Three primary systems used in continuous oral solid dose manufacturing

The continuous oral solid dose manufacturing industry is well-positioned for even further continuous manufacturing (CM) advancement as many more drug approvals are stamped in the years ahead. CM for oral solid dose form products is a transformational processing platform that is here to stay.

Although the industry is working on harmonization and some level of standardization of the platforms, CM is not a one-size-fits all offering. There are three primary system types and configurations employed in today’s modern oral solid dose form manufacturing facilities and each has its own potential benefits.

1. Fully-integrated CM systems

A fully-integrated CM system begins at bulk powder handling and ends at tablet coating. There is full integration and process control from “powders in” to final dose form coated “tablets out.” The system provides the following capabilities:

• Upstream bulk powder material handling and feed of excipients and active pharmaceutical ingredients
• Processing platforms that include direct compression, wet granulation or dry granulation
• Conventional tablet compression with fully automated tablet testing
• Post tablet compression/pre-coating tablet relaxation
• Continuous coating
• Final dose form collection and handling.

2. Partially integrated and hybrid continuous CM systems

A partially integrated and hybrid CM system typically begins at powder feed and ends at tablet compression. There is a separation of the bulk powder handling and tablet coating operation, making use of more traditional batch operations for these unit operations. The system provides the following capabilities:

• Feed of excipients and active pharmaceutical ingredients
• Processing platforms that include direct compression, wet granulation or dry granulation
• Conventional tablet compression with fully automated tablet testing

3. Advanced end-to-end continuous CM systems

An exciting and innovative area that is evolving are advanced end-to-end CM systems. These systems combine drug substance manufacturing with drug product manufacturing for a truly continuous operation. In this configuration, there is full integration and process control from chemical synthesis to final dose form coated tablets. The system provides the following capabilities:

• Upstream bulk raw material storage and feed of chemical entities
• Continuous integrated drug substance processing platforms that include dissolution, crystallization/filtration, drying and sizing
• Continuous integrated drug product processing platforms that include direct compression, wet granulation or dry granulation
• Conventional tablet compression with fully automated tablet testing
• Post tablet compression/pre-coating tablet relaxation
• Continuous coating
• Final dose form collection and handling.

While oral solid dose CM is not a one-size-fits-all approach, there are many options and configurations for the user to enter the arena. Fully integrated CM systems are among the most complex to implement. However, they also represent a growing number of installations around the world, allowing for the widest range of capabilities.

Partially integrated and hybrid continuous CM systems are a great launch pad for the user that is starting out. Direct compression systems are among the most popular and easiest to implement. Advanced end-to-end continuous CM systems offer a great deal of potential, but are the most complex.

This article originally appeared on CRB’s blog. CRB is a CFE Media content partner. Edited by Chris Vavra, production editor, Control Engineering, CFE Media, cvavra@cfemedia.com.

Original content can be found at www.crbusa.com.

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