title: Extrusion/spheronization--effect of moisture content and spheronization time on pellet characteristics.
abstract: As part of a larger effort aimed at optimizing the properties of pellets produced by spheronization of extruded masses, the effect of the moisture content of wet masses on extrusion force and torque was studied. The wet masses were composed of either microcrystalline cellulose (MCC) or mixtures of MCC with lactose or dicalcium phosphate. Based on the force and torque data, a moisture content "window" was defined for consistent extrusion. Moisture exerts a lubricant effect, and a moisture level of 100-120% w/w dry solid seemed necessary for the extrusion of MCC into rod-shaped, discrete pieces. Screen force clearly depended on the moisture content but was relatively insensitive to extruder speed, especially at 80% and 100% moisture content. The physical properties of pellets as a function of spheronization time were studied by sampling the material at known intervals. The percent yield, tapped density, and a two-dimensional sphericity index of an 18/20 mesh fraction of pellets were measured. Maximum yield, tapped density, and sphericity were achieved within 60 sec in the spheronizer. With increasing residence time, the shape and density were unchanged while the yield was severely reduced. Among the formulations studied, pellets with equal amounts of lactose and MCC were superior to those of pure MCC in yield, density, and sphericity. Based on these results, an outline to optimize the endpoint of the spheronization process for formulations containing MCC is suggested.
authors.affiliation: Chelsea Laboratories Inc., Cincinnati, Ohio 45215, USA.
authors.forename: R M
authors.initials: RM
authors.lastname: Iyer
authors.forename: L L
authors.initials: LL
authors.lastname: Augsburger
authors.forename: D G
authors.initials: DG
authors.lastname: Pope
authors.forename: R D
authors.initials: RD
authors.lastname: Shah
mesh_terms: D002482:Cellulose; D004339:Drug Compounding / Q000379:methods*; D005079:Excipients; D006813:Humidity; D008863:Microspheres; D010316:Particle Size; D014867:Water / Q000032:analysis
chemical_list: D005079:Excipients; D014867:Water; D002482:Cellulose; C109691:microcrystalline cellulose