Tablet Manufacturing

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 What is Granulation.
 Why we need Granules.
 Types of granulation.
 Excepients.
 Modern Granulation techniques.

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 Granulation is the size enlargement process in
which primary powder particles are made to
adhere to form larger, multi particle entities
called granules.
 It is the process of collecting particles together by
creating bonds between them.
Bonds are formed by
Slugging (Dry Granulation)
or
Using a binding agent. (Wet Granulation)

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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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 Wet Granulation
 Dry Granulation
 Direct Compression

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 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

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10. SAJJAD 10
 weighing
 Seiving
 Pre Mixing
 Kneading/Addition of binder
 Seiving of wet mass
 Drying of wet mass
 Seiving of dried mass
 Final Mixing

11. SAJJAD 11
 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.

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 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.

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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.

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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
Sodium Starch glycolate (Primojel) Crosslinked PVP
Cross Carmilose Sodium (Ac Di Sol) Starch
Cellulose Derivatives

16. SAJJAD 16
 Binders
 For binding the powder particles
 Examples
Natural Semi Synthetic Synthetic
Gums Methyl Cellulose PVP
Starch HPMC
Cellulose HPC
Gelatin

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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.

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 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.
De-Merits Of Wet Granulation
 Large no of equipments are required.
 Time consuming,
 More exceptients needed.
 Coastly procedure.

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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

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 Weighing
 Seiving
 Pre Mixing
 Formation Of Sluggs/Powder Sheets
 Screening of Sluggs/Powder Sheets
 Final Mixing

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 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.

24. SAJJAD 24
Formation Of Sluggs/Powder Sheets
Fine powder is converted into grains by two
methods
 Slugging (Large Size Tablets)
 chilsonator (Roller Compaction)
Slugging (Large Size Tablets)
 Tablet press is used.
 Fine powder is converted into slugs by using flat
punches and high pressure.

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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.

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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

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 Less number of equipments are required.
 No Need of moisture and heat.
 Coast effective.
De-Merits Of Dry Granulation.
 Pre compression is required.
 Produce dust.

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 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

29. SAJJAD 29
 Simple,easy and quick.
 Require few exceptients.
 Time saving.
 coast effective.
Demerits Of Direct Compression
Segregation in hoper may occur.
Flow problem may occur.
Weight variation due to poor flow.

30. SAJJAD 30
 Steam Granulation
 Melt/Thermoplastic Granulation
 Moisture Activated Dry Granulation (MADG)
 Moist Granulation Technique(MGT)
 Thermal Adhesion Granulation Process
 Foam Granulation

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