On-line monitoring of a granulation process by NIR spectroscopy

Journal of Pharmaceutical Sciences

Volumn 99, Issue 1, 2010, Pages 336-345

  Alcalà, Manel ^a   Blanco, Marcelo ^a   Bautista, Manel ^a   González, Josep M ^b  

^a UNIVERSITAT AUTÒNOMA DE BARCELONA   (Spain)

^b c Alfons XII   (Spain)

Author keywords

Granulation; Monitoring; NIR spectroscopy; Partial least squares; Principal component analysis

Indexed keywords

MICROCRYSTALLINE CELLULOSE;

ARTICLE; BULK DENSITY; NEAR INFRARED SPECTROSCOPY; ONLINE MONITORING; PARTICLE SIZE; PRINCIPAL COMPONENT ANALYSIS;

EID: 73949134593     PISSN: 00223549     EISSN: 15206017     Source Type: Journal    
DOI: 10.1002/jps.21818     Document Type: Article

References (16)

1. Royce A, Mecadon M, Holinej J, Karnachi A, Valazza S, Wei W. 2005. Process control and scale-up of high shear wet granulation. Am Pharm Rev 2:8-16.
2. Reich G. 2005. Near-infrared spectroscopy and imaging: Basic Principles and pharmaceutical applications. Adv Drug Del Rev 57:1109-1143.
3. U.S., Department of Health and Human Services. Food and Drug Administration (2004) Guidance for industry: PAT - A framework for innovative pharmaceutical development, manufacturing, and quality assurance. http://www.fda.gov/cder/guidance/6419fnl.pdf.
4. ICHGuidelines Q8, Q9, Q10. http://www.ich.org/cache/compo/276-254-1.html.
5. Rantanen J, Jorgensen A, Räsänen E, Luukonene P, Airaksinen S, Raiman J, Hänninen K, Antikainen O, Yliruusi J. 2001. Process analysis of fluidized bed granulation. AAPS PharmsciTech 2: article 21. http://www. aapspharmscitech.org/articles/pt0204/pt020421/pt020421.pdf
6. Otsuka M, Mouri Y, Matsuda Y. 2003. Chemometric evaluation of pharmaceutical properties of antipyrine granules by near-infrared spectroscopy. AAPS PharmSci 3: article 47.
7. Sekulic S, Ward HW, Brannegan DR, Stanley ED, Evans CL, Sciavolino ST, Hailey PA, Aldridge PK. 1996. On-line monitoring of powder blend homogeneity by near-infrared spectroscopy. Anal Chem 68:509-513.
8. Rantanen J, Wikström H, Turner R, Taylor LS. 2005. Use of in-line near-infrared spectroscopy in combination with chemometrics for improved understanding of pharmaceutical processes. Anal Chem 77:556-563.
9. Nieuwmeyer FJS, Damen M, Gerich A, Rusmini F, Maarschalk KV, Vromans H. 2007. Granule characterization during fluid bed drying by development of a near infrared method to determine water content and median granule size. Pharm Res 24:1854-1861.
10. Rambali B, Baert L, Massart DL. 2003. Scaling up of the fluidized bed granulation process. Int J Pharm 252:197-206.
11. Herting MG, Kleinebudde P. 2007. Roll compaction/dry granulation: Effect of raw material particle size on granule and tablet properties. Int J Pharm 338: 110-118.
12. Rambali B, Baert L, Massart DL. 2001. Using experimental design to optimize the process parameters in fluidized bed granulation on a semi-full scale. Int J Pharm 220:149-160.
13. Vojnovic D, Chicco D, El Zenary H. 1996. Doehlert experimental design applied to optmization and quality control of a granulation process in a high shear mixer. Int J Pharm 145:203-213.
14. 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.
15. Green RL, Thurau G, Pixley NC, Mateos A, Reed RA, Higgins JP. 2005. In-line monitoring of moisture content in fluid bed dryers using near-IR spectroscopy with consideration of sampling effects on method accuracy. Anal Chem 77:4515-4522.
16. Macias K, Carvajal MT. 2008. An assessment of techniques for determining particle size during high-shear wet granulation. Tablets Capsules 6: 32-40.