title: Determination of fluidized bed granulation end point using near-infrared spectroscopy and phenomenological analysis.
abstract: Simultaneous real-time monitoring of particle size and moisture content by near-infrared spectroscopy through a window into the bed of a fluidized bed granulator is used to determine the granulation end point. The moisture content and particle size determined by the near-infrared monitor correlates well with off-line moisture content and particle size measurements. The measured particle size is modeled using a population balance approach, and the moisture content is shown to follow accepted models during drying. Given a known formulation, with predefined parameters for peak moisture content, final moisture content, and final granule size, the near-infrared monitoring system can be used to control a fluidized bed granulation by determining when binder addition should be stopped and when drying of the granules is complete.
authors.affiliation: Purdue University, Department of Industrial and Physical Pharmacy, 575 Stadium Mall Drive, West Lafayette, Indiana 47907-2091, USA. paul.findlay@bms.com
authors.forename: W Paul
authors.initials: WP
authors.lastname: Findlay
authors.forename: Garnet R
authors.initials: GR
authors.lastname: Peck
authors.forename: Kenneth R
authors.initials: KR
authors.lastname: Morris
mesh_terms: D002626:Chemistry, Pharmaceutical / Q000379:methods*; D023381:Endpoint Determination / Q000379:methods*; D019265:Spectroscopy, Near-Infrared / Q000379:methods*