Application of Raman spectroscopy to process analytical technology (PAT)
- Authors: Tihonova V.V1, Saushkina A.S1
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Affiliations:
- Saint-Petersburg State Chemical Pharmaceutical University
- Issue: Vol 23, No 10 (2020)
- Pages: 35-39
- Section: Articles
- URL: https://journals.eco-vector.com/1560-9596/article/view/112788
- DOI: https://doi.org/10.29296/25877313-2020-10-05
- ID: 112788
Cite item
Open Access
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Abstract
The Raman effect predicted in 1918 and experimentally confirmed in 1928 represents the ability of molecules to inelastic scattering of monochromatic light. Raman rays obtained after contact with the substance are separated by a light filter from the Rayleigh rays and their frequencies are recorded to collect spectral information about the sample. Based on this principle, Raman spectroscopy is an expressive non-destructive and universal analysis method for identifying objects in biology, medicine, pharmacy, forensic science, gemology, food industry, etc. The active introduction into the pharmaceutical production system of the system of process-analytical technologies (PAT) as a tool for compliance with GMP standards requires the development of analysis methods that allow you to quickly and fully control the quality of products at all stages of the production process. One of analytical methods that can successfully solve the problems of the modern pharmaceutical industry is Raman spectroscopy. In contrast to the methods of pharmaceutical analysis, the key advantages of Raman spectroscopy are the absence of sample preparation and small amounts of the research object, the possibility of obtaining information from the far IR region. It is compensated for during long-term continuous use due to the consumption of reagents, such as, for example, organic solvents. The method allows one to establish the quality of pharmaceutical substances, both chemical and biological, to assess their purity and to determine the quantitative content of the target component. In addition, Raman spectroscopy combined with modern mathematical data methods makes possible to establish the completion moment of process run in closed reactors, as well as to promptly signal deviations in them. The article presents the results of a review of literature data reflecting the capabilities of Raman spectroscopy (Raman spectroscopy) for quality control of drugs and agents in process analysis technology (PAT).
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About the authors
V. V Tihonova
Saint-Petersburg State Chemical Pharmaceutical University
Email: viktoriya.tihonova@spcpu.ru
Post-graduate Student
A. S Saushkina
Saint-Petersburg State Chemical Pharmaceutical UniversityPh.D. (Pharm.), Associate Professor
References
- Государственная Фармакопея РФ XIV издания. ФС 1.2.1.1.0009.15 «Рамановская спектроскопия» [Электронный ресурс]. Режим доступа tTRL:http://resource.rucml.ru/ femVphamacopia/14_l/HTML/8. (Дата обращения 17.04.2020)
- Guidance for Industry. PAT-A Framework for Innovative-Pharmaceutical Development, Manufacturing, and Quality Assurance [Электронный ресурс]. Режим доступа: https://www.fda.gov/media/71012/download (Дата обращения: 19.07.2019)
- О Руководстве по валидации процесса производства лекарственных препаратов для медицинского применения: рекомендация Коллегии Евразийской экономической комиссии от 26.09.2017 № 19 [Электронный ресурс]. Режим доступа URL:https://gmpnews.ru/wp-content/uploads/2017/ 10/clcr_28092017_19.pdf (Дата обращения: 28.08.2020)
- Reddy J.P., Jones J.W., Wray P.S. et al. Monitoring of multiple solvent induced form changes during high shear wet granulation and drying processes using online Raman spectroscopy. International Journal of Pharmaceutics. 2018; 1-2 (541): 253-260.
- Guo iV., Hou B., Wang N. et al. In situ monitoring and modeling of the solution-mediated polymorphic transformation of rifampicin from form II to form I. Journal of Pharmaceutical Sciences. 2018; 1(107): 344-352.
- Soares F.L.F., Careneiro R.L. In-line monitoring of cocrystallization process and quantification of carbamazepine-nicotinamide cocrystal using Raman spectroscopy and chemometric tools. Spectrochimica Acta Part A: Molecular and Biomolecular Spectroscopy. 2017; 180: 1-8.
- Otaki Т., Tanabe Y., Kojima T. etal. In situ monitoring of cocrystals in formulation development using low-frequency Raman spectroscopy. International Journal of Pharmaceutics. 2018; 1-2 (542): 56-65.
- Harting J., Kleinebudde P. Development of an in-line Raman spectroscopic method for continuous API quantification during twin-screw wet granulation. European Journal of Pharmaceutics and Biopharmaceutics. 2018;125 (530): 21-29.
- Nagy B., Farkas A., Gyurkes M. et al. In-line Raman spectroscopic monitoring and feedback control of a continuous win-screw pharmaceutical powder blending and tableting process. International Journal of Pharmaceutics. 2017; 1-2(530): 169-181.
- Biramani S., Kleinebudde P. Evaluation of in-line Raman data for end-point determination of a coating process: Comparison of Science-Based Calibration, PLS-regression and univariate data analysis. European Journal of Pharmaceutics and Biopharmaceutics. 2018; 119: 28-35.
- Kim B.,Woo Y.-A. Coating process optimization through inline monitoring for coating weight gain using Raman spectroscopy and design of experiments. Journal of Pharmaceutical and Biomedical Analysis. 2018; 154: 278-284.
- Netchacovitch L., Thiry J., De Bleye C. et al. Vibrational spectroscopy and microspectroscopy analyzing qualitatively and quantitatively pharmaceutical hot melt extrudates. Journal of Pharmaceutical and Biomedical Analysis. 2015; 113: 21-33.
- Netchacovitch L., Thiry J., De Bleye C. et al. Global approach for the validation of an in-line Raman spectroscopic method to determine the API content in real-time during a hot-melt extrusion process.Talanta. 2017; 171: 45-52.
- Европейская фармакопея 9 издание [Электронный ресурс]. Режим доступа URL: http://online.edqm.eu/ent-ry.html. Дата обращения: 11.09.2019.
- Yan-Hua L., Jun-Dong Z, Кип Y. et al. Real-time Quantitative Monitoring of Synthesis Process of Clevidipine Butyrate Using Raman Spectroscopy. Chinese Journal Of Analytical Chemistry.-2017;2 (45): 1701-1708.
- Wang FI., Barona D., Oladepo S. et al. Macro-Raman spectroscopy for bulk composition and homogeneity analysis of multi-component pharmaceutical powders. Journal of Pharmaceutical and Biomedical Analysis. 2017; 1-2 (542): 21-29.
- Rantanen J., Wikstrom H.K., Rhea F.E., Taylor L.S. Improved understanding of factors contributing to quantification of anhydrate/hydrate powder mixtures. Applied Spectroscopy. 2005; 7(59): 180-191.
- Rathore A.S., Bhambure R., Ghare V. Process analytical technology (PAT) for biopharmaceutical products. Analytical and Bioanalytical Chemistry. 2010; 398: 137-154.
- Li М., Ebel B., Chauchard F. et al. Parallel comparison of in situ Raman and NIR spectroscopies to simultaneously measure multiple variables toward real-time monitoring of CHO cell bioreactor cultures. Biochemical Engineering Journal. 2018; 137: 205-213.
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