The document discusses different granulation techniques used in pharmaceutical manufacturing. It describes granulation as a size enlargement process used to improve properties like flowability and compressibility of powders for tablet making. The key granulation methods covered are wet granulation, dry granulation, and direct compression. Wet granulation involves using a liquid to form granules and allows for a wide range of excipients. Dry granulation uses pressure rather than liquid. Direct compression can be used for materials with good compression properties. Modern techniques like steam granulation are also briefly mentioned.

1. 1

2. SAJJAD 2
 What is Granulation.
 Why we need Granules.
 Types of granulation.
 Excepients.
 Modern Granulation techniques.

3. SAJJAD 3
 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)

4. SAJJAD 4
WHY we prepare Granules when we have
powders…….?

5. SAJJAD 5
 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.

6. SAJJAD 6

7. SAJJAD 7
 Wet Granulation
 Dry Granulation
 Direct Compression

8. SAJJAD 8
 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

9. SAJJAD 9

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.

12. SAJJAD 12
 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.

13. SAJJAD 13
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.

14. SAJJAD 14
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.

15. SAJJAD 15
 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

17. SAJJAD 17
 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

18. SAJJAD 18
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.

19. SAJJAD 19
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.

20. SAJJAD 20
 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.

21. SAJJAD 21
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

22. SAJJAD 22
 Weighing
 Seiving
 Pre Mixing
 Formation Of Sluggs/Powder Sheets
 Screening of Sluggs/Powder Sheets
 Final Mixing

23. SAJJAD 23
 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.

25. SAJJAD 25
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.

26. SAJJAD 26
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

27. SAJJAD 27
 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.

28. SAJJAD 28
 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

31. SAJJAD 31

32. SAJJAD 32
email @
sajjad_formanite@yahoo.com