properties.
For direct compression granular exceptients are
preffered e.g Lactose S.D,Avicel pH 102,200 etc.
Steps For Direct Compression
Weighing
Seiving
Mixing
Compression
SAJJAD 28
Simple,easy and quick.
Require few exceptients.
Time saving.
coast effective.
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Steam Granulation
Melt/Thermoplastic Granulation
Moisture Activated Dry Granulation (MADG)
Moist Granulation Technique(MGT)
Thermal Adhesion Granulation Process
Foam Granulation
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SAJJAD 31
email @
sajjad_formanite@yahoo.com
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