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Monitoring manufacturing changes using molecular laser-induced
breakdown spectroscopy (MO-LIBS)
Doucet, François R.; Faustino, Patrick J.; Tourigny, Martine; Lyon, Robbe C.;
Sabsabi, Mohamad
Student paper: no Poster presentation preferred: yes
Monitoring Manufacturing Changes using Molecular Laser-Induced Breakdown
Spectroscopy (MO-LIBS)
François R. Doucet1, Patrick J. Faustino2, Martine Tourigny3, Robbe C. Lyon2 and Mohamad
Sabsabi1
1
National Research Council of Canada (IMI), Boucherville (QC), Canada
2
Division of Product Quality Research, CDER, US FDA, Silver Spring, MD, USA
3
Pharma Laser, Boucherville (QC), Canada
Since the Process Analytical Technologies (PAT) initiative of the Food and Drug Administration (FDA) was formally introduced in 2004, FDA has encouraged the use of PAT to promote real time process understanding to facilitate innovation and risk-based regulatory decisions. In many applications, LIBS makes possible at-line rapid measurements of many formulation ingredients as well as the possibility of stand-off analysis, in-situ, in-line and on-line process monitoring. These capabilities make LIBS an attractive PAT sensor technology that can be introduced virtually everywhere in the pharmaceutical manufacturing process. LIBS is now being considered as valuable analytical tool to understand the manufacturing process of solid dosage form [1].
MO-LIBS [2] uses the molecular band emission of small diatomic fragments and chemometrics to establish predictive model that allow quantitative measurements. This innovative approach coupled to the traditional LIBS based on atomic emission allows a complete simultaneous formulation ingredients analysis.
In the present work, the feasibility of the MO-LIBS [2] approach for quantitation of active drug within a solid dosage form, as well as the effects of various manufacturing parameters on its signal, were investigated. Additionally, the influences from several physical properties of the tablets on the MO-LIBS signals were examined. It was found that compression strength of the tablets influence the MO-LIBS signal significantly. This enables the possibility of monitoring that property. The results obtained in this work will highlight the potential for MO-LIBS to be more widely applied to process monitoring and quality control of pharmaceutical products.
[1] Archambault, J. F.; Vintiloiu, A.; Kwong, E.; AAPS PharmSciTech 6, E253 (2005).
[2] Doucet, F.R., Faustino, P.J., Sabsabi, M., Lyon R.C., Analytical Chemistry (Submitted) (2007).
