(398g) 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