Glatt fluid bed technology for the coating of powders, pellets and micropellets
By Annette Grave, Norbert Pöllinger 2011
Overview
Fluid bed processes were originally used in chemical process technology. Fluid bed drying saw its first use in the pharmaceutical industry at the end of the 1950s, achieving a higher drying efficiency than the techniques that existed at the time. Many granulation processes were performed by wet granulation in a compulsory mixer, followed by drying in a shelf dryer. However, shelf drying can take up several days depending on the quality of the product.
The technology has dramatically evolved over time and in this booklet Annette Grave and Norbert Pöllinger from Glatt Pharmaceutical Services explain some basics but also the application of these versatile processes from the daily life at CDMO developing and manufacturing complex oral solid dosage products.
- Description and basic design of a fluid bed machine
- Glatt fluid bed processes
- Batch processes
- CPS® (Complex Perfect Spheres) Technology
- Wurster or bottom spray technology
- Continuous processes
- Batch processes
- Selection of the product-specific machine configuration
- Selection of a suitable Wurster bottom plate configuration depending on the quality of the product to be coated
- Spray nozzle
- Product retaining filters, baskets
- General process parameters for the Wurster coating process
- Humidity management in the process
- Parameters which influence spray liquid droplet size
- Process monitoring and PAT (Process Automation Technology)
- Standard process monitoring
- Further PAT systems for process monitoring
- Glatt HS Wurster system in total containment design
- Scale up of Wurster coating processes to production scale
- Case studies from the experiences of Glatt Pharmaceutical Services
- Case study 1: layering of active ingredients on starter pellets using the Glatt Wurster HS process
- Case study 2: Taste masking of micropellets using the Glatt HS Wurster process
- Case studies 3 and 4: process development of modified release coatings using the Glatt HS Wurster process
- Modified release coating with a high sensitivity to process parameters
- Modified release coating with „lower“ sensitivity to process parameters
- Summary
