On-line monitoring of powder blend homogeneity by near-infrared spectroscopy

被引:193
作者
Sekulic, SS
Ward, HW
Brannegan, DR
Stanley, ED
Evans, CL
Sciavolino, ST
Hailey, PA
Aldridge, PK
机构
[1] PFIZER INC, CENT RES, GROTON, CT 06340 USA
[2] PFIZER LTD, CENT RES, SANDWICH CT13 9NJ, KENT, ENGLAND
关键词
D O I
10.1021/ac950964m
中图分类号
O65 [分析化学];
学科分类号
070302 ; 081704 ;
摘要
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.
引用
收藏
页码:509 / 513
页数:5
相关论文
共 10 条
  • [1] [2] Pfizer Inc, 1993, US Patent, Patent No. [95-037575/06EP 631810-A1, 631810]
  • [2] IDENTIFICATION OF TABLET FORMULATIONS INSIDE BLISTER PACKAGES BY NEAR-INFRARED SPECTROSCOPY
    ALDRIDGE, PK
    MUSHINSKY, RF
    ANDINO, MM
    EVANS, CL
    [J]. APPLIED SPECTROSCOPY, 1994, 48 (10) : 1272 - 1276
  • [3] ANSEL HC, 1990, PHARM DOSAGE FORMS D, P134
  • [4] Ciurczak EW, 1991, PHARM TECH, V15, P140
  • [5] HAILEY PA, UNPUB J PHARM BIOMED
  • [6] HARWOOD CF, 1977, J POWDER BULK SOLIDS, V1, P1
  • [7] ANALYSIS OF INTACT TABLETS BY NEAR-INFRARED REFLECTANCE SPECTROMETRY
    LODDER, RA
    HIEFTJE, GM
    [J]. APPLIED SPECTROSCOPY, 1988, 42 (04) : 556 - 558
  • [8] SCHIESSEL R, 1991, FALK SYMP, V59, P127
  • [9] UHL VW, 1967, MIXING THEORY PRACTI
  • [10] Van Scoik K, 1992, THEORY MIXING SOLIDS