title: Agglomerate formation and growth mechanisms during melt agglomeration in a rotary processor.
abstract: The purpose of this study was to investigate the effect of the binder particle size and the binder addition method on the mechanisms of agglomerate formation and growth during melt agglomeration in a laboratory scale rotary processor. Lactose monohydrate was agglomerated with molten polyethylene glycol (PEG) 3000 by adding the PEG either as solid particles from the size fraction 0-250, 250-500, or 500-750 microm or as droplets with a median size of 25, 48, or 69 microm. It was found that the PEG particle size, the PEG droplet size, and the massing time significantly influenced the agglomerate size and size distribution. Agglomerate formation and growth were found to occur primarily by distribution and coalescence for the PEG size fraction 0-250 microm and mainly by the immersion mechanism for the PEG size fractions 250-500 and 500-750 microm. When the PEG was sprayed upon the lactose, the mechanism of agglomerate formation was supposed to be a mixture of immersion and distribution, and the agglomerate growth was found to occur by coalescence regardless of the PEG mean droplet size. Compared to high shear mixers and conventional fluid bed granulators, the mechanisms of agglomerate formation and growth in the rotary processor resembled mostly those seen in the fluid bed granulator.
authors.affiliation: Department of Pharmaceutics, The Danish University of Pharmaceutical Sciences, 2 Universitetsparken, DK-2100 Copenhagen, Denmark.
authors.forename: Thomas
authors.initials: T
authors.lastname: Vilhelmsen
authors.forename: Torben
authors.initials: T
authors.lastname: Schaefer
mesh_terms: D004339:Drug Compounding / Q000295:instrumentation / Q000379:methods*; D007785:Lactose / Q000737:chemistry*; D008855:Microscopy, Electron, Scanning; D010316:Particle Size; D011092:Polyethylene Glycols / Q000737:chemistry*; D011208:Powders
chemical_list: D011208:Powders; D011092:Polyethylene Glycols; D007785:Lactose