By Robert Sedlock
Tooling and press manufactures are faced with ongoing challenges in the tablet manufacture environments. Providing support in all aspects of the compression process should be expected from your partnering vendor. These services should include press operator training, maintenance /calibration services, quick delivery parts, tooling / tablet design and powder formulation support. When compression issues occur the above services are available to support your challenges but a change in the formulation requires a process following SUPAC (Scale-Up and Post Approval Changes) guidelines which can be time consuming and halt manufacturing. This article will describe the importance of the formulation development process and how a thorough approach can reduce manufacturing issues, costs and downtime. The case studies provided in this article were performed at the Natoli Institute for Industrial Pharmacy Research & Development – Arnold and Marie Schwartz College of Pharmacy and Health Sciences on the Brooklyn, NY campus of Long Island University.