Pharmaceuticals

High-throughput monitoring and control of pharmaceutical processes and products

Team: João Almeida Lopes, Mafalda Sarraguça, Paulo Ribeiro, Ana Silva, Rita Matias, Bjorn-Hendrik Peters

The Process Analytical Technology (PAT) initiative issued by the Food and Drug Administration (FDA) in 2003 recommends to the pharmaceutical industry the development and employment of new technologies in the production and qualification of pharmaceuticals products.
The PAT framework states that the monitoring efforts should be focussed directly on the process and not after each production step. Spectroscopic methods such as on near-infrared (NIR), Raman or acoustic coupled with reflection/immersion probes are among the PAT tools that have been providing the best results. NIR spectroscopy is a powerful tool in several pharmaceutical areas such as research and development (R&D), scale-up operations, and quality control of intermediary and final products. NIR spectroscopy is a multitasking technique. It can be used, for example, to simultaneous predict physical and chemical properties of a sample, or to understand when a specific process ended. NIR is a fast, low-cost and non-destructive technique which requires virtually no sample processing. It’s being used successfully over the last ten years to assess quality of pharmaceuticals directly on the production line. In quality control (QC), targets are methods that can be validated using the adopted guidelines for QC methods validation. The studies performed explored the comprehensive development of NIR analytical protocols for the quantification/qualification of pharmaceuticals solid formulations to be used in the pharmaceutical industry.

Publications

  • A.F.T. Silva, A. Burggraeve, Q. Denon, P. Van der Meeren, N. Sandler, T. Van Den Kerkhof, M. Hellings, C. Vervaet, J.P. Remon, J.A. Lopes, T. De Beer (2013) Particle sizing measurements in pharmaceutical applications: comparison of in-process methods versus offline methods, Eur. J. Pharm. Biopharm., 85, 1006-1018 [doi: 10.1016/j.ejpb.2013.03.032]
  • Aksu B, De Beer T, Folestad S, Ketolainen J, Lindén H, Lopes JA, de Matas M, Oostra W, Rantanen J, Weimer M (2012) Strategic funding priorities in the pharmaceutical sciences allied to Quality by Design (QbD) and Process Analytical Technology (PAT), Eur. J. Pharma. Sci., 47, 402-405
  • Sarraguça MC, Lopes JA* (2011) A near-infrared spectroscopy method to determine aminoglycosides in pharmaceutical formulations, Vib. Spectrosc., 56, 184-192
  • Sarraguça MC, Cruz AV, Amaral HR, Costa PC, Lopes JA* (2011) Comparison of different chemometric and analytical methods for the prediction of particle size distribution in pharmaceutical powders, Anal. Bioanal. Chem., 399, 2137-2147
  • Sarraguça MC, De Beer T, Verdaet C, Remon J, Lopes JA* (2010) A Batch Modelling Approach to Monitor a Freeze-Drying Process Using In-Line Raman Spectroscopy, Talanta, 83(1), 130-138
  • Sarraguça MC, Cruz A, Soares S, Costa PC, Amaral HR, Lopes JA* (2010) Determination of flow properties of pharmaceutical powders by near infrared spectroscopy, J. Pharm. Biomed. Anal., 52, 484-492
  • Sarraguça MC, Lopes JA* (2009) The use of net analyte signal (NAS) in NIR spectroscopy: interpretability and figures of merit, Anal. Chim. Acta, 642, 179-185
  • Sarraguça MC, Lopes JA* (2009) Quality Control of Pharmaceuticals with NIR: From Lab to Process Line, Vib. Spectrosc., 49(2), 204-210
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