Piramal Enterprises Limited’s Pharma Solutions business, a leading Contract Development and Manufacturing Organization (CDMO), today announced that the company has added development/commercial scale roller compaction technology to its Sellersville, Pennsylvania drug product facility. The addition of the Gerteis Macro-pactor® equipment, which is designed to handle both development and commercial scale roller compaction, enhances the site’s dry granulation and scale-up capabilities.  Market data indicates that more than twenty percent of the new chemical entities being developed use roller compaction technology in their development and/or commercialization. In addition, roller compaction is an excellent technology for processing certain active pharmaceutical ingredients (APIs).

The densification of dry blended powders is a critical capability that 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. In such cases, roller compaction provides 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 Solutions 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 a versatile piece of equipment, with the ability to handle 100-300 gram batches for small scale development as well as larger volumes when used in continuous mode. Based on customer feedback and acceptance, it is recognized as an excellent solution for both small scale development requiring roller compaction technology and larger scale clinical and commercial batches as the compounds move forward in the development cycle.