Case Study
Minimizing Direct Compression Content Uniformity Variations
Minimizing Direct Compression Content Uniformity Variations The Need A domestic pharmaceutical manufacturer was producing a highly segregating direct-compression blend of an active pharmaceutical ingredient (API) and excipients like sucrose, lactose, and microcrystalline cellulose. After blending, the material discharged from a twin-shell mixer and experienced heavy sifting segregation during flow into a portable container. The segregation effect yielded a high concentration of fine particles in the container’s center, while the material at the periphery was mostly coarse. Given that the container discharged in a funnel flow pattern, the fine particles (high in active drug content) discharged first, followed by the coarse material, which was sub-potent. Jenike & Johanson was hired to assi