A new PAT/QbD approach for the determination of blend homogeneity: Combination of on-line NIRS analysis with PC Scores Distance Analysis (PC-SDA)

European Journal of Pharmaceutics and Biopharmaceutics

Volumn 78, Issue 1, 2011, Pages 173-182

  Puchert, T ^a   Holzhauer, C V ^a   Menezes, J C ^b   Lochmann, D ^c   Reich, G ^a  

^a UNIVERSITY OF HEIDELBERG   (Germany)

^b INSTITUTO SUPERIOR TÉCNICO   (Portugal)

^c Quality Operations   (Germany)

Author keywords

Blending; Design space; NIR CI; on line NIRS; PAT; QbD

Indexed keywords

ARTICLE; CHEMOMETRICS; DATA ANALYSIS; IMAGE ANALYSIS; NEAR INFRARED SPECTROSCOPY; ONLINE ANALYTICAL PROCESSING; POWDER; PROCESS ANALYTICAL TECHNOLOGY; SYMMETRY PARAMETER IMAGE ANALYSIS;

MULTIVARIATE ANALYSIS; PRINCIPAL COMPONENT ANALYSIS; SPECTROSCOPY, NEAR-INFRARED; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 79953161873     PISSN: 09396411     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.ejpb.2010.12.015     Document Type: Article

References (49)

1. R. De Maesschalck, F.C. Sanchez, D.L. Massart, P. Doherty, and P. Hailey On-line monitoring of powder blending with near-infrared spectroscopy Appl. Spectrosc. 52 1998 725 731 (Pubitemid 128618654)
2. A.S.L. Mendez, G. de Carli, and C.V. Garcia Evaluation of powder mixing operation during batch production: application to operational qualification procedure in the pharmaceutical industry Powder Technol. 198 2010 310 313
3. C. Frahnert, M.L. Rao, and K. Grasmäder Analysis of eighteen antidepressants, four atypical antipsychotics and active metabolites in serum by liquid chromatography: a simple tool for therapeutic drug monitoring J. Chromatogr. B 794 2003 35 47 (Pubitemid 36897624)
4. S.S. Sekulic, J. Wakeman, P. Doherty, and P.A. Hailey Automated system for the on-line monitoring of powder blending processes using near-infrared spectroscopy. Part II. Qualitative approaches to blend evaluation J. Pharm. Biomed. Anal. 17 1998 1285 1309 (Pubitemid 29027737)
5. US Department of Health and Human Services: Food and Drug Administration, Guidance: PAT - A Framework for Innovative Pharmaceutical Development, Manufacturing and Quality Assurance, 2004.
6. J.K. Drennen III Quality by design - what does it really mean? JPI 2 2007 65 66
7. International Conference on Harmonisation, ICH Q8: Pharmaceutical Development: Step 4, 2006.
8. International Conference on Harmonisation, ICH Q9: Quality Risk Management Step 4, 2006.
9. International Conference on Harmonisation, ICH Q10: Pharmaceutical Quality System: Step 4, 2007.
10. R.A. Lionberger, S.L. Lee, L. Lee, A. Raw, and L.X. Yu Quality by design: concepts for ANDAs AAPS J. 10 2008 268 276
11. International Conference on Harmonisation, ICH Topic Q8 Annex - Pharmaceutical Development: Step 4, 2008.
12. P.A. Hailey, P. Doherty, P. Tapsell, T. Oliver, and P.K. Aldridge Automated system for the on-line monitoring of powder blending processes using near-infrared spectroscopy. Part I. System development and control J. Pharm. Biomed. Anal. 14 1996 551 559
13. M. Popo, S. Romero-Torres, C. Conde, and R.J. Romañach Blend uniformity analysis using stream sampling and near infrared spectroscopy AAPS PharmSciTech 3 2002 1 11
14. D.J. Wargo, and J.K. Drennen Near-infrared spectroscopic characterization of pharmaceutical powder blends J. Pharm. Biomed. Anal. 14 1996 1415 1423 (Pubitemid 26279287)
15. A.S. El-Hagrasy, and J.K. Drennen 3rd A Process Analytical Technology approach to near-infrared process control of pharmaceutical powder blending. Part III: quantitative near-infrared calibration for prediction of blend homogeneity and characterization of powder mixing kinetics J. Pharm. Sci. 95 2006 422 434 (Pubitemid 43241983)
16. L.J. Bellamy, A. Nordon, and D. Littlejohn Real-time monitoring of powder mixing in a convective blender using non-invasive reflectance NIR spectrometry Analyst 133 2008 58 64
17. H. Zhang, Z. Jiang, J.Y. Pi, H.K. Xu, and R. Du On-line monitoring of pharmaceutical production processes using hidden markov model J. Pharm. Sci. 98 2009 1487 1498
18. M. Blanco, R. Gozález Bañó, and E. Bertran Monitoring powder blending in pharmaceutical processes by use of near infrared spectroscopy Talanta 56 2002 203 212 (Pubitemid 34024074)
19. I. Storme-Paris, I. Clarot, S. Esposito, J.C. Chaumeil, A. Nicolas, F. Brion, A. Rieutord, and P. Chaminade Near InfraRed Spectroscopy homogeneity evaluation of complex powder blends in a small-scale pharmaceutical preformulation process, a real-life application Eur. J. Pharm. Biopharm. 72 2009 189 198
20. A.S. El-Hagrasy, H.R. Morris, F. D'Amico, R.A. Lodder, and J.K. Drennen 3rd Near-infrared spectroscopy and imaging for the monitoring of powder blend homogeneity J. Pharm. Sci. 90 2001 1298 1307 (Pubitemid 32867978)
21. E.T.S. Skibsted, H.F.M. Boelens, J.A. Westerhuis, D.T. Witte, and A.K. Smilde Simple assessment of homogeneity in pharmaceutical mixing processes using a near-infrared reflectance probe and control charts J. Pharm. Biomed. Anal. 41 2006 26 35
22. Z. Shi, R.P. Cogdill, S.M. Short, and C.A. Anderson Process characterization of powder blending by near-infrared spectroscopy: blend end-points and beyond J. Pharm. Biomed. Anal. 47 2008 738 745
23. F. Cuesta Sanchez, J. Toft, B. van den Bogaert, D.L. Massart, S.S. Dive, and P. Hailey Monitoring powder blending by NIR spectroscopy J. Anal. Chem. 352 1995 771 778
24. A.U. Vanarase, M. Alcala, J.I. Jerez Rozo, F.J. Muzzio, and R.J. Romanach Real-time monitoring of drug concentration in a continuous powder mixing process using NIR spectroscopy Chem. Eng. Sci. 65 2010 5728 5733
25. S. Virtanen, O. Antikainen, and J. Yliruusi Uniformity of poorly miscible powders determined by near infrared spectroscopy Int. J. Pharm. 345 2007 108 115 (Pubitemid 350087548)
26. ASTM-International, E1655-00 - Standard Practices for Infrared Multivariate Quantitative Analysis, 2010. < http://www.astm.org >.
27. G. Reich Near-infrared spectroscopy and imaging: basic principles and pharmaceutical applications Adv. Drug Deliv. Rev. 57 2005 1109 1143 (Pubitemid 40797572)
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 2007 683 700 (Pubitemid 47030775)
29. E.W. Ciurczak, and J.K. Drennen 3rd Blend uniformity analysis E.W. Ciurczak, J.K. Drennen 3rd Pharmaceutical and Medical Applications of Near-Infrared Spectroscopy 2002 Marcel Dekker, Inc. New York, USA 33 54
30. J.M. Amigo, J. Cruz, M. Bautista, S. Maspoch, J. Coello, and M. Blanco Study of pharmaceutical samples by NIR chemical-image and multivariate analysis Trends Anal. Chem. 27 2008 696 713
31. E.N. Lewis, L.H. Kidder, and E. Lee NIR chemical imaging as a process analytical tool Inn. Pharm. Tech. 2006 1 5
32. W. Li, A. Woldu, R. Kelly, J. McCool, R. Bruce, H. Rasmussen, J. Cunningham, and D. Winstead Measurement of drug agglomerates in powder blending simulation samples by near infrared chemical imaging Int. J. Pharm. 350 2008 369 373
33. H. Ma, and C.A. Anderson Characterization of pharmaceutical powder blends by NIR chemical imaging J. Pharm. Sci. 97 2008 3305 3320
34. T. Puchert, D. Lochmann, J.C. Menezes, G. Reich, A multivariate approach for the statistical evaluation of near-infrared chemical images using Symmetry Parameter Image Analysis (SPIA), Eur. J. Pharm. Biopharm., accepted for publication.
35. W. Li, M.C. Johnson, R. Bruce, H. Rasmussen, and G.D. Worosila The effect of beam size on real-time determination of powder blend homogeneity by an online near infrared sensor J. Pharm. Biomed. Anal. 43 2007 711 717 (Pubitemid 44960547)
36. SAS Institute, JMP Design of Experiments, Version 5.1.2, SAS Institute Inc., Cary, USA, 2004, pp. 3-175.
37. Z.R. Lazic Design and analysis of experiments Z.R. Lazic, Design of Experiments in Chemical Engineering 2004 Wiley-VCH Weinheim 157 464
38. D. Brone, A. Alexander, and F.J. Muzzio Quantitative characterization of mixing of dry powders in V-blenders AIChE J. 44 1998 271 278
39. R.J. Barnes, M.S. Dhanoa, and S.J. Lister Standard normal variate transformation and de-trending of near-infrared diffuse reflectance spectra Appl. Spectrosc. 43 1989 772 777
40. A. Savitzky, and H.J.E. Golay Smoothing and differentiation of data by simplified least squares procedures Anal. Chem. 36 1964 1627 1639
41. A. Candolfi, R. De Maesschalck, D. Jouan-Rimbaud, P.A. Hailey, and D.L. Massart The influence of data pre-processing in the pattern recognition of excipients near-infrared spectra J. Pharm. Biomed. Anal. 21 1999 115 132 (Pubitemid 29430148)
42. J.L.S. Lee, and I.S. Gilmore Principal component analysis J.C. Vickerman, I.S. Gilmore, Surface Analysis - The Principal Techniques second ed. 2009 John Wiley & Sons, Ltd. Chichester, UK 571 579
43. J.D. Kirsch, and J.K. Drennen 3rd Near-infrared spectroscopic monitoring of the film coating process Pharm. Res. 13 1996 234 237 (Pubitemid 26072143)
44. F.Y. Shih, and Y.-T. Wu Three-dimensional Euclidean distance transformation and its application to shortest path planning Pattern Recogn. 37 2004 79 92 (Pubitemid 37418419)
45. R. De Maesschalck, D. Jouan-Rimbaud, and D.L. Massart The Mahalanobis distance Chemometr. Intell. Lab. Syst. 50 2000 1 18 (Pubitemid 30019315)
46. T. Kourti, and J.F. MacGregor Process analysis, monitoring and diagnosis, using multivariate projection methods Chemometr. Intell. Lab. Syst. 28 1995 3 21
47. US Department of Health and Human Services: Food and Drug Administration, Guidance for Industry: Powder Blends and Finished Dosage Units - Stratified In-Process Dosage Unit Sampling and Assessment, 2003.
48. European Pharmacopoeia, 2.9.6, Uniformity of Content of Single-Dose Preparations, seventh ed., 2010.
49. European Pharmacopoeia, 2.9.40, Uniformity of Dosage Units, seventh ed., 2010.