Dynamic calibration for the in-line NIR monitoring of film thickness of pharmaceutical tablets processed in a fluid-bed coater

Journal of Pharmaceutical Sciences

Volumn 99, Issue 1, 2010, Pages 325-335

  Lee, Min Jeong ^a   Park, Cho Rong ^a   Kim, Ah Young ^a   Kwon, Byung Soo ^b   Bang, Kyu Ho ^b   Cho, Young Sang ^c   Jeong, Myung Yung ^d   Choi, Guang Jin ^a  

^a Inje University   (South Korea)

^b R and D Center   (South Korea)

^c Korea Institute of Science and Technology   (South Korea)

^d Pusan National University   (South Korea)

Author keywords

Automation; Coating; Fluid bed; Near infrared spectroscopy; Principal component analysis; Processing; Tableting

Indexed keywords

ARTICLE; FILM COATING; NEAR INFRARED SPECTROSCOPY; TABLET THICKNESS;

EID: 73949158850     PISSN: 00223549     EISSN: 15206017     Source Type: Journal    
DOI: 10.1002/jps.21795     Document Type: Article

References (21)

1. US-DHHS, US-FDA. 2002. Pharmaceutical CGMPs for the 21st century: A risk-based approach; a science and risk-based approach to product quality regulation incorporating an integrated quality systems approach. http://www.fda.gov/oc/guidance/gmp.html.
2. US-DHHS, US-FDA, CDER/CVM/ORA. 2004. PAT - A framework for innovative pharmaceutical development, manufacturing, and quality assurance, Pharmaceutical CGMPs.
3. Mowery MD, Sing R, Kirsch J, Razaghi A, Bechard S, Reed RA. 2002. Rapid at-line analysis of coating thickness and uniformity on tablets using laser induced breakdown spectroscopy. J Pharm Biomed Anal 28:935-943.
4. Fitzgerald AJ, Cole BE, Taday PF. 2005. Nondestructive analysis of tablet coating thickness using terahertz pulsed imaging. J Pharm Sci 94:177-183.
5. Akseli I, Cetinkaya C. 2008. Drug tablet thickness estimation using air-coupled acoustics. Int J Pharm 351:165-173.
6. Romero-Torres S, Perez-Ramos JD, Morris KR, Grant ER. 2005. Raman spectroscopic measurement of tablet-to-tablet coating variability. J Pharm Biomed Anal 38:270-274.
7. Romero-Torres S, Perez-Ramos JD, Morris KR, Grant ER. 2006. Raman spectroscopy for tablet coating thickness quantification and coating characterization in the presence of strong fluorescent interference. J Pharm Biomed Anal 41:811-819.
8. Kauffman JF, Dellibovi M, Cunningham CR. 2007. Raman spectroscopy of coated pharmaceutical tablets and physical models for multivariate calibration to tablet coating thickness. J Pharm Biomed Anal 43:39-48.
9. Ciurczak EW, Drennen JK III. 2002. Pharmaceutical and medical applications of near-infrared spectroscopy. New York: Marcel Dekker Inc. pp. 21-33.
10. Roggo Y, Chalus P, Maurer L, Lema-Martinez C, Edmond A, Jent N. 2007. A review of near infrared spectroscopy and chemometrics in pharmaceutical technologies. J Pharm Biomed Anal 44:683-700.
11. Kirsch JD, Drennen JK. 1995. Determination of film-coated tablet parameters by near-infrared spectroscopy. J Pharm Biomed Anal 13:1273-1281.
12. Kirsch JD, Drennen JK. 1996. Near-infrared spectroscopic monitoring of the film coating process. Pharm Res 13:234-237.
13. Han SM, Faulkner PG. 1996. Determination of SB 216469-S during tablet production using near-infrared reflectance spectroscopy. J Pharm Biomed Anal 14:1681-1689.
14. Andersson M, Josefson M, Langkilde FW, Wahlund K-G. 1999. Monitoring of a thin film coating process for tablets using near infrared reflectance spectrometry. J Pharm Biomed Anal 20:27-37.
15. Andersson M, Folestad F, Gottfries J, Johansson MO, Josefson M, Wahlund K-G. 2000. Quantitative analysis of film coating in a fluidized bed process by in-line NIR spectrometry and multivariate batch calibration. Anal Chem 72:2099-2108.
16. Perez-Ramos JD, Findlay WP, Peck G, Morris KR. 2005. Quantitative analysis of film coating in a pan coater based on in-line sensor measurement. AAPS PharmSciTech 6:E127-E136.
17. Tabasi SH, Fahmy R, Bensley D, O'Brien C, Hoag SW. 2008. Quality by design, Part I: Application of NIR spectroscopy to monitor tablet manufacturing process. J Pharm Sci 97:4040-4051.
18. Tabasi SH, Fahmy R, Bensley D, O'Brien C, Hoag SW. 2008. Quality by design, Part II: Application of NIR spectroscopy to monitor the coating process for a pharmaceutical sustained release product. J Pharm Sci 97:4052-4066.
19. Tabasi SH, Fahmy R, Bensley D, O'Brien C, Hoag SW. 2008. Quality by design, Part III: Study of curing process of sustained release products using NIR spectroscopy. J Pharm Sci 97:4067-4086.
20. Moes JJ, Ruijken MM, Gout E, Frijlink HW, Ugwoke MI. 2008. Application of process analytical technology in tablet process development using NIR spectroscopy: Blend uniformity, content uniformity and coating thickness measurements. Int J Pharm 357:108-118.
21. Seitavuopio P, Heinamaki J, Rantanen J, Yliruusi J. 2006. Monitoring tablet surface roughness during the film coating process. AAPS PharmSciTech 7:E1-E6.