Extrusion and spheronization is a readily acceptable pharmaceutical process providing several advantages in the development of drug products. Through formulation development, the extrusion and spheronization process allows the ability to administer a drug substance with different release profiles, administer more than one drug substance in a single dosage form, or combine two drug substances with known incompatibilities in a single unit.
Initially, the process calls for wet granulating, or “wet massing” the formulation. The wet mass is added into the extruder where it is forced through a specific sized screen to form cylindrical extrudates. The wet extrudates are added to the spheronizer, equipped with a high speed spinning plate. The high speed “roping” rounds off the cylindrical shapes into uniform spheres. The resultant spheres are dried in a fluid bed dryer and particle size selected by sieve cuts. The spheres may undergo additional processing steps to apply functional or cosmetic coatings using the fluid bed dryer with a Wurster insert. The coated spheres may be used for encapsulation, compression, or direct packaging into sachets or pouches for dosing. This webinar will provide an inside look to Xcelience’s capabilities using this technology.
Key Learning Objectives:
1. Technical advantages of extrusion and spheronization
2. Excipient selection for the extrusion process
3. Examples of process equipment available in the industry, specifically at Xcelience
4. Dosage form examples
Jeff Williamson, Manager, Pre-Formulation and Formulation Development, Xcelience
Jeff Williamson is Manager, Pre-formulation and Formulation Development at Xcelience. Jeff and his team are responsible for drug substance characterization, drug product formulation and process development. Jeff received his B.S. in Chemistry from Radford University and has worked in the Pharmaceutical industry for over 22 years. Prior to joining Xcelience, Jeff gained a significant amount of experience through several scientific positions at Metrics Contract Services, Guilford Pharmaceuticals and ALPHARMA USPD (now Actavis).
Who Should Attend?
Formulation and process development professionals involved with the development of drug products, including the following functions:
- Drug Discovery and Development
- Drug Manufacturing and Operations
- Drug Product/ Pharmaceutical Development
- Formulation and Process Development
- Clinical Trial Materials
- Chemistry & Manufacturing
- CMC Consultant
- Senior Scientists
- Contract Manufacturing Operations
Xcelience offers a suite of services enabling clients to partner with a single CDMO for all their clinical outsourcing needs. Services include preformulation, analytical services, formulation development, GMP manufacturing, small-scale commercial manufacturing, and clinical supplies packaging and logistics. Xcelience takes pride in delivering the highest standards in science and service with an emphasis on quality, cost and speed.