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Gerteis® roller compactor applications
Starting as a technology historically reserved for moisture or heat sensitive products, roller compaction has evolved to become a widely used pharmaceutical granulation technology with broad applications. The dry granulate is either an intermediate product to be further processed into tablets, or it already represents the final bulk product to be packed in sachets, pouches, blister packs, plastic bottles, canisters, or used in tablet manufacturing or capsule production.
GERTEIS Maschinen + Processengineering AG is a Swiss manufacturer of high-quality pharma-grade roller compactors. GERTEIS® has set the standard since 1986 with its unique dry granulation technology. The company’s understanding of the dry granulation process combined with patented roller compaction systems make GERTEIS® the technology leader in the field of dry granulation.
Pharmaceutical granulation concepts
The main purpose for dry granulation is to increase the bulk density of the compacted powders and to optimize the particle size to ensure a better flow of distributed material as a result, the produced powder is easier processable.
Granulated powder blends become more homogeneous, are insensitive towards segregation, and their uniformity increases. Furthermore, granulation reduces dusts and fines, especially for bulk products, resulting in little or no material wastage and low dust exposure.
Industries using roller compaction
Roller compaction with Gerteis® technology is used for a wide range of products and is not limited to moisture or heat sensitive products. A wide variety of formulations can be processed in batches or for continuous manufacturing processes, including high-containment compaction of proprietary or generic, blockbuster or orphan drugs, high or low drug loads, for immediate or sustained release, API combinations, and many more. Further roller compaction is a versatile, efficient, and time- and money saving method.
Whenever pharmaceutical granules of high product quality are required, roller compactors using variable gap and sophisticated process controls are needed. While the pharmaceutical industry is still the key market with 95% of all compactors, Gerteis® roller compactors are also used in the Food and Chemical industries (Figure 1).
Dry granulation pharma compactor applications
The number of pharmaceutical products being manufactured by Gerteis® roller compactors continue to increase steadily as this method has proven to be one of the most economical. It is continuous, has a relatively large throughput, requires little floor space, needs very little energy and benefits from the absence of granulation liquids and drying equipment.
Roller compaction can be applied to a wide range of products. Many generic drugs are dry granulated, for example Metformin, Ibuprofen, antihypertensives, and antibiotics. It is becoming more and more common. However, a lot of proprietary products are developed with dry granulation right from the beginning. The range includes blockbusters such as Metformin but also orphan drugs like Bosentan.
Although roller compaction is a continuous manufacturing (CM) process suitable for both large and small throughput rates, almost all products are manufactured in batch format. The reason for this is that currently few products have been approved as a fully continuous production process. One example, Symdeko from Vertex was approved 2018 by the FDA having dry granulation machinery integrated in a CM pharma process. Additionally, Symdeko is a combination of two APIs used for the treatment of cystic fibrosis, demonstrating that candidates for roller compaction are not limited to single API products. Other examples of API combinations can be found within the antihypertensive drugs such as Trandolapril & Verapamil or Valsartan & Hydrochlorothiazide (HTCZ).
The drug load for dry granulation formulations ranges from very high (> 90% for Metformin or Ibuprofen) to very low (< 1% for Cabergolin). For formulations with high drug load the properties of the API become crucial, and it is not always possible to achieve efficient compaction with such high drug loads. For very low drug loads the challenge is to reach a uniform distribution of the API throughout the whole blended batch.
Roller compaction can be used for both immediate and sustained release formulations and can also be used in the manufacture of effervescent formulations in one blend without separating the carbonate salts and the acid components. This reduces the effort of manufacturing two separate batches of wet granulate to only one manufacturing step.
Even if a substance was originally developed in wet granulation, it is often possible to change the granulation method to dry granulation. Since this usually comes with registration changes, we recommend a business case calculation and a feasibility study as basis for further decisions. Successful changes from wet to dry granulation have already been performed with Metformin, Ibuprofen or Triamteren & Hydrochlorothiazide (HTCZ). Table 1 gives an excerpt of APIs processed by roller compaction.
Compaction of highly potent substances
Driven by the need of containing and handling highly potent APIs (HPAPIs) roller compactor pharmaceutical solutions for different containment levels have been developed. Various leading CDMO companies such as Almac Pharma Services, Catalent Pharma Solutions, Fareva, Lonza, PCI Pharma Services have high containment pharma roller compactors from Gerteis® in their manufacturing line. Occupational exposure limit (OEL) levels of less than 0.1 µg/m3 (OEB 5 level) can be achieved.