Continuous Tableting and Coating

Continuous oral solid dose (OSD) manufacturing provides significant benefits in cost of implementation compared with batch manufacturing through reductions in time and drug substance required for development, facility footprint, a simpler, product-based manufacturing process and a flexible facility that can be configured for different processes and products.

The deliverables from the project included

• proof that an integrated continuous tablet production system is a viable platform for both cost-effective drug product development and a flexible compact and robust manufacturing platform wherein scale up in time eliminates the technical and cost issues associated with traditional scale-up in batch size
• the development and demonstration of an integrated continuous blending and direct compression system for tablet production with online product quality attribute measurement
• demonstration that online measurements, together with a data management system to synchronize the data, in conjunction with a process that has a well-defined residence time distribution, can provide the information required for both active process control and quality assurance
• the development and demonstration of a continuous tablet coating system that delivers homogenous coating that’s better than conventional batch coating systems and is compatible with both the need to coat small quantities of material during development and yet provide the capacity required for production.

The partnership highlighted the value of considering both the flow of physical product and the flow of information required to ensure that the product emerging from the system met the required quality specifications. The pivotal element of this test work was a number of extended continuous trials that showed convincingly that the technology was able to robustly produce a high quality product during an extended period.

The close coupling of the blending process to the tablet production step eliminates many of the concerns regarding blended product segregation during transport and storage, meaning that this process could be used a robust manufacturing method for a wider range of products, particularly where a low cost method of local manufacturing is needed for new markets.

Analysis by GSK of the coating deposition showed that the new ConsiGma® coater was capable of achieving a move even coat distribution than existing coating technology.