Experiment: Preparation of Paracetamol Tablets by Wet
Granulation Method
Aim
To prepare paracetamol tablets using the wet granulation method.
Reference: Singh I, Kumar P. Preformulation studies for direct compression suitability of
cefuroxime axetil and paracetamol: a graphical representation using SeDeM diagram. Acta
Pol Pharm. 2012; 69:87 93.
Requirements
Chemicals: Paracetamol, Acacia, Lactose, Potato starch (for paste), Talc, Magnesium
stearate
Glassware/Appliances: Measuring cylinder, Beaker, Mortar and pestle, Granulating sieve,
Standard sieve set
Equipment: Tablet punching machine, Hot air oven/drying tray
Theory
Paracetamol (acetaminophen) is a widely used analgesic and antipyretic drug, effective in
treating mild to moderate pain such as headache, toothache, backache, and fever associated
with cold or flu. Tablet formulation often requires granulation to improve flowability,
compressibility, and uniformity. Wet granulation involves agglomerating powder particles by
adding a binding solution to form granules, which are then dried, sized, and compressed into
tablets. Binders (e.g., starch paste, acacia) improve cohesion, while lubricants (e.g., magnesium
stearate) and glidants (e.g., talc) enhance manufacturability.
Formula (Per Tablet)
Sr. Quantity
Ingredient Function
No. (mg)
Active
1 Paracetamol 50.0
ingredient
2 Acacia Dry binder 5.0
3 Lactose Filler 150.0
Potato starch paste (15% w/v) or Primogel (5%
4 Binder (wet) q.s.
w/v)
5 Talc Glidant 5.0
6 Magnesium stearate Lubricant 5.0
Procedure
1. Sifting: Weigh paracetamol and pass it through a 100# sieve to remove lumps.
2. Mixing: Mix paracetamol with starch powder uniformly in a mortar and pestle.
3. Binder preparation: Prepare 10% starch paste by dispersing starch in boiling water
and stirring until a translucent paste is obtained.
4. Granulation: Add the starch paste slowly (dropwise) to the powder mixture with
continuous mixing until a cohesive mass is formed. Note the volume of binder used.
5. Wet screening: Pass the cohesive mass through a 12# granulating sieve onto a tray.
6. Drying: Dry the wet granules in a tray dryer/hot air oven at 50 °C for 30 minutes.
7. Sizing: Pass the partially dried granules through a 16# sieve to obtain uniform
granules and continue drying for another 30 minutes until moisture is removed.
8. Blending: Mix the dried granules with talc and magnesium stearate for lubrication.
9. Compression: Compress the final blend into tablets using a tablet punching machine.
Results
Paracetamol tablets were successfully prepared by the wet granulation method. The prepared
tablets were stored in a well-closed container or strip-packed to protect them from moisture.
