(643e) Powder to Dry Granules in a Single Step Wet Granulation and Drying Process

In this study, a new technology is evaluated for the continuous wet granulation from API powder blend. The aim is to reduce footprint and operation time to prepare ready-to-compress granules. This technology merges the usually separated steps of granulating drying and sizing, into a single step process. As the case study, low dose caffeine formulation was investigated, in a formulation containing 44% of microcrystalline cellulose, a component that requires a substantial amount of granulating liquid to granulate, 44% of α-lactose monohydrate, and 3% of Polyvinylpyrrolidone used as binder. PVP was premixed with all other components via the dry-binder addition method. All solid ingredients were passed through a No. 35 mesh to ensure deagglomeration. Distilled water was used as granulation liquid. The process was run on a STEERLife Integraal® continuous processor with granulating and drying zones kept at temperatures ranging from 30 deg C to 120 deg C. Air flows in the same direction of the powder along the screws, to transport the evaporated granulating liquid and to aid drying as they were produced.

A surface response analysis on granule moisture content, size distribution, porosity and compactibility were conducted by exploring three operating parameters, i.e., L/S ratio, feeder throughput, and screw speed through a three-level center cubic face design with three replicated central points. The goal of the study is to obtain optimal conditions for producing dry granules that flow easily, and that compact well. An important conclusion of the work is that for certain conditions, granules that compact well, are completely dried can be produced continuously, and in a few seconds with this technology.