Near Infrared Spectroscopic Method Development Based On Effective Simple Models for Continuous Quantitative Monitoring of Powder Mixing and Final Dosage Product in a Pharmaceutical Process

NIR Spectroscopic Method Development Based on Effective Simple Models for Continuous Quantitative Monitoring of Powder Mixing and Final Dosage Product in a Pharmaceutical Process

This research addresses the need to make near infrared (NIR) calibration models more robust. NIR spectroscopy has been effectively used for chemical quantification and to determine various physical properties of pharmaceutical samples [1-4]. Multivariate calibration methods have proven to be an excellent tool for extracting quantitative and physical information from NIR spectra. In spite of this progress there are still examples of NIR calibration models developed with lab prepared calibration samples with very poor prediction ability of manufacturing process samples [5, 6]. These research efforts provide evidence that there is still the need to identify how process variation affects the effectiveness, robustness and reliability of NIR calibration models. Within an established quality system and for a particular manufacturing process, one would expect an inverse relationship between the level of process understanding and the risk of producing a poor quality product [7]. Therefore, the proposed work will provide knowledge on the specific variation of the NIR spectra resulting from the effects of the individual manufacturing unit operations.

References

1.            Barajas, M.J., et al., Near-Infrared Spectroscopic Method for Real-Time Monitoring of Pharmaceutical Powders During Voiding. Applied Spectroscopy, 2007. 61(5): p. 490-496.

2.            Ropero, J., et al., Near-infrared Spectroscopy for the In-line Characterization of Powder Voiding Part I: Development of the Methodology. Journal of Pharmaceutical Innovation, 2009. 4(4): p. 187-197.

3.            Blanco, M. and M. Alcalá, Simultaneous quantification of five active principles in a pharamacutical preparation: Development and validation of near infrared spectroscopic method. European Journal of Pharamaceutical Sciences, 2006. 27: p. 280-286.

4.            Ropero, J., et al., Near-Infrared Chemical Imaging Slope as a New Method to Study Tablet Compaction and Tablet Relaxation. Appl. Spectrosc., 2011. 65(4): p. 459-465.

5.            Blanco, M., M. Bautista, and M. Alcalá, Preparing calibration sets for use in pharmaceutical analysis by NIR spectroscopy. Journal of Pharmaceutical Sciences, 2008. 97(3): p. 1236-1245.

6.            Blanco, M., et al., Influence of the procedure used to prepare the calibration sample set on the performance of near infrared spectroscopy in quantitative pharmaceutical analyses. Analyst, 2001. 126(7): p. 1129-34

7.            FDA, Guidance for industry: PAT – A framework for innovative pharmaceutical development, manufacturing and quality assurance; September 2004