Chapter 34 – Development.pdfVIP

C H A P T E R 34 34 Development, Optimization, and Scale-up of Process Parameters: Wurster Coating David Jones 34.1 INTRODUCTION atomized by air at a preselected pressure and volume. The spray pattern is generally a solid cone of droplets, with a spray angle ranging from approximately 30–50° In 1959, Dr Dale Wurster, then at the University of Figure 34.3 . The so-called “ coating zone ” which is Wisconsin, introduced an air suspension coating tech- formed is a narrow ellipse, and varies in volume nique now known as the Wurster system. The Wurster process enjoys widespread use in the pharmaceutical industry for layering and film-coating of particles and pellets, as well as the emerging controlled-release tab- let dosage forms. Product containers typically range in size from 3.5 100–500 g batch sizes to 46 up to approximately 800 kg . The Wurster process is used commercially for coating particles from less than 100 microns to tablets, and for layering to produce core materials. 34.2 BASIC DESIGN The basic design components of a commercially available Wurster system are shown in Figure 34.1 and Figure 34.2. The coating chamber is typically slightly conical, and houses a cylindrical partition open on both ends that is about half the diameter of the bottom of the coating chamber in up to 24 Wurster coaters . At the base of the chamber is an orifice plate that is divided into two regions. The open area of the plate that is under the partition is very permeable. This per- mits a high volume and velocity of air to pneumatically transport the substrate vertically. As they accelerate upward, particles pass a spray nozzle that is mounted in the center of this up bed orifice plate. The noz- FIGURE 34.1 Glatt model GPCG-60 fluid-bed processor fit- zle is r