A novel methodology to study polymodal particle size distributions produced during continuous wet granulation

摘要: It is important during powder granulation to obtain particles of a homogeneous size especially in critical situations such as pharmaceutical manufacture. To date, homogeneity particle distribution has been defined by the use d50 combined with span distribution, which found ineffective for polymodal distributions. This work focuses on demonstrating limitations parameter quantify and proposes novel improved metric based transformation typical curve into factor can vary from 0 100%. The potential this method characterisation tool demonstrated through its application production granules using two different materials. workspace an 11mm twin screw granulator was common excipients (α-lactose monohydrate microcrystalline cellulose). Homogeneity obtained varied dramatically 95% same workspace, allowing identification process parameters (e.g. feed rate, liquid/solid ratio, torque velocities). In addition it operational conditions required produce most product within range 5μm-2.2mm both