Different modes of dynamic image analysis in monitoring of pharmaceutical dry milling process

International Journal of Pharmaceutics

Volumn 391, Issue 1-2, 2010, Pages 107-114

  Nalluri, Venkateshwar Rao ^a,b   Schirg, Peter ^c   Gao, Xin ^d   Virdis, Antoine ^d   Imanidis, Georgios ^a,b   Kuentz, Martin ^a  

^a UNIVERSITY OF APPLIED SCIENCES AND ARTS NORTHWESTERN SWITZERLAND   (Switzerland)

^b UNIVERSITY OF BASEL   (Switzerland)

^c NOVARTIS PHARMA AG   (Switzerland)

^d Frewitt SA   (Switzerland)

Author keywords

Conical mill; Dynamic image analysis; Process analytical technology (PAT); Process analyzers; Quality by design; Shape factor

Indexed keywords

ALPHA LACTOSE; CROSCARMELLOSE SODIUM; EXCIPIENT; GRANULAC 200; GRANULAC 70; MICROCRYSTALLINE CELLULOSE; POVIDONE; PRISMALAC 40; UNCLASSIFIED DRUG; VIVAPUR 101; VIVAPUR 102; XENON;

ARTICLE; CAMERA; CONTROLLED STUDY; CORRELATION ANALYSIS; DISPERSION; DRUG DESIGN; DRUG DETERMINATION; DRUG DOSAGE FORM; DRUG MANUFACTURE; DRY POWDER; IMAGE ANALYSIS; LIGHT; ONLINE ANALYSIS; PARTICLE SIZE; PRIORITY JOURNAL; PROCESS DEVELOPMENT; PROCESS TECHNOLOGY;

DRUG COMPOUNDING; EXCIPIENTS; IMAGE PROCESSING, COMPUTER-ASSISTED; PARTICLE SIZE; POWDERS; QUALITY CONTROL; TECHNOLOGY, PHARMACEUTICAL; TIME FACTORS;

EID: 77952887486     PISSN: 03785173     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.ijpharm.2010.02.027     Document Type: Article

References (20)

1. Almeida-Prieto S., Blanco-Mendez J., Otero-Espinar F.J. Image analysis of the shape of granulated powder grains. J. Pharm. Sci. 2004, 93:621-634.
2. Bauer-Brandl A., Becker D. Evaluation of a conical mill for screening of direct compression formulations. Drug Dev. Ind. Pharm. 1996, 22:417-430.
3. Fariss G., Keintz R., Okoye P. Thermal effusivity and power consumption as PAT tools for monitoring granulation end point. Pharm. Technol. 2006, 30:60-72.
4. Greaves D., Boxall J., Mulligan J., Montesi A., Creek J., Sloan E.D., Koh C.A. Measuring the particle size of a known distribution using the focused beam reflectance measurement technique. Chem. Eng. Sci. 2008, 63:5410-5419.
5. Guidance for industry PAT-A framework for innovative pharmaceutical development, manufacturing, and quality assurance. U.S. Department of Health and Human Services Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Center for Veterinary Medicine (CVM), Office of Regulatory Affairs (ORA), Pharmaceutical cGMPs; September 2004, http://www.avarent.com/docs/pat.pdf.
6. Hlinak A.J., Kuriyan K., Morris K.R., Reklaitis G.V., Basu P.K. Understanding critical material properties for solid dosage form design. J. Pharm. Innov. 2006, 1:12-17.
7. Hui T.L., Wah C.L., Heng P.W.S. Rapid and convenient microsphere sizing: using a PAT instrument and pilot-scale spray dryer can provide real-time information regarding process and product size. Pharm. Technol., Asia Pacific 2008, 2(3):25-29.
8. Ma Z., Merkus H.G., van der Veen H.G., Wong M., Scarlett B. On-line measurement of particle size and shape using laser diffraction. Part. Part. Syst. Charact. 2001, 18:243-247.
9. Naervaenen T., Lipsanen T., Antikainen O., Raeikkoenen H., Heinaemaeki J., Yliruusi J. Gaining fluid bed process understanding by in-line particle size analysis. J. Pharm. Sci. 2009, 98:1110-1117.
10. National Instruments, 2005. User's manual for LabVision. Austin, TX, USA http://www.ni.com/pdf/manuals/322916a.pdf.
11. Parrott E.L. Milling of pharmaceutical solids. J. Pharm. Sci. 1974, 63:813-829.
12. Petrak D. Simultaneous measurement of particle size and particle velocity by the spatial filtering technique. Part. Syst. Charact. 2002, 19:391-400.
13. Rabinski G., Thomas D. Dynamic digital image analysis: emerging technology for particle characterization. Water Sci. Technol. 2004, 50:19-26.
14. Schmidt-Lehr S., Moritz H., Juergens K.C. On-line control of particle size during fluidized bed granulation. Pharm. Ind. 2007, 69:478-484.
15. Scott B., Wilcock A. Process analytical technology in the pharmaceutical industry: a tool kit for continuous improvement. PDA J. Pharm. Sci. Technol. 2006, 60:17-53.
16. Shekunov B.Y., Chattopadhyay P., Tong H.H.Y., Chow A.H.L. Particle size analysis in pharmaceutics: principles, methods and applications. Pharm. Res. 2007, 24:203-227.
17. Vendola T.A., Hancock B.C. The effect of mill type on two dry-granulated placebo formulations. Pharm. Technol. 2008, 32:72-86.
18. Xu R., Andreina Di Guida O. Comparison of sizing small particles using different technologies. Powder Technol. 2003, 132:145-153.
19. Xu R., Santana J. Dynamic image analysis: Improving size measurement of nonspherical particles. Powder Bulk Eng. 2002, 16:24-27.
20. Yu W., Hancock B.C. Evaluation of dynamic image analysis for characterizing pharmaceutical excipient particles. Int. J. Pharm. 2008, 361:150-157.