Real-time determination of critical quality attributes using near-infrared spectroscopy: A contribution for Process Analytical Technology (PAT)

Quality by design (QbD) and process analytical technology (PAT) applications in pharmaceutical industry

“…In assessing the performance of the production process, chemometric methods, a useful tool for defining mathematical correlation, can be applied to real-time monitoring and control to realize the characterization of raw and intermediate products [1,14,15]. To optimize a tablet formulation NIRS Raman spectroscopy PCA Tablet formulation can be designed by using QbD [18] To determine the quantification of active pharmaceutical ingredients using PAT Fluorescence spectroscopy PLS Rapid and non-destructive method was developed simultaneous quantification of two active pharmaceutical ingredients in a tablet formulation [19] To develop a new method using direct analysis in real time mass spectrometry with PAT DART-MS HPLC Not required Rapid process development method was proposed using PAT [20] To investigate on line quantitative monitoring of alcohol precipitation NIRS PSO, LS-SVM, PLS Can be used as a process analyzer for noninvasive and online quantitative monitoring of alcohol precipitation [21] To investigate crystallization process UV Vis c PCA PAT tools can be used to explore crystallization process [22] To evaluate and control the coating process of drug NIRS PLS PAT can be used for drug coating process [23] Pharmaceutical granulation process NIRS PLS NIRS is a useful PAT tool [24] Extraction process NIRS PLS Successful models have been built and applied online for extraction process [25] …”

“…Rosas et al [24] developed a method for the non-invasive determination of the critical quality attributes (CQAs) of a pharmaceutical granulate with a view to reduce its manufacturing time and to obtain a better knowledge of the effects of some variables used in the production process. They reported that near Infrared spectroscopy (NIRS) has been successfully used to develop faster and non-invasive quantitative methods for real-time prediction of the critical quality attributes (CQA) of pharmaceutical granulates (API content, pH, moisture, flowability, the angle of repose, and particle size).…”

Strategy for design NIR calibration sets based on process spectrum and model space: An innovative approach for process analytical technology

“…Variability in S p can be increased or decreased by using a multiplying factor m close to unity. Simply adding up the spectra as described above provides an "extended variability matrix" S red*m [14][15][16].…”

“…To this end, we constructed a different PLS calibration model for each stage by using a simple, novel approach requiring no reference method to select the calibration set. The proposed approach incorporate the variability of production samples to the calibration set via an algebraic procedure involving addition of the process spectrum [14][15][16]. Also, it uses the model space (a new concept based on the statistics Hotelling's T 2 and Q-residuals [17][18][19]) to optimize the sample selection process and facilitate construction of the calibration model.…”

Study of fluid bed granulation processes with new technology approaches

“…The proper understanding of all operations and variables connecting the raw materials to the end products is one of the key factors to ensuring the quality of the products and continuous improvement in their production (Rosas et al, 2012). …”