A PAT approach to improve process understanding of high shear wet granulation through in-line particle measurement using FBRM C35

Journal of Pharmaceutical Sciences

Volumn 99, Issue 7, 2010, Pages 3205-3212

  Huang, Jun ^a   Kaul, Goldi ^a   Utz, Julia ^b   Hernandez, Pedro ^a   Wong, Victor ^a   Bradley, Daragh ^a   Nagi, Arwinder ^a   O'Grady, Des ^c  

^a PFIZER INC   (United States)

^b Excella GmbH   (Germany)

^c Mettler Toledo Autochem   (United States)

Author keywords

Critical process parameter (CPP); Critical quality attribute (CQA); Design of experiments (DOE); FBRM C35; Focused beam reflectance measurement (FBRM); High shear wet granulation; Particle size; Particle size distribution (PSD); Process analytical technology (PAT); Quality by design (QbD)

Indexed keywords

ARTICLE; BATCH PROCESS; DIAGNOSIS, MEASUREMENT AND ANALYSIS; DRUG GRANULATION; EXPERIMENTAL DESIGN; FOCUSED BEAM REFLECTANCE MEASUREMENT; HIGH SHEAR WET GRANULATION; PARTICLE SIZE; PROCESS DEVELOPMENT; PROCESS TECHNOLOGY; QUALITY CONTROL;

EID: 77953298309     PISSN: 00223549     EISSN: 15206017     Source Type: Journal    
DOI: 10.1002/jps.22089     Document Type: Article

References (17)

1. Bouwman AM, Henstra MJ, Hegge JJ, Zhang Z, Ingram A, Seville JP, Frijlink HW. 2005. The relation between granule size, granule stickiness, and torque in the high-shear granulation process. Pharm Res 22:270-275. (Pubitemid 40487211)
2. Ghorab MK, Adeyeye MC. 2007. High shear mixing granulation of ibuprofen and beta-cyclodextrin: Effects of process variables on ibuprofen dissolution. AAPS PharmSciTech 8:E84.
3. Jorgensen AC, Luukkonen P, Rantanen J, Schaefer T, Juppo AM, Yliruusi J. 2004. Comparison of torque measurements and near-infrared spectroscopy in characterization of a wet granulation process. J Pharm Sci 93:2232-2243. (Pubitemid 39129621)
4. Rantanen J, Wikstrom 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. (Pubitemid 40116836)
5. Briens L, Daniher D, Tallevi A. 2007. Monitoring high-shear granulation using sound and vibration measurements. Int J Pharm 331:54-60. (Pubitemid 46176501)
6. Gamble JF, Dennis AB, Tobyn M. 2009. Monitoring and endpoint prediction of a small scale wet granulation process using acoustic emission. Pharm Dev Technol 14:299-304.
7. Hansuld EM, Briens L, McCann JA, Sayani A. 2009. Audible acoustics in high-shear wet granulation: Application of frequency filtering. Int J Pharm 378:37-44.
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 205:79-92.
9. Arp Z. 2007. High shear wet granulation processes with in situ particle characterization. AAPS annual meeting, San Diego.
10. Hu X, Cunningham JC, Winstead D. 2008. Study growth kinetics in fluidized bed granulation with at-line FBRM. Int J Pharm 347:54-61.
11. Michaels JN, Farber L, Wong GS, Hapgood K, Heidel SJ, Farabaugh J, Chou J-H, Tardos GI. 2009. Steady states in granulation of pharmaceutical powders with application to scale-up. Powder Technol 189:295-303.
12. Alex RH, Phillip DF, Parisa AB, Jean DS. 2002. Estimating average particle size by focused beam reflectance measurement (FBRM). Particle Particle Syst Characterization 19:84-95.
13. Scott C, Black S. 2005. In-line analysis of impurity effects on crystallisation. Organic Process Res Dev 9:890-893.
14. Hukkanen EJ, Braatz RD. 2003. Measurement of particle size distribution in suspension polymerization using in situ laser backscattering. Sensors Actuators B: Chem 96:451-459.
15. Bob DeC, Paul AL, Peter AV. 2004. Focused beam reflectance technique for in situ particle sizing in wastewater treatment settling tanks. J Chem Technol Biotechnol 79: 610-618.
16. Angeles B, Elena DLF, Carlos N, Concepcion MM, Julio T. 2002. Focused beam reflectant measurement as a tool to measure flocculation. Tappi J 1:14-20.
17. Jeffers P, Raposo S, Lima-Costa M-E, Connolly P, Glennon B, Kieran PM. 2003. Focussed beam reflectance measurement (FBRM) monitoring of particle size and morphology in suspension cultures of morinda citrifolia and Centaurea calcitrapa. Biotechnol Lett 25:2023-2028.