1. Aram I. Ibrahim University of sulaimani College of pharmacy
Industrial Pharmacy
Granulation 2
Aram I. Ibrahim
University of sulaimani
College of pharmacy

2. Contents Introduction Advantages Method of preparation
Dry granulation method
Wet granulation method

3. Introduction
Granulation is the process of collecting particles together by creating bonds between them, Bonds are formed by compression or by using a binding agent.

4. Introduction cont.
Granules are dosage forms that consist of particles ranging from 0.2 to 4.0 mm, depending on the subsequent use of the granules.
They are intended for oral administration. Some are swallowed as such, some are chewed and some are dissolved or dispersed in water.

5. Advantages To avoid powder segregation. To enhance the flow of powder.
To produce uniform mixtures.
To produce dust free formulations.
To eliminate poor content uniformity.
To improve characteristics of mixing.

7. Method of preparation Dry granulation method Wet granulation method
without using a liquid solution.
Wet granulation method
addition of a liquid solution.

8. Dry granulation
Dry granulation granules are formed generally without adding binding material by compaction.
Dry granulation can well be applied in the case of moisture or heat sensitive or unstable materials.

9. Dry granulation Advantages Rapid method Requiring low energy
No hydrolytic decomposition
Heating can be avoided
Needs few tools
Small work place
Expensive drying operations are avoidable

10. Dry granulation Disadvantages requires a special apparatus.
The mechanical hardness of granules is lower.
Product shows a heterogeneous particle size dispersion because of high proportion of powder material, thus has relatively unappropriate flowablity.

11. Dry granulation Dry granulation by briquetting
Briquetting is a compressing operation, during which large size compressed material is performed as the first step.
briquettes have approximately mm diameter, flat and cylindrical shape with 5-15 mm thickness are produced by performing high compressing force.

12. Dry granulation Dry granulation by compactor
Granulation is started with previously compaction of material.
Granules are formed due to mechanical adhesion and compaction, compression, when compression forces act.
Steps:
1) compaction
2) chopping
3) sieving

13. Wet granulation
Wet granulation similar to dry granulation, starts also with preparatory operation of active substances and excipients (compounding, chopping, sieving).
Firstly properties of active substance (e.g. dose, solubility, incompatibility, volume mass) should be considered at choosing granulation excipients.

14. Wet granulation Most frequently applied diluents during granulation:
Lactose
starch
cellulose
sucrose
glucose
mannitol
sorbitol
urea
xylitol

15. Wet granulation
Most commonly used binding materials, which create binding force between particles are the followings:
1) sugars
sucrose
glucose
2) polymers
natural polymers
gelatin
acacia
tragacanth
starch
Synthetic polymers EC MC
CMC
SCMC
Water or ethanol can be used as a binding liquid also.

16. Steps in wet granulation
Mixing of the drug(s) and excipients.
Mixing of binder solution with powder mix. to form wet mass.
Coarse screening of wet mass using a suitable sieve.
Drying of moist granules.
Screening of dry granules through a suitable sieve.

17. Steps in wet granulation
Manual granulation
oscillating granulator

18. Questions !