Overview of the Extrusion-Spheronization Process

The extrusion-spheronization process is comonnly used in the pharmaceutical industry to make uniformly sized spheroids. It is especially useful for making dense granules for controlled-release solid dosage oral forms with a minimum amount of excipients.

Extrusion is a necessary first step in the extrusion-spheronization process. The size of the extruder aperture will dictate the approximate size of the resulting spheriods.

The extrusion-spheronization process can be broken down into the following steps:

• Dry mixing of the active ingredients and excipients to acheive a momogenious powder
• Wet massing, with binder added to the dry mixture
• Extrusion into a spaghetti-like extrudate
• Spheronization to from the extrudate in to spheroids of uniform size
• Drying
• Dry sizing, or sifting (optional) to acheive the desired size distribution
• Coating (optional)