Multiparticulate Drug Delivery pp Cite as. Extrusion-spheronization is one of the important techniques for pellet production. In most cases, the extruded-spheronized pellets are then coated with a functional coating. Extrusion-spheronization is a robust process and allows high drug loading of the pellets. The mean particle size is mainly determined by the die diameter, and its distribution is usually controlled to obtain a narrow particle size distribution. A pelletization aid is required to allow extrusion and spheronization of drugs, and microcrystalline cellulose MCC is the standard pelletization aid used in the industry.
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Agglomeration through extrusion and spheronization is one of the oldest techniques for manufacturing pellets. The process consists of four process steps: Moistening the powder mixture, forming cylinder-shaped agglomerate through extrusion, breaking and rounding the extrudate to round pellets through spheronization, and drying the finished product. The dry, mixed, powdery active substances are kneaded into a dough with a liquid.
This dough then pressed through an extruder. The diameter of the openings in the extrusion plate or extrusion basket determines the strength of the elongated extrusion threads that result. For technical reasons, the resulting pellets are larger than micrometers. The ratio of liquid to solid material together with the size of the extruder holes significantly determines the quality of the extrudates. The final drying ensures the pellet hardness. Even if the ball-shaped extrudate is imperfect, the evenness of the surface still creates good conditions for subsequent coating.
For many pharmaceutical applications, extruded pellets are achieved in suitable quality if a sufficient portion of microcrystalline cellulose is added. In the pharmaceutical industry, pellets of medium particle sizes from to 2, micrometers are used for most applications. In other industries, the size of the pellets can be several centimeters. Just the way you need it.
Extrusion / Spheronization
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.
Improving Control of the Extrusion Spheronization Process
The Science and Practice of Extrusion-Spheronization
Capsugel has extensive experience and capabilities in optimizing pediatric and multiparticulate formulations. The technology chosen is dependent upon multiple active ingredient and formulation criteria, e. The process consists of five operations. The wet mass is added into an LCI Multigranulator MG 55 where it is forced through a specific screen to form cylindrical extrudates using either dome, radial or axial extrusion for process optimization.