Evaluation of three approaches for real-time monitoring of roller compaction with near-infrared spectroscopy

AAPS PharmSciTech

Volumn 13, Issue 3, 2012, Pages 1005-1012

  Acevedo, David ^a   Muliadi, Ariel ^b   Giridhar, Arun ^b   Litster, James D ^b,c   Romañach, Rodolfo J ^a  

^a UNIVERSITY OF PUERTO RICO   (Puerto Rico)

^b PURDUE UNIVERSITY   (United States)

^c PURDUE UNIVERSITY   (United States)

Author keywords

density distribution; near infrared spectroscopy; process analytical technology; quality by design; roller compaction

Indexed keywords

MICROCRYSTALLINE CELLULOSE;

ACCURACY; ARTICLE; CALIBRATION; CONTROLLED STUDY; DENSITY; LASER; MODEL; MULTIVARIATE ANALYSIS; NEAR INFRARED SPECTROSCOPY; PARTIAL LEAST SQUARES REGRESSION; PREDICTION; PRINCIPAL COMPONENT ANALYSIS; PRIORITY JOURNAL; PROCESS CONTROL; PROCESS MONITORING; QUALITATIVE ANALYSIS; STANDARD; TABLET COMPRESSION;

CELLULOSE; COMPUTER SYSTEMS; PRINCIPAL COMPONENT ANALYSIS; SPECTROSCOPY, NEAR-INFRARED;

EID: 84866058850     PISSN: None     EISSN: 15309932     Source Type: Journal    
DOI: 10.1208/s12249-012-9825-0     Document Type: Article

References (20)

1. Yusof YA, Smith AC, Briscoe BJ. Roll compaction of maize powder. Chem Eng Sci. 2005;60(14):3919-31.
2. Miller R. Roller compaction technology. In: Parikh DM, editor. Handbook of pharmaceutical granulation technology. New York: Marcel Dekker, Inc; 1997. p. 99-148.
3. Cunningham JC, Winstead D, Zavaliangos A. Understanding variation in roller compaction through finite element-based process modeling. Comput Chem Eng. 2010;34(7):1058-71.
4. Falzone AM, Peck GE, Mccabe GP. Effects of changes in roller compactor parameters on granulations produced by compaction. Drug Dev Ind Pharm. 1992;18(4):469-89.
5. Lecompte T, Doremus P, Thomas G, Perier-Camby L, Le Thiesse J-C, Masteau J-C, et al. Dry granulation of organic powdersdependence of pressure 2D-distribution on different process parameters. Chem Eng Sci. 2005;60(14):3933-40.
6. Johanson JR. A rolling theory for granular solids. J Appl Mech. 1965;32(4):842-8.
7. Bindhumadhavan G, Seville JPK, Adams MJ, Greenwood RW, Fitzpatrick S. Roll compaction of a pharmaceutical excipient: experimental validation of rolling theory for granular solids. Chem Eng Sci. 2005;60(14):3891-7.
8. Peter K. Roll compaction/dry granulation: pharmaceutical applications. Eur J Pharm Biopharm. 2004;58(2):317-26.
9. Miguélez-Morán AM, Wu C-Y, Dong H, Seville JPK. Characterisation of density distributions in roller-compacted ribbons using micro-indentation and X-ray micro-computed tomography. Eur J Pharm Biopharm. 2009;72(1):173-82.
10. Akseli I, Lyer S, Lee HP, Cuitiño AM. A quantitative correlation of the effect of density distributions in roller-compacted ribbons on the mechanical properties of tablets using ultrasonics and X-ray tomography. AAPS PharmSciTech. 2011;12(3):834-53.
11. Lim H, Dave VS, Kidder L, Neil Lewis E, Fahmy R, Hoag SW. Assessment of the critical factors affecting the porosity of roller compacted ribbons and the feasibility of using NIR chemical imaging to evaluate the porosity distribution. Int J Pharm. 2011;410(1-2):1-8.
12. Gupta A, Peck GE, Miller RW, Morris KR. Real-time near-infrared monitoring of content uniformity, moisture content, compact density, tensile strength, and young's modulus of roller compacted powder blends. J Pharm Sci. 2005;94(7):1589-97.
13. Gupta A, Peck GE, Miller RW, Morris KR. Nondestructive measurements of the compact strength and the particle-size distribution after milling of roller compacted powders by near-infrared spectroscopy. J Pharm Sci. 2004;93(4):1047-53.
14. Soh JLP, Boersen N, Carvajal MT, Morris KR, Peck GE, Pinal R. Importance of raw material attributes for modeling ribbon and granule properties in roller compaction: multivariate analysis on roll gap and NIR spectral slope as process critical control parameters. J Pharm Innov. 2007;2(3):106-24.
15. Feng T, Wang F, Pinal R, Wassgren C, Carvajal MT. Investigation of the variability of NIR in-line monitoring of roller compaction process by using fast Fourier transform (FFT) analysis. AAPS PharmSciTech. 2008;9(2):419-24.
16. Dahm J, Dahm K, Pedroa A, Ferreira M. Speaking theoretically understanding confusing phenomena in remission spectra. NIR News. 2010;21(3):14-8.
17. Barajas MJ, Rodriguez A, Vargas W, Conde C, Ropero J, Figueroa J, et al. A near infrared spectroscopic method for real time monitoring of pharmaceutical powders during voiding. Appl Spectrosc. 2007;61(5):490-6.
18. Giridhar A, Hamdan IM, Joglekar G, Venkatasubramanian V, Reklaiti GV. Real-time process management in particulate and pharmaceutical systems. European Symposium for Computer Aided Process Engineering (ESCAPE) 21; May 29-June 1; Greece 2011.
19. Hamdan IM, Reklaitis GV, Venkatasubramanian V. Exceptional events management applied to roller compaction of pharmaceutical powders. J Pharm Innov. 2010;5(4):147-60.
20. Hamdan IM. Exceptional events management applied to continuous pharmaceutical manufacturing. Purdue University; West Lafayette, IN, 2010.