Why is Granulation Necessary?

The granulation process allows particles to stick together more firmly. It

increases the particle size of the constituents used, which are mostly very

fine powders. The greater the particle size of a constituent, greater will be its

compressive or binding ability.

Granulation process for tablet manufacturing process is mainly of two types:

1. Wet Granulation

2. Dry Granulation

1. Wet Granulation

In wet granulation technique, the following steps are involved:

Sifting: Active Pharmaceutical Ingredient (API) and excipients are sifted,

usually through a 40 mass or 60 mass sieve. When API and excipients are

sifted they mix together.

Mixing: In order to mix them up more thoroughly, the dry mixing process is

utilized. Once the mixing is complete, granulating fluid is added to rapid

mixture granulator or RMG.

Drying: The materials are then dried in a dryer, usually a fluid bed dryer or

a tray dryer. When the constituents have dried, they are then milled using 16

mass or 20 mass sieves.

Lubrication: The final step is lubrication in order to make the particles

adhere firmly together. This is done with the addition of a lubricating agent.

The use of lubricating agents is particular to the types of API and excipients

used. The most commonly used lubricating agent is magnesium stearate. The

material formed is thus ready for further compression and manufacturing.

2. Dry Granulation

Dry granulation does not involve the use of a liquid lubricating agent. This is

because constituents utilized might chemically react with the agent used, thus dry

granulation equipment technique is used.

Dispensing: The first step in dry granulation is dispensing of the API and

excipients used, in specified amounts.

Dry Mixing or Blending: Once both the constituents are dispensed, API and

intragranular excipients are mixed together through dry mixing.

Compaction: After dry mixing of the materials, they are passed through roller

powder compactors for compaction. This results in the formation of slugs. Slugs

are the rough form of tablets, usually quite large in size.