Comparison of torque measurements and near-infrared spectroscopy in characterization of a wet granulation process

Journal of Pharmaceutical Sciences

Volumn 93, Issue 9, 2004, Pages 2232-2243

  Jørgensen, Anna Cecilia ^a,b   Luukkonen, Pirjo ^c   Rantanen, Jukka ^a   Schæfer, Torben ^b   Juppo, Anne Mari ^c   Yliruusi, Jouko ^a  

^a UNIVERSITY OF HELSINKI   (Finland)

^b UNIVERSITY OF COPENHAGEN   (Denmark)

^c ASTRAZENECA R AND D   (Sweden)

Author keywords

Granulation; High shear mixer; Monitoring; Near infrared spectroscopy; Pseudopolymorphism; Torque; Water; Wet granulation

Indexed keywords

ALPHA LACTOSE; MICROCRYSTALLINE CELLULOSE; PHARMATOSE 200M; THEOPHYLLINE; WATER;

ADDITION REACTION; ARTICLE; DRUG GRANULATION; DRUG GRANULE; HIGH SHEAR MIXER; HUMIDITY; IMPELLER; INFRARED SPECTROSCOPY; MIXER; MOISTURE; PROCESS MONITORING; SHEAR FLOW; TORQUE; WATER ABSORPTION; WATER CONTENT; WET GRANULATION;

EID: 4344644776     PISSN: 00223549     EISSN: None     Source Type: Journal    
DOI: 10.1002/jps.20132     Document Type: Article

References (26)

1. Lindberg N-O. 1977. Studies on granulation in a small planetary mixer. II. Granulation of lactose and an antacid mixture. Acta Pharm Suec 14:197-204.
2. Bier HP, Leuenberger H, Sucker H. 1979. Determination of the uncritical quantity of granulating liquid by power measurements on planetary mixers. Pharm Ind 41:375-380.
3. Leuenberger H, Bier HP, Sucker H. 1979. Theory of the granulating-liquid requirement in the conventional granulation process. Pharm Technol 3:60-68.
4. Corvari V, Fry WC, Seibert WL, Augsburger L. 1992. Instrumentation of a high-shear mixer: Evaluation and comparison of a new capacitive sensor, a watt meter, and a strain-gage torque sensor for wet granulation monitoring. Pharm Res 9:1525-1533.
5. Kopcha M, Roland E, Bubb G, Vadino WA. 1992. Monitoring the granulation process in a high shear mixer/granulator: An evaluation of three approaches to instrumentation. Drug Dev Ind Pharm 18:1945-1968.
6. Holm P, Schæfer T, Kristensen HG. 1985. Granulation in high-speed mixers. Part VI. Effects of process conditions on power consumption and granule growth. Powder Technol 43:225-233.
7. Holm P, Schæfer T, Larsen C. 2001. End-point detection in a wet granulation process. Pharm Dev Technol 6:181-192.
8. Whitaker M, Baker GR, Westrup J, Goulding PA, Rudd DR, Belchamber RM, Collins MP. 2000. Application of acoustic emission to the monitoring and end point determination of a high shear granulation process. Int J Pharm 205:79-91.
9. Talu I, Tardos GI, van Ommen JR. 2001. Use of stress fluctuations to monitor wet granulation of powders. Powder Technol 117:149-162.
10. Watano S. 2001. Direct control of wet granulation processes by image processing system. Powder Technol 117:163-172.
11. Osborne BG, Fearn T, Hindle PH. 1993. Practical NIR spectroscopy with applications in food and beverage analysis, 2nd ed. Harlow, UK: Longman Group UK.
12. 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.
13. Rantanen J, Lehtola S, Rämet P, Mannermaa J-P, Yliruusi J. 1998. On-line monitoring of moisture content in an instrumented fluidized bed granulator with a multi-channel NIR moisture sensor. Powder Technol 99:163-170.
14. Watano S, Terashita K, Miyanami K. 1991. Determination of end-point with a complex granulation applying infrared moisture sensor. Chem Pharm Bull 39:1013-1017.
15. Herman J, Remon JP, Visavarungroj N, Schwartz JB, Klinger GH. 1988. Formation of theophylline monohydrate during the pelletisation of microcrystalline cellulose-anhydrous theophylline blends. Int J Pharm 42:15-18.
16. Räsänen E, Rantanen J, Jørgensen A, Karjalainen M, Paakkari T, Yliruusi J. 2001. Novel identification of pseudopolymorphic changes of theophylline during wet granulation using near infrared spectroscopy. J Pharm Sci 90:389-396.
17. Density of solids, European Pharmacopoeia, 2001, 4th ed. Strasbourg, France: Council of Europe, pp 57-58.
18. Luukkonen P, Rantanen J, Mäkelä K, Räsänen E, Tenhunen J, Yliruusi J. 2001. Characterization of wet massing behavior of silicified microcrystalline cellulose and α-lactose monohydrate using near-infrared spectroscopy. Pharm Dev Technol 6:1-9.
19. Holm P, Schæfer T, Kristensen HG. 1985. Granulation in high-speed mixers. Part V. Power consumption and temperature changes during granulation. Powder Technol 43:213-223.
20. Kibbe AH, editor. 2000. Handbook of pharmaceutical excipients, 3rd ed. Washington, DC: American Pharmaceutical Association, pp 276-285.
21. The Merck Index, an encyclopedia of chemicals, drugs, and biologicals, 2001, 13th ed. Whitehouse Station, NJ: Merck & Co., Inc. p 1654.
22. Jaiyeoba KT, Spring MS. 1980. The granulation of ternary mixtures: The effect of the solubility of the excipients. J Pharm Pharmacol 32:1-5.
23. Burns DA, Ciurczak EW. 2001. Handbook of near-infrared analysis, 2nd ed. Basel, Switzerland: Marcel Dekker AG.
24. Williams P, Norris K. 1987. Near-infrared technology in the agricultural and food industries, 1st ed. St. Paul, MI: American Assosiation of Cereal Chemists, Inc.
25. Snow RH, Allen T, Ennis BJ, Litster JD. 1997. Size reduction and size enlargement. In: Perry R, Green D, editors. Perry's Chemical engineer's handbook, 7th ed. New York: McGraw-Hill. pp 20-1-20-89.
26. Hailey PA, Doherty P, Tapsell P, Oliver T, Aldridge PK. 1996. 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 14:551-559.