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.g. dose level, taste-masking requirements. Extrusion / spheronization is one technology option for producing uniformly sized spheroids.
It is useful for making dense granules for controlled-release solid oral dosage forms with a minimum amount of excipients, as well as multiparticulates used for immediate, modified, or sustained-release.
Extrusion / spheronization is especially useful in producing dense granules for controlled release applications, but can be used for optimized immediate release formulations. Through formulation development, the extrusion / spheronization process can also be used to develop drug products with different release profiles, administer more than one drug substance in a single dosage form, or combine two drug substances with known incompatibilities in a single unit. The physical advantages of extrusion / spheronization vs. other multiparticulate approaches can include relatively high drug loading, improved flow properties, narrow particle size distribution, smooth and readily "coatable" surface, low friability, and uniform packing characteristics.
The process consists of five operations. Initially, the process calls for wet granulating or “wet massing” the formulation. 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. The wet extrudate is added to an LCI Marumerizer QJ230T spheronizer equipped with a high speed spinning plate which forms uniform spheres from the extrudate "rope". The resultant spheres are dried in a fluid bed dryer and particle size is selected by sieve cuts.
The spheres may undergo additional processing steps to apply functional or cosmetic coatings using fluid bed processing with a Wurster insert. The coated spheres may be used for encapsulation, compression, or direct packaging into sachets or pouches for dosing. Capsugel is equipped to produce multiparticulates with extrusion / spheronization technology from lab scale through clinical trial material and small-scale commercial quantities. Primary packaging in either vials or sachets and secondary packaging services are also available.