Jamrógiewicz Marzena, Cal Krzysztof, Gruszecka Magdalena, Ciesielski Aleksander
Medical University of Gdansk, Faculty of Pharmacy with Subfaculty of Laboratory Medicine, Department of Physical Chemistry, 80-416 Gdańsk, Hallera 107, Poland.
Acta Pol Pharm. 2013 May-Jun;70(3):419-29.
Near infrared (NIR) spectroscopy was used for estimation of powder blend homogeneity and manufacturing control of a medicinal product powder mixture containing active pharmaceutical ingredient (API). Aiming at initiating a Process Analytical Technology (PAT) activity, the first step was a stationary mode at-line evaluation. In this, the content of pharmaceutical active compound in the powder mixtures intended to the direct tabletting was estimated based on recorded NIR spectra. Five formulations containing different quantities of API were prepared and analyzed also by a reference method--UV-Vis spectroscopy. A chemometric model was developed for calculation of the API amount in the mixtures. The Principal Component Regression (PCR) and Partial Least Squares (PLS) algorithms were used to obtain a model useful in further implementation for the PAT recommendations, into in-line blending control.
近红外（NIR）光谱法用于评估含活性药物成分（API）的药品粉末混合物的粉末混合均匀性及生产控制。为启动过程分析技术（PAT）活动，第一步是进行静态模式的在线评估。在此过程中，基于记录的近红外光谱估算用于直接压片的粉末混合物中药物活性化合物的含量。制备了五种含有不同量API的制剂，并采用紫外可见光谱法这一参考方法进行分析。开发了一种化学计量学模型用于计算混合物中API的含量。使用主成分回归（PCR）和偏最小二乘法（PLS）算法来获得一个模型，该模型可用于进一步实施PAT建议，以实现在线混合控制。
