Piramal Enterprises’ Pharma Solutions CDMO business has added development/commercial scale roller compaction technology to its Sellersville, Pennsylvania drug product facility. The addition of Gerteis Macro-pactor equipment, designed to handle both development and commercial scale roller compaction, enhances the site’s dry granulation and scale-up capabilities.
Market data reportedly indicates that more than 20% of the chemical entities being developed use roller compaction technology in their development or commercialisation. The technology is also used for processing certain active pharmaceutical ingredients (APIs).
The densification of dry blended powders is required to handle products with poor API flow properties and instances where the API is moisture sensitive. Wet granulation is sometimes used to overcome these challenges, but many APIs are not amenable to wet granulation, Piramal says. In such cases, roller compaction is a viable option to densify material and generate granules which can be further processed into capsules or tablets.
Peter DeYoung, Chief Executive Officer, Piramal Pharma said: “As part of our effort to provide comprehensive drug development and manufacturing services to customers in North America and around the world, we continually conduct internal due diligence on our capabilities. After the acquisition of our Sellersville site, we identified the need to enhance our dry granulation technology and moved forward with a plan to address it. It’s just a small part of efforts to recognize customer needs around the world and provide timely solutions.”
The Gerteis Macro-pactor is able to handle 100-300g batches for small scale development as well as larger volumes when used in continuous mode.
