Pelletization Process

• Pelletization is the process of converting fine powders or granules into small, free-flowing, spherical units.
• Pelletization Process can be achieved through various techniques:

Common Pelletization Techniques:

1. Extrusion-Spheronization:

   • The most widely used method for producing pellets.

   • Steps:

     • Mixing and Wet Massing: The drug and excipients are blended, and a binder solution is added to form a wet mass.
     • Extrusion: The wet mass is passed through an extruder to form cylindrical extrudates.
     • Spheronization: The extrudates are broken into smaller units and rounded into spherical pellets in a spheronizer.
     • Drying: The pellets are dried to reduce moisture content.

2. Layering Techniques:

   • Used to apply layers of drug or excipients onto an inert core.

   • Types:

     • Solution/Suspension Layering: A solution or suspension of the drug is sprayed onto the cores while rotating in a pan or fluidized bed.
     • Powder Layering: Dry powder is layered onto cores, followed by binder spraying.

3. Direct Pelletization:

   • Involves forming pellets directly from powders in high-shear granulators or fluidized bed processors without the extrusion step.
   • Often requires specialized excipients like MCC.

4. Cryopelletization:

   • Used for temperature-sensitive drugs.
   • The liquid formulation is dropped into liquid nitrogen, forming frozen pellets.

5. Hot Melt Extrusion:

   • Suitable for drugs with poor water solubility.
   • The drug and polymer are melted and extruded to form pellets.

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