Monitoring galenical process development by near infrared chemical imaging: One case study

European Journal of Pharmaceutics and Biopharmaceutics

Volumn 68, Issue 3, 2008, Pages 828-837

  Gendrin, C ^a,b   Roggo, Y ^a   Spiegel, C ^a   Collet, C ^b  

^a F HOFFMANN LA ROCHE LTD   (Switzerland)

^b UNIVERSITÉ DE STRASBOURG   (France)

Author keywords

Extrusion; Galenical development; Homogeneity; Multivariate analysis; Near infrared imaging; Process Analytical Technology

Indexed keywords

ARTICLE; BIOTECHNOLOGY; CRYSTALLIZATION; MULTIVARIATE ANALYSIS; NEAR INFRARED SPECTROSCOPY; PARTICLE SIZE; UNIVARIATE ANALYSIS;

SPECTROSCOPY, NEAR-INFRARED; TABLETS; TECHNOLOGY, PHARMACEUTICAL;

EID: 39849105217     PISSN: 09396411     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.ejpb.2007.08.008     Document Type: Article

References (16)

1. Bakeev K.A. Process Analytical Technology (2005), Blackwell Publishing, Oxford
2. http://www.fda.gov/cder/OPS/PAT.htm.
3. Braekeleer K., Juan A., Sanchez F.C., Hailey P.A., Sharp D.C.A., Dunn P., and Massart D.L. Determination of the end point of a chemical synthesis process using on-line measured mid-infrared spectra. Appl. Spectrosc. 54 (2000) 601-607
4. Blanco M., Eustaquio A., Gonzalez J.M., and Serrano D. Identification and quantitation assays for intact tablets of two related pharmaceutical preparations by reflectance near-infrared spectroscopy: validation of the procedure. J. Pharm. Biomed. Anal. 22 (2000) 139-148
5. Buckton G., Yonemochi E., Hammond J., and Moffat A. The use of near infra-red spectroscopy to detect changes in the form of amorphous and crystalline lactose. Int. J. Pharm. 168 (1998) 231-241
6. Fevotte G., Calas J., Puel F., and Hoff C. Applications of NIR spectroscopy to monitoring and analyzing the solid state during industrial crystallization processes. Int. J. Pharm. 273 (2004) 159-169
7. Lin T.P., and Hsu C.C. Determination of residual moisture in lyophilized protein pharmaceuticals using a rapid and non-invasive method: near infrared spectroscopy. PDA J. Pharm. Sci. Technol./PDA 56 4 (2002) 196-205
8. Blanco M., Gozalez Bano R., and Bertran E. Monitoring powder blending in pharmaceutical processes by use of near infrared spectroscopy. Talanta 56 (2002) 203-212
9. Chalus P., Roggo Y., Walter S., and Ulmschneider M. Near-infrared determination of active substance content in intact low-dosage tablets. Talanta 66 (2005) 1294-1302
10. Roggo Y., Roeseler C., and Ulmschneider M. Near infrared spectroscopy for qualitative comparison of pharmaceutical batches. J. Pharm. Biomed. Anal. 36 (2004) 777-786
11. Lewis N., Schoppelrei J., Lee E., and Kidder L. Near-infrared chemical imaging as a process analytical tool. In: Bakeev K.A. (Ed). Process Analytical Technology (2005), Blackwell, London 187-225
12. Clarke F. Extracting process-related information from pharmaceutical dosage forms using near infrared microscopy. Vib. Spectrosc. 34 (2004) 25-35
13. Roggo Y., Edmond A., Chalus P., and Ulmschneider M. Infrared hyperspectral imaging for qualitative analysis of pharmaceutical solid forms. Anal. Chim. Acta 535 (2005) 79-87
14. Burger J., and Geladi P. Hyperspectral NIR imaging for calibration and prediction: a comparison between image and spectrometer data for studying organic and biological samples. Analyst 131 (2006) 1152
15. Gendrin C., Roggo Y., and Collet C. Content uniformity of pharmaceutical solid dosage forms by near Infrared hyperspectral imaging: a feasibility study. Talanta (2007) 10.1016/j.talanta.2007.04.054
16. Breitenbach J. Melt extrusion: from process to drug delivery technology. Eur. J. Pharm. Biopharm. 54 (2002) 107-117