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Roller compaction is a relatively new process in the pharmaceutical industry and is gaining ground in terms of approved products and process equipment. Highlights of this process technology include:
1. Simple, low-cost process
Roller compaction (RC) is a simple process that can cost-effectively granulate material to a desired size and shape. The process only requires a feed hopper, a compaction chamber, two pairs of counter rotating rolls, and a vibratory/de-agglomeration station. In addition, there is minimal dust created by this process.
2. Scaleability
Since the process has minimal limitations for size, it is easily scalable for both large and small batch sizes. As a result, it is a great option for scaling from R&D to clinical production and commercial production.
3. Quality of the end product
The end product produced from the RC process has uniform particle size distribution, high flowability, and excellent content uniformity. This process also has the potential to reduce the number of process steps since wet granulation and drying may not be necessary for some formulations.
4. Improved safety
Safety is improved as the process does not require added liquid. This makes the process an attractive option for those formulations which are sensitive to moisture. In addition, the process may be performed in a sealed chamber, thereby reducing operator exposure.
5. Improved product stability
As the drying step is not necessary in some formulations, this can improve the stability of some of the ingredients. The low temperatures generated by the RC process reduce any thermal degradation of the ingredients.
Overall, roller compaction is gaining more traction in the industry due to the simplicity of the process, scalability, quality of the end product, improved safety, and improved product stability. Through its ease of operation, fast throughput times, and improved process control, it is definitely a beneficial process within the pharmaceutical industry.
