In-line analysis of a fluid bed pellet coating process using a combination of near infrared and Raman spectroscopy

Journal of Chemometrics

Volumn 24, Issue 7-8, 2010, Pages 544-557

  Bogomolov, Andrey ^a   Engler, Maximiliane ^a   Melichar, Michael ^b   Wigmore, Anthony ^b  

^a J and M Analytik AG   (Germany)

^b Global Engineering Alliance GEA   (Germany)

Author keywords

Acryl EZE; Data augmentation; Lighthouse Probe; Moisture monitoring; Multivariate curve resolution; Near infrared spectroscopy; Opadry red; Pellet coating; Process analytical technology; Raman spectroscopy; SIMPLISMA

Indexed keywords

COATINGS; INFRARED DEVICES; MOISTURE CONTROL; NEAR INFRARED SPECTROSCOPY; PELLETIZING; RAMAN SPECTROSCOPY; REGRESSION ANALYSIS; SPECTROSCOPIC ANALYSIS; SPECTRUM ANALYSIS;

ACRYL-EZE; DATA AUGMENTATION; FLUID-BEDS; LIGHTHOUSE PROBE; MOISTURE MONITORING; MULTIVARIATE CURVE RESOLUTION; OPADRY RED; PELLET COATINGS; PROCESS ANALYTICAL TECHNOLOGY; SIMPLISMA;

PROBES;

EID: 77957084369     PISSN: 08869383     EISSN: 1099128X     Source Type: Journal    
DOI: 10.1002/cem.1329     Document Type: Article

References (33)

1. PAT-A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance. FDA Guidance for Industry. Available at: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070305.pdf [27 August 2009].
2. Aaltonen J, Gordon KC, Strachan CJ, Rades T. Perspectives in the use of spectroscopy to characterize pharmaceutical solids. Int. J. Pharm. 2008; 364: 159-169.
3. Sparén A, Johansson J, Svensson O, Folestad S, Claybourn M. Transmission Raman spectroscopy for quantitative analysis of pharmaceutical solids. Am. Pharm. Rev. 2009; 12: 62-73.
4. Walker GM, Bell SEJ, Greene BK, Zhai H, Jones DS, Andrews GP. The application of in-situ Raman spectroscopy to pharmaceutical fluidized bed granulation processes. Am. Pharm. Rev. 2009; 13: 64-70.
5. De Beer TRM, Allesø M, Goethals F, Coppens A, Heyden YV, Lopez De Diego H, Rantanen J, Verpoort F, Vervaet C, Remon JP, Baeyens WRG. Implementation of a process analytical technology system in a freeze-drying process using Raman spectroscopy for in-line process monitoring. Anal. Chem. 2007; 79: 7992-8003.
6. Hagrasy AEl, Chang S-Y, Desai D, Kiang S. Application of Raman Spectroscopy for Quantitative In-Line Monitoring of Tablet Coating. Am. Pharm. Rev. 2009; 9: 40-45.
7. Roggo Y, Chalus P, Maurer L, Lema-Martinez C, Edmond A, Jent N. A review of near infrared spectroscopy and chemometrics in pharmaceutical technologies. J. Pharm. Biomed. Anal. 2007; 44: 683-700.
8. Rodionova OY, Sokovikov YV, Pomerantsev AL. Quality control of packed raw materials in pharmaceutical industry. Anal. Chim. Acta 2009; 642: 222-227.
9. Rodionova OY, Houmøller LP, Pomerantsev AL, Geladi P, Burger J, Dorofeyev VL, Arzamastsev AP. NIR spectrometry for counterfeit drug detection: a feasibility study. Anal. Chim. Acta 2009; 549: 151-158.
10. Radtke G, Knop K, Lippold C. In-process control of direct pelletisation in the rotary fluidized bed using NIR spectroscopy. NIR News 1999; 10: 4-12.
11. Green RL, Thurau G, Pixley NC, Mateos A, Reed RA, Higgins JP. In-line monitoring of moisture content in fluid bed dryers using near-IR spectroscopy with consideration of sampling effects on method accuracy. Anal. Chem. 2005; 77: 4515-4522.
12. Nieuwmeyer FJS, Damen M, Gerich Ad, Rusmini F, vander Voort Maarschalk K, Vromans H. Granule characterization during fluid bed drying by development of a near infrared method to determine water contentandmediangranulesize.Pharm. Res.2007; 24:1854-1861.
13. Wold S, Cheney J, Kettaneh N, McCready C. The chemometric analysis of point and dynamic data in pharmaceutical and biotech production (PAT)-some objectives and approaches. Chemom. Intell. Lab. Syst. 2006; 84: 159-163.
14. Bogomolov A, Melichar M, Wigmore A, Grau K. Enabling PAT with the Lighthouse Probe. CAC-2008: 11th International Conference on Chemometrics in Analytical Chemistry, 30th June-4th July 2008, Montpellier, France, Book of Abstracts, 2: 201-203.
15. Device for optical measurements of substance concentrations [Vorrichtung zur optischen Messung von Stoffkonzentrationen], German Patent No. [Gebrauchsmuster Nr.] 10 2006 004 916.0, Int. Patent. No. PCT/EP207/00838, application of 01.02.2006.
16. Device for the analysis, specifically for photometric or spectrophotometric analysis [Vorrichtung zur Analyse, insbesondere fotometrischen oder spectralfotometrischen Analyse], German Patent No. [Gebrauchsmuster Nr.] 10 2006 013 341.2, application of 23.03.2006.
17. Calibration device for a measurement head [Kalibriervorrichtung für eine Messsonde], German Patent No. [Gebrauchsmuster Nr.] 20 2008 001 376.3, application of 30.01.2008.
18. Device for optical measurements of substances [Vorrichtung zur optischen Messung von Stoffen], German Patent No. [Gebrauchsmuster Nr.] 20 2008 003 764.6, application of 18.03.2008.
19. Windig W, Guilment J. Interactive self-modeling mixture analysis. Anal. Chem. 1991; 63: 1425-1432.
20. Windig W, Lippert JL, Robbins MJ, Kresinske KR, Twist JP, Snyder AP. Interactive self-modeling multivariate analysis. Chemom. Intell. Lab. Syst. 1990; 9: 7-30.
21. Bogomolov A, Hachey M, Williams A. Software for interactive curve resolution using SIMPLISMA. In Progress in Chemometrics Research, Pomerantsev AL (ed.). Nova Science Publishers: New York, 2005; 119-135.
22. Esbensen KH. Multivariate Data Analysis-In Practice (5th edn). CAMO Process AS: Oslo, 2001; 75-76, 137-154, 256-258.
23. The Unscrambler technical references online http://www.camo.com/ TheUnscrambler/Appendices [10 April 2010].
24. Andersson M, Folestad S, Gottfries J, Johansson MO, Josefson M, Wahlund K-G. Quantitative analysis of film coating in a fluidized bed process by in-line NIR spectrometry and multivariate batch calibration. Anal. Chem. 2000; 72: 2099-2108.
25. Berntsson O, Burger T, Folestad S, Danielsson L-G, Kuhn J, Fricke J. Eeffective sample size in diffuse reflectance near-IR spectrometry. Anal. Chem. 1999; 71: 617-623.
26. Kucheryavski S, Esbensen KH, Bogomolov A. Monitoring of pellet coating process with image analysis-a feasibility study. J. Chemom. Published Online: 26 May 2010.
27. Bogomolov A, Windig W, Geer SM, Blondell DB, Robbins MJ. Interactive series baseline correction algorithm, Winter Symposium on Chemometrics (WSC-4), Chernogolovka, Russia, 15-18 February 2005.
28. Windig W, Gallagher N, Boruta M, Hachey M, Bogomolov A. Selfmodeling mixture analysis by pure variable methods, Federation of Analytical Chemistry and Spectroscopy Societies (FACSS), Quebec, Canada, 9-13 October 2005.
29. Socrates G. Infrared Characteristic Group Frequencies: Tables and Charts (2nd edn). Wiley: Toronto, 1994.
30. Online spectral database. http://riodb01.ibase.aist.go.jp/sdbs/cgi-bin/cre_index.cgi [25 August 1999].
31. Tauler R, Kowalski B. Multivariate curve resolution applied to spectral data from multiple runs of an industrial process. Anal. Chem. 1993; 65: 2040-2047.
32. Malinowski ER. Factor Analysis in Chemistry (3rd edn). Wiley: New York, 2002; 200-206.
33. De Groot PG, Swierenga H, Postma GJ, Melssen WJ, Buydens LMC. Effect on the partial least-squares prediction of Yarn properties combining Raman and infrared measurements and applying wavelength selection. Appl. Spectrosc. 2003; 57: 642-648.