Parametric analysis of continuous high shear wet granulation

摘要: OF THE THESIS PARAMETRIC ANALYSIS CONTINUOUS HIGH SHEAR WET GRANULATION By WEI MENG Thesis Director: Fernando J. Muzzio, Ph.D Wet granulation (WG) is widely used in the pharmaceutical industry. This technology has many advantages such as enhancing compression and powder handling, decreasing ingredient segregation ensuring content uniformity. Currently, a high level of interest exists continuous version this technology, both by US FDA, large manufacturers. Continuous manufacturing can provide significant technical business relative to batch methods. They are more robust controllable achieve same production rates processes much smaller thus less capital-intensive equipment. In recent years, different WG techniques have been investigated. However, integration these unit operations into complete tablet line still bottleneck due cost poor understanding process. work, highshear wet process examined based on placebo formulation comprising 69.7% ∂∂ -lactose monohydrate, 29.3% microcrystalline cellulose 1% Magnesium stearate. Two variables (rotation speed, L/S ratio) two design parameters (blade configuration nozzle position) selected for I-optimal design. The collected granules dried fluid bed drier desirable LOD (~ 3%). Granule