Gaining fluid bed process understanding by in-line particle size analysis

Journal of Pharmaceutical Sciences

Volumn 98, Issue 3, 2009, Pages 1110-1117

  Närvänen, Tero ^a   Lipsanen, Tanja ^a   Antikainen, Osmo ^b   Räikkönen, Heikki ^b   Heinämäki, Jyrki ^b   Yliruusi, Jouko ^b  

^a ORION CORPORATION   (Finland)

^b UNIVERSITY OF HELSINKI   (Finland)

Author keywords

Drying; Fluid bed; Granulation; Particle size; Processing

Indexed keywords

ARTICLE; DRUG FORMULATION; DRUG MANUFACTURE; FILTRATION; FLUID BED GRANULATION; FLUIDIZATION; GOOD MANUFACTURING PRACTICE; INTERMETHOD COMPARISON; PARTICLE SIZE; SPATIAL FILTERING TECHNIQUE;

EID: 62849097737     PISSN: 00223549     EISSN: 15206017     Source Type: Journal    
DOI: 10.1002/jps.21486     Document Type: Article

References (28)

1. Kristensen HG, Schaefer T. 1987. A review on pharmaceutical wet-granulation. Drug Dev Ind Pharm 13:803-872.
2. Faure A, York P, Rowe RC. 2001. Process control and scale-up of pharmaceutical wet granulation processes: A review. Eur J Pharm Biopharm 52:269-277.
3. Boerefijn R, Hounslow MJ. 2005. Studies of fluid bed granulation in an industrial R&D context. Chem Eng Sci 60:3879-3890.
4. Food and Drug Administration FDA, 2004. Guidance for Industry; PAT - A framework for innovative pharmaceutical development, manufacturing and quality assurance.
5. International Conference on Harmonisation, 2005. ICH harmonised tripartite guideline; Pharmaceutical Development Q8.
6. Frake P, Greenhalgh D, Grierson SM, Hempenstall JM, Rudd DR. 1997. Process control and end-point determination of a fluid bed granulation by application of near infra-red spectroscopy. Int J Pharm 151:75-80.
7. Goebel SG, Steffens KJ. 1998. Online-measurement of moisture and particle size in the fluidized-bed processing with the near-infrared-spectroscopy. Pharm Ind 60:889-895.
8. Rantanen J, Räsänen E, Tenhunen J, Känsäkoski M, Mannermaa J-P, Yliruusi J. 2000. In-line moisture measurement during granulation with a four-wavelength near infrared sensor: An evaluation of particle size and binder effects. Eur J Pharm Biopharm 50:271-276.
9. Otsuka M, Mouri Y, Matsuda Y. 2003. Chemometric evaluation of pharmaceutical properties of antipyrine granules by near-infrared spectroscopy. AAPS PharmSciTech 4:375-381.
10. Findlay WP, Peck GR, Morris KR. 2005. Determination of fluidized bed granulation end point using near-infrared spectroscopy and phenomenological analysis. J Pharm Sci 94:604-612.
11. Watano S, Miyanami K. 1995. Image processing for on-line monitoring of granule size distribution and shape in fluidized bed granulation. Powder Technol 83:55-60.
12. Watano S, Sato Y, Miyanami K. 1996. Control of granule growth in fluidized bed granulation by an image processing system. Chem Pharm Bull 44:1556-1560.
13. Watano S, Sato Y, Miyanami K. 1997. Optimization and validation of an image processing system in fluidized bed granulation. Adv Powder Technol 8:269-277.
14. Watano S. 2001. Direct control of wet granulation processes by image processing system. Powder Technol 117:163-172.
15. Laitinen N, Antikainen O, Rantanen J, Yliruusi J. 2004. New perspectives for visual characterization of pharmaceutical solids. J Pharm Sci 93:165-176.
16. Halstensen M, de Bakker P, Esbensen KH. 2005. Acoustic chemometric monitoring of fluidized bed granulation: Part I. Powder Handling Process 17:206-211.
17. Halstensen M, de Bakker P, Esbensen KH. 2006. Acoustic chemometric monitoring of an industrial granulation production process - A PAT feasibility study. Chemometr Intell Lab Syst 84:88-97.
18. Ruf A, Worlitschek J, Mazzotti M. 2000. Modeling and experimental analysis of PSD measurements through FBRM. Part Part Syst Charact 17:167-179.
19. Petrak D. 2002. Simultaneous measurement of particle size and particle velocity by the spatial filtering technique. Part Part Syst Charact 19:391-400.
20. Braatz RD. 2002. Advanced control of crystallization processes. Ann Rev Control 26:87-99.
21. Kougoulos E, Jones AG, Jennings KH, Wood-Kaczmar MW. 2005. Use of focused beam reflectance measurement (FBRM) and process video imaging (PVI) in a modified mixed suspension mixed product removal (MSMPR) cooling crystallizer. J Cryst Growth 273:529-534.
22. Barrett P, Smith B, Worlitschek J, Bracken V, O'Sullivan B, O'Grady D. 2005. A review of the use of process analytical technology for the understanding and optimization of production batch crystallization processes. Org Proc Res Dev 9:348-355.
23. Hu X, Cunningham JC, Winstead D. 2008. Study growth kinetics in fluidised bed granulation with at-line FBRM. Int J Pharm 347:54-61.
24. Rantanen J, Känsäkoski M, Suhonen J, Tenhunen J, Lehtonen S, Rajalahti T, Mannermaa JP, Yliruusi J. 2000. Next generation fluidized bed granulator automation. AAPS PharmSciTech 1: article 10 (http://www. aapspharmscitech.org\).
25. Bloemen HHJ, De Kroon MGM. 2005. Transformation of chord length distributions into particle size distributions using least squares techniques. Part Sci Technol 23:377-386.
26. Hoffmann AC, Romp EJ. 1991. Segregation in a fluidized powder of a continuous size distribution. Powder Technol 66:119-126.
27. Huilin L, Yurong H, Gidaspow D, Lidan Y, Yukun Q. 2003. Size segregation of binary mixture of solids in bubbling fluidized beds. Powder Technol 134:86-97.
28. Wormsbecker M, Adams A, Pugsley T, Winters C. 2005. Segregation by size difference in a conical fluidized bed of pharmaceutical granulate. Powder Technol 153:72-80.