Introduction and Technical Notes for Dry Granulation – Roller Compaction

Pharmaceutical companies of all shapes and sizes are under pressure to work smarter in order to move drug candidates forward faster and maximize the chance for success. Dry granulation/roller compaction technologies can enable innovators to improve product performance, reduce process development costs and timelines and minimize scale-up issues.

This webinar will specifically address:

• Advantages/Disadvantages of dry granulation over wet granulation
• Applications of dry granulation/roller compaction for delivering flowable, compactable granules
• Overcoming challenges such as poor solubility, hygrophilic/stability, heat lability, and drug loading
• Minimizing scale-up issues with streamlined technology from the experimental area to GMP manufacturing
• De-risking process development by coupling a preformulation feedback loop for particle characterization

For Pharmaceutical Companies (large, mid-size, specialty, emerging & virtual), particularly those involved with Small Molecule Pipeline Products.

Theodore Koontz manages the Manufacturing, Warehouse and Facility Departments at Xcelience. He helps to ensure that all drug products manufactured by Xcelience meet or exceed cGMP requirements, as well as servicing the wide-ranging and stringent demands of Xcelience's many customers.

Mr. Koontz has more than 17 years of industry experience with solid oral dosage forms in the areas of manufacturing, operations, analytical and formulation development. He is renowned for his ability to apply his considerable experience, creativity and knowledge of cGMPs to develop processes which allow customers to utilize unconventional methods to create clinical trial materials that meet a wide variety of needs.

As a founding member of the Manufacturing Department when it was part of MDS Pharma Services, Mr. Koontz played the key role in developing the manufacturing systems and facilities, as well as expanding the manufacturing team as the company grew. Mr. Koontz left MDS in 2003 to serve as manager of GMP Operations at Shire Labs, Inc. (currently known as Supernus Pharmaceuticals, Inc.).

He returned to Xcelience in 2006 to lead the Manufacturing Department again, and has since taken leadership responsibility for the Warehouse and Facilities Departments. Mr. Koontz also has prior experience with Somerset Pharmaceuticals, Inc., in formulations development and analytical chemistry.

Partnering with a specialist for early drug development can significantly reduce product risk and accelerate development timelines. Since 1997, Xcelience has been renowned for reliably expediting drug development and reducing compound risk. Our scientists have considerable experience overcoming challenging physical and chemical properties in a manner that results in improved solubility and compound bioavailability. Our outstanding quality record, development expertise, disciplined project management and willingness to customize enables us to deliver real advantage to pharmaceutical innovators focused on small molecule development.