Determination of Spatially Resolved Tablet Density and Hardness Using Near-Infrared Chemical Imaging (NIR-CI)

被引:10
作者
Talwar, Sameer [1 ]
Roopwani, Rahul [1 ]
Anderson, Carl A. [1 ,2 ]
Buckner, Ira S. [1 ,2 ]
Drennen, James K., III [1 ,2 ]
机构
[1] Duquesne Univ, Grad Sch Pharmaceut Sci, Pittsburgh, PA 15282 USA
[2] Duquesne Univ, Duquesne Ctr Pharmaceut Technol, Pittsburgh, PA 15282 USA
关键词
Chemical imaging; Euclidean distance; hardness; micro-indentation; near-infrared spectroscopy; pharmaceutical tablets; pixel sampling; relative density; solid fraction; spatially resolved density; PHARMACEUTICAL APPLICATIONS; LEAST-SQUARES; SPECTROSCOPY; COMPACTION; CHEMOMETRICS; STRENGTH; SIMULATION; PREDICTION; REGRESSION; FORCE;
D O I
10.1177/0003702817693856
中图分类号
TH7 [仪器、仪表];
学科分类号
0804 ; 080401 ; 081102 ;
摘要
Near-infrared chemical imaging (NIR-CI) combines spectroscopy with digital imaging, enabling spatially resolved analysis and characterization of pharmaceutical samples. Hardness and relative density are critical quality attributes (CQA) that affect tablet performance. Intra-sample density or hardness variability can reveal deficiencies in formulation design or the tableting process. This study was designed to develop NIR-CI methods to predict spatially resolved tablet density and hardness. The method was implemented using a two-step procedure. First, NIR-CI was used to develop a relative density/solid fraction (SF) prediction method for pure microcrystalline cellulose (MCC) compacts only. A partial least squares (PLS) model for predicting SF was generated by regressing the spectra of certain representative pixels selected from each image against the compact SF. Pixel selection was accomplished with a threshold based on the Euclidean distance from the median tablet spectrum. Second, micro-indentation was performed on the calibration compacts to obtain hardness values. A univariate model was developed by relating the empirical hardness values to the NIR-CI predicted SF at the micro-indented pixel locations: this model generated spatially resolved hardness predictions for the entire tablet surface.
引用
收藏
页码:1906 / 1914
页数:9
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