title: On-line monitoring of powder blend homogeneity by near-infrared spectroscopy.
abstract: Near-infrared spectroscopy is evaluated as an on-line technique for monitoring the homogeneity of a pharmaceutical blend during the blending process. Blends containing 10% sodium benzoate (model active), which provided an aromatic functionality typical of many pharmaceutical compounds, 39% microcrystalline cellulose (Avicel PH102), 50% lactose, and 1% magnesium stearate were developed to mimic the properties of an actual pharmaceutical blend. A twin-shell V-blender was modified to allow installation of a diffuse reflectance fiber-optic probe at the axis of rotation, and spectra were collected during three experiments using a commercially available near-infrared spectrophotometer. In each experiment, blender control and spectral data collection were controlled by a compilation of software packages. The experiments detected spectral changes which eventually converged to a point of constant variance. Further analysis of the spectral data showed the blend is homogeneous long before a typical blending period is complete. Near-infrared spectroscopy has proven to be a feasible and effective method for the "real time" noninvasive determination of homogeneity in a pharmaceutical blend.
authors: Pfizer Central Research, Eastern Point Road, Groton, Connecticut, 06340 and Pfizer Central Research, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK.
authors: S S
authors: SS
authors: Sekulic
authors: H W
authors: HW
authors: Ward
authors: D R
authors: DR
authors: Brannegan
authors: E D
authors: ED
authors: Stanley
authors: C L
authors: CL
authors: Evans
authors: S T
authors: ST
authors: Sciavolino
authors: P A
authors: PA
authors: Hailey
authors: P K
authors: PK
authors: Aldridge