title: Spectroscopic approach for on-line monitoring of particle size during the processing of pharmaceutical nanoparticles.
abstract: A novel application of near-infrared (near-IR) spectroscopy for the on-line determination of nanoparticle size of a drug compound in a high solids dispersion is described. The on-line spectroscopic technique provides real-time data for process monitoring and control and overcomes the limitations that are encountered using laboratory-based instrumentation for nanoparticle size determination. Near-IR spectroscopy is capable of providing an accuracy of 2.4 nm near the endpoint of particle production, where the volume-weighted D90 particle size is determined to be 200-220 nm. The accuracy is adequate for endpoint control, which minimizes excess processing and provides control over the particle size throughout nanoparticle production.
authors.affiliation: Merck Research Laboratories, Merck and Co., Inc., P.O. Box 4, WP78-110, West Point, Pennsylvania 19486, USA. John_Higgins2@Merck.com
authors.forename: John P
authors.initials: JP
authors.lastname: Higgins
authors.forename: Steven M
authors.initials: SM
authors.lastname: Arrivo
authors.forename: Gert
authors.initials: G
authors.lastname: Thurau
authors.forename: Robert L
authors.initials: RL
authors.lastname: Green
authors.forename: William
authors.initials: W
authors.lastname: Bowen
authors.forename: Andrew
authors.initials: A
authors.lastname: Lange
authors.forename: Allen C
authors.initials: AC
authors.lastname: Templeton
authors.forename: Denise L
authors.initials: DL
authors.lastname: Thomas
authors.forename: Robert A
authors.initials: RA
authors.lastname: Reed
mesh_terms: D004339:Drug Compounding / Q000379:methods* / Q000592:standards; D036103:Nanotechnology / Q000379:methods; D009862:Online Systems; D010316:Particle Size; D004364:Pharmaceutical Preparations; D012542:Scattering, Radiation; D013055:Spectrophotometry, Infrared / Q000379:methods
chemical_list: D004364:Pharmaceutical Preparations