Improving Control of the Extrusion Spheronization Process

By Rakesh P. Patel, M.M. Patel, J.K. Patel, N.A. Patel and D.M. Patel, Ganpat University, Kherva, Gujarat, India
PharmaManufacturing.com
Extrusion spheronization can be an efficient route to pellet dosage forms, but close control of temperature and speed is critical.

Pellets are increasingly being used as multiple unit-dosage forms. They offer manufacturing advantages such as improved flow, reduced friability, narrow particle size distribution, ease of coating and uniform packing, but they also offer therapeutic benefits. For instance, they prevent the buildup of high local concentrations of bioactive agents that might irritate the stomach. They also reduce the variability of plasma profiles between subjects and within the same patient, by reducing variations in gastric emptying rates and overall transit times.
Pharmaceutical pellets are typically manufactured via extrusion spheronization, a three-step process introduced in the late 1960s, that results in spherical granulates roughly 1 mm in diameter. In this process, the powder is formed into a wet mass, which is forced through a restricted area (extrusion) to form strands of extrudate that are broken into short lengths and rounded by placement on a rotating plate within a cylinder.

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