Sekulic S S, Ward H W, Brannegan D R, Stanley E D, Evans C L, Sciavolino S T, Hailey P A, Aldridge P K
Pfizer Central Research, Eastern Point Road, Groton, Connecticut, 06340 and Pfizer Central Research, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK.
Anal Chem. 1996 Feb 1;68(3):509-13. doi: 10.1021/ac950964m.
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.
近红外光谱法作为一种在线技术，用于监测混合过程中药物混合物的均匀性。制备了含有10%苯甲酸钠（模型活性成分）、39%微晶纤维素（微晶纤维素PH102）、50%乳糖和1%硬脂酸镁的混合物，以模拟实际药物混合物的性质，其中苯甲酸钠提供了许多药物化合物典型的芳香官能团。对双壳V型混合器进行了改造，以便在旋转轴处安装漫反射光纤探头，并使用市售近红外分光光度计在三个实验过程中收集光谱。在每个实验中，混合器控制和光谱数据收集由软件包的汇编进行控制。实验检测到光谱变化，最终收敛到一个恒定方差点。对光谱数据的进一步分析表明，在典型混合期结束之前很久，混合物就已经均匀了。近红外光谱法已被证明是一种用于“实时”无创测定药物混合物均匀性的可行且有效的方法。
