Development of a Process Analytical Technology (PAT) for in-line monitoring of film thickness and mass of coating materials during a pan coating operation

European Journal of Pharmaceutical Sciences

Volumn 43, Issue 4, 2011, Pages 244-250

  Gendre, Claire ^a,b,c   Genty, Muriel ^a   Boiret, Mathieu ^a   Julien, Marc ^a   Meunier, Loïc ^a   Lecoq, Olivier ^b   Baron, Michel ^b   Chaminade, Pierre ^c   Péan, Jean Manuel ^a  

^a INSTITUT DE RECHERCHES INTERNATIONALES SERVIER   (France)

^b UNIVERSITÉ DE TOULOUSE   (France)

^c University Paris Saclay   (France)

Author keywords

Coating; In line measurements; Near Infrared Spectroscopy (NIRS); Process Analytical Technology (PAT); Real time monitoring; Terahertz Pulsed Imaging (TPI)

Indexed keywords

COPOLYMER; ETHYL CELLULOSE; MACROGOL; POLYVINYL ALCOHOL;

AQUEOUS SOLUTION; ARTICLE; DRUG COATING; FILM; IMAGING; NEAR INFRARED SPECTROSCOPY; ONLINE MONITORING; PRIORITY JOURNAL; PROCESS ANALYTICAL TECHNOLOGY; PROCESS TECHNOLOGY; QUANTITATIVE ANALYSIS; TECHNOLOGY; TERAHERTZ PULSED IMAGING;

CELLULOSE; CHEMISTRY, PHARMACEUTICAL; DRUG COMPOUNDING; MULTIVARIATE ANALYSIS; PHARMACEUTICAL PREPARATIONS; POLYETHYLENE GLYCOLS; POLYMERS; PRINCIPAL COMPONENT ANALYSIS; SPECTROSCOPY, NEAR-INFRARED; TABLETS, ENTERIC-COATED; TECHNOLOGY, PHARMACEUTICAL; TERAHERTZ IMAGING;

EID: 79959618960     PISSN: 09280987     EISSN: 18790720     Source Type: Journal    
DOI: 10.1016/j.ejps.2011.04.017     Document Type: Article

References (35)

1. M. Andersson, M. Josefson, F.W. Langkilde, and K. Wahlund Monitoring of a film coating process for tablets using near infrared reflectance spectrometry J. Pharm. Biomed. Anal. 20 1999 27 37 (Pubitemid 29206581)
2. M. Andersson, S. Folestad, J. Gottfries, M.O. Johansson, M. Josefson, and K. Wahlund Quantitative analysis of film coating in a fluidized bed process by in-line NIR Spectrometry and multivariate batch calibration Anal. Chem. 72 2000 2099 2108 (Pubitemid 30316588)
3. R.J. Barnes, M.S. Dhanoa, and S.J. Lister Standard normal variate transformation and detrending of near infrared diffuse reflectance Appl. Spectrosc. 43 5 1989 772 779
4. K.H. Bauer, K. Lehmann, H.P. Osterwald, and G. Rothgang Coated Pharmaceutical Dosage Form: Fundamentals, Manufacturing Techniques, Biopharmaceutical Aspects, Test Methods and Raw Materials 1998 Medpharm GmbH, Scientific Publishers Stuttgart
5. C. Cahyadi, A. Karande, L. Chan, and P. Heng Comparative study of non-destructive methods to quantify thickness of tablet coatings Int. J. Pharm. 398 2010 39 49
6. R.P. Cogdill, R. Forcht, Y. Shen, P.F. Taday, J. Creekmore, C.A. Anderson, and J.K. Drennen Comparison of terahertz pulse imaging and near-infrared spectroscopy for rapid, non-destructive analysis of tablet coating thickness and uniformity J. Pharm. Innov. 2 1 2007 29 36 (Pubitemid 350054206)
7. A.J. Fitzgerald, B.E. Cole, and P.F. Taday Nondestructive analysis of tablet coating thickness using Terahertz Pulsed Imaging J. Pharm. Sci. 94 1 2005 177 183 (Pubitemid 40116381)
8. Food and Drug Administration, 2004. Guidance for Industry. PAT - A Framework for Innovative Pharmaceutical, Development, Manufacturing and Quality Assurance.
9. S.M. Han, and P.G. Faulker Determination of SB 216469-S during tablet production using near-infrared reflectance spectroscopy J. Pharm. Biomed. Anal. 14 12 1996 1681 1689 (Pubitemid 26306906)
10. L. Ho, R. Müller, M. Römer, K. Gordon, J. Heinämäki, P. Kleinebudde, M. Pepper, T. Rades, Y. Shen, C. Strachan, P. Taday, and J. Zeitler Analysis of sustained-release tablet film coats using terahertz pulsed imaging J. Control. Release 119 2007 253 261 (Pubitemid 46770883)
11. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, 2009. Pharmaceutical Development Q8 (R2).
12. J.D. Kirsch, and J.K. Drennen Determination of film-coated tablet parameters by near-infrared spectroscopy J. Pharm. Biomed. Anal. 13 1995 1273 1281
13. J.D. Kirsch, and J.K. Drennen Near-Infrared Spectroscopic monitoring of the film coating process Pharm. Res. 13 1996 234 237 (Pubitemid 26072143)
14. C.C. Larsen, J.M. Sonnergaard, P. Bertelsen, and P. Holm Validation of an image analysis method for estimating coating thickness on pellets Eur. J. Pharm. Sci. 18 2003 191 196 (Pubitemid 36184758)
15. M.-J. Lee, C.-R. Park, A.-Y. Kim, B.-S. Kwon, K.-H. Bang, Y.-S. Cho, M.-Y. Jeong, and G.-J. Choi Dynamic calibration for the in-line NIR monitoring of thickness of pharmaceutical tablets processed in a fluid-bed coater J. Pharm. Sci. 99 2010 325 335
16. M.-J. Lee, D.-Y. Seo, H.-C. Lee, I.-C. Wang, W.-S. Kim, M.-Y. Jeong, and G.-J. Choi In-line NIR quantification of film thickness on pharmaceutical pellets during a fluid bed coating process Int. J. Pharm. 403 2011 66 72
17. L. Maurer, and H. Leuenberger Terahertz pulsed imaging and near infrared imaging to monitor the coating process of pharmaceutical tablets Int. J. Pharm. 370 2009 8 16
18. J.W. McGinity, and L.A. Felton Aqueous Polymeric Coatings for Pharmaceutical Dosage Forms third ed. 2008 Informa Healthcare New York
19. J.J. Moes, M.M. Ruijken, E. Gout, H.W. Frijlink, and M.I. Ugwoke Application of process analytical technology in tablet process development using NIR Spectroscopy: blend uniformity, content uniformity and coating thickness measurements Int. J. Pharm. 357 2008 108 118
20. M. Možina, D. Tomaževič, S. Leben, F. Pernuš, and B. Likar Digital imaging as a process analytical technology tool for fluid-bed pellet coating process Eur. J. Pharm. Sci. 41 1 2010 156 162
21. S. Muschert, F. Siepmann, Y. Cuppok, B. Leclercq, B. Carlin, and J. Siepmann Improved long term stability of aqueous ethylcellulose film coatings: importance of the type of drug and starter core Int. J. Pharm. 368 2009 138 145
22. T. Naes, T. Isaksson, T. Fearn, and T. Davies A User-Friendly Guide to Multivariate Calibration and Classification 2002 NIR Publications Chichester
23. B.G. Osborne, T. Fearn, and P.H. Hindle Practical NIR spectroscopy with applications in food and beverage analysis second ed. 1993 Longman Group
24. J. Perez-Ramos, W. Findlay, G. Peck, and K. Morris Quantitative analysis of film coating in a pan coater based on in-line sensor measurement AAPS PharmSciTech 6 2005 E127 E136 (Pubitemid 41644136)
25. S. Porter, G. Sackett, and L. Liu Development, optimization and scale-up of process parameters: pan coating Y. Qiu, Y. Chen, G.G.Z. Zhang, Developing Solid Oral Dosage Forms: Pharmaceutical Theory and Practice first ed. 2009 Academic Press New York 761 805
26. G. Reich Near Infrared Spectroscopy and imaging: basic principles and pharmaceutical application Adv. Drug Deliv. Rev. 57 2005 1109 1143 (Pubitemid 40797572)
27. Y. Roggo, N. Jent, A. Edmond, P. Chalus, and M. Ulmschneider Characterizing process effects on pharmaceutical solid forms using near-infrared spectroscopy and infrared imaging Eur. J. Pharm. Biopharm. 61 2005 100 110 (Pubitemid 41096694)
28. Y. Roggo, P. Chalus, L. Maurer, C. Lema-Martinez, A. Edmond, and N. Jent A review of near infrared spectroscopy and chemometrics in pharmaceutical technologies J. Pharm. Biomed. Anal. 44 3 2007 683 700 (Pubitemid 47030775)
29. M. Römer, J. Heinämäki, C. Strachan, N. Sandler, and J. Yliruusi Prediction of tablet film-coating thickness using a rotating plate coating system and NIR spectroscopy AAPS PharmSciTech 9 4 2008 1047 1053
30. A. Savitzky, and M.J. Golay Smoothing and differentiation of data by simplified least squares procedures Anal. Chem. 36 1964 1627 1639
31. F. Siepmann, A. Hoffmann, B. Leclercq, B. Carlin, and J. Siepmann How to adjust desired drug release patterns from ethylcellulose-coated dosage forms J. Control. Release 119 2007 182 189 (Pubitemid 46778759)
32. S.H. Tabasi, R. Fahmy, D. Bensley, C. O'Brien, and S.W. Hoag Quality by design: Part II. Application of NIR spectroscopy to monitor the coating process for a pharmaceutical sustained release product J. Pharm. Sci. 97 9 2008 4052 4066
33. S. Wold, M. Sjöström, and L. Eriksson PLS-regression: a basic tool of chemometrics Chem. Int. Lab. Syst. 58 2001 109 130 (Pubitemid 33033283)
34. J.A. Zeitler, and L.F. Gladden In-vitro tomography and non-destructive imaging at depth of pharmaceutical solid dosage forms Eur. J. Pharm. Biopharm. 71 2008 2 22
35. J.A. Zeitler, Y. Shen, C. Baker, P.F. Taday, M. Pepper, and T. Rades Analysis of coating structures and interfaces in solid oral dosage forms by three dimensional terahertz pulsed imaging J. Pharm. Sci. 96 2 2007 330 340 (Pubitemid 46363564)