Pharmaceutical Pellet Processing
Pellets offer many additional features compared with conventional tablets. GEA is able to offer a comprehensive range of pelletization processes and help you to select the procedure that best suits your needs.
Our pelletizing solutions include extrusion and spheronization, production by powder layering and liquid layering, and pelletization by melt and wet granulation.
Process & Product Development
Based on our strong commitment to process development, Pharmaceutical Technology Centres in Belgium, Denmark, Switzerland, the UK, Singapore, China and USA provide global technical support and know-how to the life science industries. Our experienced staff can assist with process development, optimisation and transfer, and our state-of-the-art test and application centres can produce pharmaceutical dosage forms for clinical studies. Customers can also rent or hire equipment to perform in-house product development and process feasibility work.
Pelletizing Process Principles
Liquid layering of pellets: The multi-functional PRECISION-COATER™ and top spray coater systems can all be used to make pellets by layering the active material onto an inert core. Non-pareil starter pellets are sprayed with a solution or suspension of the active material and dried simultaneously.
Powder layering of pellets: When the active ingredient is in powder form, pelletization can be achieved by spraying starter pellets with the active powder and, at the same time, a liquid binder solution. The layered pellets are then dried.
Melt granulation pelletization: Melt pelletization can be done using the PMA™ Pellet Processor or the ULTIMAPRO™ Single Pot Processor. The active and binder powders are mixed and heated to a temperature above the melting point of the binder. Granulation and pelletization are then done in a single operation.
This is a very fast, truly one-pot process during which a heated jacket or optional microwave energy can be used to melt the powders. Special polymer liners are also available to minimize sticking. Applications include forming pellets from 0.5–2.0 mm in diameter at batch sizes up to 150 kg. By selecting an appropriate binder material, sustained release forms can be developed without additional coating.
Wet granulation pelletization: The active substance is mixed with microcrystalline cellulose (5–30%) and the mixture is granulated with water or an organic solvent. During the process, the granules are compacted and spheronized. This operation can be performed using the PMA™ Pellet Processor or the ULTIMAPRO™.
Again, special polymer liners can be used to minimize sticking and specific impellers can be selected for optimal pellet quality. Extremely round pellets (0.5–2.0 mm in diameter) can be produced at batch capacities up to 150 kg.
Extrusion and spheronization: The NICA™ Pelletizing System is a turnkey pellet production plant that combines a mixer/granulator, extruder and spheronizer in a single, integrated process. Wet powders continuously pass through a low-shear radial extruder; the extrusions are fragmented and formed into pellets in the spheronizer.
The process is fast, robust, continuous and easy to scale-up. Standalone units and fully integrated systems are available. Very high drug loads can be processed and integration with up- and downstream equipment is possible. Predictable pellet sizes of 0.5–3.0 mm can be achieved at capacities up to 300 kg/h.