title: Mass-balanced blend uniformity analysis of pharmaceutical powders by at-line near-infrared spectroscopy with a fiber-optic probe.
abstract: A near-infrared (NIR) fiber-optic probe was used at-line to study the blending dynamics of pharmaceutical powder blends on a mass-balanced basis. The probe with a flexible fiber-optic cable can be inserted directly into a 10-L bin blender to get quantitative readings. NIR calibration models were developed and validated for the probe based on a designed 50-sample calibration set. A model formulation containing acetaminophen, mannitol, Avicel, magnesium stearate and AcDiSol was used in the study. The blending study was conducted at 18 rpm for 20 min. NIR probe scans were performed at 1 min intervals and five different locations in the bin. Thief samples were collected and later analyzed by a bench-top NIR instrument to confirm the results from the probe. Complete blending profiles were constructed and compared based on the assay results from both instruments.
authors.affiliation: Analytical Development, Johnson & Johnson Pharmaceutical Research & Development, LLC, Spring House, PA 19477, United States. wli1@prdus.jnj.com
authors.forename: Weiyong
authors.initials: W
authors.lastname: Li
authors.forename: Mark C
authors.initials: MC
authors.lastname: Johnson
authors.forename: Rick
authors.initials: R
authors.lastname: Bruce
authors.forename: Steven
authors.initials: S
authors.lastname: Ulrich
authors.forename: Henrik
authors.initials: H
authors.lastname: Rasmussen
authors.forename: Gregory D
authors.initials: GD
authors.lastname: Worosila
mesh_terms: D000082:Acetaminophen / Q000737:chemistry; D002138:Calibration; D002482:Cellulose / Q000737:chemistry; D002626:Chemistry, Pharmaceutical / Q000379:methods*; D004339:Drug Compounding / Q000379:methods*; D005336:Fiber Optic Technology; D008353:Mannitol / Q000737:chemistry; D055100:Optical Fibers; D010316:Particle Size; D004364:Pharmaceutical Preparations / Q000032:analysis* / Q000737:chemistry; D011208:Powders; D019265:Spectroscopy, Near-Infrared / Q000379:methods*; D013229:Stearic Acids / Q000737:chemistry; D013678:Technology, Pharmaceutical / Q000379:methods*; D013997:Time Factors
chemical_list: D004364:Pharmaceutical Preparations; D011208:Powders; D013229:Stearic Acids; D000082:Acetaminophen; D008353:Mannitol; C031183:stearic acid; D002482:Cellulose