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Exploring Transmission Raman Spectroscopy and its Potential use in the Pharmaceutical Industry

Shashi Ravi Suman Rudrangi
Shashi Ravi Suman Rudrangi

This document discusses the potential use of transmission Raman spectroscopy (TRS) in the pharmaceutical industry. TRS is presented as a technique that could provide rapid, non-invasive analysis of pharmaceutical dosage forms from early development through manufacturing quality control. The document compares TRS to existing techniques like HPLC and NIR spectroscopy, noting advantages of TRS such as being non-destructive and having no sample preparation or fluorescence issues. The aim is to explore the TRS technique and investigate its applications through powder modeling studies and comparison to other analytical methods.

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Exploring Transmission Raman Spectroscopy and its Potential use in the Pharmaceutical Industry Shashi Ravi Suman Rudrangi, Bruce D. Alexander and Stephen R. Wicks School of Science, University of Greenwich, Chatham Maritime, Kent, U.K. Corresponding Author: rs86@gre.ac.uk ABSTRACT Commercial pressure and patient needs are drivers for accelerating the development and commercialisation of medicinal products. This leads to increased demands also on pharmaceutical analysis that can no longer afford to rely solely on traditional measurement strategies and will entail high levels of selectivity and sensitivity as opposed to speed of analysis. This requires modern analytical techniques to be fast, robust and rich in information, need minimal method development and be applied from early development through to production, still having sufficient accuracy and precision, reflecting different needs in the R&D phase and manufacturing quality control. Here, we compare and contrast Transmission Raman Spectroscopy (TRS), High Performance Liquid Chromatography (HPLC) and Near-infrared Spectroscopy (NIR), their scientific and operational methods and their interchange, using model drugs that are representative of problematic development candidates. EXISTING TECHNIQUES High Pressure Liquid Chromatography Near Infrared Spectroscopy Raman Spectroscopy High selectivity. Non-invasive and non-destructive. High speed. Incumbent technique. Sharp spectra ease interpretation. Little or no sample preparation. Benchmark analytical technique to High selectivity. Non-invasive and non-destructive. identify and quantify mixtures. Small calibration sets. Excellent for wide range of samples. RR NIR spectra of Paracetamol tablet HPLC analysis of Paracetamol standard Limitations: Limitations: Low selectivity. Raman spectra of Blister Pack, Very slow and destructive. Sensitive to variations in physical Paracetamol tablet, Microcrystalline Method development is not trivial. parameters. cellulose Difficult to detect co-elution in Interpretation is difficult. Limitations: standard detection modes. Lengthy calibration sets make Problem of sub sampling. Limited to analysis of compounds not validation difficult and expensive. Sensitivity. reactive with mobile/stationary phase. Problem of sub sampling. Fluorescence. TRANSMISSION RAMAN SPECTROSCOPY New extension of Conventional Raman. Potential for rapid quantitative analysis of pharmaceutical dosage forms. Applicable in early development through to manufacturing quality control. Backscattering T (Conventional) Transmission Advantages of TRS over other techniques: 損 Rapid, non-invasive, non-destructive, and high accuracy. 損 No surface sensitivity as in Reflectance NIR, conventional Raman. 損 No phase changes due to sample preparation. 損 Sub sampling is less of a problem. 損 No problem of fluorescence as in Raman. Transmission and Conventional Raman spectra of Capsule 損 Potential to provide quantitative information on the mixtures. AIMS REFERENCES TRS is a comparatively new technique. Our aim is to explore 1. H. Wang, C. K. Mann, T.J. Vickers (2002). Appl. Spectrosc. 56(12):153 the technique and investigate its potential applications. 2. J. Johansson, S. Pettersson, S. Folestad (2005). J. Pharm. Biomed. Anal. 39: 516. 3. J. Johansson, A. Sparen, O. Svensson, S. Folestad and M. Claybourn (2007). Appl. Comparison of HPLC, NIR and TRS techniques. Spectrosc. 61(11): 1211. Powder modelling studies. 4. C. Eliasson, N. A. Macleod and P. Matousek (2008). Central Laser Facility Annual Report 2007-2008.

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Exploring Transmission Raman Spectroscopy and its Potential use in the Pharmaceutical Industry

  • 1. Exploring Transmission Raman Spectroscopy and its Potential use in the Pharmaceutical Industry Shashi Ravi Suman Rudrangi, Bruce D. Alexander and Stephen R. Wicks School of Science, University of Greenwich, Chatham Maritime, Kent, U.K. Corresponding Author: rs86@gre.ac.uk ABSTRACT Commercial pressure and patient needs are drivers for accelerating the development and commercialisation of medicinal products. This leads to increased demands also on pharmaceutical analysis that can no longer afford to rely solely on traditional measurement strategies and will entail high levels of selectivity and sensitivity as opposed to speed of analysis. This requires modern analytical techniques to be fast, robust and rich in information, need minimal method development and be applied from early development through to production, still having sufficient accuracy and precision, reflecting different needs in the R&D phase and manufacturing quality control. Here, we compare and contrast Transmission Raman Spectroscopy (TRS), High Performance Liquid Chromatography (HPLC) and Near-infrared Spectroscopy (NIR), their scientific and operational methods and their interchange, using model drugs that are representative of problematic development candidates. EXISTING TECHNIQUES High Pressure Liquid Chromatography Near Infrared Spectroscopy Raman Spectroscopy High selectivity. Non-invasive and non-destructive. High speed. Incumbent technique. Sharp spectra ease interpretation. Little or no sample preparation. Benchmark analytical technique to High selectivity. Non-invasive and non-destructive. identify and quantify mixtures. Small calibration sets. Excellent for wide range of samples. RR NIR spectra of Paracetamol tablet HPLC analysis of Paracetamol standard Limitations: Limitations: Low selectivity. Raman spectra of Blister Pack, Very slow and destructive. Sensitive to variations in physical Paracetamol tablet, Microcrystalline Method development is not trivial. parameters. cellulose Difficult to detect co-elution in Interpretation is difficult. Limitations: standard detection modes. Lengthy calibration sets make Problem of sub sampling. Limited to analysis of compounds not validation difficult and expensive. Sensitivity. reactive with mobile/stationary phase. Problem of sub sampling. Fluorescence. TRANSMISSION RAMAN SPECTROSCOPY New extension of Conventional Raman. Potential for rapid quantitative analysis of pharmaceutical dosage forms. Applicable in early development through to manufacturing quality control. Backscattering T (Conventional) Transmission Advantages of TRS over other techniques: 損 Rapid, non-invasive, non-destructive, and high accuracy. 損 No surface sensitivity as in Reflectance NIR, conventional Raman. 損 No phase changes due to sample preparation. 損 Sub sampling is less of a problem. 損 No problem of fluorescence as in Raman. Transmission and Conventional Raman spectra of Capsule 損 Potential to provide quantitative information on the mixtures. AIMS REFERENCES TRS is a comparatively new technique. Our aim is to explore 1. H. Wang, C. K. Mann, T.J. Vickers (2002). Appl. Spectrosc. 56(12):153 the technique and investigate its potential applications. 2. J. Johansson, S. Pettersson, S. Folestad (2005). J. Pharm. Biomed. Anal. 39: 516. 3. J. Johansson, A. Sparen, O. Svensson, S. Folestad and M. Claybourn (2007). Appl. Comparison of HPLC, NIR and TRS techniques. Spectrosc. 61(11): 1211. Powder modelling studies. 4. C. Eliasson, N. A. Macleod and P. Matousek (2008). Central Laser Facility Annual Report 2007-2008.